(a) Scope and purpose. (1) This subpart applies to the submission and consideration of petitions under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act), by a State or a political subdivision of a State, requesting exemption of a State requirement from preemption under section 403A(a) of the act.

(2) Section 403A(b) of the act provides that where a State requirement has been preempted under section 403A(a) of the act, the State may petition the agency for an exemption. The agency may grant the exemption, under such conditions as it may prescribe by regulation, if the agency finds that the State requirement will not cause any food to be in violation of any applicable requirement under Federal law, will not unduly burden interstate commerce, and is designed to address a particular need for information that is not met by the preemptive Federal requirement.

(b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).

(2) Agency means the Food and Drug Administration.

(3) Commissioner means the Commissioner of Food and Drugs.

(4) State means a State as defined in section 201(a)(1) of the act (which includes a territory of the United States, the District of Columbia, and Puerto Rico) or any political subdivision of a State having authority to issue food standards and food labeling regulations having force of law.

(5) State requirement means any statute, standard, regulation, or other requirement that is issued by a State.

(c) Prerequisites for petitions for exemption from preemption. The Food and Drug Administration will consider a petition for exemption from preemption on its merits only if the petition demonstrates that:

(1) The State requirement was enacted or was issued as a final rule by an authorized official of the State and is in effect or would be in effect but for the provisions of section 403A of the act.

(2) The State requirement is subject to preemption under section 403A(a) of the act because of a statutory provision listed in that section or because of a Federal standard or other Federal regulation that is in effect, or that has been published as a final rule with a designated effective date, and that was issued under the authority of a statutory provision listed in that section. For the purposes of this subpart, all petitions seeking exemption from preemption under section 403A(a)(3) through (a)(5) of the act submitted before May 8, 1992, will be considered timely even though the applicable statutory provisions or regulations are not yet in effect.

(3) The petitioner is an official of a State having authority to act for, or on behalf of, the Government in applying for an exemption of State requirements from preemption.

(4) The State requirement is subject to preemption under section 403A(a) of the act because it is not identical to the requirement of the preemptive Federal statutory provision or regulation including a standard of identity, quality, and fill. “Not identical to” does not refer to the specific words in the requirement but instead means that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food, or concerning a food container, that:

(i) Are not imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act; or

(ii) Differ from those specifically imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act.

(d) Form of petition. (1) All information included in the petition should meet the general requirements of § 10.20(c) of this chapter.

(2) An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.)

(3) Petitions for exemption from preemption for a State requirement shall be submitted to the Division of Dockets Management in the following form:

(e) Submission of petition for exemption; public disclosure. The availability for public disclosure of a petition for exemption will be governed by the rules specified in § 10.20(j) of this chapter.

(f) Agency consideration of petitions. (1) Unless otherwise specified in this section, all relevant provisions and requirements of subpart B of part 10 of this chapter, are applicable to State petitions requesting exemption from Federal preemption under section 403A(b) of the act.

(2) If a petition does not meet the prerequisite requirements of paragraph (c) of this section, the agency will issue a letter to the petitioner denying the petition and stating in what respect the petition does not meet these requirements.

(3) If a petition appears to meet the prerequisite requirements in paragraph (c) of this section, it will be filed by the Division of Dockets Management, stamped with the date of filing, and assigned a docket number. The docket number identifies the file established by the Division of Dockets Management for all submissions relating to the petition, as provided in this part. Subsequent submissions relating to the matter must refer to the docket number and will be filed in the docket file. The Division of Dockets Management will promptly notify the petitioner in writing of the filing and docket number of a petition.

(4) Any interested person may submit written comments to the Division of Dockets Management on a filed petition as provided in § 10.30(d) of this chapter.

(5) Within 90 days of the date of filing the agency will furnish a response to the petitioner. The response will either:

(i) State that the agency has tentatively determined that the petition merits the granting of an exemption, and that it intends to publish in the Federal Register a proposal to grant the exemption through rulemaking;

(ii) Deny the petition and state the reasons for such denial; or

(iii) Provide a tentative response indicating why the agency has been unable to reach a decision on the petition, e.g., because of other agency priorities or a need for additional information.

(g) If a State submitted a petition for exemption of a State requirement from preemption under section 403A(a)(3) through (a)(5) of the act before May 8, 1992, that State requirement will not be subject to preemption until:

(1) November 8, 1992; or

(2) Action on the petition, whichever occurs later.

(a) Under section 307 of the Federal Food, Drug, and Cosmetic Act (the act), a State may bring, in its own name and within its own jurisdiction, proceedings for the civil enforcement, or to restrain violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f), 403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food that is the subject of the proceedings is located in the State.

(b) No proceeding may be commenced by a State under paragraph (a) of this section:

(1) Before 30 days after the State has given notice to the Food and Drug Administration (FDA) that the State intends to bring such proceeding.

(2) Before 90 days after the State has given notice to FDA of such intent if FDA has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding.

(3) If FDA is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.

(c) A State may intervene as a matter of right, in any court proceeding described in paragraph (b)(3) of this section.

(d) The notification that a State submits in accordance with paragraph (b) of this section should include the following information and be submitted in the following recommended format:

(e) The letter of notification should be signed by a State official authorized by the State to institute the contemplated enforcement actions.

(f) The letter of notification should be sent to the Division of Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, FAX number 202-205-4642.

(g) FDA will notify the State of the date in which its letter of notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-605) (within 2 working days after date of receipt). This date will be the date of notification for the purposes of paragraph (b) of this section.

(h) The Director, Division of Enforcement, Office of Field Programs, Center for Food Safety and Applied Nutrition, FDA, will respond to the State's notification within 30 days of the date of notification by advising:

(1) Whether FDA has commenced an informal or formal enforcement action pertaining to the food that is the subject of the notification; or

(2) Whether FDA is prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled informal or formal enforcement action pertaining to such food.

(i) Information contained in State notification letters shall be exempt from public disclosure to the same extent to which such information would be so exempt pursuant to §§ 20.61, 20.64, and 20.88 of this chapter.

(j) Definitions. (1) Informal enforcement actions include warning letters, recalls, detentions, or other administrative enforcement actions that pertain to the food in question.

(2) Formal enforcement actions include seizures, injunctions, or other civil judicial enforcement actions that pertain to the food in question. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0275.)

In accordance with section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading.

(a) A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is filled to less than its capacity for reasons other than:

(1) Protection of the contents of the package;

(2) The requirements of the machines used for enclosing the contents in such package;

(3) Unavoidable product settling during shipping and handling;

(4) The need for the package to perform a specific function (e.g., where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly communicated to consumers;

(5) The fact that the product consists of a food packaged in a reusable container where the container is part of the presentation of the food and has value which is both significant in proportion to the value of the product and independent of its function to hold the food, e.g., a gift product consisting of a food or foods combined with a container that is intended for further use after the food is consumed; or durable commemorative or promotional packages; or

(6) Inability to increase level of fill or to further reduce the size of the package (e.g., where some minimum package size is necessary to accommodate required food labeling (excluding any vignettes or other nonmandatory designs or label information), discourage pilfering, facilitate handling, or accommodate tamper-resistant devices).

(b) [Reserved]

(a) For the purposes of this section, the term iodized salt or iodized table salt is designated as the name of salt for human food use to which iodide has been added in the form of cuprous iodide or potassium iodide permitted by §§ 184.1265 and 184.1634 of this chapter. In the labeling of such products, all words in the name shall be equal in prominence and type size. The statement “This salt supplies iodide, a necessary nutrient” shall appear on the label immediately following the name and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in § 101.7 of this chapter.

(b) Salt or table salt for human food use to which iodide has not been added shall bear the statement, “This salt does not supply iodide, a necessary nutrient.” This statement shall appear immediately following the name of the food and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in § 101.7 of this chapter.

(c) Salt, table salt, iodized salt, or iodized table salt to which anticaking agents have been added may bear in addition to the ingredient statement designating the anticaking agent(s), a label statement describing the characteristics imparted by such agent(s) (for example, “free flowing”), providing such statement does not appear with greater prominence or in type size larger than the statements which immediately follow the name of the food as required by paragraphs (a) and (b) of this section.

(d) Individual serving-sized packages containing less than 1/2 ounce and packages containing more than 2 1/2 pounds of a food described in this section shall be exempt from declaration of the statements which paragraphs (a) and (b) of this section require immediately following the name of the food. Such exemption shall not apply to the outer container or wrapper of a multiunit retail package.

(e) All salt, table salt, iodized salt, or iodized table salt in packages intended for retail sale shipped in interstate commerce 18 months after the date of publication of this statement of policy in the Federal Register, shall be labeled as prescribed by this section; and if not so labeled, the Food and Drug Administration will regard them as misbranded within the meaning of sections 403 (a) and (f) of the Federal Food, Drug, and Cosmetic Act.

The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be:

(a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference;

(c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious “principal display panel” such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

(a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions:

(1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used.

(2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel.

(3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.

(b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter.

(c) All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than one-sixteenth inch in height unless an exemption pursuant to paragraph (f) of this section is established. The requirements for conspicuousness and legibility shall include the specifications of §§ 101.7(h)(1) and (2) and 101.15.

(1)(i) Soft drinks packaged in bottles manufactured before October 31, 1975 shall be exempt from the requirements prescribed by this section to the extent that information which is blown, lithographed, or formed onto the surface of the bottle is exempt from the size and placement requirements of this section.

(ii) Soft drinks packaged in bottles shall be exempt from the size and placement requirements prescribed by this section if all of the following conditions are met:

(A) If the soft drink is packaged in a bottle bearing a paper, plastic foam jacket, or foil label, or is packaged in a nonreusable bottle bearing a label lithographed onto the surface of the bottle or is packaged in metal cans, the product shall not be exempt from any requirement of this section other than the exemptions created by § 1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all required information in the specified minimum type size, except the label will not be required to bear the information required by § 101.5 if this information appears on the bottle closure or on the lid of the can in a type size not less than one-sixteenth inch in height, or if embossed on the lid of the can in a type size not less than one-eighth inch in height.

(B) If the soft drink is packaged in a bottle which does not bear a paper, plastic foam jacket or foil label, or is packaged in a reusable bottle bearing a label lithographed onto the surface of the bottle:

(1) Neither the bottle nor the closure is required to bear nutrition labeling in compliance with § 101.9, except that any multiunit retail package in which it is contained shall bear nutrition labeling if required by § 101.9; and any vending machine in which it is contained shall bear nutrition labeling if nutrition labeling is not present on the bottle or closure, if required by § 101.9.

(2) All other information pursuant to this section shall appear on the top of the bottle closure prominently and conspicuously in letters and/or numbers no less than one thirty-second inch in height, except that if the information required by § 101.5 is placed on the side of the closure in accordance with § 1.24(a)(5)(ii) of this chapter, such information shall appear in letters and/or numbers no less than one-sixteenth inch in height.

(3) Upon the petition of any interested person demonstrating that the bottle closure is too small to accommodate this information, the Commissioner may by regulation establish an alternative method of disseminating such information. Information appearing on the closure shall appear in the following priority:

(i) The statement of ingredients.

(ii) The name and address of the manufacturer, packer, or distributor.

(iii) The statement of identity.

(2) Individual serving-size packages of food served with meals in restaurants, institutions, and on board passenger carriers, and not intended for sale at retail, are exempt from type-size requirements of this paragraph, provided:

(i) The package has a total area of 3 square inches or less available to bear labeling;

(ii) There is insufficient area on the package available to print all required information in a type size of 1/16 inch in height;

(iii) The information required by paragraph (b) of this section appears on the label in accordance with the provisions of this paragraph, except that the type size is not less than 1/32 inch in height.

(d)(1) Except as provided by §§ 101.9(j)(13) and (j)(17) and 101.36(i)(2) and (i)(5), all information required to appear on the principal display panel or on the information panel under this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as provided by §§ 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and other nonmandatory label information shall not be considered. If there is insufficient space for all of this information to appear on a single panel, it may be divided between these two panels, except that the information required under any given section or part shall all appear on the same panel. A food whose label is required to bear the ingredient statement on the principal display panel may bear all other information specified in paragraph (b) of this section on the information panel.

(2) Any food, not otherwise exempted in this section, if packaged in a container consisting of a separate lid and body, and bearing nutrition labeling pursuant to § 101.9, and if the lid qualifies for and is designed to serve as a principal display panel, shall be exempt from the placement requirements of this section in the following respects:

(i) The name and place of business information required by § 101.5 shall not be required on the body of the container if this information appears on the lid in accordance with this section.

(ii) The nutrition information required by § 101.9 shall not be required on the lid if this information appears on the container body in accordance with this section.

(iii) The statement of ingredients required by § 101.4 shall not be required on the lid if this information appears on the container body in accordance with this section. Further, the statement of ingredients is not required on the container body if this information appears on the lid in accordance with this section.

(e) All information appearing on the information panel pursuant to this section shall appear in one place without other intervening material.

(f) If the label of any package of food is too small to accommodate all of the information required by §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter, the Commissioner may establish by regulation an acceptable alternative method of disseminating such information to the public, e.g., a type size smaller than one-sixteenth inch in height, or labeling attached to or inserted in the package or available at the point of purchase. A petition requesting such a regulation, as an amendment to this paragraph, shall be submitted under part 10 of this chapter.

(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.

(b) Such statement of identity shall be in terms of:

(1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or, in the absence thereof,

(2) The common or usual name of the food; or, in the absence thereof,

(3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food.

(c) Where a food is marketed in various optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity; except that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement. This specification does not affect the required declarations of identity under definitions and standards for foods promulgated pursuant to section 401 of the act.

(d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.

(1) A food shall be deemed to be an imitation and thus subject to the requirements of section 403(c) of the act if it is a substitute for and resembles another food but is nutritionally inferior to that food.

(2) A food that is a substitute for and resembles another food shall not be deemed to be an imitation provided it meets each of the following requirements:

(i) It is not nutritionally inferior to the food for which it substitutes and which it resembles.

(ii) Its label bears a common or usual name that complies with the provisions of § 102.5 of this chapter and that is not false or misleading, or in the absence of an existing common or usual name, an appropriately descriptive term that is not false or misleading. The label may, in addition, bear a fanciful name which is not false or misleading.

(3) A food for which a common or usual name is established by regulation (e.g., in a standard of identity pursuant to section 401 of the act, in a common or usual name regulation pursuant to part 102 of this chapter, or in a regulation establishing a nutritional quality guideline pursuant to part 104 of this chapter), and which complies with all of the applicable requirements of such regulation(s), shall not be deemed to be an imitation.

(4) Nutritional inferiority includes:

(i) Any reduction in the content of an essential nutrient that is present in a measurable amount, but does not include a reduction in the caloric or fat content provided the food is labeled pursuant to the provisions of § 101.9, and provided the labeling with respect to any reduction in caloric content complies with the provisions applicable to caloric content in part 105 of this chapter.

(ii) For the purpose of this section, a measurable amount of an essential nutrient in a food shall be considered to be 2 percent or more of the Daily Reference Value (DRV) of protein listed under § 101.9(c)(7)(iii) and of potassium listed under § 101.9(c)(9) per reference amount customarily consumed and 2 percent or more of the Reference Daily Intake (RDI) of any vitamin or mineral listed under § 101.9(c)(8)(iv) per reference amount customarily consumed, except that selenium, molybdenum, chromium, and chloride need not be considered.

(iii) If the Commissioner concludes that a food is a substitute for and resembles another food but is inferior to the food imitated for reasons other than those set forth in this paragraph, he may propose appropriate revisions to this regulation or he may propose a separate regulation governing the particular food.

(f) A label may be required to bear the percentage(s) of a characterizing ingredient(s) or information concerning the presence or absence of an ingredient(s) or the need to add an ingredient(s) as part of the common or usual name of the food pursuant to subpart B of part 102 of this chapter.

(g) Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins).

(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by § 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with § 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.

(2) The descending order of predominance requirements of paragraph (a)(1) of this section do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., “Contains _ percent or less of ___” or “Less than _ percent of ___.” The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying phrase applies may be present in an amount greater than the stated threshold.

(b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that:

(1) Spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of § 101.22.

(2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternatives:

(i) By declaring the established common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in subchapter B of this chapter that has specific labeling provisions for optional ingredients, optional ingredients may be declared within the parenthetical listing in accordance with those provisions.

(ii) By incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself.

(3) Skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk may be declared as “skim milk” or “nonfat milk”.

(4) Milk, concentrated milk, reconstituted milk, and dry whole milk may be declared as “milk”.

(5) Bacterial cultures may be declared by the word “cultured” followed by the name of the substrate, e.g., “made from cultured skim milk or cultured buttermilk”.

(6) Sweetcream buttermilk, concentrated sweetcream buttermilk, reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may be declared as “buttermilk”.

(7) Whey, concentrated whey, reconstituted whey, and dried whey may be declared as “whey”.

(8) Cream, reconstituted cream, dried cream, and plastic cream (sometimes known as concentrated milk fat) may be declared as “cream”.

(9) Butteroil and anhydrous butterfat may be declared as “butterfat”.

(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may be declared as “eggs”.

(11) Dried egg whites, frozen egg whites, and liquid egg whites may be declared as “egg whites”.

(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be declared as “egg yolks”.

(13) [Reserved]

(14) Each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., “beef fat”, “cottonseed oil”) in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as “___ shortening” or “blend of ___ oils”, the blank to be filled in with the word “vegetable”, “animal”, “marine”, with or without the terms “fat” or “oils”, or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., “vegetable oil shortening (soybean and cottonseed oil)”. For products that are blends of fats and/or oils and for foods in which fats and/or oils constitute the predominant ingredient, i.e., in which the combined weight of all fat and/or oil ingredients equals or exceeds the weight of the most predominant ingredient that is not a fat or oil, the listing of the common or usual names of such fats and/or oils in parentheses shall be in descending order of predominance. In all other foods in which a blend of fats and/or oils is used as an ingredient, the listing of the common or usual names in parentheses need not be in descending order of predominance if the manufacturer, because of the use of varying mixtures, is unable to adhere to a constant pattern of fats and/or oils in the product. If the fat or oil is completely hydrogenated, the name shall include the term hydrogenated, or if partially hydrogenated, the name shall include the term partially hydrogenated. If each fat and/or oil in a blend or the blend is completely hydrogenated, the term “hydrogenated” may precede the term(s) describing the blend, e.g., “hydrogenated vegetable oil (soybean, cottonseed, and palm oils)”, rather than preceding the name of each individual fat and/or oil; if the blend of fats and/or oils is partially hydrogenated, the term “partially hydrogenated” may be used in the same manner. Fat and/or oil ingredients not present in the product may be listed if they may sometimes be used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as “or”, “and/or”, “contains one or more of the following:”, e.g., “vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)”. No fat or oil ingredient shall be listed unless actually present if the fats and/or oils constitute the predominant ingredient of the product, as defined in this paragraph (b)(14).

(15) When all the ingredients of a wheat flour are declared in an ingredient statement, the principal ingredient of the flour shall be declared by the name(s) specified in §§ 137.105, 137.200, 137.220 and 137.225 of this chapter, i.e., the first ingredient designated in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising flour is “flour”, “white flour”, “wheat flour”, or “plain flour”; the first ingredient designated in the ingredient list of durum flour is “durum flour”; the first ingredient designated in the ingredient list of whole wheat flour, or bromated whole wheat flour is “whole wheat flour”, “graham flour”, or “entire wheat flour”; and the first ingredient designated in the ingredient list of whole durum wheat flour is “whole durum wheat flour”.

(16) Ingredients that act as leavening agents in food may be declared in the ingredient statement by stating the specific common or usual name of each individual leavening agent in parentheses following the collective name “leavening”, e.g., “leavening (baking soda, monocalcium phosphate, and calcium carbonate)”. The listing of the common or usual name of each individual leavening agent in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of leavening agents in the product, the listing of individual leavening agents need not be in descending order of predominance. Leavening agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as “or”, “and/or”, “contains one or more of the following:”.

(17) Ingredients that act as yeast nutrients in foods may be declared in the ingredient statement by stating the specific common or usual name of each individual yeast nutrient in parentheses following the collective name “yeast nutrients”, e.g., “yeast nutrients (calcium sulfate and ammonium phosphate)”. The listing of the common or usual name of each individual yeast nutrient in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of yeast nutrients in the product, the listing of the common or usual names of individual yeast nutrients need not be in descending order of predominance. Yeast nutrients not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as “or”, “and/or”, or “contains one or more of the following:”.

(18) Ingredients that act as dough conditioners may be declared in the ingredient statement by stating the specific common or usual name of each individual dough conditioner in parentheses following the collective name “dough conditioner”, e.g., “dough conditioners (L-cysteine, ammonium sulfate)”. The listing of the common or usual name of each dough conditioner in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of dough conditioners in the product, the listing of the common or usual names of individual dough conditioners need not be in descending order of predominance. Dough conditioners not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as “or”, “and/or”, or “contains one or more of the following:”.

(19) Ingredients that act as firming agents in food (e.g., salts of calcium and other safe and suitable salts in canned vegetables) may be declared in the ingredient statement, in order of predominance appropriate for the total of all firming agents in the food, by stating the specific common or usual name of each individual firming agent in descending order of predominance in parentheses following the collective name “firming agents”. If the manufacturer is unable to adhere to a constant pattern of firming agents in the food, the listing of the individual firming agents need not be in descending order of predominance. Firming agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as “or”, “and/or”, “contains one or more of the following:”.

(20) For purposes of ingredient labeling, the term sugar shall refer to sucrose, which is obtained from sugar cane or sugar beets in accordance with the provisions of § 184.1854 of this chapter.

(21) [Reserved]

(22) Wax and resin ingredients on fresh produce when such produce is held for retail sale, or when held for other than retail sale by packers or repackers shall be declared collectively by the phrase “coated with food-grade animal-based wax, to maintain freshness” or the phrase “coated with food-grade vegetable-, petroleum-, beeswax-, and/or shellac-based wax or resin, to maintain freshness” as appropriate. The terms “food-grade” and “to maintain freshness” are optional. The term lac-resin may be substituted for the term shellac.

(23) When processed seafood products contain fish protein ingredients consisting primarily of the myofibrillar protein fraction from one or more fish species and the manufacturer is unable to adhere to a constant pattern of fish species in the fish protein ingredient, because of seasonal or other limitations of species availability, the common or usual name of each individual fish species need not be listed in descending order of predominance. Fish species not present in the fish protein ingredient may be listed if they are sometimes used in the product. Such ingredients must be identified by words indicating that they may not be present, such as “or”, “and/or”, or “contains one or more of the following:” Fish protein ingredients may be declared in the ingredient statement by stating the specific common or usual name of each fish species that may be present in parentheses following the collective name “fish protein”, e.g., “fish protein (contains one or more of the following: Pollock, cod, and/or pacific whiting)”.

(c) When water is added to reconstitute, completely or partially, an ingredient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to reconstitute the ingredient to single strength. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as “water” in the ingredient statement.

(d) When foods characterized on the label as “nondairy” contain a caseinate ingredient, the caseinate ingredient shall be followed by a parenthetical statement identifying its source. For example, if the manufacturer uses the term “nondairy” on a creamer that contains sodium caseinate, it shall include a parenthetical term such as “a milk derivative” after the listing of sodium caseinate in the ingredient list.

(e) If the percentage of an ingredient is included in the statement of ingredients, it shall be shown in parentheses following the name of the ingredient and expressed in terms of percent by weight. Percentage declarations shall be expressed to the nearest 1 percent, except that where ingredients are present at levels of 2 percent or less, they may be grouped together and expressed in accordance with the quantifying guidance set forth in paragraph (a)(2) of this section.

(f) Except as provided in § 101.100, ingredients that must be declared on labeling because there is no label for the food, including foods that comply with standards of identity, shall be listed prominently and conspicuously by common or usual name in the manner prescribed by paragraph (b) of this section.

(g) When present, the ingredient list on dietary supplement products shall be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label and shall be preceded by the word “Ingredients,” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with § 101.36(d), in which case the ingredients listed outside the nutrition label shall be in a list preceded by the words “Other ingredients.” Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list.

(h) The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Herbal Products Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-588-1171, FAX 301-588-1174, e-mail: ahpa@ahpa.org, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The listing of these names on the label shall be followed by statements of:

(1) The part of the plant (e.g., root, leaves) from which the dietary ingredient is derived (e.g., “Garlic bulb” or “Garlic (bulb)”), except that this designation is not required for algae. The name of the part of the plant shall be expressed in English (e.g., “flower” rather than “flos”);

(2) The Latin binomial name of the plant, in parentheses, except that this name is not required when it is available in the reference entitled: Herbs of Commerce for the common or usual name listed on the label, and, when required, the Latin binomial name may be listed before the part of the plant. Any name in Latin form shall be in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature and shall include the designation of the author or authors who published the Latin name, when a positive identification cannot be made in its absence. The International Code of Botanical Nomenclature (Tokyo Code), 1994 edition, a publication of the International Association for Plant Taxonomy, is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the International Code of Botanical Nomenclature may be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany, and University Bookstore, Southern Illinois University, Carbondale, IL 62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) On labels of single-ingredient dietary supplements that do not include an ingredient list, the identification of the Latin binomial name, when needed, and the part of the plant may be prominently placed on the principal display panel or information panel, or included in the nutrition label.

(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as “Manufactured for ___”, “Distributed by ___”, or any other wording that expresses the facts.

(d) The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP code shall appear either on the label or the labeling (including invoice).

(e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading.

(a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The statement shall be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, or viscous, or a mixture of solid and liquid; except that such statement may be in terms of dry measure if the food is a fresh fruit, fresh vegetable, or other dry commodity that is customarily sold by dry measure. If there is a firmly established general consumer usage and trade custom of declaring the contents of a liquid by weight, or a solid, semisolid, or viscous product by fluid measure, it may be used. Whenever the Commissioner determines that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination in the case of a specific packaged food does not facilitate value comparisons by consumers and offers opportunity for consumer confusion, he will by regulation designate the appropriate term or terms to be used for such commodity.

(b)(1) Statements of weight shall be in terms of avoirdupois pound and ounce.

(2) Statements of fluid measure shall be in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall:

(i) In the case of frozen food that is sold and consumed in a frozen state, express the volume at the frozen temperature.

(ii) In the case of refrigerated food that is sold in the refrigerated state, express the volume at 40 °F (4 °C).

(iii) In the case of other foods, express the volume at 68 °F (20 °C).

(3) Statements of dry measure shall be in terms of the U.S. bushel of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions thereof.

(c) When the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such statement of weight, measure, or size of the individual units of the foods as will provide such information.

(d) The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places. A statement that includes small fractions of an ounce shall be deemed to permit smaller variations than one which does not include such fractions.

(e) The declaration shall be located on the principal display panel of the label, and with respect to packages bearing alternate principal panels it shall be duplicated on each principal display panel.

(f) The declaration shall appear as a distinct item on the principal display panel, shall be separated (by at least a space equal to the height of the lettering used in the declaration) from other printed label information appearing above or below the declaration and (by at least a space equal to twice the width of the letter “N” of the style of type used in the quantity of contents statement) from other printed label information appearing to the left or right of the declaration. It shall not include any term qualifying a unit of weight, measure, or count (such as “jumbo quart” and “full gallon”) that tends to exaggerate the amount of the food in the container. It shall be placed on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the declaration of net quantity of contents meets the other requirements of this part.

(g) The declaration shall accurately reveal the quantity of food in the package exclusive of wrappers and other material packed therewith: Provided, That in the case of foods packed in containers designed to deliver the food under pressure, the declaration shall state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is included in the net quantity declaration.

(h) The declaration shall appear in conspicuous and easily legible boldface print or type in distinct contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that a declaration of net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is so formed on the surface. Requirements of conspicuousness and legibility shall include the specifications that:

(1) The ratio of height to width (of the letter) shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide).

(2) Letter heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards.

(3) When fractions are used, each component numeral shall meet one-half the minimum height standards.

(i) The declaration shall be in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:

(1) Not less than one-sixteenth inch in height on packages the principal display panel of which has an area of 5 square inches or less.

(2) Not less than one-eighth inch in height on packages the principal display panel of which has an area of more than 5 but not more than 25 square inches.

(3) Not less than three-sixteenths inch in height on packages the principal display panel of which has an area of more than 25 but not more than 100 square inches.

(4) Not less than one-fourth inch in height on packages the principal display panel of which has an area of more than 100 square inches, except not less than 1/2 inch in height if the area is more than 400 square inches.

(j) On packages containing less than 4 pounds or 1 gallon and labeled in terms of weight or fluid measure:

(1) The declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound (see examples set forth in paragraphs (m) (1) and (2) of this section), or in the case of liquid measure, in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see examples in paragraphs (m) (3) and (4) of this section).

(2) If the net quantity of contents declaration appears on a random package, that is a package which is one of a lot, shipment, or delivery of packages of the same consumer commodity with varying weights and with no fixed weight pattern, it may, when the net weight exceeds 1 pound, be expressed in terms of pounds and decimal fractions of the pound carried out to not more than two decimal places. When the net weight does not exceed 1 pound, the declaration on the random package may be in decimal fractions of the pound in lieu of ounces (see example in paragraph (m)(5) of this section).

(3) The declaration may appear in more than one line. The term “net weight” shall be used when stating the net quantity of contents in terms of weight. Use of the terms “net” or “net contents” in terms of fluid measure or numerical count is optional. It is sufficient to distinguish avoirdupois ounce from fluid ounce through association of terms; for example, “Net wt. 6 oz” or “6 oz Net wt.” and “6 fl oz” or “Net contents 6 fl oz”.

(k) On packages containing 4 pounds or 1 gallon or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of fluid measure, it shall be expressed in the largest whole unit (gallons followed by common or decimal fraction of a gallon or by the next smaller whole unit or units (quarts, or quarts and pints)) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see paragraph (m)(6) of this section).

(l) [Reserved]

(m) Examples:

(1) A declaration of 1 1/2 pounds weight shall be expressed as “Net Wt. 24 oz (1 lb 8 oz),” “Net Wt. 24 oz (1 1/2 lb),” or “Net Wt. 24 oz (1.5 lb)”.

(2) A declaration of three-fourths pound avoirdupois weight shall be expressed as “Net Wt. 12 oz”.

(3) A declaration of 1 quart liquid measure shall be expressed as “Net 32 fl oz (1 qt)”.

(4) A declaration of 1 3/4 quarts liquid measure shall be expressed as “Net contents 56 fluid ounces (1 quart 1 1/2 pints)” or as “Net 56 fluid oz (1 qt 1 pt 8 oz)”, but not in terms of quart and ounce such as “Net 56 fluid oz (1 quart 24 ounces)”.

(5) On a random package, declaration of three-fourths pound avoirdupois may be expressed as “Net Wt. .75 lb”.

(6) A declaration of 2 1/2 gallons liquid measure shall be expressed as “Net contents 2 1/2 gallons,” “Net contents 2.5 gallons,” or “Net contents 2 gallons 2 quarts” and not as “2 gallons 4 pints”.

(n) For quantities, the following abbreviations and none other may be employed (periods and plural forms are optional):

(o) Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in nondeceptive terms the net quantity of contents; Provided, that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the food contained in the package; for example, “jumbo quart” and “full gallon”. Dual or combination declarations of net quantity of contents as provided for in paragraphs (a), (c), and (j) of this section (for example, a combination of net weight plus numerical count, net contents plus dilution directions of a concentrate, etc.) are not regarded as supplemental net quantity statements and may be located on the principal display panel.

(p) A separate statement of the net quantity of contents in terms of the metric system is not regarded as a supplemental statement and an accurate statement of the net quantity of contents in terms of the metric system of weight or measure may also appear on the principal display panel or on other panels.

(q) The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. Reasonable variations caused by loss or gain of moisture during the course of good distribution practice or by unavoidable deviations in good manufacturing practice will be recognized. Variations from stated quantity of contents shall not be unreasonably large.

(r) The declaration of net quantity of contents on pickles and pickle products, including relishes but excluding one or two whole pickles in clear plastic bags which may be declared by count, shall be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof.

(s) On a multiunit retail package, a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and, in parentheses, the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces, except that such declaration of total quantity need not be followed by an additional parenthetical declaration in terms of the largest whole units and subdivisions thereof, as required by paragraph (j)(1) of this section. A multiunit retail package may thus be properly labeled: “6-16 oz bottles - (96 fl oz)” or “3-16 oz cans - (net wt. 48 oz)”. For the purposes of this section, “multiunit retail package” means a package containing two or more individually packaged units of the identical commodity and in the same quantity, intended to be sold as part of the multiunit retail package but capable of being individually sold in full compliance with all requirements of the regulations in this part. Open multiunit retail packages that do not obscure the number of units or prevent examination of the labeling on each of the individual units are not subject to this paragraph if the labeling of each individual unit complies with the requirements of paragraphs (f) and (i) of this section. The provisions of this section do not apply to that butter or margarine covered by the exemptions in § 1.24(a) (10) and (11) of this chapter.

(t) Where the declaration of net quantity of contents is in terms of net weight and/or drained weight or volume and does not accurately reflect the actual quantity of the contents or the product falls below the applicable standard of fill of container because of equipment malfunction or otherwise unintentional product variation, and the label conforms in all other respects to the requirements of this chapter (except the requirement that food falling below the applicable standard of fill of container shall bear the general statement of substandard fill specified in § 130.14(b) of this chapter), the mislabeled food product, including any food product that fails to bear the general statement of substandard fill specified in § 130.14(b) of this chapter, may be sold by the manufacturer or processor directly to institutions operated by Federal, State or local governments (schools, prisons, hospitals, etc.): Provided, That:

(1) The purchaser shall sign a statement at the time of sale stating that he is aware that the product is mislabeled to include acknowledgment of the nature and extent of the mislabeling, (e.g., “Actual net weight may be as low as _% below labeled quantity”) and that any subsequent distribution by him of said product except for his own institutional use is unlawful. This statement shall be kept on file at the principal place of business of the manufacturer or processor for 2 years subsequent to the date of shipment of the product and shall be available to the Food and Drug Administration upon request.

(2) The product shall be labeled on the outside of its shipping container with the statement(s):

(i) When the variation concerns net weight and/or drained weight or volume, “Product Mislabeled. Actual net weight (drained weight or volume where appropriate) may be as low as _% below labeled quantity. This Product Not for Retail Distribution”, the blank to be filled in with the maximum percentage variance between the labeled and actual weight or volume of contents of the individual packages in the shipping container, and

(ii) When the variation is in regard to a fill of container standard, “Product Mislabeled. Actual fill may be as low as _% below standard of fill. This Product Not for Retail Distribution”.

(3) The statements required by paragraphs (t)(2) (i) and (ii) of this section, which may be consolidated where appropriate, shall appear prominently and conspicuously as compared to other printed matter on the shipping container and in boldface print or type on a clear, contrasting background in order to render them likely to be read and understood by the purchaser under ordinary conditions of purchase.

(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for the purposes of this section:

Authorized official of a vending machine operator means an owner, operator, agent in charge, or any other person authorized by a vending machine operator who is not otherwise subject to section 403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator with the Food and Drug Administration (“FDA”) for purposes of paragraph (d) of this section.

Vending machine means a self-service machine that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses servings of food in bulk or in packages, or prepared by the machine, without the necessity of replenishing the machine between each vending operation.

Vending machine operator means a person(s) or entity that controls or directs the function of the vending machine, including deciding which articles of food are sold from the machine or the placement of the articles of food within the vending machine, and is compensated for the control or direction of the function of the vending machine.

(b) Articles of food not covered. Articles of food sold from a vending machine are not covered vending machine food if:

(1) The prospective purchaser can view:

(i) The calories, serving size, and servings per container listed in the Nutrition Facts label on the vending machine food without any obstruction. The Nutrition Facts label must be in the format required in § 101.9(c) and (d). The Nutrition Facts label must be in a size that permits the prospective purchaser to be able to easily read the nutrition information contained in the Nutrition Facts label on the article of food in the vending machine. Smaller formats allowed for Nutrition Facts for certain food labeling under FDA regulation at § 101.9 are not considered to be a size that a prospective purchaser is able to easily read; or

(ii) The calories, serving size, and servings per container listed in a reproduction of the Nutrition Facts label on the vending machine food, provided that the reproduction is a reproduction of an actual Nutrition Facts label that complies with § 101.9 for a vending machine food, is presented in a size that permits the prospective purchaser to be able to easily read the nutrition information, and the calories, serving size, and servings per container are displayed by the vending machine before the prospective purchaser makes his or her purchase; or

(2) The prospective purchaser can otherwise view visible nutrition information, including, at a minimum, the total number of calories for the article of food as sold at the point of purchase. This visible nutrition information must appear on the food label itself. The visible nutrition information must be clear and conspicuous and able to be easily read on the article of food while in the vending machine, in a type size at least 150 percent of the size required by § 101.7(i) for the net quantity of contents declaration on the front of the package, and with sufficient color and contrasting background to other print on the label to permit the prospective purchaser to clearly distinguish the information.

(c) Requirements for calorie labeling for certain food sold from vending machines - (1) Applicability; covered vending machine food. For the purposes of this section, the term “covered vending machine food” means an article of food that is:

(i) Sold from a vending machine that does not permit the prospective purchaser to examine the Nutrition Facts label prior to purchase as provided in paragraph (b)(1) of this section or otherwise provide visible nutrition information at the point of purchase as provided in paragraph (b)(2) of this section; and

(ii) Sold from a vending machine that:

(A) Is operated by a person engaged in the business of owning or operating 20 or more vending machines; or

(B) Is operated by a vending machine operator that has voluntarily elected to be subject to the requirements of this section by registering with FDA under paragraph (d) of this section.

(2) Calorie declaration. (i) The number of calories for a covered vending machine food must be declared in the following manner:

(A) To the nearest 5-calorie increment up to and including 50 calories and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero.

(B) The term “Calories” or “Cal” must appear adjacent to the caloric content value for each food in the vending machine.

(C) The calorie declaration for a packaged food must include the total calories present in the packaged food, regardless of whether the packaged food contains a single serving or multiple servings. The vending machine operator may voluntarily disclose calories per serving in addition to the total calories for the food.

(D) If a covered vending machine food is one where the prospective purchaser selects among options to produce a final vended product (e.g., vended coffee, hot chocolate or tea with options for added sugar, sugar substitute, milk, and cream), calories must be declared per option or for the final vended products.

(ii) Calorie declarations for covered vending machine food must be clear and conspicuous and placed prominently in the following manner:

(A) The calorie declarations may be placed on a sign in close proximity to the article of food or selection button, i.e., in, on, or adjacent to the vending machine, but not necessarily attached to the vending machine, so long as the calorie declaration is visible at the same time as the food, its name, price, selection button, or selection number is visible. The sign must give calorie declarations for those articles of food that are sold from that particular vending machine.

(B) When the calorie declaration is in or on the vending machine, the calorie declaration must be in a type size no smaller than the name of the food on the machine (not the label), selection number, or price of the food as displayed on the vending machine, whichever is smallest, with the same prominence, i.e., the same color, or in a color at least as conspicuous, as the color of the name, if applicable, or price of the food or selection number, and the same contrasting background, or a background at least as contrasting as the background used for the item it is in closest proximity to, i.e., name, selection number, or price of the food item as displayed on the machine.

(C) When the calorie declaration is on a sign adjacent to the vending machine, the calorie declaration must be in a type size large enough to render it likely to be read and understood by the prospective purchaser under customary conditions of purchase and use, and in a type that is all black or one color on a white or other neutral background that contrasts with the type color.

(D) Where the vending machine only displays a picture or other representation or name of the food item, the calorie declaration must be in close proximity to the picture or other representation or name, or in close proximity to the selection button.

(E) For electronic vending machines (e.g., machines with digital or electronic or liquid crystal display (LCD) displays), the calorie declaration must be displayed before the prospective purchaser makes his or her purchase.

(F) For vending machines with few choices, e.g., popcorn, the calorie declaration may appear on the face of the machine so long as the declaration is prominent, not crowded by other labeling on the machine, and the type size is no smaller than the name of the food on the machine (not the label), selection number, or price of the food as displayed on the vending machine, whichever is smallest.

(d) Voluntary provision of calorie labeling for foods sold from vending machines - (1) Applicability. A vending machine operator that is not subject to the requirements of section 403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act may, through its authorized official, voluntarily register with FDA to be subject to the requirements established in paragraph (c)(2) of this section. An authorized official of a vending machine operator that voluntarily registers cannot be subject to any State or local nutrition labeling requirements that are not identical to the requirements in 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act.

(2) Who may register? A vending machine operator that is not otherwise subject to the requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act may register with FDA.

(3) What information is required? The vending machine operator must provide FDA with the following information:

(i) The contact information (including name, address, phone number, email address), for the vending machine operator;

(ii) The address of the location of each vending machine owned or operated by the vending machine operator that is being registered;

(iii) Preferred mailing address (if different from the vending machine operator address), for purposes of receiving correspondence; and

(iv) Certification that the information submitted is true and accurate, that the person or firm submitting it is authorized to do so, and that each registered vending machine will be subject to the requirements of this section.

(v) Information should be submitted by email by typing complete information into the portable document format (PDF) form, saving it on the registrant's computer, and sending it by email to menulawregistration@fda.hhs.gov. If email is not available, the registrant can either fill in the PDF form and print it out (or print out the blank PDF and fill in the information by hand or typewriter), and either fax the completed form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine Labeling Registration, White Oak Building 22, rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD 20993.

(vi) Authorized officials of a vending machine operator who elect to be subject to the Federal requirements can register by visiting http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has created a form that contains fields requesting the information in paragraph (d) of this section and made the form available at this Web site. Registrants must use this form to ensure that complete information is submitted.

(vii) To keep the establishment's registration active, the authorized official of the vending machine operator must register every other year within 60 days prior to the expiration of the vending machine operator's current registration with FDA. Registration will automatically expire if not renewed.

(e) Vending machine operator contact information. (1) A vending machine operator that is subject to section 403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act or a vending machine operator that voluntarily registers to be subject to the requirements under paragraph (d) of this section must provide its contact information for vending machines selling covered vending machine food. The contact information must list the vending machine operator's name, telephone number, and mailing address or email address.

(2) The contact information must be readable and may be placed on the face of the vending machine, or otherwise must be placed with the calorie declarations as described in paragraph (c)(2)(ii) of this section (i.e., on the sign in, on, or adjacent to the vending machine).

(f) Signatures. Signatures obtained under paragraph (d) of this section that meet the definition of electronic signatures in § 11.3(b)(7) of this chapter are exempt from the requirements of part 11 of this chapter.

(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.

(1) When food is in package form, the required nutrition labeling information shall appear on the label in the format specified in this section.

(2) When food is not in package form, the required nutrition labeling information shall be displayed clearly at the point of purchase (e.g., on a counter card, sign, tag affixed to the product, or some other appropriate device). Alternatively, the required information may be placed in a booklet, looseleaf binder, or other appropriate format that is available at the point of purchase.

(3) Solicitation of requests for nutrition information by a statement “For nutrition information write to ___________ ” on the label or in the labeling or advertising for a food, or providing such information in a direct written reply to a solicited or unsolicited request, does not subject the label or the labeling of a food exempted under paragraph (j) of this section to the requirements of this section if the reply to the request conforms to the requirements of this section.

(4) If any vitamin or mineral is added to a food so that a single serving provides 50 percent or more of the Reference Daily Intake (RDI) for the age group for which the product is intended, as specified in paragraph (c)(8)(iv) of this section, of any one of the added vitamins or minerals, unless such addition is permitted or required in other regulations, e.g., a standard of identity or nutritional quality guideline, or is otherwise exempted by the Commissioner, the food shall be considered a food for special dietary use within the meaning of § 105.3(a)(1)(iii) of this chapter.

(b) Except as provided in § 101.9(h)(3), all nutrient and food component quantities shall be declared in relation to a serving as defined in this section.

(1) The term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food. When the food is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.

(2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion * * * *” (reference amounts) that appear in § 101.12(b) using the procedures described below. For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ___ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the reference amounts in § 101.12(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrient content claims or health claims.

(i) For products in discrete units (e.g., muffins, sliced products, such as sliced bread, or individually packaged products within a multiserving package) and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., pancakes and syrup), the serving size shall be declared as follows:

(A) If a unit weighs 50 percent or less of the reference amount, the serving size shall be the number of whole units that most closely approximates the reference amount for the product category;

(B) If a unit weighs more than 50 percent, but less than 67 percent of the reference amount, the manufacturer may declare one unit or two units as the serving size;

(C) If a unit weighs 67 percent or more, but less than 200 percent of the reference amount, the serving size shall be one unit;

(D) If a unit weighs at least 200 percent and up to and including 300 percent of the applicable reference amount, the serving size shall be the amount that approximates the reference amount. In addition to providing a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per serving size, the manufacturer shall provide a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per individual unit. The first column would be based on the serving size for the product and the second column would be based on the individual unit. The exemptions in paragraphs (b)(12)(i)(A), (B), and (C) of this section apply to this provision.

(E) The serving size for maraschino cherries shall be expressed as 1 cherry with the parenthetical metric measure equal to the average weight of a medium size cherry.

(F) The serving size for products that naturally vary in size (e.g., pickles, shellfish, whole fish, and fillet of fish) may be the amount in ounces that most closely approximates the reference amount for the product category. Manufacturers shall adhere to the requirements in paragraph (b)(5)(vi) of this section for expressing the serving size in ounces.

(G) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., pancakes and syrup), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in § 101.12(f).

(H) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in § 101.9 (that is, are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit.

(ii) For products in large discrete units that are usually divided for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., cake mix, pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption (e.g., prepared cake packaged with a can of frosting), the serving size shall be the fractional slice of the ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/6 cabbage) that most closely approximates the reference amount for the product category, and may be the fraction of the package used to make the reference amount for the unprepared product determined in § 101.12(c) or the fraction of the large discrete unit represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in § 101.12(f). In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3.

(iii) For nondiscrete bulk products (e.g., breakfast cereal, flour, sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese kits), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., peanut butter and jelly), the serving size shall be the amount in household measure that most closely approximates the reference amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in § 101.12(f).

(3) The serving size for meal products and main dish products as defined in § 101.13 (l) and (m) that comes in single-serving containers as defined in paragraph (b)(6) of this section shall be the entire content (edible portion only) of the package. Serving size for meal products and main dish products in multiserving containers shall be based on the reference amount applicable to the product in § 101.12(b) if the product is listed in § 101.12(b). Serving size for meal products and main dish products in multiserving containers that are not listed in § 101.12(b) shall be based on the reference amount according to § 101.12(f).

(4) A variety pack, such as a package containing several varieties of single-serving units as defined in paragraph (b)(2)(i) of this section, and a product having two or more compartments with each compartment containing a different food, shall provide nutrition information for each variety or food per serving size that is derived from the reference amount in § 101.12(b) applicable for each variety or food and the procedures to convert the reference amount to serving size in paragraph (b)(2) of this section.

(5) For labeling purposes, the term common household measure or common household unit means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other common household equipment used to package food products (e.g., jar, tray). In expressing serving size in household measures, except as specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and (b)(5)(vii) of this section, the following rules shall be used:

(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate except for beverages. For beverages, a manufacturer may use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments. Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3 tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 teaspoons.

(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.

(iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not applicable, ounces may be used with an appropriate visual unit of measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2 pickle). Ounce measurements shall be expressed in 0.5 oz increments most closely approximating the reference amount.

(iv) A description of the individual container or package shall be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar).

(v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., cake mix, pizza kit), the fraction or portion of the package may be used.

(vi) Ounces with an appropriate visual unit of measure, as described in paragraph (b)(5)(iii) of this section, may be used for products that naturally vary in size as provided for in paragraph (b)(2)(i)(F) of this section.

(vii) As provided for in § 101.9(h)(1), for products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g. dry macaroni and cheese mix, cake and muffin mixes with separate ingredient packages, pancakes and syrup), nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this section, or alternatively in ounces with an appropriate visual unit of measure, as described in paragraph (b)(5)(iii) of this section (e.g., declared as separate components: “3 oz dry macaroni (84 g/about 2/3 cup)” and “1 oz dry cheese mix (28 g/about 2 tbsp);” declared as a composite value: “4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry cheese mix)”).

(viii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz means 30 mL, and 1 oz in weight means 28 g.

(ix) When a serving size, determined from the reference amount in § 101.12(b) and the procedures described in this section, falls exactly half way between two serving sizes, e.g., 2.5 tbsp, manufacturers shall round the serving size up to the next incremental size.

(6) A product that is packaged and sold individually that contains less than 200 percent of the applicable reference amount must be considered to be a single-serving container, and the entire content of the product must be labeled as one serving. In addition to providing a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per serving, for a product that is packaged and sold individually that contains more than 150 percent and less than 200 percent of the applicable reference amount, the Nutrition Facts label may voluntarily provide, to the left of the column that provides nutrition information per container (i.e., per serving), an additional column that lists the quantitative amounts and percent Daily Values per common household measure that most closely approximates the reference amount.

(7) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(6) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams) except for single-serving containers.

(i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to § 101.9(b)(9). However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement.

(ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments.

(iii) In addition, serving size may be declared in ounce and fluid ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce quantity equivalent to the metric quantity should be expressed in 0.1 oz increments.

(iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for fluid ounce.

(v) For products that only require the addition of water or another ingredient that contains insignificant amounts of nutrients in the amount added and that are prepared in such a way that there are no significant changes to the nutrient profile, the amount of the finished product may be declared in parentheses at the end of the serving size declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup prepared)).

(vi) To promote uniformity in label serving sizes in household measures declared by different manufacturers, FDA has provided a guidance document entitled, “Guidelines for Determining the Gram Weight of the Household Measure.” The guidance document can be obtained from the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(8) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section.

(i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term about (e.g., about 2 servings, about 3.5 servings).

(ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size (e.g., maraschino cherries, pickles), the manufacturer may state the typical number of servings per container (e.g., usually 5 servings).

(iii) For random weight products, manufacturers may declare “varied” for the number of servings per container provided the nutrition information is based on the reference amount expressed in the appropriate household measure based on the hierarchy described in paragraph (b)(5) of this section. Random weight products are foods such as cheeses that are sold as random weights that vary in size, such that the net contents for different containers would vary. The manufacturer may provide the typical number of servings in parentheses following the “varied” statement.

(iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in § 101.9 (that is, are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package.

(v) For packages containing several individually packaged multiserving units, the number of servings shall be determined by multiplying the number of individual multiserving units in the total package by the number of servings in each individual unit.

(9) The declaration of nutrient and food component content shall be on the basis of food as packaged or purchased with the exception of raw fish covered under § 101.42 (see 101.44), packaged single-ingredient products that consist of fish or game meat as provided for in paragraph (j)(11) of this section, and of foods that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed (e.g., canned fish, maraschino cherries, pickled fruits, and pickled vegetables). Declaration of nutrient and food component content of raw fish shall follow the provisions in § 101.45. Declaration of the nutrient and food component content of foods that are packed in liquid which is not customarily consumed shall be based on the drained solids.

(10) Another column of figures may be used to declare the nutrient and food component information:

(i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as packaged or purchased;

(ii) Per one unit if the serving size of a product in discrete units is more than 1 unit.

(iii) Per cup popped for popcorn in a multiserving container.

(11) If a product is promoted on the label, labeling, or advertising for a use that differs in quantity by twofold or greater from the use upon which the reference amount in § 101.12(b) was based (e.g., liquid cream substitutes promoted for use with breakfast cereals), the manufacturer shall provide a second column of nutrition information based on the amount customarily consumed in the promoted use, in addition to the nutrition information per serving derived from the reference amount in § 101.12(b), except that nondiscrete bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils), or traditionally used for multipurposes (e.g., eggs, butter, margarine), and multipurpose baking mixes are exempt from this requirement.

(12)(i) Products that are packaged and sold individually and that contain at least 200 percent and up to and including 300 percent of the applicable reference amount must provide an additional column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values for the entire package, as well as a column listing the quantitative amounts and percent Daily Values for a serving that is less than the entire package (i.e., the serving size derived from the reference amount). The first column would be based on the serving size for the product and the second column would be based on the entire contents of the package.

(A) This provision does not apply to products that meet the requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1) of this section or to products that meet the requirements to use the linear format in paragraph (j)(13)(ii)(A)(2) of this section.

(B) This provision does not apply to raw fruits, vegetables, and seafood for which voluntary nutrition labeling is provided in the product labeling or advertising or when claims are made about the product.

(C) This provision does not apply to products that require further preparation and provide an additional column of nutrition information under paragraph (e) of this section, to products that are commonly consumed in combination with another food and provide an additional column of nutrition information under paragraph (e) of this section, to products that provide an additional column of nutrition information for two or more groups for which RDIs are established (e.g., both infants and children less than 4 years of age), to popcorn products that provide an additional column of nutrition information per 1 cup popped popcorn, or to varied-weight products covered under paragraph (b)(8)(iii) of this section.

(ii) When a nutrient content claim or health claim is made on the label of a product that uses a dual column as required in paragraph (b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed by a statement that sets forth the basis on which the claim is made, except that the statement is not required for products when the nutrient that is the subject of the claim meets the criteria for the claim based on the reference amount for the product and the entire container or the unit amount. When a nutrient content claim is made, the statement must express that the claim refers to the amount of the nutrient per serving (e.g., “good source of calcium per serving” or “per X [insert unit]_serving”) or per reference amount (e.g., “good source of calcium per [insert reference amount (e.g., per 8 ounces)]), as required based on § 101.12(g). When a health claim is made, the statement shall be “A serving of _ounces of this product conforms to such a diet.”

(c) The declaration of nutrition information on the label and in labeling of a food shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraphs (f) or (j) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraphs (d) or (e) of this section.

(1) “Calories, total,” “Total calories,” or “Calories”: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parentheses immediately following the statement of the caloric content.

(i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving.

(A) Using specific Atwater factors (i.e., the Atwater method) given in table 13, USDA Handbook No. 74 (slightly revised, 1973),

(B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11;

(C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate (less the amount of non-digestible carbohydrates and sugar alcohols), and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11. A general factor of 2 calories per gram for soluble non-digestible carbohydrates shall be used. The general factors for caloric value of sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall be used;

(D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of this chapter, or by other means, as appropriate;

(E) Using bomb calorimetry data subtracting 1.25 calories per gram protein to correct for incomplete digestibility, as described in USDA Handbook No. 74 (slightly revised, 1973) p. 10; or

(F) Using the following general factors for caloric value of sugar alcohols: Isomalt - 2.0 calories per gram, lactitol - 2.0 calories per gram, xylitol - 2.4 calories per gram, maltitol - 2.1 calories per gram, sorbitol - 2.6 calories per gram, hydrogenated starch hydrolysates - 3.0 calories per gram, mannitol - 1.6 calories per gram, and erythritol - 0 calories per gram.

(ii) “Calories from saturated fat” or “Calories from saturated” (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section in a serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories as provided in paragraph (d)(5) of this section.

(2) “Fat, total” or “Total fat”: A statement of the number of grams of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides where fatty acids are aliphatic carboxylic acids consisting of a chain of alkyl groups and characterized by a terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 ( 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(i) “Saturated fat,” or “Saturated”: A statement of the number of grams of saturated fat in a serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat in a serving if no claims are made about fat, fatty acid, or cholesterol content, and if “calories from saturated fat” is not declared. Except as provided for in paragraph (f) of this section, if a statement of the saturated fat content is not required and, as a result, not declared, the statement “Not a significant source of saturated fat” shall be placed at the bottom of the table of nutrient values. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 gram ( 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(ii) “Trans fat” or “Trans”: A statement of the number of grams of trans fat in a serving, defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans configuration, except that label declaration of trans fat content information is not required for products that contain less than 0.5 gram of total fat in a serving if no claims are made about fat, fatty acid or cholesterol content. The word “trans” may be italicized to indicate its Latin origin. Trans fat content shall be indented and expressed as grams per serving to the nearest 0.5 ( 1/2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content, when declared, shall be expressed as zero. Except as provided for in paragraph (f) of this section, if a statement of the trans fat content is not required and, as a result, not declared, the statement “Not a significant source of trans fat” shall be placed at the bottom of the table of nutrient values.

(iii) “Polyunsaturated fat” or “Poly-unsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat in a serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a food other than one that meets the criteria in § 101.62(b)(1) for a claim for “fat free,” label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 ( 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(iv) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat in a serving defined as cis-monounsaturated fatty acids may be declared voluntarily except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a food other than one that meets the criteria in § 101.62(b)(1) for a claim for “fat free,” label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 ( 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(3) “Cholesterol”: A statement of the cholesterol content in a serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams cholesterol in a serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. Except as provided for in paragraph (f) of this section, if cholesterol content is not required and, as a result, not declared, the statement “Not a significant source of cholesterol” shall be placed at the bottom of the table of nutrient values in the same type size. If the food contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as “less than 5 milligrams.”

(4) “Sodium”: A statement of the number of milligrams of sodium in a specified serving of food expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.

(5) “Fluoride” (VOLUNTARY): A statement of the number of milligrams of fluoride in a specified serving of food may be declared voluntarily, except that when a claim is made about fluoride content, label declaration shall be required. Fluoride content shall be expressed as zero when the serving contains less than 0.1 milligrams of fluoride, to the nearest 0.1-milligram increment when the serving contains less than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 milligram-increment when a serving contains more than 0.8 milligrams of fluoride. Bottled water that bears a statement about added fluoride, as permitted by § 101.13(q)(8), must bear nutrition labeling that complies with requirements for the simplified format in paragraph (f) of this section.

(6) “Carbohydrate, total” or “Total carbohydrate”: A statement of the number of grams of total carbohydrate in a serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, or if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the food. This calculation method is described in A. L. Merrill and B. K. Watt, “Energy Value of Foods - Basis and Derivation,” USDA Handbook 74 (slightly revised 1973) pp. 2 and 3, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section).

(i) “Dietary fiber”: A statement of the number of grams of total dietary fiber in a serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero. Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health. Except as provided for in paragraph (f) of this section, if dietary fiber content is not required, and as a result not declared, the statement “Not a significant source of dietary fiber” shall be placed at the bottom of the table of nutrient values in the same type size. The following isolated or synthetic nondigestible carbohydrate(s) have been determined by FDA to have physiological effects that are beneficial to human health and, therefore, shall be included in the calculation of the amount of dietary fiber: [beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A)), psyllium husk (as described in § 101.81(c)(2)(ii)(B)(1)), cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose. The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (11) of this section to verify the declared amount of dietary fiber in the label and labeling of food when a mixture of dietary fiber, and added nondigestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food.

(A) “Soluble fiber” (VOLUNTARY): A statement of the number of grams of soluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (11) of this section to verify the declared amount of soluble fiber in the label and labeling of food when a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.”

(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (11) of this section to verify the declared amount of insoluble fiber in the label and labeling of food when a mixture of insoluble and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(ii) “Total Sugars”: A statement of the number of grams of sugars in a serving, except that the label declaration of sugars content is not required for products that contain less than 1 gram of sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Except as provided for in paragraph (f) of this section, if a statement of the total sugars content is not required and, as a result, not declared, the statement “Not a significant source of total sugars” shall be placed at the bottom of the table of nutrient values in the same type size. Total sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Total sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(iii) “Added Sugars”: A statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content. Except as provided for in paragraph (f) of this section, if a statement of the added sugars content is not required and, as a result, not declared, the statement “Not a significant source of added sugars” shall be placed at the bottom of the table of nutrient values in the same type size. Added sugars are either added during the processing of foods, or are packaged as such, and include sugars (free, mono and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type, except that fruit or vegetable juice concentrated from 100 percent juices sold to consumers, fruit or vegetable juice concentrates used towards the total juice percentage label declaration under § 101.30 or for Brix standardization under § 102.33(g)(2) of this chapter, fruit juice concentrates which are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standard of identities set forth in §§ 150.140 and 150.160 of this chapter, or the fruit component of fruit spreads shall not be labeled as added sugars. Added sugars content shall be indented under Total Sugars and shall be prefaced with the word “Includes” followed by the amount (in grams) “Added Sugars” (“Includes `X' g Added Sugars”). It shall be expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When a mixture of naturally occurring and added sugars is present in the food, and for specific foods containing added sugars, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation and/or non-enzymatic browning, the manufacturer must make and keep records in accordance with paragraphs (g)(10) and (11) of this section to verify the declared amount of added sugars in the label and labeling of food.

(iv) “Sugar alcohol” (VOLUNTARY): A statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or total sugars, or added sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term “sugar alcohol,” the name of the specific sugar alcohol (e.g., “xylitol”) present in the food may be used in the nutrition label provided that only one sugar alcohol is present in the food. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(7) “Protein”: A statement of the number of grams of protein in a serving, expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in foods represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a food represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as a Percent of Daily Value. When the protein quality in a food as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a food represented or purported to be specifically for infants through 12 months, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis as given in the “Official Methods of Analysis of the AOAC International,” except when official AOAC procedures described in this paragraph (c)(7) require a specific factor other than 6.25, that specific factor shall be used.

(i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be specifically for infants through 12 months or children 1 through 3 years of age. When such a declaration is provided, it should be placed on the label adjacent to the statement of grams of protein and aligned under the column headed “Percent Daily Value,” and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the food is represented or purported to be specifically for infants through 12 months and the protein quality value is less than 40 percent of the reference standard.

(ii) The “corrected amount of protein (gram) per serving” for foods represented or purported for adults and children 1 or more years of age is equal to the actual amount of protein (gram) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” except that when official AOAC procedures described in paragraph (c)(7) of this section require a specific factor other than 6.25, that specific factor shall be used. For foods represented or purported to be specifically for infants through 12 months, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject food protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.

(iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, a value of 11 grams of protein shall be the RDI for infants through 12 months, a value of 13 grams shall be the DRV for children 1 through 3 years of age, and a value of 71 grams of protein shall be the RDI for pregnant women and lactating women.

(8) “Vitamins and minerals”: The requirements related to including a statement of the amount per serving of vitamins and minerals are described in this paragraph (c)(8).

(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be specifically for infants through 12 months, children 1 through 3 years, pregnant women, and lactating women shall use the RDIs that are specified for the intended group. For foods represented or purported to be specifically for both infants through 12 months of age and children 1 through 3 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants through 12 months of age and children 1 through 3 years of age. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. The percent Daily Value based on the RDI values for pregnant women and lactating women shall be declared on food represented or purported to be specifically for pregnant women and lactating women. All other foods shall use the RDI for adults and children 4 or more years of age.

(ii) The declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include vitamin D, calcium, iron, and potassium in that order, for infants through 12 months, children 1 through 3 years of age, pregnant women, lactating women, and adults and children 4 or more years of age, except quantitative weights for these vitamins and minerals are not required for labels described in paragraph (j)(13) of this section. The declaration of folic acid shall be included as a quantitative amount by weight when added as a nutrient supplement or a claim is made about the nutrient. The declaration of vitamins and minerals in a food, as a quantitative amount by weight and percent of the RDI, may include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section. The declaration of vitamins and minerals shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section as a statement of the amount per serving of the vitamins and minerals as described in this paragraph (c)(8)(ii), calculated as a percent of the RDI and expressed as a percent of the Daily Value, when they are added as a nutrient supplement, or when a claim is made about them, unless otherwise stated as quantitative amount by weight and percent of the Daily Value. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or the labeling or advertising and the vitamins and minerals are:

(A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another food; or

(B) Included in a food solely for technological purposes and declared only in the ingredient statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section.

(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Quantitative amounts and percentages of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients)” or “Contains <2 percent of the Daily Value of this (these) nutrient (nutrients).” Alternatively, except as provided for in paragraph (f) of this section, if vitamin D, calcium, iron, or potassium is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a significant source of - (listing the vitamins or minerals omitted)” is placed at the bottom of the table of nutrient values. Either statement shall be in the same type size as nutrients that are indented. The quantitative amounts of vitamins and minerals, excluding sodium, shall be the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and the levels of significance given in paragraph (c)(8)(iv) of this section, except that zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared in tenths of a milligram).

(iv) The following RDIs, nomenclature, and units of measure are established for the following vitamins and minerals which are essential in human nutrition:

(v) The following synonyms may be added in parentheses immediately following the name of the nutrient or dietary component:

(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent DV of vitamin A in the food (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)”). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section.

(vii) When the amount of folate is declared in the labeling of a conventional food or a dietary supplement, the nutrient name “folate” shall be listed for products containing folate (natural folate, and/or synthetic folate as a component of dietary supplement, such as calcium salt of L-5-MTHF), folic acid, or a mixture of folate and folic acid. The name of the synthetic form of the nutrient “folic acid”, when added or a claim is made about the nutrient, shall be included in parentheses after this declaration with the amount of folic acid. The declaration must be folate in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement) and the percent DV based on folate in mcg DFE, or for conventional food, may be expressed as folate and the percent DV based on folate in mcg DFE. When declared, folic acid must be in parentheses, mcg of folic acid as shown in paragraph (d)(12) of this section in the display that illustrates voluntary declaration of nutrition information.

(9) The following DRVs, nomenclature, and units of measure are established for the following food components:

(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on foods in the following format, as shown in paragraph (d)(12) of this section, except on foods where the tabular display is permitted as provided for in paragraph (d)(11) of this section, on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those food products on which the simplified format is required to be used as provided for in paragraph (f) of this section, on foods for infants through 12 months of age and children 1 through 3 years of age as provided for in paragraph (j)(5) of this section, and on foods in small or intermediate-sized packages as provided for in paragraph (j)(13) of this section. In the interest of uniformity of presentation, FDA strongly recommends that the nutrition information be presented using the graphic specifications set forth in appendix B to part 101.

(i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.

(ii) All information within the nutrition label shall utilize:

(A) Except as provided for in paragraph (c)(2)(ii) of this section, a single easy-to-read type style,

(B) Upper and lower case letters,

(C) At least one point leading (i.e., space between two lines of text) except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section as shown in paragraph (d)(12), and

(D) Letters should never touch.

(iii) Information required in paragraphs (d)(7) and (8) of this section shall be in type size no smaller than 8 point. Information required in paragraph (d)(5) of this section for the “Calories” declaration shall be highlighted in bold or extra bold and shall be in a type size no smaller than 16 point except the type size for this information required in the tabular displays as shown in paragraphs (d)(11), (e)(6)(ii), and (j)(13)(ii)(A)(1) of this section and the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section shall be in a type size no smaller than 10 point. The numeric amount for the information required in paragraph (d)(5) of this section shall also be highlighted in bold or extra bold type and shall be in a type size no smaller than 22 point, except the type size for this information required for the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, and for the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section no smaller than 14 point. The information required in paragraphs (d)(4), (6), and (9) of this section shall be in a type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall be in a type size no smaller than 6 point.

(iv) The headings required by paragraphs (d)(2), (d)(3)(ii), (d)(4), and (d)(6) of this section (i.e., “Nutrition Facts,” “Serving size,” “Amount per serving,” and “% Daily Value*”), the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., “Calories,” “Total Fat,” “Cholesterol,” “Sodium,” “Total Carbohydrate” and “Protein”), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted in bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. No other information shall be highlighted.

(v) A hairline rule that is centered between the lines of text shall separate “Nutrition Facts” from the servings per container statement required in paragraph (d)(3)(i) of this section and shall separate each nutrient and its corresponding percent Daily Value required in paragraphs (d)(7)(i) and (ii) of this section from the nutrient and percent Daily Value above and below it, as shown in paragraph (d)(12) of this section and in Appendix B to Part 101.

(2) The information shall be presented under the identifying heading of “Nutrition Facts” which shall be set in a type size no smaller than all other print size in the nutrition label except for the numerical information for “Calories” required in paragraph (d)(5) of this section, and except for labels presented according to the format provided for in paragraphs (d)(11), (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section, as shown in paragraph (d)(12) of this section.

(3) Information on servings per container and serving size shall immediately follow the heading as shown in paragraph (d)(12) of this section. Such information shall include:

(i) “__ servings per container”: The number of servings per container, except that this statement is not required on single serving containers as defined in paragraph (b)(6) of this section or on other food containers when this information is stated in the net quantity of contents declaration. The information required in this paragraph shall be located immediately after the “Nutrition Facts” heading and shall be in a type size no smaller than 10 point, except the type size for this information shall be no smaller than 9 point in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section and the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section. For the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, the actual number of servings may be listed after the servings per container declaration.

(ii) “Serving size”: A statement of the serving size as specified in paragraph (b)(7) of this section which shall immediately follow the “__servings per container” declaration. The information required in this paragraph shall be highlighted in bold or extra bold and be in a type size no smaller than 10 point, except the type size shall be no smaller than 9 point for this information in the tabular displays as shown in paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, and the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section. The serving size amount must be right justified if adequate space is available. If the “Serving size” declaration does not fit in the allocated space a type size of no smaller than 8 point may be used on packages of any size.

(4) A subheading “Amount per serving” shall be separated from the serving size information by a bar as shown in paragraph (d)(12) of this section, except this information is not required for the dual column formats shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section.

(5) Information on calories shall immediately follow the subheading “Amount per serving” and shall be declared in one line. If “Calories from saturated fat” is declared, it shall be indented under “Calories” and shall be in a type size no smaller than 8 point.

(6) The column heading “% Daily Value,” followed by an asterisk (e.g., “% Daily Value*”), shall be separated from information on calories by a bar as shown in paragraph (d)(12) of this section. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the left of, and below, this column heading. The column headings “Percent Daily Value,” “Percent DV,” or “% DV” may be substituted for “% Daily Value.”

(7) Except as provided for in paragraph (j)(13)(ii)(A)(2) of this section, nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label, except for folic acid in conventional food and voluntarily declared vitamins and minerals expressed as a statement of the amount per serving calculated as a percent of the RDI and expressed as a percent Daily Value, shall be declared as follows:

(i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a “g” for grams, “mg” for milligrams, or “mcg” for micrograms as shown in paragraph (d)(12) of this section. The symbol “<” may be used in place of “less than.”

(ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading “% Daily Value” established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %).

(8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 235 mg 6%) or may be listed horizontally. When listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line, as shown in paragraph (d)(12) of this section in the side-by-side display. When more than four vitamins and minerals are declared voluntarily as shown in paragraph (d)(12) of this section in the label which illustrates the mandatory plus voluntary provisions of paragraph (d) of this section, they may be declared vertically with percentages listed under the column headed “% Daily Value.”

(9) A footnote, preceded by an asterisk, shall be placed beneath the list of vitamins and minerals and shall be separated from the list by a bar, except that the footnote may be omitted from foods that can use the terms “calorie free,” “free of calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietary insignificant source of calories” on the label or in the labeling of foods as defined in § 101.60(b). The first sentence of the footnote: “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet” may be used on foods that can use the terms “calorie free,” “free of calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietary insignificant source of calories” on the label or in the labeling of foods as defined in § 101.60(b). The footnote shall state: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” If the food product is represented or purported to be for children 1 through 3 years of age, the second sentence of the footnote shall substitute “1,000 calories” for “2,000 calories.”

(10) Caloric conversion information on a per gram basis for fat, carbohydrate, and protein may be presented beneath the information required in paragraph (d)(9) of this section, separated from that information by a hairline. This information may be presented horizontally as shown in paragraph (d)(12) of this section (i.e., “Calories per gram: fat 9, carbohydrate 4, protein 4”) or vertically in columns.

(11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in paragraph (d)(9) of this section, the information required in paragraph (d)(9) may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.

(ii) If the space beneath the mandatory declaration of potassium is not adequate to accommodate any remaining vitamins and minerals to be declared or the information required in paragraph (d)(9) of this section, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the nutrients and the percent DV information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.

(iii) If there is not sufficient continuous vertical space (i.e., approximately 3 in) to accommodate the required components of the nutrition label up to and including the mandatory declaration of potassium, the nutrition label may be presented in a tabular display as shown in the following sample label.

(12) The following sample labels illustrate the mandatory provisions and mandatory plus voluntary provisions of paragraph (d) of this section and the side-by-side display.

(13)(i) Nutrition labels on the outer label of packages of products that contain two or more separately packaged foods that are intended to be eaten individually (e.g., variety packs of cereals or snack foods) or of packages that are used interchangeably for the same type of food (e.g., round ice cream containers) may use an aggregate display.

(ii) Aggregate displays shall comply with the format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified immediately to the right of the “Nutrition Facts” heading, and both the quantitative amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food. The following sample label illustrates an aggregate display.

(14) In accordance with § 101.15(c)(2), when nutrition labeling must appear in a second language, the nutrition information may be presented in a separate nutrition label for each language or in one nutrition label with the information in the second language following that in English. Numeric characters that are identical in both languages need not be repeated (e.g., “Protein/Proteinas 2 g”). All required information must be included in both languages.

(e) Nutrition information may be presented for two or more forms of the same food (e.g., both “as purchased” and “as prepared”) or for common combinations of food as provided for in paragraph (h)(4) of this section, for different units (e.g., slices of bread or per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDIs are established (e.g., both infants through 12 months of age and children 1 through 3 years of age) as shown in paragraph (e)(5) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that:

(1) Following the serving size information there shall be two or more column headings accurately describing the amount per serving size of the form of the same food (e.g., “Per 1/4 cup mix” and “Per prepared portion”), the combinations of food, the units, or the RDI groups that are being declared as shown in paragraph (e)(5) of this section.

(2) The quantitative information by weight as required in paragraph (d)(7)(i) and the information required in paragraph (d)(7)(ii) of this section shall be presented for the form of the product as packaged and for any other form of the product (e.g., “as prepared” or combined with another ingredient as shown in paragraph (e)(5) of this section).

(3) When the dual labeling is presented for two or more forms of the same food, for combinations of food, for different units, or for two or more groups for which RDIs are established, the quantitative information by weight and the percent Daily Value shall be presented in two columns and the columns shall be separated by vertical lines as shown in paragraph (e)(5) of this section.

(4) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, potassium as shown in paragraph (e)(5) of this section.

(5) The following sample label illustrates the provisions of paragraph (e) of this section:

(6) When dual labeling is presented for a food on a per serving basis and per container basis as required in paragraph (b)(12)(i) of this section or on a per serving basis and per unit basis as required in paragraph (b)(2)(i)(D) of this section, the quantitative information by weight as required in paragraph (d)(7)(i) and the percent Daily Value as required in paragraph (d)(7)(ii) shall be presented in two columns, and the columns shall be separated by vertical lines as shown in the displays in paragraph (e)(6)(i) of this section.

(i) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, and potassium as shown in the following sample labels.

(ii) The following sample label illustrates the provisions of paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that use the tabular display.

(f) The declaration of nutrition information may be presented in the simplified format set forth herein when a food product contains insignificant amounts of eight or more of the following: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium; except that for foods intended for infants through 12 months of age and children 1 through 3 years of age to which paragraph (j)(5)(i) of this section applies, nutrition information may be presented in the simplified format when a food product contains insignificant amounts of six or more of the following: Calories, total fat, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.

(1) An “insignificant amount” shall be defined as that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrate, dietary fiber, and protein, it shall be an amount that allows a declaration of “less than 1 gram.”

(2) The simplified format shall include information on the following nutrients:

(i) Total calories, total fat, total carbohydrate, protein, and sodium;

(ii) Any other nutrients identified in paragraph (f) of this section that are present in the food in more than insignificant amounts; and

(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are required to be added as a nutrient supplement to foods for which a standard of identity exists.

(iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this section voluntarily added to the food as nutrient supplements.

(3) Other nutrients that are naturally present in the food in more than insignificant amounts may be voluntarily declared as part of the simplified format.

(4) If any nutrients are declared as provided in paragraphs (f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the simplified format or if any nutrition claims are made on the label or in labeling, the statement “Not a significant source of ____” (with the blank filled in with the name(s) of any nutrient(s) identified in paragraph (f) of this section that are present in insignificant amounts) shall be included at the bottom of the nutrition label.

(5) Except as provided for in paragraphs (j)(5) and (j)(13) of this section, nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section, except that the footnote required in paragraph (d)(9) of this section is not required, and an asterisk shall be placed at the bottom of the label followed by the statement “% DV = % Daily Value” when “Daily Value” is not spelled out in the heading, as shown in paragraph (f)(4).

(g) Compliance with this section shall be determined as follows:

(1) A collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, or in the absence of any common container code or marking, a day's production, constitutes a “lot.”

(2) The sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot. Unless a particular method of analysis is specified in paragraph (c) of this section, composites shall be analyzed by appropriate methods as given in the “Official Methods of Analysis of the AOAC International,” or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures.

(3) Two classes of nutrients are defined for purposes of compliance:

(i) Class I. Added nutrients in fortified or fabricated foods; and

(ii) Class II. Naturally occurring (indigenous) nutrients. When a nutrient is naturally occurring (indigenous) in a food or an ingredient that is added to a food, the total amount of such nutrient in the final food product is subject to class II requirements, except that when an exogenous source of the nutrient is also added to the final food product, the total amount of the nutrient in the final food product (indigenous and exogenous) is subject to class I requirements.

(4) A food with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat shall be deemed to be misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) unless it meets the following requirements:

(i) When a vitamin, mineral, protein, or dietary fiber meets the definition of a Class I nutrient, the nutrient content of the composite must be formulated to be at least equal to the value for that nutrient declared on the label.

(ii) When a vitamin, mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or dietary fiber meets the definition of a Class II nutrient, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.

(5) A food with a label declaration of calories, total sugars, added sugars (when the only source of sugars in the food is added sugars), total fat, saturated fat, trans fat, cholesterol, or sodium shall be deemed to be misbranded under section 403(a) of the act if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls above this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.

(6) Reasonable excesses of vitamins, minerals, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar alcohols, polyunsaturated or monounsaturated fat over labeled amounts are acceptable within current good manufacturing practice. Reasonable deficiencies of calories, total sugars, added sugars, total fat, saturated fat, trans fat, cholesterol, or sodium under labeled amounts are acceptable within current good manufacturing practice.

(7) Compliance will be based on the metric measure specified in the label statement of serving size.

(8) Alternatively, compliance with the provisions set forth in paragraphs (g)(1) through (6) of this section may be provided by use of an FDA approved database that has been computed following FDA guideline procedures and where food samples have been handled in accordance with current good manufacturing practice to prevent nutrition loss. FDA approval of a database shall not be considered granted until the Center for Food Safety and Applied Nutrition has agreed to all aspects of the database in writing. The approval will be granted where a clear need is presented (e.g., raw produce and seafood). Approvals will be in effect for a limited time, e.g., 10 years, and will be eligible for renewal in the absence of significant changes in agricultural or industry practices. Approval requests shall be submitted in accordance with the provisions of § 10.30 of this chapter. Guidance in the use of databases may be found in the “FDA Nutrition Labeling Manual - A Guide for Developing and Using Data Bases,” available from the Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 or by going to http://www.fda.gov.

(9) When it is not technologically feasible, or some other circumstance makes it impracticable, for firms to comply with the requirements of this section (e.g., to develop adequate nutrient profiles to comply with the requirements of paragraph (c) of this section), FDA may permit alternative means of compliance or additional exemptions to deal with the situation. Firms in need of such special allowances shall make their request in writing to the Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(10) The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows:

(i) When a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food, a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.

(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.

(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.

(iv) When a mixture of naturally occurring and added sugars is present in the food, a manufacturer must make and keep written records of the amount of added sugars added to the food during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient).

(v) When the amount of sugars added to food products is reduced through non-enzymatic browning and/or fermentation, manufacturers must:

(A) Make and keep records of all relevant scientific data and information relied upon by the manufacturer that demonstrates the amount of added sugars in the food after non-enzymatic browning and/or fermentation and a narrative explaining why the data and information are sufficient to demonstrate the amount of added sugars declared in the finished food, provided the data and information used is specific to the type of food that is subject to non-enzymatic browning and/or fermentation; or

(B) Make and keep records of the amount of added sugars added to the food before and during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient) and in no event shall the amount of added sugars declared exceed the amount of total sugars on the label; or

(C) Submit a petition, under 21 CFR 10.30, to request an alternative means of compliance. The petition must provide scientific data or other information for why the amount of added sugars in a serving of the product is likely to have a significant reduction in added sugars compared to the amount added prior to non-enzymatic browning and/or fermentation. A significant reduction would be where reduction in added sugars after non-enzymatic browning and/or fermentation may be significant enough to impact the label declaration for added sugars by an amount that exceeds the reasonable deficiency acceptable within good manufacturing practice under paragraph (g)(6) of this section. In addition, the scientific data or other information must include the reason that the manufacturer is unable to determine a reasonable approximation of the amount of added sugars in a serving of their finished product and a description of the process that they used to come to that conclusion.

(vi) When a mixture of all rac-α-tocopherol and RRR-α-tocopherol is present in a food, manufacturers must make and keep written records of the amount of all rac-α-tocopherol added to the food and RRR-α-tocopherol in the finished food.

(vii) When a mixture of folate and folic acid is present in a food, manufacturers must make and keep written records of the amount of synthetic folate and/or folic acid added to the food and the amount of naturally-occurring folate in the finished food.

(11) Records necessary to verify certain nutrient declarations that are specified in paragraph (g)(10) of this section must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request, during an inspection, for official review and photocopying or other means of reproduction. Records required to verify information on the label may be kept either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records which must be kept in accordance with part 11 of this chapter. These records must be accurate, indelible, and legible.

Failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this paragraph (g)(11), would result in the food being misbranded under section 403(a)(1) of the act.

(h) Products with separately packaged ingredients or foods, with assortments of food, or to which other ingredients are added by the user may be labeled as follows:

(1) If a product consists of two or more separately packaged ingredients enclosed in an outer container or of assortments of the same type of food (e.g., assorted nuts or candy mixtures) in the same retail package, nutrition labeling shall be located on the outer container or retail package (as the case may be) to provide information for the consumer at the point of purchase. However, when two or more food products are simply combined together in such a manner that no outer container is used, or no outer label is available, each product shall have its own nutrition information, e.g., two boxes taped together or two cans combined in a clear plastic overwrap. When separately packaged ingredients or assortments of the same type of food are intended to be eaten at the same time, the nutrition information may be specified per serving for each component or as a composite value.

(2) If a product consists of two or more separately packaged foods that are intended to be eaten individually and that are enclosed in an outer container (e.g., variety packs of cereals or snack foods), the nutrition information shall:

(i) Be specified per serving for each food in a location that is clearly visible to the consumer at the point of purchase; and

(ii) Be presented in separate nutrition labels or in one aggregate nutrition label with separate columns for the quantitative amount by weight and the percent Daily Value for each food.

(3) If a package contains a variety of foods, or an assortment of foods, and is in a form intended to be used as a gift, the nutrition labeling shall be in the form required by paragraphs (a) through (f) of this section, but it may be modified as follows:

(i) Nutrition information may be presented on the label of the outer package or in labeling within or attached to the outer package.

(ii) In the absence of a reference amount customarily consumed in § 101.12(b) that is appropriate for the variety or assortment of foods in a gift package, the following may be used as the standard serving size for purposes of nutrition labeling of foods subject to this paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage liquids (e.g., syrups); 8 ounces for beverages that consist of milk and fruit juices, nectars and fruit drinks; and 12 fluid ounces for other beverages. However, the reference amounts customarily consumed in § 101.12(b) shall be used for purposes of evaluating whether individual foods in a gift package qualify for nutrient content claims or health claims.

(iii) The number of servings per container may be stated as “varied.”

(iv) Nutrition information may be provided per serving for individual foods in the package, or, alternatively, as a composite per serving for reasonable categories of foods in the package having similar dietary uses and similar significant nutritional characteristics. Reasonable categories of foods may be used only if accepted by FDA. In determining whether a proposed category is reasonable, FDA will consider whether the values of the characterizing nutrients in the foods proposed to be in the category meet the compliance criteria set forth in paragraphs (g)(3) through (6) of this section. Proposals for such categories may be submitted in writing to the Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(v) If a food subject to paragraph (j)(13) of this section because of its small size is contained in a gift package, the food need not be included in the determination of nutrition information under paragraph (h) of this section if it is not specifically listed in a promotional catalogue as being present in the gift package, and:

(A) It is used in small quantities primarily to enhance the appearance of the gift package; or

(B) It is included in the gift package as a free gift or promotional item.

(4) If a food is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare nutrition information on the basis of the food as consumed in the format required in paragraph (e) of this section; e.g., a dry ready-to-eat cereal may be described with the percent Daily Value and the quantitative amounts for the cereal as sold (e.g., per ounce), and the percent Daily Value and the quantitative amounts for the cereal and milk as suggested in the label (e.g., per ounce of cereal and 1/2cup of vitamin D fortified skim milk); and a cake mix may be labeled with the percent Daily Value and the quantitative amounts for the dry mix (per serving) and the percent Daily Value and the quantitative amounts for the serving of the final cake when prepared, as shown in paragraph (e)(5) of this section: Provided, that, the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.

(i) Except as provided in paragraphs (j)(13) and (j)(17) of this section, the location of nutrition information on a label shall be in compliance with § 101.2.

(j) The following foods are exempt from this section or are subject to special labeling requirements:

(1)(i) Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section, § 101.10, or § 101.11, as applicable.

(ii) For purposes of this paragraph, calculation of the amount of sales shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years, reasonable estimates must indicate that annual sales will not exceed the amounts specified. For foreign firms that ship foods into the United States, the business activities to be included shall be the total amount of food sales, as well as other sales to consumers, by the firm in the United States.

(2) Except as provided in § 101.11, food products that are:

(i) Served in restaurants, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section;

(ii) Served in other establishments in which food is served for immediate human consumption (e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; bakeries, delicatessens, and retail confectionery stores where there are facilities for immediate consumption on the premises; food service vendors, such as lunch wagons, ice cream shops, mall cookie counters, vending machines, and sidewalk carts where foods are generally consumed immediately where purchased or while the consumer is walking away, including similar foods sold from convenience stores; and food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices), Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising, except as provided in § 101.8(c). Claims or other nutrition information, except as provided in § 101.8(c), subject the food to the provisions of this section;

(iii) Sold only in such facilities, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section;

(iv) Used only in such facilities and not served to the consumer in the package in which they are received (e.g., foods that are not packaged in individual serving containers); or

(v) Sold by a distributor who principally sells food to such facilities: Provided, That:

(A) This exemption shall not be available for those foods that are manufactured, processed, or repackaged by that distributor for sale to any persons other than restaurants or other establishments that serve food for immediate human consumption, and

(B) The manufacturer of such products is responsible for providing the nutrition information on the products if there is a reasonable possibility that the product will be purchased directly by consumers.

(3) Except as provided in § 101.11, food products that are:

(i) Of the type of food described in paragraphs (j)(2)(i) and (j)(2)(ii) of this section,

(ii) Ready for human consumption,

(iii) Offered for sale to consumers but not for immediate human consumption,

(iv) Processed and prepared primarily in a retail establishment, and

(v) Not offered for sale outside of that establishment (e.g., ready-to-eat foods that are processed and prepared on-site and sold by independent delicatessens, bakeries, or retail confectionery stores where there are no facilities for immediate human consumption; by in-store delicatessen, bakery, or candy departments; or at self-service food bars such as salad bars), Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section.

(4) Except as provided in § 101.11, foods that contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information under paragraph (c) of this section, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information, except as provided in § 101.8(c), subject the food to the provisions of this section. An insignificant amount of a nutrient or food component shall be that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrate, dietary fiber, and protein, it shall be an amount that allows a declaration of “less than 1 gram.” Examples of foods that are exempt under this paragraph include coffee beans (whole or ground), tea leaves, plain unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors.

(5)(i) Foods, other than infant formula, represented or purported to be specifically for infants through 12 months of age and children 1 through 3 years of age shall bear nutrition labeling. The nutrients declared for infants through 12 months of age and children 1 through 3 years of age shall include calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, total sugars, added sugars, protein, and the following vitamins and minerals: Vitamin D, calcium, iron, and potassium.

(ii) Foods, other than infant formula, represented or purported to be specifically for infants through 12 months of age shall bear nutrition labeling, except that:

(A) Such labeling shall not declare a percent Daily Value for saturated fat, trans fat, cholesterol, sodium, dietary fiber, total sugars, or added sugars and shall not include a footnote.

(B) The following sample label illustrates the provisions of paragraph (j)(5)(ii) of this section.

(C)-(E) [Reserved]

(iii) Foods, other than infant formula, represented or purported to be specifically for children 1 through 3 years of age shall include a footnote that states: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 1,000 calories a day is used for general nutrition advice.”

(A) The following sample label illustrates the provisions of paragraph (j)(5)(iii) of this section.

(B) [Reserved]

(6) Dietary supplements, except that such foods shall be labeled in compliance with § 101.36.

(7) Infant formula subject to section 412 of the act, as amended, except that such foods shall be labeled in compliance with part 107 of this chapter.

(8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. A food is subject to this exemption only if:

(i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;

(ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

(iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;

(iv) It is intended to be used under medical supervision; and

(v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

(9) Food products shipped in bulk form that are not for distribution to consumers in such form and that are for use solely in the manufacture of other foods or that are to be processed, labeled, or repacked at a site other than where originally processed or packed.

(10) Raw fruits, vegetables, and fish subject to section 403(q)(4) of the act, except that the labeling of such foods should adhere to guidelines in § 101.45. This exemption is contingent on the food bearing no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to nutrition labeling in accordance with § 101.45. The term fish includes freshwater or marine fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal life.

(11) Packaged single-ingredient products that consist of fish or game meat (i.e., animal products not covered under the Federal Meat Inspection Act or the Poultry Products Inspection Act, such as flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) subject to this section may provide required nutrition information for a 3-ounce cooked edible portion (i.e., on an “as prepared” basis), except that:

(i) Such products that make claims that are based on values as packaged must provide nutrition information on an as packaged basis, and

(ii) Nutrition information is not required for custom processed fish or game meats.

(12) Game meats (i.e., animal products not covered under the Federal Meat Inspection Act or the Poultry Products Inspection Act, such as flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) may provide required nutrition information on labeling in accordance with the provisions of paragraph (a)(2) of this section.

(13)(i) Foods in small packages that have a total surface area available to bear labeling of less than 12 square inches, Provided, That the labels for these foods bear no nutrition claims or other nutrition information in any context on the label or in labeling or advertising, except as provided in § 101.8(c). Claims or other nutrition information, except as provided in § 101.8(c), subject the food to the provisions of this section.

(A) The manufacturer, packer, or distributor shall provide on the label of packages that qualify for and use this exemption an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., “For nutrition information, call 1-800-123-4567”).

(B) When such products bear nutrition labeling, either voluntarily or because nutrition claims or other nutrition information is provided, all required information shall be in type size no smaller than 6 point or all upper-case type of 1-16 inches minimum height, except that individual serving-size packages of food served with meals in restaurants, institutions, and on board passenger carriers, and not intended for sale at retail, may comply with § 101.2(c)(2).

(ii) Foods in packages that have a total surface area available to bear labeling of 40 or less square inches may modify the requirements of paragraphs (c) through (f) and (i) of this section by one or more of the following means:

(A) Presenting the required nutrition information in a tabular or, as provided below, linear (i.e., string) fashion rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Nutrition information may be given in a linear fashion only if the label will not accommodate a tabular display.

(1) The following sample label illustrates the tabular display for small packages.

(2) The following sample label illustrates the linear display.

(B) Using any of the following abbreviations:

(C) Presenting the required nutrition information on any label panel.

(14) Shell eggs packaged in a carton that has a top lid designed to conform to the shape of the eggs are exempt from outer carton label requirements where the required nutrition information is clearly presented immediately beneath the carton lid or in an insert that can be clearly seen when the carton is opened.

(15) The unit containers in a multiunit retail food package where:

(i) The multiunit retail food package labeling contains all nutrition information in accordance with the requirements of this section;

(ii) The unit containers are securely enclosed within and not intended to be separated from the retail package under conditions of retail sale; and

(iii) Each unit container is labeled with the statement “This Unit Not Labeled For Retail Sale” in type size not less than 1/16-inch in height, except that this statement shall not be required when the inner unit containers bear no labeling at all. The word “individual” may be used in lieu of or immediately preceding the word “Retail” in the statement.

(16) Food products sold from bulk containers: Provided, That nutrition information required by this section be displayed to consumers either on the labeling of the bulk container plainly in view or in accordance with the provisions of paragraph (a)(2) of this section.

(17) Foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition label. The space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered in determining the sufficiency of available space on the principal display panel for the placement of the nutrition label. Nonmandatory label information on the information panel shall not be considered in determining the sufficiency of available space for the placement of the nutrition label.

(18) Food products that are low-volume (that is, they meet the requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of this section); that, except as provided in paragraph (j)(18)(iv) of this section, are the subject of a claim for an exemption that provides the information required under paragraph (j)(18)(iv) of this section, that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.

(i) For food products first introduced into interstate commerce before May 8, 1994, the product shall be exempt for the period:

(A) Between May 8, 1995, and May 7, 1996, if, for the period between May 8, 1994, and May 7, 1995, the person claiming the exemption employed fewer than an average of 300 full-time equivalent employees and fewer than 400,000 units of that product were sold in the United States; and

(B) Between May 8, 1996, and May 7, 1997, if for the period between May 8, 1995, and May 7, 1996, the person claiming the exemption employed fewer than an average of 200 full-time equivalent employees and fewer than 200,000 units of that product were sold in the United States.

(ii) For all other food products, the product shall be eligible for an exemption for any 12-month period if, for the preceding 12 months, the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States, or in the case of a food product that was not sold in the 12-month period preceding the period for which exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which exemption is claimed.

(iii) If a person claims an exemption under paragraphs (j)(18)(i) or (j)(18)(ii) of this section for a food product and then, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the appropriate number, or the number of food products sold in the United States exceeds the appropriate number, or, if at the end of the period of such exemption, the food product no longer qualifies for an exemption under the provisions of paragraphs (j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 months from the date that the product was no longer qualified as a low-volume product of a small business to comply with this section.

(iv) A notice shall be filed with the Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units:

(A) Name and address of person requesting exemption. This should include a telephone number or FAX number that can be used to contact the person along with the name of a specific contact;

(B) Names of the food products (including the various brand names) for which exemption is claimed;

(C) Name and address of the manufacturer, distributor, or importer of the food product for which an exemption is claimed, if different than the person that is claiming the exemption;

(D) The number of full-time equivalent employees. Provide the average number of full-time equivalent individuals employed by the person and its affiliates for the 12 months preceding the period for which a small business exemption is claimed for a product. The average number of full-time equivalent employees is to be determined by dividing the total number of hours of salary or wages paid to employees of the person and its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours × 52 weeks);

(E) Approximate total number of units of the food product sold by the person in the United States in the 12-month period preceding that for which a small business exemption is claimed. Provide the approximate total number of units sold, or expected to be sold, in a 12-month period for each product for which an exemption is claimed. For products that have been in production for 1 year or more prior to the period for which exemption is claimed, the 12-month period is the period immediately preceding the period for which an exemption is claimed. For other products, the 12-month period is the period for which an exemption is claimed; and

(F) The notice shall be signed by a responsible individual for the person who can certify the accuracy of the information presented in the notice. The individual shall certify that the information contained in the notice is a complete and accurate statement of the average number of full-time equivalent employees of this person and its affiliates and of the number of units of the product for which an exemption is claimed sold by the person. The individual shall also state that should the average number of full-time equivalent employees or the number of units of food products sold in the United States by the person exceed the applicable numbers for the time period for which exemption is claimed, the person will notify FDA of that fact and the date on which the number of employees or the number of products sold exceeded the standard.

(v) FDA may by regulation lower the employee or units of food products requirements of paragraph (j)(18)(ii) of this section for any food product first introduced into interstate commerce after May 8, 2002, if the agency determines that the cost of compliance with such lower requirement will not place an undue burden on persons subject to it.

(vi) For the purposes of this paragraph, the following definitions apply:

(A) Unit means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers.

(B) Food product means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods.

(C) Person means all domestic and foreign affiliates, as defined in 13 CFR 121.401, of the corporation, in the case of a corporation, and all affiliates, as defined in 13 CFR 121.401, of a firm or other entity, when referring to a firm or other entity that is not a corporation.

(D) Full-time equivalent employee means all individuals employed by the person claiming the exemption. This number shall be determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours × 52 weeks).

(k) A food labeled under the provisions of this section shall be deemed to be misbranded under sections 201(n) and 403(a) of the act if its label or labeling represents, suggests, or implies:

(1) That the food, because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom. Information about the relationship of a dietary property to a disease or health-related condition may only be provided in conformance with the requirements of § 101.14 and part 101, subpart E.

(2) That the lack of optimum nutritive quality of a food, by reason of the soil on which that food was grown, is or may be responsible for an inadequacy or deficiency in the quality of the daily diet.

(3) That the storage, transportation, processing, or cooking of a food is or may be responsible for an inadequacy or deficiency in the quality of the daily diet.

(4) That a natural vitamin in a food is superior to an added or synthetic vitamin.

(l) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2404 and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) AOAC Reseller. Techstreet, 6300 Interfirst Dr., Ann Arbor, MI 48108, Toll free in United States: 1-800-699-9277, Outside United States: 1-734-780-8000, Fax: 1-734-780-2046, www.techstreet.com,techstreet.service@thomsonreuters.com. FDA does not endorse any particular reseller and notes that other resellers also may have the reference for sale. Consult FDA at 240-402-2404 for more information on additional resellers.

(i) “Official Methods of Analysis of the AOAC INTERNATIONAL,” 19th Edition, Volumes 1 and 2, 2012.

(ii) [Reserved]

(2) Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO), Publications Division, Viale delle Terme di Caracalla, 00100 Rome, Italy

(i) FAO Food and Nutrition Paper 51,”Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1991. http://apps.who.int/iris/bitstream/10665/38133/1/9251030979_eng.pdf.

(ii) [Reserved]

(3) United States Department of Agriculture (USDA), Agricultural Research Service, Washington, DC, Nutrient Data Laboratory, Bldg. 005 Room 105 BARC-West, Beltsville, MD 20705, 301-504-0630. http://www.ars.usda.gov/News/docs.htm?docid=9447.

(i) USDA Handbook No. 74, Energy Value of Foods - basis and derivation, by A. L. Merrill and B. K. Watt, (slightly revised, 1973) http://www.ars.usda.gov/SP2UserFiles/Place/80400525/Data/Classics/ah74.pdf.

(ii) [Reserved]

Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this part) or a health claim (as defined in § 101.14 and permitted by a regulation in subpart E of this part) is made, except that information on the nutrient amounts that are the basis for the claim (e.g., “low fat, this meal provides less than 10 grams of fat”) may serve as the functional equivalent of complete nutrition information as described in § 101.9. For the purposes of this section, restaurant food includes two categories of food. It includes food which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments. It also includes food which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in the previous sentence, and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment. For standard menu items that are offered for sale in covered establishments (as defined in § 101.11(a)), the information in the written nutrition information required by § 101.11(b)(2)(ii)(A) will serve to meet the requirements of this section. Nutrient levels may be determined by nutrient databases, cookbooks, or analyses or by other reasonable bases that provide assurance that the food or meal meets the nutrient requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in § 101.45 and other reasonable means.

(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for purposes of this section:

Authorized official of a restaurant or similar retail food establishment means the owner, operator, agent in charge, or other person authorized by the owner, operator, or agent in charge to register the restaurant or similar retail food establishment, which is not otherwise subject to section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of this section.

Combination meal means a standard menu item that consists of more than one food item, for example a meal that includes a sandwich, a side dish, and a drink. A combination meal may be represented on the menu or menu board in narrative form, numerically, or pictorially. Some combination meals may include a variable menu item or be a variable menu item as defined in this paragraph where the components may vary. For example, the side dish may vary among several options (e.g., fries, salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk, or juice) and the customer selects which of these items will be included in the meal.

Covered establishment means a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that is registered to be covered under paragraph (d) of this section.

Custom order means a food order that is prepared in a specific manner based on an individual customer's request, which requires the covered establishment to deviate from its usual preparation of a standard menu item, e.g., a club sandwich without the bacon if the establishment usually includes bacon in its club sandwich.

Daily special means a menu item that is prepared and offered for sale on a particular day, that is not routinely listed on a menu or menu board or offered by the covered establishment, and that is promoted by the covered establishment as a special menu item for that particular day.

Doing business under the same name means sharing the same name. The term “name” refers to either:

(i) The name of the establishment presented to the public; or

(ii) If there is no name of the establishment presented to the public (e.g., an establishment with the generic descriptor “concession stand”), the name of the parent entity of the establishment. When the term “name” refers to the name of the establishment presented to the public under paragraph (i) of this definition, the term “same” includes names that are slight variations of each other, for example, due to the region, location, or size (e.g., “New York Ave. Burgers” and “Pennsylvania Ave. Burgers” or “ABC” and “ABC Express”).

Food on display means restaurant-type food that is visible to the customer before the customer makes a selection, so long as there is not an ordinary expectation of further preparation by the consumer before consumption.

Food that is part of a customary market test means food that appears on a menu or menu board for less than 90 consecutive days in order to test consumer acceptance of the product.

Location means a fixed position or site.

Menu or menu board means the primary writing of the covered establishment from which a customer makes an order selection, including, but not limited to, breakfast, lunch, and dinner menus; dessert menus; beverage menus; children's menus; other specialty menus; electronic menus; and menus on the Internet. Determining whether a writing is or is part of the primary writing of the covered establishment from which a customer makes an order selection depends on a number of factors, including whether the writing lists the name of a standard menu item (or an image depicting the standard menu item) and the price of the standard menu item, and whether the writing can be used by a customer to make an order selection at the time the customer is viewing the writing. The menus may be in different forms, e.g., booklets, pamphlets, or single sheets of paper. Menu boards include those inside a covered establishment as well as drive-through menu boards at covered establishments.

Offering for sale substantially the same menu items means offering for sale a significant proportion of menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if the name of the menu item varies, (e.g., “Bay View Crab Cake” and “Ocean View Crab Cake”). “Menu items” in this definition refers to food items that are listed on a menu or menu board or that are offered as self-service food or food on display. Restaurants and similar retail food establishments that are part of a chain can still be offering for sale substantially the same menu items if the availability of some menu items varies within the chain. Having the same name may indicate, but does not necessarily guarantee, that menu items are substantially the same.

Restaurant or similar retail food establishment means a retail establishment that offers for sale restaurant-type food, except if it is a school as defined by 7 CFR 210.2 or 220.2.

Restaurant-type food means food that is:

(i) Usually eaten on the premises, while walking away, or soon after arriving at another location; and

(ii) Either:

(A) Served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments; or

(B) Processed and prepared primarily in a retail establishment, ready for human consumption, of the type described in paragraph (ii)(A) of this definition, and offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment.

Self-service food means restaurant-type food that is available at a salad bar, buffet line, cafeteria line, or similar self-service facility and that is served by the customers themselves. Self-service food also includes self-service beverages.

Standard menu item means a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a self-service food or food on display.

Temporary menu item means a food that appears on a menu or menu board for less than a total of 60 days per calendar year. The 60 days includes the total of consecutive and non-consecutive days the item appears on the menu.

Variable menu item means a standard menu item that comes in different flavors, varieties, or combinations, and is listed as a single menu item.

(b) Requirements for nutrition labeling for food sold in covered establishments - (1) Applicability. (i) The labeling requirements in this paragraph (b) apply to standard menu items offered for sale in covered establishments.

(ii)(A) The labeling requirements in this paragraph (b) do not apply to foods that are not standard menu items, including:

(1) Items such as condiments that are for general use, including those placed on the table or on or behind the counter; daily specials; temporary menu items; custom orders; food that is part of a customary market test; and

(2) Self-service food and food on display that is offered for sale for less than a total of 60 days per calendar year or fewer than 90 consecutive days in order to test consumer acceptance.

(B) The labeling requirements of paragraph (b)(2)(iii) of this section do not apply to alcoholic beverages that are foods on display and are not self-service foods.

(2) Nutrition information. (i) Except as provided by paragraph (b)(2)(i)(A)(8) of this section, the following must be provided on menus and menu boards:

(A) The number of calories contained in each standard menu item listed on the menu or menu board, as usually prepared and offered for sale. In the case of multiple-serving standard menu items, this means the calories declared must be for the whole menu item listed on the menu or menu board as usually prepared and offered for sale (e.g., “pizza pie: 1600 cal”); or per discrete serving unit as long as the discrete serving unit (e.g., pizza slice) and total number of discrete serving units contained in the menu item are declared on the menu or menu board, and the menu item is usually prepared and offered for sale divided in discrete serving units (e.g., “pizza pie: 200 cal/slice, 8 slices”). The calories must be declared in the following manner:

(1) The number of calories must be listed adjacent to the name or the price of the associated standard menu item, in a type size no smaller than the type size of the name or the price of the associated standard menu item, whichever is smaller, in the same color, or a color at least as conspicuous as that used for the name of the associated standard menu item, and with the same contrasting background or a background at least as contrasting as that used for the name of the associated standard menu item.

(2) To the nearest 5-calorie increment up to and including 50 calories and to the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero.

(3) The term “Calories” or “Cal” must appear as a heading above a column listing the number of calories for each standard menu item or adjacent to the number of calories for each standard menu item. If the term “Calories” or “Cal” appears as a heading above a column of calorie declarations, the term must be in a type size no smaller than the smallest type size of the name or price of any menu item on that menu or menu board in the same color or a color at least as conspicuous as that used for that name or price and in the same contrasting background or a background at least as contrasting as that used for that name or price. If the term “Calories” or “Cal” appears adjacent to the number of calories for the standard menu item, the term “Calories” or “Cal” must appear in the same type size and in the same color and contrasting background as the number of calories.

(4) Additional requirements that apply to each individual variable menu item:

(i) When the menu or menu board lists flavors or varieties of an entire individual variable menu item (such as soft drinks, ice cream, doughnuts, dips, and chicken that can be grilled or fried), the calories must be declared separately for each listed flavor or variety. Where flavors or varieties have the same calorie amounts (after rounding in accordance with paragraph (b)(2)(i)(A)(2) of this section), the calorie declaration for such flavors or varieties can be listed as a single calorie declaration adjacent to the flavors or varieties, provided that the calorie declaration specifies that the calorie amount listed represents the calorie amounts for each individual flavor or variety.

(ii) When the menu or menu board does not list flavors or varieties for an entire individual variable menu item, and only includes a general description of the variable menu item (e.g., “soft drinks”), the calories must be declared for each option with a slash between the two calorie declarations where only two options are available (e.g., “150/250 calories”) or as a range in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section where more than two options are available (e.g., “100-250 calories”).

(iii) When the menu or menu board describes flavors or varieties for only part of an individual variable menu item (such as different types of cheese offered in a grilled cheese sandwich (e.g., “Grilled Cheese (Cheddar or Swiss)”), the calories must be declared for each option with a slash between the two calorie declarations where only two options are available (e.g., “450/500 calories”) or as a range in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section where more than two options are available (e.g., “450-550 calories”).

(5) Additional requirements that apply to a variable menu item that is offered for sale with the option of adding toppings listed on the menu or menu board. When the menu or menu board lists toppings that can be added to a menu item (such as pizza or ice cream):

(i) The calories must be declared for the basic preparation of the menu item as listed (e.g., “small pizza pie,” “single scoop ice cream”).

(ii) The calories must be separately declared for each topping listed on the menu or menu board (e.g., pepperoni, sausage, green peppers, onions on pizza; fudge, almonds, sprinkles on ice cream), specifying that the calories are added to the calories contained in the basic preparation of the menu item. Where toppings have the same calorie amounts (after rounding in accordance with paragraph (b)(2)(i)(A)(2) of this section), the calorie declaration for such toppings can be listed as a single calorie declaration adjacent to the toppings, provided that the calorie declaration specifies that the calorie amount listed represents the calorie amount for each individual topping.

(iii) The calories for the basic preparation of the menu item must be declared for each size of the menu item. The calories for each topping listed on the menu or menu board must be declared for each size of the menu item, or declared using a slash between the two calorie declarations for each topping where only two sizes of the menu item are available (e.g., “adds 150/250 cal”) or as a range for each topping in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section where more than two sizes of the menu item are available (e.g., “adds 100-250 cal”). If a slash between two calorie declarations or a range of calorie declarations is used, the menu or menu board must indicate that the variation in calories for each topping arises from the size of the menu item to which the toppings are added.

(iv) If the amount of the topping included on the basic preparation of the menu item decreases based on the total number of toppings ordered for the menu item (such as is sometimes the case with pizza toppings), the calories for each topping must be declared as single values representing the calories for each topping when added to a one-topping menu item, specifying that the calorie declaration is for the topping when added to a one-topping menu item.

(6) Additional requirements that apply to a combination meal. Except as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:

(i) When the menu or menu board lists two options for menu items in a combination meal (e.g., a sandwich with a side salad or chips), the calories must be declared for each option with a slash between the two calorie declarations (e.g., “350/450 calories”).

(ii) When the menu or menu board lists three or more options for menu items in a combination meal (e.g., a sandwich with chips, a side salad, or fruit), the calories must be declared as a range in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., “350-500 calories”).

(iii) When the menu or menu board includes a choice to increase or decrease the size of a combination meal, the calorie difference must be declared for the increased or decreased size with a slash between two calorie declarations (e.g., “Adds 100/150 calories,” “Subtracts 100/150 calories”) if the menu or menu board lists two options for menu items in the combination meal, or as a range in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., “Adds 100-250 calories,” “Subtracts 100-250 calories”) if the menu or menu board lists three or more options for menu items in the combination meal.

(iv) Where the menu or menu board describes an opportunity for a consumer to combine standard menu items for a special price (e.g.,”Combine Any Sandwich with Any Soup or Any Salad for $8.99”), and the calories for each standard menu item, including each size option as described in paragraph (b)(2)(i)(A)(6)(iii) of this section if applicable, available for the consumer to combine are declared elsewhere on the menu or menu board, the requirements of paragraphs (b)(2)(i)(A)(6)(i), (ii), and (iii) of this section do not apply.

(7) Additional format requirements for declaring calories for an individual variable menu item, a combination meal, and toppings as a range, if applicable. Calories declared as a range must be in the format “xx-yy,” where “xx” is the caloric content of the lowest calorie variety, flavor, or combination, and “yy” is the caloric content of the highest calorie variety, flavor, or combination.

(8) Exception for a variable menu item that has no clearly identifiable upper bound to the range of calories: If the variable menu item appears on the menu or menu board and is a self-service food or food on display, and there is no clearly identifiable upper bound to the range, e.g., all-you-can-eat buffet, then the menu or menu board must include a statement, adjacent to the name or price of the item, referring customers to the self-service facility for calorie information, e.g., “See buffet for calorie declarations.” This statement must appear in a type size no smaller than the type size of the name or price of the variable menu item, whichever is smaller, and in the same color or a color at least as conspicuous as that used for that name or price, with the same contrasting background or a background at least as contrasting as that used for that name or price.

(9) Additional requirements that apply to beverages that are not self-service. For beverages that are not self-service, calories must be declared based on the full volume of the cup served without ice, unless the covered establishment ordinarily dispenses and offers for sale a standard beverage fill (i.e., a fixed amount that is less than the full volume of the cup per cup size) or dispenses a standard ice fill (i.e., a fixed amount of ice per cup size). If the covered establishment ordinarily dispenses and offers for sale a standard beverage fill or dispenses a standard ice fill, the covered establishment must declare calories based on such standard beverage fill or standard ice fill.

(B) The following statement designed to enable consumers to understand, in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” For menus and menu boards targeted to children, the following options may be used as a substitute for or in addition to the succinct statement: “1,200 to 1,400 calories a day is used for general nutrition advice for children ages 4 to 8 years, but calorie needs vary.” or “1,200 to 1,400 calories a day is used for general nutrition advice for children ages 4 to 8 years and 1,400 to 2,000 calories a day for children ages 9 to 13 years, but calorie needs vary.”

(1) This statement must be posted prominently and in a clear and conspicuous manner in a type size no smaller than the smallest type size of any calorie declaration appearing on the same menu or menu board and in the same color or in a color at least as conspicuous as that used for the calorie declarations and with the same contrasting background or a background at least as contrasting as that used for the calorie declarations.

(2) For menus, this statement must appear on the bottom of each page of the menu. On menu pages that also bear the statement required by paragraph (b)(2)(i)(C) of this section, this statement must appear immediately above, below, or beside the statement required by paragraph (b)(2)(i)(C) of this section.

(3) For menu boards, this statement must appear on the bottom of the menu board, immediately above, below, or beside the statement required by paragraph (b)(2)(i)(C) of this section.

(C) The following statement regarding the availability of the additional written nutrition information required in paragraph (b)(2)(ii) of this section must be on all forms of the menu or menu board: “Additional nutrition information available upon request.”

(1) This statement must be posted prominently and in a clear and conspicuous manner in a type size no smaller than the smallest type size of any calorie declaration appearing on the same menu or menu board and in the same color or in a color at least as conspicuous as that used for the caloric declarations, and with the same contrasting background or a background at least as contrasting as that used for the caloric declarations.

(2) For menus, the statement must appear on the bottom of the first page with menu items immediately above, below, or beside the succinct statement required by paragraph (b)(2)(i)(B) of this section.

(3) For menu boards, the statement must appear on the bottom of the menu board immediately above, below, or beside the succinct statement required by paragraph (b)(2)(i)(B) of this section.

(ii) The following nutrition information for a standard menu item must be available in written form on the premises of the covered establishment and provided to the customer upon request. This nutrition information must be presented in the order listed and using the measurements listed, except as provided in paragraph (b)(2)(ii)(B) of this section. Rounding of these nutrients must be in compliance with § 101.9(c). The information must be presented in a clear and conspicuous manner, including using a color, type size, and contrasting background that render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Covered establishments may use the abbreviations allowed for Nutrition Facts for certain packaged foods in § 101.9(j)(13)(ii)(B):

(A)(1) Total calories (cal);

(2) Calories from fat (fat cal);

(3) Total fat (g);

(4) Saturated fat (g);

(5) Trans fat (g);

(6) Cholesterol (mg);

(7) Sodium (mg);

(8) Total carbohydrate (g);

(9) Dietary fiber (g);

(10) Sugars (g); and

(11) Protein (g).

(B) If a standard menu item contains insignificant amounts of all the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of this section, the establishment is not required to include nutrition information regarding the standard menu item in the written form. However, if the covered establishment makes a nutrient content claim or health claim, the establishment is required to provide nutrition information on the nutrient that is the subject of the claim in accordance with § 101.10. For standard menu items that contain insignificant amounts of six or more of the required nutrients, the declaration of nutrition information required by paragraph (b)(2)(ii)(A) of this section may be presented in a simplified format.

(1) An insignificant amount is defined as that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrates, dietary fiber, and protein, it must be an amount that allows a declaration of “less than one gram.”

(2) The simplified format must include information, in a column, list, or table, on the following nutrients:

(i) Total calories, total fat, total carbohydrates, protein, and sodium; and

(ii) Calories from fat, and any other nutrients identified in paragraph (b)(2)(ii)(A) of this section that are present in more than insignificant amounts.

(3) If the simplified format is used, the statement “Not a significant source of __” (with the blank filled in with the names of the nutrients required to be declared in the written nutrient information and calories from fat that are present in insignificant amounts) must be included at the bottom of the list of nutrients.

(C) For variable menu items, the nutrition information listed in paragraph (b)(2)(ii)(A) of this section must be declared as follows for each size offered for sale:

(1) The nutrition information required in paragraph (b)(2)(ii)(A) of this section must be declared for the basic preparation of the item and, separately, for each topping, flavor, or variable component.

(2) Additional format requirements for toppings if the amount of the topping included on the basic preparation of the menu item decreases based on the total number of toppings ordered for the menu item (such as is sometimes the case with pizza toppings). The nutrients for such topping must be declared as single values representing the nutrients for each topping when added to a one-topping menu item, specifying that the nutrient declaration is for the topping when added to a one-topping menu item.

(3) If the calories and other nutrients are the same for different flavors, varieties, and variable components of the combination meal, each variety, flavor, and variable component of the combination meal is not required to be listed separately. All items that have the same nutrient values could be listed together with the nutrient values listed only once.

(D) The written nutrition information required in paragraph (b)(2)(ii)(A) of this section may be provided on a counter card, sign, poster, handout, booklet, loose leaf binder, or electronic device such as a computer, or in a menu, or in any other form that similarly permits the written declaration of the required nutrient content information for all standard menu items. If the written nutrition information is not in a form that can be given to the customer upon request, it must be readily available in a manner and location on the premises that allows the customer/consumer to review the written nutrition information upon request.

(iii) The following must be provided for a standard menu item that is self-service or on display.

(A) Calories per displayed food item (e.g., a bagel, a slice of pizza, or a muffin), or if the food is not offered for sale in a discrete unit, calories per serving (e.g., scoop, cup), and the serving or discrete unit used to determine the calorie content (e.g., “per scoop” or “per muffin”) on either: A sign adjacent to and clearly associated with the corresponding food; (e.g., “150 calories per scoop); a sign attached to a sneeze guard with the calorie declaration and the serving or unit used to determine the calorie content above each specific food so that the consumer can clearly associate the calorie declaration with the food, except that if it is not clear to which food the calorie declaration and serving or unit refers, then the sign must also include the name of the food, e.g., “Broccoli and cheese casserole - 200 calories per scoop”; or a single sign or placard listing the calorie declaration for several food items along with the names of the food items, so long as the sign or placard is located where a consumer can view the name, calorie declaration, and serving or unit of a particular item while selecting that item.

(1) For purposes of paragraph (b)(2)(iii)(A) of this section, “per displayed food item”; means per each discrete unit offered for sale, for example, a bagel, a slice of pizza, or a muffin.

(2) For purposes of paragraph (b)(2)(iii)(A) of this section, “per serving” means, for each food:

(i) Per serving instrument used to dispense the food offered for sale, provided that the serving instrument dispenses a uniform amount of the food (e.g., a scoop or ladle);

(ii) If a serving instrument that dispenses a uniform amount of food is not used to dispense the food, per each common household measure (e.g., cup or tablespoon) offered for sale or per unit of weight offered for sale, e.g., per quarter pound or per 4 ounces; or

(iii) Per total number of fluid ounces in the cup in which a self-service beverage is served and, if applicable, the description of the cup size (e.g., “140 calories per 12 fluid ounces (small)”).

(3) The calories must be declared in the following manner:

(i) To the nearest 5-calorie increment up to and including 50 calories and to the nearest 10-calorie increment above 50 calories except that amounts less than 5 calories may be expressed as zero.

(ii) If the calorie declaration is provided on a sign with the food's name, price, or both, the calorie declaration, accompanied by the term “Calories” or “Cal” and the amount of the serving or displayed food item on which the calories declaration is based must be in a type size no smaller than the type size of the name or price of the menu item whichever is smaller, in the same color, or a color that is at least as conspicuous as that used for that name or price, using the same contrasting background or a background at least as contrasting as that used for that name or price. If the calorie declaration is provided on a sign that does not include the food's name, price, or both, the calorie declaration, accompanied by the term “Calories” or “Cal” and the amount of the serving or displayed food item on which the calorie declaration is based must be clear and conspicuous.

(iii) For self-service beverages, calorie declarations must be accompanied by the term “fluid ounces” and, if applicable, the description of the cup size (e.g., “small,” “medium”).

(B) For food that is self-service or on display and is identified by an individual sign adjacent to the food itself where such sign meets the definition of a menu or menu board under paragraph (a) of this section, the statement required by paragraph (b)(2)(i)(B) of this section and the statement required by paragraph (b)(2)(i)(C) of this section. These two statements may appear on the sign adjacent to the food itself; on a separate, larger sign, in close proximity to the food that can be easily read as the consumer is making order selections; or on a large menu board that can be easily read as the consumer is viewing the food.

(C) The nutrition information in written form required by paragraph (b)(2)(ii) of this section, except for packaged food insofar as it bears nutrition labeling information required by and in accordance with paragraph (b)(2)(ii) of this section and the packaged food, including its label, can be examined by a consumer before purchasing the food.

(c) Determination of nutrient content. (1) A covered establishment must have a reasonable basis for its nutrient declarations. Nutrient values may be determined by using nutrient databases (with or without computer software programs), cookbooks, laboratory analyses, or other reasonable means, including the use of Nutrition Facts on labels on packaged foods that comply with the nutrition labeling requirements of section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and § 101.9, FDA nutrient values for raw fruits and vegetables in Appendix C of this part, or FDA nutrient values for cooked fish in Appendix D of this part.

(2) Nutrient declarations for standard menu items must be accurate and consistent with the specific basis used to determine nutrient values. A covered establishment must take reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

(3) A covered establishment must provide to FDA, within a reasonable period of time upon request, information substantiating nutrient values including the method and data used to derive these nutrient values. This information must include the following:

(i) For nutrient databases:

(A) The name and version (including the date of the version) of the database, and, as applicable, the name of the applicable software company and any Web site address for the database. The name and version of a database would include the name and version of the computer software, if applicable;

(B) The recipe or formula used as a basis for the nutrient declarations;

(C)(1) Information on:

(i) The amount of each nutrient that the specified amount of each ingredient identified in the recipe contributes to the menu item; and

(ii) How the database was used including calculations or operations (e.g., worksheets or computer printouts) to determine the nutrient values for the standard menu items;

(2) If the information in paragraph (c)(3)(i)(C)(1) of this section is not available, certification attesting that the database will provide accurate results when used appropriately and that the database was used in accordance with its instructions;

(D) A detailed listing (e.g., printout) of the nutrient values determined for each standard menu item.

(E) Any other information pertinent to the final nutrient values of the standard menu item (e.g., information about what might cause slight variations in the nutrient profile such as moisture variations);

(F) A statement signed and dated by a responsible individual, employed at the covered establishment or its corporate headquarters or parent entity, who can certify that the information contained in the nutrient analysis is complete and accurate; and

(G) A statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

(ii) For published cookbooks that contain nutritional information for recipes in the cookbook:

(A) The name, author, and publisher of the cookbook used;

(B) If available, information provided by the cookbook or from the author or publisher about how the nutrition information for the recipes was obtained;

(C) A copy of the recipe used to prepare the standard menu item and a copy of the nutrition information for that standard menu item as provided by the cookbook; and

(D) A statement signed and dated by a responsible individual employed at the covered establishment certifying that that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined. (Recipes may be divided as necessary to accommodate differences in the portion size derived from the recipe and that are served as the standard menu item but no changes may be made to the proportion of ingredients used.)

(iii) For laboratory analyses:

(A) A copy of the recipe for the standard menu item used for the nutrient analysis;

(B) The name and address of the laboratory performing the analysis;

(C) Copies of analytical worksheets, including the analytical method, used to determine and verify nutrition information;

(D) A statement signed and dated by a responsible individual, employed at the covered establishment or its corporate headquarters or parent entity, who can certify that the information contained in the nutrient analysis is complete and accurate; and

(E) A statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

(iv) For nutrition information provided by other reasonable means:

(A) A detailed description of the means used to determine the nutrition information;

(B) A recipe or formula used as a basis for the nutrient determination;

(C) Any data derived in determining the nutrient values for the standard menu item, e.g., nutrition information about the ingredients used with the source of the nutrient information;

(D) A statement signed and dated by a responsible individual, employed at the covered establishment or its corporate headquarters or parent entity, who can certify that the information contained in the nutrient analysis is complete and accurate; and

(E) A statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

(d) Voluntary registration to be subject to the menu labeling requirements - (1) Applicability. A restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items may voluntarily register to be subject to the requirements established in this section. Restaurants and similar retail food establishments that voluntarily register will no longer be subject to non-identical State or local nutrition labeling requirements.

(2) Who may register? The authorized official of a restaurant or similar retail food establishment as defined in paragraph (a) of this section, which is not otherwise subject to paragraph (b) of this section, may register with FDA.

(3) What information is required? Authorized officials for restaurants and similar retail food establishments must provide FDA with the following information on Form FDA 3757:

(i) The contact information (including name, address, phone number, and email address) for the authorized official;

(ii) The contact information (including name, address, phone number, and email address) of each restaurant or similar retail food establishment being registered, as well as the name and contact information for an official onsite, such as the owner or manager, for each specific restaurant or similar retail food establishment;

(iii) All trade names the restaurant or similar retail food establishment uses;

(iv) Preferred mailing address (if different from location address for each establishment) for purposes of receiving correspondence; and

(v) Certification that the information submitted is true and accurate, that the person submitting it is authorized to do so, and that each registered restaurant or similar retail food establishment will be subject to the requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act and this section.

(4) How to register. Authorized officials of restaurants and similar retail food establishments who elect to be subject to requirements in section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act can register by visiting http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has created a form (Form 3757) that contains fields requesting the information in paragraph (d)(3) of this section and made the form available at this Web site. Registrants must use this form to ensure that complete information is submitted.

(i) Information should be submitted by email by typing complete information into the form (PDF), saving it on the registrant's computer, and sending it by email to menulawregistration@fda.hhs.gov.

(ii) If email is not available, the registrant can either fill in the form (PDF) and print it out (or print out the blank PDF and fill in the information by hand or typewriter), and either fax the completed form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD 20993.

(5) When to renew the registration. To keep the establishment's registration active, the authorized official of the restaurant or similar retail food establishment must register every other year within 60 days prior to the expiration of the establishment's current registration with FDA. Registration will automatically expire if not renewed.

(e) Signatures. Signatures obtained under paragraph (d) of this section that meet the definition of electronic signatures in § 11.3(b)(7) of this chapter are exempt from the requirements of part 11 of this chapter.

(f) Misbranding. A standard menu item offered for sale in a covered establishment shall be deemed misbranded under sections 201(n), 403(a), 403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its label or labeling is not in conformity with paragraph (b) or (c) of this section.

(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that:

(1) FDA calculated the reference amounts for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These reference amounts are based on data set forth in appropriate national food consumption surveys.

(2) FDA calculated the reference amounts for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These reference amounts are based on data set forth in appropriate national food consumption surveys. Such reference amounts are to be used only when the food is specially formulated or processed for use by an infant or by a child under 4 years of age.

(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.

(4) To determine the amount of food customarily consumed per eating occasion, FDA considered the mean, median, and mode of the consumed amount per eating occasion.

(5) When survey data were insufficient, FDA took various other sources of information on serving sizes of food into consideration. These other sources of information included:

(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;

(ii) Serving sizes recommended in comments;

(iii) Serving sizes used by manufacturers and grocers; and

(iv) Serving sizes used by other countries.

(6) Because they reflect the amount customarily consumed, the reference amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.

(7) The reference amount is based on the major intended use of the food (e.g., milk as a beverage and not as an addition to cereal).

(8) The reference amounts for products that are consumed as an ingredient of other foods, but that may also be consumed in the form in which they are purchased (e.g., butter), are based on use in the form purchased.

(9) FDA sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform reference amount.

(b) The following reference amounts shall be used as the basis for determining serving sizes for specific products:

(c) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a reference amount for the product in the prepared form, but not the unprepared form, then the reference amount for the unprepared product must be the amount of the unprepared product required to make the reference amount for the prepared product as established in paragraph (b) of this section.

(d) The reference amount for an imitation or substitute food or altered food, such as a “low calorie” version, shall be the same as for the food for which it is offered as a substitute.

(e) If a food is modified by incorporating air (aerated), and thereby the density of the food is lowered by 25 percent or more in weight than that of an appropriate reference regular food as described in § 101.13(j)(1)(ii)(A), and the reference amount of the regular food is in grams, the manufacturer may determine the reference amount of the aerated food by adjusting for the difference in density of the aerated food relative to the density of the appropriate reference food provided that the manufacturer will show FDA detailed protocol and records of all data that were used to determine the density-adjusted reference amount for the aerated food. The reference amount for the aerated food shall be rounded to the nearest 5-g increment. Such products shall bear a descriptive term indicating that extra air has been incorporated (e.g., whipped, aerated). The density-adjusted reference amounts described in paragraph (b) of this section may not be used for cakes except for cheese cake. The differences in the densities of different types of cakes having different degrees of air incorporation have already been taken into consideration in determining the reference amounts for cakes in § 101.12(b). In determining the difference in density of the aerated and the regular food, the manufacturer shall adhere to the following:

(1) The regular and the aerated product must be the same in size, shape, and volume. To compare the densities of products having nonsmooth surfaces (e.g., waffles), manufacturers shall use a device or method that ensures that the volumes of the regular and the aerated products are the same.

(2) Sample selections for the density measurements shall be done in accordance with the provisions in § 101.9(g).

(3) Density measurements of the regular and the aerated products shall be conducted by the same trained operator using the same methodology (e.g., the same equipment, procedures, and techniques) under the same conditions.

(4) Density measurements shall be replicated a sufficient number of times to ensure that the average of the measurements is representative of the true differences in the densities of the regular and the “aerated” products.

(f) For products that have no reference amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., peanut putter and jelly, cracker and cheese pack, pancakes and syrup, cake and frosting), the reference amount for the combined product shall be determined using the following rules:

(1) The reference amount for the combined product must be the reference amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient (e.g., peanut butter, pancakes, cake) plus proportioned amounts of all minor ingredients.

(2) If the reference amounts are in compatible units, the weights or volumes must be summed (e.g., the reference amount for equal volumes of peanut butter and jelly for which peanut butter is represented as the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly)). If the reference amounts are in incompatible units, all amounts must be converted to weights and summed, e.g., the reference amount for pancakes and syrup would be 110 g (the reference amount for pancakes) plus the weight of the proportioned amount of syrup.

(g) The reference amounts set forth in paragraphs (b) through (f) of this section shall be used in determining whether a product meets the criteria for nutrient content claims, such as “low calorie,” and for health claims. If the serving size declared on the product label differs from the reference amount, and the product meets the criteria for the claim only on the basis of the reference amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the reference amount as it appears in paragraph (b) of this section followed, in parenthesis, by the amount in common household measure if the reference amount is expressed in measures other than common household measures (e.g., for a beverage, “Very low sodium, 35 mg or less per 240 mL (8 fl oz)”).

(h) The Commissioner of Food and Drugs, either on his or her own initiative or in response to a petition submitted pursuant to part 10 of this chapter, may issue a proposal to establish or amend a reference amount in paragraph (b) of this section. A petition to establish or amend a reference amount shall include:

(1) Objective of the petition;

(2) A description of the product;

(3) A complete sample product label including nutrition label, using the format established by regulation;

(4) A description of the form (e.g., dry mix, frozen dough) in which the product will be marketed;

(5) The intended dietary uses of the product with the major use identified (e.g., milk as a beverage and chips as a snack);

(6) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;

(7) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);

(8) The names of the most closely related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);

(9) The suggested reference amount (the amount of edible portion of food as consumed, excluding bone, seed, shell, or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested reference amount. In determining the reference amount, general principles and factors in paragraph (a) of this section should be followed.

(10) The suggested reference amount shall be expressed in metric units. Reference amounts for fluids shall be expressed in milliliters. Reference amounts for other foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons, are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density, such as frozen desserts.

(i) In expressing the reference amounts in milliliters, the following rules shall be followed:

(A) For volumes greater than 30 milliliters (mL), the volume shall be expressed in multiples of 30 mL.

(B) For volumes less than 30 mL, the volume shall be expressed in milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL.

(ii) In expressing the reference amounts in grams, the following general rules shall be followed:

(A) For quantities greater than 10 g, the quantity shall be expressed in the nearest 5-g increment.

(B) For quantities less than 10 g, exact gram weights shall be used.

(11) A petition to create a new subcategory of food with its own reference amount shall include the following additional information:

(i) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the reference amount for the parent category to warrant a separate reference amount. Data must include sample size; and the mean, standard deviation, median, and modal consumed amount per eating occasion for the petitioned product and for other products in the category, excluding the petitioned product. All data must be derived from the same survey data.

(ii) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the petitioned product from the rest of the products in the category.

(12) A claim for categorical exclusion under § 25.30 or § 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter, and

(13) In conducting research to collect or process food consumption data in support of the petition, the following general guidelines should be followed.

(i) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.

(ii) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.

(iii) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.

(iv) The methodology used to collect or process data should be fully documented and should include: study design, sampling procedures, materials used (e.g., questionnaire, and interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse.

(14) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule consistent with the Negotiated Rulemaking Act (5 U.S.C. 561).

(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.

(b) A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under § 101.9 or under § 101.36 (that is, a nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation and with the applicable regulations in subpart D of this part or in part 105 or part 107 of this chapter.

(1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the food, e.g., “low sodium” or “contains 100 calories.”

(2) An implied nutrient content claim is any claim that:

(i) Describes the food or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or

(ii) Suggests that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”).

(3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on food intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of this chapter.

(4) Reasonable variations in the spelling of the terms defined in part 101 and their synonyms are permitted provided these variations are not misleading (e.g., “hi” or “lo”).

(5) For dietary supplements, claims for calories, fat, saturated fat, and cholesterol may not be made on products that meet the criteria in § 101.60(b)(1) or (b)(2) for “calorie free” or “low calorie” claims, except, in the case of calorie claims, when an equivalent amount of a similar dietary supplement (e.g., another protein supplement) that the labeled food resembles and for which it substitutes, normally exceeds the definition for “low calorie” in § 101.60(b)(2).

(c) Information that is required or permitted by § 101.9 or § 101.36, as applicable, to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims.

(d) A “substitute” food is one that may be used interchangeably with another food that it resembles, i.e., that it is organoleptically, physically, and functionally (including shelf life) similar to, and that it is not nutritionally inferior to unless it is labeled as an “imitation.”

(1) If there is a difference in performance characteristics that materially limits the use of the food, the food may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim as defined in paragraph (j)(2)(iii) of this section, informing the consumer of such difference (e.g., “not recommended for frying”).

(2) This disclaimer shall be in easily legible print or type and in a size no less than that required by § 101.7(i) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer shall be no less than one-half the size of the claim but no smaller than one-sixteenth of an inch, unless the package complies with § 101.2(c)(5), in which case the disclaimer may be in type of not less than one thirty-second of an inch.

(e)(1) Because the use of a “free” or “low” claim before the name of a food implies that the food differs from other foods of the same type by virtue of its having a lower amount of the nutrient, only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food, may bear such a claim (e.g., “low sodium potato chips”).

(2) Any claim for the absence of a nutrient in a food, or that a food is low in a nutrient when the food has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the food inherently meets the criteria and shall clearly refer to all foods of that type and not merely to the particular brand to which the labeling attaches (e.g., “corn oil, a sodium-free food”).

(f) A nutrient content claim shall be in type size no larger than two times the statement of identity and shall not be unduly prominent in type style compared to the statement of identity.

(g) [Reserved]

(h)(1) If a food, except a meal product as defined in § 101.13(l), a main dish product as defined in § 101.13(m), or food intended specifically for use by infants and children less than 2 years of age, contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium per reference amount customarily consumed, per labeled serving, or, for a food with a reference amount customarily consumed of 30 g or less or 2 tablespoons or less, per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50 g criterion refers to the “as prepared” form), then that food must bear a statement disclosing that the nutrient exceeding the specified level is present in the food as follows: “See nutrition information for __ content” with the blank filled in with the identity of the nutrient exceeding the specified level, e.g., “See nutrition information for fat content.”

(2) If a food is a meal product as defined in § 101.13(l), and contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg of sodium per labeled serving, then that food must disclose, in accordance with the requirements as provided in paragraph (h)(1) of this section, that the nutrient exceeding the specified level is present in the food.

(3) If a food is a main dish product as defined in § 101.13(m), and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol, or 720 mg of sodium per labeled serving, then that food must disclose, in accordance with the requirements as provided in paragraph (h)(1) of this section, that the nutrient exceeding the specified level is present in the food.

(4)(i) The disclosure statement “See nutrition information for __ content” shall be in easily legible boldface print or type, in distinct contrast to other printed or graphic matter, and in a size no less than that required by § 101.7(i) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclosure statement shall be no less than one-half the size of the claim but no smaller than one-sixteenth of an inch, unless the package complies with § 101.2(c)(2), in which case the disclosure statement may be in type of not less than one thirty-second of an inch.

(ii) The disclosure statement shall be immediately adjacent to the nutrient content claim and may have no intervening material other than, if applicable, other information in the statement of identity or any other information that is required to be presented with the claim under this section (e.g., see paragraph (j)(2) of this section) or under a regulation in subpart D of this part (e.g., see §§ 101.54 and 101.62). If the nutrient content claim appears on more than one panel of the label, the disclosure statement shall be adjacent to the claim on each panel except for the panel that bears the nutrition information where it may be omitted.

(iii) If a single panel of a food label or labeling contains multiple nutrient content claims or a single claim repeated several times, a single disclosure statement may be made. The statement shall be adjacent to the claim that is printed in the largest type on that panel.

(i) Except as provided in § 101.9 or § 101.36, as applicable, or in paragraph (q)(3) of this section, the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if:

(1) The use of the statement on the food implicitly characterizes the level of the nutrient in the food and is consistent with a definition for a claim, as provided in subpart D of this part, for the nutrient that the label addresses. Such a claim might be, “less than 3 g of fat per serving;”

(2) The use of the statement on the food implicitly characterizes the level of the nutrient in the food and is not consistent with such a definition, but the label carries a disclaimer adjacent to the statement that the food is not “low” in or a “good source” of the nutrient, such as “only 200 mg sodium per serving, not a low sodium food.” The disclaimer must be in easily legible print or type and in a size no less than that required by § 101.7(i) for the net quantity of contents statement except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer shall be no less than one-half the size of the claim but no smaller than one-sixteenth of an inch unless the package complies with § 101.2(c)(5), in which case the disclaimer may be in type of not less less than one thirty-second of an inch, or

(3) The statement does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect (e.g., “100 calories” or “5 grams of fat”), in which case no disclaimer is required.

(4) “Percent fat free” claims are not authorized by this paragraph. Such claims shall comply with § 101.62(b)(6).

(j) A food may bear a statement that compares the level of a nutrient in the food with the level of a nutrient in a reference food. These statements shall be known as “relative claims” and include “light,” “reduced,” “less” (or “fewer”), and “more” claims.

(1) To bear a relative claim about the level of a nutrient, the amount of that nutrient in the food must be compared to an amount of nutrient in an appropriate reference food as specified below.

(i)(A) For “less” (or “fewer”) and “more” claims, the reference food may be a dissimilar food within a product category that can generally be substituted for one another in the diet (e.g., potato chips as reference for pretzels, orange juice as a reference for vitamin C tablets) or a similar food (e.g., potato chips as reference for potato chips, one brand of multivitamin as reference for another brand of multivitamin).

(B) For “light,” “reduced,” “added,” “extra,” “plus,” “fortified,” and “enriched” claims, the reference food shall be a similar food (e.g., potato chips as a reference for potato chips, one brand of multivitamin for another brand of multivitamin), and

(ii)(A) For “light” claims, the reference food shall be representative of the type of food that includes the product that bears the claim. The nutrient value for the reference food shall be representative of a broad base of foods of that type; e.g., a value in a representative, valid data base; an average value determined from the top three national (or regional) brands, a market basket norm; or, where its nutrient value is representative of the food type, a market leader. Firms using such a reference nutrient value as a basis for a claim, are required to provide specific information upon which the nutrient value was derived, on request, to consumers and appropriate regulatory officials.

(B) For relative claims other than “light,” including “less” and “more” claims, the reference food may be the same as that provided for “light” in paragraph (j)(1)(ii)(A) of this section, or it may be the manufacturer's regular product, or that of another manufacturer, that has been offered for sale to the public on a regular basis for a substantial period of time in the same geographic area by the same business entity or by one entitled to use its trade name. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting label is internally consistent to (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information and the declaration of the percentage of nutrient by which the food has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.

(2) For foods bearing relative claims:

(i) The label or labeling must state the identity of the reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs (e.g., “50 percent less fat than (reference food)” or “1/3 fewer calories than (reference food)”),

(ii) This information shall be immediately adjacent to the most prominent claim. The type size shall be in accordance with paragraph (h)(4)(i) of this section.

(iii) The determination of which use of the claim is in the most prominent location on the label or labeling will be made based on the following factors, considered in order:

(A) A claim on the principal display panel adjacent to the statement of identity;

(B) A claim elsewhere on the principal display panel;

(C) A claim on the information panel; or

(D) A claim elsewhere on the label or labeling.

(iv) The label or labeling must also bear:

(A) Clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving with that in the reference food; and

(B) This statement shall appear adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(3) A relative claim for decreased levels of a nutrient may not be made on the label or in labeling of a food if the nutrient content of the reference food meets the requirement for a “low” claim for that nutrient (e.g., 3 g fat or less).

(k) The term “modified” may be used in the statement of identity of a food that bears a relative claim that complies with the requirements of this part, followed immediately by the name of the nutrient whose content has been altered (e.g., “Modified fat cheesecake”). This statement of identity must be immediately followed by the comparative statement such as “Contains 35 percent less fat than ___.” The label or labeling must also bear the information required by paragraph (j)(2) of this section in the manner prescribed.

(l) For purposes of making a claim, a “meal product shall be defined as a food that:

(1) Makes a major contribution to the total diet by:

(i) Weighing at least 10 ounces (oz) per labeled serving; and

(ii) Containing not less than three 40-g portions of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (l)(1)(ii)(E) of this section.

(A) Bread, cereal, rice, and pasta group;

(B) Fruits and vegetables group;

(C) Milk, yogurt, and cheese group;

(D) Meat, poultry, fish, dry beans, eggs, and nuts group; except that;

(E) These foods shall not be sauces (except for foods in the above four food groups that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings or garnishes; and

(2) Is represented as, or is in a form commonly understood to be, a breakfast, lunch, dinner, or meal. Such representations may be made either by statements, photographs, or vignettes.

(m) For purposes of making a claim, a “main dish product” shall be defined as a food that:

(1) Makes a major contribution to a meal by

(i) Weighing at least 6 oz per labeled serving; and

(ii) Containing not less than 40 g of food, or combinations of foods, from each of at least two of the following four food groups, except as noted in paragraph (m)(1)(ii)(E) of this section.

(A) Bread, cereal, rice, and pasta group;

(B) Fruits and vegetables group;

(C) Milk, yogurt, and cheese group;

(D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except that:

(E) These foods shall not be sauces (except for foods in the above four food groups that are in the sauces) gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and

(2) Is represented as, or is in a form commonly understood to be, a main dish (e.g, not a beverage or a dessert). Such representations may be made either by statements, photographs, or vignettes.

(n) Nutrition labeling in accordance with § 101.9, § 101.10, or § 101.36, as applicable, shall be provided for any food for which a nutrient content claim is made.

(o) Except as provided in § 101.10, compliance with requirements for nutrient content claims in this section and in the regulations in subpart D of this part, will be determined using the analytical methodology prescribed for determining compliance with nutrition labeling in § 101.9.

(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in § 101.12(b) through (f) shall be used in determining whether a product meets the criteria for a nutrient content claim. If the serving size declared on the product label differs from the reference amount customarily consumed, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by § 101.12(g) (e.g., “very low sodium, 35 mg or less per 240 milliliters (8 fl oz.)”).

(2) The criteria for the claim shall be immediately adjacent to the most prominent claim in easily legible print or type and in a size in accordance with paragraph (h)(4)(i) of this section.

(q) The following exemptions apply:

(1) Nutrient content claims that have not been defined by regulation and that are contained in the brand name of a specific food product that was the brand name in use on such food before October 25, 1989, may continue to be used as part of that brand name for such product, provided that they are not false or misleading under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act). However, foods bearing such claims must comply with section 403(f), (g), and (h) of the act;

(2) A soft drink that used the term diet as part of its brand name before October 25, 1989, and whose use of that term was in compliance with § 105.66 of this chapter as that regulation appeared in the Code of Federal Regulations on that date, may continue to use that term as part of its brand name, provided that its use of the term is not false or misleading under section 403(a) of the act. Such claims are exempt from the requirements of section 403(r)(2) of the act (e.g., the disclosure statement also required by § 101.13(h)). Soft drinks marketed after October 25, 1989, may use the term “diet” provided they are in compliance with the current § 105.66 of this chapter and the requirements of § 101.13.

(3)(i) A statement that describes the percentage of a vitamin or mineral in the food, including foods intended specifically for use by infants and children less than 2 years of age, in relation to a Reference Daily Intake (RDI) as defined in § 101.9 may be made on the label or in labeling of a food without a regulation authorizing such a claim for a specific vitamin or mineral unless such claim is expressly prohibited by regulation under section 403(r)(2)(A)(vi) of the act.

(ii) Percentage claims for dietary supplements. Under section 403(r)(2)(F) of the act, a statement that characterizes the percentage level of a dietary ingredient for which a reference daily intake (RDI) or daily reference value (DRV) has not been established may be made on the label or in labeling of dietary supplements without a regulation that specifically defines such a statement. All such claims shall be accompanied by any disclosure statement required under paragraph (h) of this section.

(A) Simple percentage claims. Whenever a statement is made that characterizes the percentage level of a dietary ingredient for which there is no RDI or DRV, the statement of the actual amount of the dietary ingredient per serving shall be declared next to the percentage statement (e.g., “40 percent omega-3 fatty acids, 10 mg per capsule”).

(B) Comparative percentage claims. Whenever a statement is made that characterizes the percentage level of a dietary ingredient for which there is no RDI or DRV and the statement draws a comparison to the amount of the dietary ingredient in a reference food, the reference food shall be clearly identified, the amount of that food shall be identified, and the information on the actual amount of the dietary ingredient in both foods shall be declared in accordance with paragraph (j)(2)(iv) of this section (e.g., “twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)”).

(4) The requirements of this section do not apply to:

(i) Infant formulas subject to section 412(h) of the act; and

(ii) Medical foods defined by section 5(b) of the Orphan Drug Act.

(5) A nutrient content claim used on food that is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments shall comply with the requirements of this section and the appropriate definition in subpart D of this part, except that:

(i) Such claim is exempt from the requirements for disclosure statements in paragraph (h) of this section and §§ 101.54(d), 101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and (d)(5)(ii)(C); and

(ii) In lieu of analytical testing, compliance may be determined using a reasonable basis for concluding that the food that bears the claim meets the definition for the claim. This reasonable basis may derive from recognized data bases for raw and processed foods, recipes, and other means to compute nutrient levels in the foods or meals and may be used provided reasonable steps are taken to ensure that the method of preparation adheres to the factors on which the reasonable basis was determined (e.g., types and amounts of ingredients, cooking temperatures, etc.). Firms making claims on foods based on this reasonable basis criterion are required to provide to appropriate regulatory officials on request the specific information on which their determination is based and reasonable assurance of operational adherence to the preparation methods or other basis for the claim; and

(iii) A term or symbol that may in some contexts constitute a claim under this section may be used, provided that the use of the term or symbol does not characterize the level of a nutrient, and a statement that clearly explains the basis for the use of the term or symbol is prominently displayed and does not characterize the level of a nutrient. For example, a term such as “lite fare” followed by an asterisk referring to a note that makes clear that in this restaurant “lite fare” means smaller portion sizes than normal; or an item bearing a symbol referring to a note that makes clear that this item meets the criteria for the dietary guidance established by a recognized dietary authority would not be considered a nutrient content claim under § 101.13.

(6) Nutrient content claims that were part of the common or usual names of foods that were subject to a standard of identity on November 8, 1990, are not subject to the requirements of paragraphs (b) and (h) of this section or to definitions in subpart D of this part.

(7) Implied nutrient content claims may be used as part of a brand name, provided that the use of the claim has been authorized by the Food and Drug Administration. Petitions requesting approval of such a claim may be submitted under § 101.69(o).

(8) The term fluoridated, fluoride added or with added fluoride may be used on the label or in labeling of bottled water that contains added fluoride.

(a) Definitions. For purposes of this section, the following definitions apply:

(1) Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition.

(2) Substance means a specific food or component of food, regardless of whether the food is in conventional food form or a dietary supplement that includes vitamins, minerals, herbs, or other similar nutritional substances.

(3) Nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.

(4) Disqualifying nutrient levels means the levels of total fat, saturated fat, cholesterol, or sodium in a food above which the food will be disqualified from making a health claim. These levels are 13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium, per reference amount customarily consumed, per label serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tablespoons or less, per 50 g. For dehydrated foods that must have water added to them prior to typical consumption, the per 50-g criterion refers to the as prepared form. Any one of the levels, on a per reference amount customarily consumed, a per label serving size or, when applicable, a per 50 g basis, will disqualify a food from making a health claim unless an exception is provided in subpart E of this part, except that:

(i) The levels for a meal product as defined in § 101.13(l) are 26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg of sodium per label serving size, and

(ii) The levels for a main dish product as defined in § 101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol, or 720 mg of sodium per label serving size.

(5) Disease or health-related condition means damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition (claims pertaining to such diseases are thereby not subject to § 101.14 or § 101.70).

(b) Eligibility. For a substance to be eligible for a health claim:

(1) The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup (e.g., the elderly) is at risk, or, alternatively, the petition submitted by the proponent of the claim otherwise explains the prevalence of the disease or health-related condition in the U.S. population and the relevance of the claim in the context of the total daily diet and satisfies the other requirements of this section.

(2) If the substance is to be consumed as a component of a conventional food at decreased dietary levels, the substance must be a nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the Food and Drug Administration (FDA) has required to be included in the label or labeling under 21 U.S.C. 343(q)(2)(A); or

(3) If the substance is to be consumed at other than decreased dietary levels:

(i) The substance must, regardless of whether the food is a conventional food or a dietary supplement, contribute taste, aroma, or nutritive value, or any other technical effect listed in § 170.3(o) of this chapter, to the food and must retain that attribute when consumed at levels that are necessary to justify a claim; and

(ii) The substance must be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act.

(c) Validity requirement. FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.

(d) General health claim labeling requirements. (1) When FDA determines that a health claim meets the validity requirements of paragraph (c) of this section, FDA will propose a regulation in subpart E of this part to authorize the use of that claim. If the claim pertains to a substance not provided for in § 101.9 or § 101.36, FDA will propose amending that regulation to include declaration of the substance.

(2) When FDA has adopted a regulation in subpart E of this part providing for a health claim, firms may make claims based on the regulation in subpart E of this part, provided that:

(i) All label or labeling statements about the substance-disease relationship that is the subject of the claim are based on, and consistent with, the conclusions set forth in the regulations in subpart E of this part;

(ii) The claim is limited to describing the value that ingestion (or reduced ingestion) of the substance, as part of a total dietary pattern, may have on a particular disease or health-related condition;

(iii) The claim is complete, truthful, and not misleading. Where factors other than dietary intake of the substance affect the relationship between the substance and the disease or health-related condition, such factors may be required to be addressed in the claim by a specific regulation in subpart E of this part;

(iv) All information required to be included in the claim appears in one place without other intervening material, except that the principal display panel of the label or labeling may bear the reference statement, “See ___ for information about the relationship between ___ and ___,” with the blanks filled in with the location of the labeling containing the health claim, the name of the substance, and the disease or health-related condition (e.g., “See attached pamphlet for information about calcium and osteoporosis”), with the entire claim appearing elsewhere on the other labeling, Provided that, where any graphic material (e.g., a heart symbol) constituting an explicit or implied health claim appears on the label or labeling, the reference statement or the complete claim shall appear in immediate proximity to such graphic material;

(v) The claim enables the public to comprehend the information provided and to understand the relative significance of such information in the context of a total daily diet; and

(vi) If the claim is about the effects of consuming the substance at decreased dietary levels, the level of the substance in the food is sufficiently low to justify the claim. To meet this requirement, if a definition for use of the term low has been established for that substance under this part, the substance must be present at a level that meets the requirements for use of that term, unless a specific alternative level has been established for the substance in subpart E of this part. If no definition for “low” has been established, the level of the substance must meet the level established in the regulation authorizing the claim; or

(vii) If the claim is about the effects of consuming the substance at other than decreased dietary levels, the level of the substance is sufficiently high and in an appropriate form to justify the claim. To meet this requirement, if a definition for use of the term high for that substance has been established under this part, the substance must be present at a level that meets the requirements for use of that term, unless a specific alternative level has been established for the substance in subpart E of this part. If no definition for “high” has been established (e.g., where the claim pertains to a food either as a whole food or as an ingredient in another food), the claim must specify the daily dietary intake necessary to achieve the claimed effect, as established in the regulation authorizing the claim; Provided That:

(A) Where the food that bears the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its reference amount customarily consumed, and the labeled serving size differs from that amount, the claim shall be followed by a statement explaining that the claim is based on the reference amount rather than the labeled serving size (e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors. A serving of _ ounces of this product conforms to such a diet.”).

(B) Where the food that bears the claim is sold in a restaurant or in other establishments in which food that is ready for immediate human consumption is sold, the food can meet the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the food has a reasonable basis on which to believe that the food that bears the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) of this section and provides that basis upon request.

(3) Nutrition labeling shall be provided in the label or labeling of any food for which a health claim is made in accordance with § 101.9; for restaurant foods, in accordance with § 101.10; or for dietary supplements, in accordance with § 101.36.

(e) Prohibited health claims. No expressed or implied health claim may be made on the label or in labeling for a food, regardless of whether the food is in conventional food form or dietary supplement form, unless:

(1) The claim is specifically provided for in subpart E of this part; and

(2) The claim conforms to all general provisions of this section as well as to all specific provisions in the appropriate section of subpart E of this part;

(3) None of the disqualifying levels identified in paragraph (a)(4) of this section is exceeded in the food, unless specific alternative levels have been established for the substance in subpart E of this part; or unless FDA has permitted a claim despite the fact that a disqualifying level of a nutrient is present in the food based on a finding that such a claim will assist consumers in maintaining healthy dietary practices, and, in accordance with the regulation in subpart E of this part that makes such a finding, the label bears a disclosure statement that complies with § 101.13(h), highlighting the nutrient that exceeds the disqualifying level;

(4) Except as provided in paragraph (e)(3) of this section, no substance is present at an inappropriate level as determined in the specific provision authorizing the claim in subpart E of this part;

(5) The label does not represent or purport that the food is for infants and toddlers less than 2 years of age except if the claim is specifically provided for in subpart E of this part; and

(6) Except for dietary supplements or where provided for in other regulations in part 101, subpart E, the food contains 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition.

(f) The requirements of this section do not apply to:

(1) Infant formulas subject to section 412(h) of the Federal Food, Drug, and Cosmetic Act, and

(2) Medical foods defined by section 5(b) of the Orphan Drug Act.

(g) Applicability. The requirements of this section apply to foods intended for human consumption that are offered for sale, regardless of whether the foods are in conventional food form or dietary supplement form.

(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of:

(1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

(3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

(4) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 403 (e) or (i) of the act, shall apply if such insufficiency is caused by:

(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(2) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 403(f) of the act; or

(3) The use of label space for any representation in a foreign language.

(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.

(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language: Provided, however, That individual serving-size packages of foods containing no more than 1 1/2 avoirdupois ounces or no more than 1 1/2 fluid ounces served with meals in restaurants, institutions, and passenger carriers and not intended for sale at retail are exempt from the requirements of this paragraph (c)(2), if the only representation in the foreign language(s) is the name of the food.

(3) If any article of labeling (other than a label) contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on such article of labeling.

(a) Self-pressurized containers. (1) The label of a food packaged in a self-pressurized container and intended to be expelled from the package under pressure shall bear the following warning:

(2) In the case of products intended for use by children, the phrase “except under adult supervision” may be added at the end of the last sentence in the warning required by paragraph (a)(1) of this section.

(3) In the case of products packaged in glass containers, the word “break” may be substituted for the word “puncture” in the warning required by paragraph (a)(1) of this section.

(4) The words “Avoid spraying in eyes” may be deleted from the warning required by paragraph (a)(1) of this section in the case of a product not expelled as a spray.

(b) Self-pressurized containers with halocarbon or hydrocarbon propellants. (1) In addition to the warning required by paragraph (a) of this section, the label of a food packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or a hydrocarbon shall bear the following warning:

(2) The warning required by paragraph (b)(1) of this section is not required for the following products:

(i) Products expelled in the form of a foam or cream, which contain less than 10 percent propellant in the container.

(ii) Products in a container with a physical barrier that prevents escape of the propellant at the time of use.

(iii) Products of a net quantity of contents of less than 2 ounces that are designed to release a measured amount of product with each valve actuation.

(iv) Products of a net quantity of contents of less than one-half ounce.

(c) Food containing or manufactured with a chlorofluorocarbon or other ozone-depleting substance. Labeling requirements for foods that contain or are manufactured with a chlorofluorocarbon or other ozone-depleting substance designated by the Environmental Protection Agency (EPA) are set forth in 40 CFR part 82.

(d) Protein products. (1) The label and labeling of any food product in liquid, powdered, tablet, capsule, or similar forms that derives more than 50 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, and that is represented for use in reducing weight shall bear the following warning:

(2) Products described in paragraph (d)(1) of this section are exempt from the labeling requirements of that paragraph if the protein products are represented as part of a nutritionally balanced diet plan providing 400 or more Calories (kilocalories) per day and the label or labeling of the product specifies the diet plan in detail or provides a brief description of that diet plan and adequate information describing where the detailed diet plan may be obtained and the label and labeling bear the following statement:

(3) The label and labeling of food products represented or intended for dietery (food) supplementation that derive more than 50 percent of their total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, that are represented specifically for purposes other than weight reduction; and that are not covered by the requirements of paragraph (d) (1) and (2) of this section; shall bear the following statement:

(4) The provisions of this paragraph are separate from and in addition to any labeling requirements promulgated by the Federal Trade Commission for protein supplements.

(5) Protein products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to consumers in such container are exempt from the labeling requirements of this paragraph.

(6) The warning and notice statements required by paragraphs (d) (1), (2), and (3) of this section shall appear prominently and conspicuously on the principal display panel of the package label and any other labeling.

(e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement:

(2)(i) The warning statement required by paragraph (e)(1) of this section shall appear prominently and conspicuously on the information panel of the immediate container label.

(ii) If a product is packaged in unit-dose packaging, and if the immediate container bears labeling but not a label, the warning statement required by paragraph (e)(1) of this section shall appear prominently and conspicuously on the immediate container labeling in a way that maximizes the likelihood that the warning is intact until all of the dosage units to which it applies are used.

(3) Where the immediate container is not the retail package, the warning statement required by paragraph (e)(1) of this section shall also appear prominently and conspicuously on the information panel of the retail package label.

(4) The warning statement shall appear on any labeling that contains warnings.

(5) The warning statement required by paragraph (e)(1) of this section shall be set off in a box by use of hairlines.

(f) Foods containing psyllium husk. (1) Foods containing dry or incompletely hydrated psyllium husk, also known as psyllium seed husk, and bearing a health claim on the association between soluble fiber from psyllium husk and reduced risk of coronary heart disease, shall bear a label statement informing consumers that the appropriate use of such foods requires consumption with adequate amounts of fluids, alerting them of potential consequences of failing to follow usage recommendations, and informing persons with swallowing difficulties to avoid consumption of the product (e.g., “NOTICE: This food should be eaten with at least a full glass of liquid. Eating this product without enough liquid may cause choking. Do not eat this product if you have difficulty in swallowing.”). However, a product in conventional food form may be exempt from this requirement if a viscous adhesive mass is not formed when the food is exposed to fluids.

(2) The statement shall appear prominently and conspicuously on the information panel or principal display panel of the package label and any other labeling to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. The statement shall be preceded by the word “NOTICE” in capital letters.

(g) Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens. (1) For purposes of this paragraph (g), “juice” means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrate of such liquid or puree.

(2) The label of:

(i) Any juice that has not been processed in the manner described in paragraph (g)(7) of this section; or

(ii) Any beverage containing juice where neither the juice ingredient nor the beverage has been processed in the manner described in paragraph (g)(7) of this section, shall bear the following warning statement:

(3) The warning statement required by this paragraph (g) shall not apply to juice that is not for distribution to retail consumers in the form shipped and that is for use solely in the manufacture of other foods or that is to be processed, labeled, or repacked at a site other than originally processed, provided that for juice that has not been processed in the manner described in paragraph (g)(7) of this section, the lack of such processing is disclosed in documents accompanying the juice, in accordance with the practice of the trade.

(4) The warning statement required by paragraph (g)(2) of this section shall appear prominently and conspicuously on the information panel or on the principal display panel of the label of the container.

(5) The word “WARNING” shall be capitalized and shall appear in bold type.

(6) The warning statement required by paragraph (g)(2) of this section, when on a label, shall be set off in a box by use of hairlines.

(7)(i) The requirements in this paragraph (g) shall not apply to a juice that has been processed in a manner that will produce, at a minimum, a reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, of the following magnitude:

(A) A 5-log (i.e., 100,000-fold) reduction; or

(B) A reduction that is equal to, or greater than, the criterion established for process controls by any final regulation requiring the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of juice.

(ii) For the purposes of this paragraph (g), the “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice.

(h) Shell eggs. (1) The label of all shell eggs, whether in intrastate or interstate commerce, shall bear the following statement:

(2) The label statement required by paragraph (h)(1) of this section shall appear prominently and conspicuously, with the words “SAFE HANDLING INSTRUCTIONS” in bold type, on the principal display panel, the information panel, or on the inside of the lid of egg cartons. If this statement appears on the inside of the lid, the words “Keep Refrigerated” must appear on the principal display panel or information panel.

(3) The label statement required by paragraph (h)(1) of this section shall be set off in a box by use of hairlines.

(4) Shell eggs that have been, before distribution to consumers, specifically processed to destroy all viable Salmonella shall be exempt from the requirements of paragraph (h) of this section.

(5) The safe handling statement for shell eggs that are not for direct sale to consumers, e.g., those that are to be repacked or labeled at a site other than where originally processed, or are sold for use in food service establishments, may be provided on cartons or in labeling, e.g., invoices or bills of lading in accordance with the practice of the trade.

(6) Under sections 311 and 361 of the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the agency in the enforcement of paragraphs (h)(1) through (h)(5) of this section, and is authorized to inspect or regulate establishments handling packed shell eggs, may in its own jurisdiction, enforce paragraphs (h)(1) through (h)(5) of this section through inspections under paragraph (h)(8) of this section and through administrative enforcement remedies identified in paragraph (h)(7) of this section until FDA notifies the State or locality in writing that such assistance is no longer needed. When providing such assistance, a State or locality may follow the hearing procedures set out in paragraphs (h)(7)(ii)(C) through (h)(7)(ii)(D) of this section, substituting, where necessary, appropriate State or local officials for designated FDA officials or may utilize State or local hearing procedures if such procedures satisfy due process.

(7) This paragraph (h) is established under authority of both the Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under the act, the agency can enforce the food misbranding provisions under 21 U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance of implementing enforcement regulations; therefore, FDA has established the following administrative enforcement procedures for the relabeling, diversion, or destruction of shell eggs and informal hearings under the PHS Act:

(i) Upon finding that any shell eggs are in violation of this section an authorized FDA representative or State or local representative in accordance with paragraph (h)(6) of this section may order such eggs to be relabeled under the supervision of said representative, diverted, under the supervision of said representative for processing in accordance with the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.), or destroyed by or under the supervision of an officer or employee of the FDA, or, if applicable, of the State or locality, in accordance with the following procedures:

(A) Order for relabeling, diversion, or destruction under the PHS Act. Any district office of the FDA or any State or locality acting under paragraph (h)(6) of this section, upon finding shell eggs held in violation of this regulation, may serve upon the person in whose possession such eggs are found a written order that such eggs be relabeled with the required statement in paragraph (h)(1) of this section before further distribution. If the person chooses not to relabel, the district office of the FDA or, if applicable, the appropriate State or local agency may serve upon the person a written order that such eggs be diverted (from direct consumer sale, e.g., to food service) under the supervision of an officer or employee of the issuing entity, for processing in accordance with the EPIA (21 U.S.C. 1031 et seq.) or destroyed by or under the supervision of the issuing entity, within 10-working days from the date of receipt of the order.

(B) Issuance of order. The order shall include the following information:

(1) A statement that the shell eggs identified in the order are subject to relabeling, diversion for processing in accordance with the EPIA, or destruction;

(2) A detailed description of the facts that justify the issuance of the order;

(3) The location of the eggs;

(4) A statement that these eggs shall not be sold, distributed, or otherwise disposed of or moved except as provided in paragraph (h)(7)(i)(E) of this section;

(5) Identification or description of the eggs;

(6) The order number;

(7) The date of the order;

(8) The text of this entire section;

(9) A statement that the order may be appealed by written appeal or by requesting an informal hearing;

(10) The name and phone number of the person issuing the order; and

(11) The location and telephone number of the responsible office or agency and the name of its director.

(C) Approval of director. An order, before issuance, shall be approved by the director of the office or agency issuing the order. If prior written approval is not feasible, prior oral approval shall be obtained and confirmed by written memorandum as soon as possible.

(D) Labeling or marking of shell eggs under order. An FDA, State, or local representative issuing an order under paragraph (h)(7)(i)(A) of this section shall label or mark the shell eggs with official tags that include the following information:

(1) A statement that the shell eggs are detained in accordance with regulations issued under section 361(a) of the PHS Act (42 U.S.C. 264(a)).

(2) A statement that the shell eggs shall not be sold, distributed or otherwise disposed of or moved except, after notifying the issuing entity in writing, to:

(i) Relabel, divert them for processing in accordance with the EPIA, or destroy them, or

(ii) Move them to another location for holding pending appeal.

(3) A statement that the violation of the order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 368 of the PHS Act, 42 U.S.C. 271).

(4) The order number and the date of the order, and the name of the government representative who issued the order.

(E) Sale or other disposition of shell eggs under order. After service of the order, the person in possession of the shell eggs that are the subject of the order shall not sell, distribute, or otherwise dispose of or move any eggs subject to the order unless and until the notice is withdrawn after an appeal except, after notifying FDA's district office or, if applicable, the State or local agency in writing, to:

(1) Relabel, divert, or destroy them as specified in paragraph (h)(7)(i) of this section, or

(2) Move them to another location for holding pending appeal.

(ii) The person on whom the order for relabeling, diversion, or destruction is served may either comply with the order or appeal the order to an Office of Regulatory Affairs Program Director.

(A) Appeal of a detention order. Any appeal shall be submitted in writing to the FDA District Director in whose district the shell eggs are located within 5-working days of the issuance of the order. If the appeal includes a request for an informal hearing, the hearing shall be held within 5-working days after the appeal is filed or, if requested by the appellant, at a later date, which shall not be later than 20-calendar days after the issuance of the order. The order may also be appealed within the same period of 5-working days by any other person having an ownership or proprietary interest in such shell eggs. The appellant of an order shall state the ownership or proprietary interest the appellant has in the shell eggs.

(B) Summary decision. A request for a hearing may be denied, in whole or in part and at any time after a request for a hearing has been submitted, if the Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director determines that no genuine and substantial issue of fact has been raised by the material submitted in connection with the hearing or from matters officially noticed. If the presiding FDA official determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.

(C) Informal hearing. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The informal hearing shall be conducted by an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director, and a written summary of the proceedings shall be prepared by the presiding FDA official.

(1) The presiding FDA official may direct that the hearing be conducted in any suitable manner permitted by law and this section. The presiding FDA official has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct an informal, fair, expeditious, and impartial hearing, and to enforce the requirements concerning the conduct of hearings.

(2) Employees of FDA will first give a full and complete statement of the action which is the subject of the hearing, together with the information and reasons supporting it, and may present oral or written information relevant to the hearing. The party requesting the hearing may then present oral or written information relevant to the hearing. All parties may conduct reasonable examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing.

(3) The hearing shall be informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views will be made or considered, but any party may comment upon or rebut any information and views presented by another party.

(4) The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding FDA official's report of the hearing.

(5) The presiding FDA official shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the presiding FDA official may give the parties the opportunity to review and comment on the report of the hearing.

(6) The presiding FDA official shall include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a statement of reasons.

(D) Written appeal. If the appellant appeals the detention order but does not request a hearing, the presiding FDA official shall render a decision on the appeal affirming or revoking the detention within 5-working days after the receipt of the appeal.

(E) Presiding FDA official's decision. If, based on the evidence presented at the hearing or by the appellant in a written appeal, the presiding FDA official finds that the shell eggs were held in violation of this section, he shall affirm the order that they be relabeled, diverted under the supervision of an officer or employee of FDA for processing under the EPIA, or destroyed by or under the supervision of an officer or employee of FDA; otherwise, the presiding FDA official shall issue a written notice that the prior order is withdrawn. If the presiding FDA official affirms the order, he shall order that the relabeling, diversion, or destruction be accomplished within 10-working days from the date of the issuance of his decision. The presiding FDA official's decision shall be accompanied by a statement of the reasons for the decision. The decision of the presiding FDA official shall constitute final agency action, reviewable in the courts.

(F) No appeal. If there is no appeal of the order and the person in possession of the shell eggs that are subject to the order fails to relabel, divert, or destroy them within 10-working days, or if the demand is affirmed by the presiding FDA official after an appeal and the person in possession of such eggs fails to relabel, divert, or destroy them within 10-working days, the FDA district office, or, if applicable, the State or local agency may designate an officer or employee to divert or destroy such eggs. It shall be unlawful to prevent or to attempt to prevent such diversion or destruction of the shell eggs by the designated officer or employee.

(8) Persons engaged in handling or storing packed shell eggs for retail distribution shall permit authorized representatives of FDA to make at any reasonable time such inspection of the establishment in which shell eggs are being held, including inspection and sampling of the labeling of such eggs as may be necessary in the judgment of such representatives to determine compliance with the provisions of this section. Inspections may be made with or without notice and will ordinarily be made during regular business hours.

(9) No State or local governing entity shall establish or continue in effect any law, rule, regulation, or other requirement requiring safe handling instructions on unpasteurized shell eggs that are less stringent than those required in paragraphs (h)(1) through (h)(5) of this section.

(a) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic.

(b) The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.

(c) Among representations in the labeling of a food which render such food misbranded is any representation that expresses or implies a geographical origin of the food or any ingredient of the food except when such representation is either:

(1) A truthful representation of geographical origin.

(2) A trademark or trade name provided that as applied to the article in question its use is not deceptively misdescriptive. A trademark or trade name composed in whole or in part of geographical words shall not be considered deceptively misdescriptive if it:

(i) Has been so long and exclusively used by a manufacturer or distributor that it is generally understood by the consumer to mean the product of a particular manufacturer or distributor; or

(ii) Is so arbitrary or fanciful that it is not generally understood by the consumer to suggest geographic origin.

(3) A part of the name required by applicable Federal law or regulation.

(4) A name whose market significance is generally understood by the consumer to connote a particular class, kind, type, or style of food rather than to indicate geographical origin.

(a)(1) The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes the substances listed in §§ 172.515(b) and 182.60 of this chapter except where these are derived from natural sources.

(2) The term spice means any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose significant function in food is seasoning rather than nutritional; that is true to name; and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in § 182.10 and part 184 of this chapter, such as the following:

(3) The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in §§ 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in § 172.510 of this chapter.

(4) The term artificial color or artificial coloring means any “color additive” as defined in § 70.3(f) of this chapter.

(5) The term chemical preservative means any chemical that, when added to food, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices, substances added to food by direct exposure thereof to wood smoke, or chemicals applied for their insecticidal or herbicidal properties.

(b) A food which is subject to the requirements of section 403(k) of the act shall bear labeling, even though such food is not in package form.

(c) A statement of artificial flavoring, artificial coloring, or chemical preservative shall be placed on the food or on its container or wrapper, or on any two or all three of these, as may be necessary to render such statement likely to be read by the ordinary person under customary conditions of purchase and use of such food. The specific artificial color used in a food shall be identified on the labeling when so required by regulation in part 74 of this chapter to assure safe conditions of use for the color additive.

(d) A food shall be exempt from compliance with the requirements of section 403(k) of the act if it is not in package form and the units thereof are so small that a statement of artificial flavoring, artificial coloring, or chemical preservative, as the case may be, cannot be placed on such units with such conspicuousness as to render it likely to be read by the ordinary individual under customary conditions of purchase and use.

(e) A food shall be exempt while held for sale from the requirements of section 403(k) of the act (requiring label statement of any artificial flavoring, artificial coloring, or chemical preservatives) if said food, having been received in bulk containers at a retail establishment, is displayed to the purchaser with either (1) the labeling of the bulk container plainly in view or (2) a counter card, sign, or other appropriate device bearing prominently and conspicuously the information required to be stated on the label pursuant to section 403(k).

(f) A fruit or vegetable shall be exempt from compliance with the requirements of section 403(k) of the act with respect to a chemical preservative applied to the fruit or vegetable as a pesticide chemical prior to harvest.

(g) A flavor shall be labeled in the following way when shipped to a food manufacturer or processor (but not a consumer) for use in the manufacture of a fabricated food, unless it is a flavor for which a standard of identity has been promulgated, in which case it shall be labeled as provided in the standard:

(1) If the flavor consists of one ingredient, it shall be declared by its common or usual name.

(2) If the flavor consists of two or more ingredients, the label either may declare each ingredient by its common or usual name or may state “All flavor ingredients contained in this product are approved for use in a regulation of the Food and Drug Administration.” Any flavor ingredient not contained in one of these regulations, and any nonflavor ingredient, shall be separately listed on the label.

(3) In cases where the flavor contains a solely natural flavor(s), the flavor shall be so labeled, e.g., “strawberry flavor”, “banana flavor”, or “natural strawberry flavor”. In cases where the flavor contains both a natural flavor and an artificial flavor, the flavor shall be so labeled, e.g., “natural and artificial strawberry flavor”. In cases where the flavor contains a solely artificial flavor(s), the flavor shall be so labeled, e.g., “artificial strawberry flavor”.

(h) The label of a food to which flavor is added shall declare the flavor in the statement of ingredients in the following way:

(1) Spice, natural flavor, and artificial flavor may be declared as “spice”, “natural flavor”, or “artificial flavor”, or any combination thereof, as the case may be.

(2) An incidental additive in a food, originating in a spice or flavor used in the manufacture of the food, need not be declared in the statement of ingredients if it meets the requirements of § 101.100(a)(3).

(3) Substances obtained by cutting, grinding, drying, pulping, or similar processing of tissues derived from fruit, vegetable, meat, fish, or poultry, e.g., powdered or granulated onions, garlic powder, and celery powder, are commonly understood by consumers to be food rather than flavor and shall be declared by their common or usual name.

(4) Any salt (sodium chloride) used as an ingredient in food shall be declared by its common or usual name “salt.”

(5) Any monosodium glutamate used as an ingredient in food shall be declared by its common or usual name “monosodium glutamate.”

(6) Any pyroligneous acid or other artificial smoke flavors used as an ingredient in a food may be declared as artificial flavor or artificial smoke flavor. No representation may be made, either directly or implied, that a food flavored with pyroligneous acid or other artificial smoke flavor has been smoked or has a true smoked flavor, or that a seasoning sauce or similar product containing pyroligneous acid or other artificial smoke flavor and used to season or flavor other foods will result in a smoked product or one having a true smoked flavor.

(7) Because protein hydrolysates function in foods as both flavorings and flavor enhancers, no protein hydrolysate used in food for its effects on flavor may be declared simply as “flavor,” “natural flavor,” or “flavoring.” The ingredient shall be declared by its specific common or usual name as provided in § 102.22 of this chapter.

(i) If the label, labeling, or advertising of a food makes any direct or indirect representations with respect to the primary recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, or other means, or if for any other reason the manufacturer or distributor of a food wishes to designate the type of flavor in the food other than through the statement of ingredients, such flavor shall be considered the characterizing flavor and shall be declared in the following way:

(1) If the food contains no artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name of the characterizing flavor, e.g., “vanilla”, in letters not less than one-half the height of the letters used in the name of the food, except that:

(i) If the food is one that is commonly expected to contain a characterizing food ingredient, e.g., strawberries in “strawberry shortcake”, and the food contains natural flavor derived from such ingredient and an amount of characterizing ingredient insufficient to independently characterize the food, or the food contains no such ingredient, the name of the characterizing flavor may be immediately preceded by the word “natural” and shall be immediately followed by the word “flavored” in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., “natural strawberry flavored shortcake,” or “strawberry flavored shortcake”.

(ii) If none of the natural flavor used in the food is derived from the product whose flavor is simulated, the food in which the flavor is used shall be labeled either with the flavor of the product from which the flavor is derived or as “artificially flavored.”

(iii) If the food contains both a characterizing flavor from the product whose flavor is simulated and other natural flavor which simulates, resembles or reinforces the characterizing flavor, the food shall be labeled in accordance with the introductory text and paragraph (i)(1)(i) of this section and the name of the food shall be immediately followed by the words “with other natural flavor” in letters not less than one-half the height of the letters used in the name of the characterizing flavor.

(2) If the food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) “artificial” or “artificially flavored”, in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., “artificial vanilla”, “artificially flavored strawberry”, or “grape artificially flavored”.

(3) Wherever the name of the characterizing flavor appears on the label (other than in the statement of ingredients) so conspicuously as to be easily seen under customary conditions of purchase, the words prescribed by this paragraph shall immediately and conspicuously precede or follow such name, without any intervening written, printed, or graphic matter, except:

(i) Where the characterizing flavor and a trademark or brand are presented together, other written, printed, or graphic matter that is a part of or is associated with the trademark or brand may intervene if the required words are in such relationship with the trademark or brand as to be clearly related to the characterizing flavor; and

(ii) If the finished product contains more than one flavor subject to the requirements of this paragraph, the statements required by this paragraph need appear only once in each statement of characterizing flavors present in such food, e.g., “artificially flavored vanilla and strawberry”.

(iii) If the finished product contains three or more distinguishable characterizing flavors, or a blend of flavors with no primary recognizable flavor, the flavor may be declared by an appropriately descriptive generic term in lieu of naming each flavor, e.g., “artificially flavored fruit punch”.

(4) A flavor supplier shall certify, in writing, that any flavor he supplies which is designated as containing no artificial flavor does not, to the best of his knowledge and belief, contain any artificial flavor, and that he has added no artificial flavor to it. The requirement for such certification may be satisfied by a guarantee under section 303(c)(2) of the act which contains such a specific statement. A flavor user shall be required to make such a written certification only where he adds to or combines another flavor with a flavor which has been certified by a flavor supplier as containing no artificial flavor, but otherwise such user may rely upon the supplier's certification and need make no separate certification. All such certifications shall be retained by the certifying party throughout the period in which the flavor is supplied and for a minimum of three years thereafter, and shall be subject to the following conditions:

(i) The certifying party shall make such certifications available upon request at all reasonable hours to any duly authorized office or employee of the Food and Drug Administration or any other employee acting on behalf of the Secretary of Health and Human Services. Such certifications are regarded by the Food and Drug Administration as reports to the government and as guarantees or other undertakings within the meaning of section 301(h) of the act and subject the certifying party to the penalties for making any false report to the government under 18 U.S.C. 1001 and any false guarantee or undertaking under section 303(a) of the act. The defenses provided under section 303(c)(2) of the act shall be applicable to the certifications provided for in this section.

(ii) Wherever possible, the Food and Drug Administration shall verify the accuracy of a reasonable number of certifications made pursuant to this section, constituting a representative sample of such certifications, and shall not request all such certifications.

(iii) Where no person authorized to provide such information is reasonably available at the time of inspection, the certifying party shall arrange to have such person and the relevant materials and records ready for verification as soon as practicable: Provided, That, whenever the Food and Drug Administration has reason to believe that the supplier or user may utilize this period to alter inventories or records, such additional time shall not be permitted. Where such additional time is provided, the Food and Drug Administration may require the certifying party to certify that relevant inventories have not been materially disturbed and relevant records have not been altered or concealed during such period.

(iv) The certifying party shall provide, to an officer or representative duly designated by the Secretary, such qualitative statement of the composition of the flavor or product covered by the certification as may be reasonably expected to enable the Secretary's representatives to determine which relevant raw and finished materials and flavor ingredient records are reasonably necessary to verify the certifications. The examination conducted by the Secretary's representative shall be limited to inspection and review of inventories and ingredient records for those certifications which are to be verified.

(v) Review of flavor ingredient records shall be limited to the qualitative formula and shall not include the quantitative formula. The person verifying the certifications may make only such notes as are necessary to enable him to verify such certification. Only such notes or such flavor ingredient records as are necessary to verify such certification or to show a potential or actual violation may be removed or transmitted from the certifying party's place of business: Provided, That, where such removal or transmittal is necessary for such purposes the relevant records and notes shall be retained as separate documents in Food and Drug Administration files, shall not be copied in other reports, and shall not be disclosed publicly other than in a judicial proceeding brought pursuant to the act or 18 U.S.C. 1001.

(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

(k) The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients in the manner specified in paragraphs (k)(1) and (k)(2) of this section, except that colorings added to butter, cheese, and ice cream, if declared, may be declared in the manner specified in paragraph (k)(3) of this section, and colorings added to foods subject to §§ 105.62 and 105.65 of this chapter shall be declared in accordance with the requirements of those sections.

(1) A color additive or the lake of a color additive subject to certification under 721(c) of the act shall be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter, except that it is not necessary to include the “FD&C” prefix or the term “No.” in the declaration, but the term “Lake” shall be included in the declaration of the lake of the certified color additive (e.g., Blue 1 Lake). Manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter.

(2) Color additives not subject to certification and not otherwise required by applicable regulations in part 73 of this chapter to be declared by their respective common or usual names may be declared as “Artificial Color,” “Artificial Color Added,” or “Color Added” (or by an equally informative term that makes clear that a color additive has been used in the food). Alternatively, such color additives may be declared as “Colored with ________” or “________ color,” the blank to be filled in with the name of the color additive listed in the applicable regulation in part 73 of this chapter.

(3) When a coloring has been added to butter, cheese, or ice cream, it need not be declared in the ingredient list unless such declaration is required by a regulation in part 73 or part 74 of this chapter to ensure safe conditions of use for the color additive. Voluntary declaration of all colorings added to butter, cheese, and ice cream, however, is recommended.

(a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice (i.e., the product's advertising, label, or labeling bears the name of, or variation on the name of, or makes any other direct or indirect representation with respect to, any fruit or vegetable juice), or the label or labeling bears any vignette (i.e., depiction of a fruit or vegetable) or other pictorial representation of any fruit or vegetable, or the product contains color and flavor that gives the beverage the appearance and taste of containing a fruit or vegetable juice. The beverage may be carbonated or noncarbonated, concentrated, full-strength, diluted, or contain no juice. For example, a soft drink (soda) that does not represent or suggest by its physical characteristics, name, labeling, ingredient statement, or advertising that it contains fruit or vegetable juice does not purport to contain juice and therefore does not require a percent juice declaration.

(b)(1) If the beverage contains fruit or vegetable juice, the percentage shall be declared by the words “Contains _ percent (or %) ___ juice” or “_ percent (or %) juice,” or a similar phrase, with the first blank filled in with the percentage expressed as a whole number not greater than the actual percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., “Contains 50 percent apple juice” or “50 percent juice”).

(2) If the beverage contains less than 1 percent juice, the total percentage juice shall be declared as “less than 1 percent juice” or “less than 1 percent ___ juice” with the blank filled in with the name of the particular fruit or vegetable.

(3) If the beverage contains 100 percent juice and also contains non-juice ingredients that do not result in a diminution of the juice soluble solids or, in the case of expressed juice, in a change in the volume, when the 100 percent juice declaration appears on a panel of the label that does not also bear the ingredient statement, it must be accompanied by the phrase “with added ___,” the blank filled in with a term such as “ingredient(s),” “preservative,” or “sweetener,” as appropriate (e.g., “100% juice with added sweetener”), except that when the presence of the non-juice ingredient(s) is declared as a part of the statement of identity of the product, this phrase need not accompany the 100 percent juice declaration.

(c) If a beverage contains minor amounts of juice for flavoring and is labeled with a flavor description using terms such as “flavor”, “flavored”, or “flavoring” with a fruit or vegetable name and does not bear:

(1) The term “juice” on the label other than in the ingredient statement; or

(2) An explicit vignette depicting the fruit or vegetable from which the flavor derives, such as juice exuding from a fruit or vegetable; or

(3) Specific physical resemblance to a juice or distinctive juice characteristic such as pulp then total percentage juice declaration is not required.

(d) If the beverage does not meet the criteria for exemption from total juice percentage declaration as described in paragraph (c) of this section and contains no fruit or vegetable juice, but the labeling or color and flavor of the beverage represents, suggests, or implies that fruit or vegetable juice may be present (e.g., the product advertising or labeling bears the name, a variation of the name, or a pictorial representation of any fruit or vegetable, or the product contains color and flavor that give the beverage the appearance and taste of containing a fruit or vegetable juice), then the label shall declare “contains zero (0) percent (or %) juice”. Alternatively, the label may declare “Containing (or contains) no ___ juice”, or “no ___ juice”, or “does not contain ___ juice”, the blank to be filled in with the name of the fruits or vegetables represented, suggested, or implied, but if there is a general suggestion that the product contains fruit or vegetable juice, such as the presence of fruit pulp, the blank shall be filled in with the word “fruit” or “vegetable” as applicable (e.g., “contains no fruit juice”, or “does not contain fruit juice”).

(e) If the beverage is sold in a package with an information panel as defined in § 101.2, the declaration of amount of juice shall be prominently placed on the information panel in lines generally parallel to other required information, appearing:

(1) Near the top of the information panel, with no other printed label information appearing above the statement except the brand name, product name, logo, or universal product code; and

(2) In easily legible boldface print or type in distinct contrast to other printed or graphic matter, in a height not less than the largest type found on the information panel except that used for the brand name, product name, logo, universal product code, the title phrase “Nutrition Facts,” the declaration of “Serving size,” “Calories” and the numerical value for “Calories appearing in the nutrition information as required by § 101.9.

(f) The percentage juice declaration may also be placed on the principal display panel, provided that the declaration is consistent with that presented on the information panel.

(g) If the beverage is sold in a package that does not bear an information panel as defined in § 101.2, the percentage juice declaration shall be placed on the principal display panel, in type size not less than that required for the declaration of net quantity of contents statement in § 101.7(i), and be placed near the name of the food.

(h)(1) In enforcing these regulations, the Food and Drug Administration will calculate the labeled percentage of juice from concentrate found in a juice or juice beverage using the minimum Brix levels listed below where single-strength (100 percent) juice has at least the specified minimum Brix listed below:

(2) If there is no Brix level specified in paragraph (h)(1) of this section, the labeled percentage of that juice from concentrate in a juice or juice beverage will be calculated on the basis of the soluble solids content of the single-strength (unconcentrated) juice used to produce such concentrated juice.

(i) Juices directly expressed from a fruit or vegetable (i.e., not concentrated and reconstituted) shall be considered to be 100 percent juice and shall be declared as “100 percent juice.”

(j) Calculations of the percentage of juice in a juice blend or a diluted juice product made directly from expressed juice (i.e., not from concentrate) shall be based on the percentage of the expressed juice in the product computed on a volume/volume basis.

(k) If the product is a beverage that contains a juice whose color, taste, or other organoleptic properties have been modified to the extent that the original juice is no longer recognizable at the time processing is complete, or if its nutrient profile has been diminished to a level below the normal nutrient range for the juice, then that juice to which such a major modification has been made shall not be included in the total percentage juice declaration.

(l) A beverage required to bear a percentage juice declaration on its label, that contains less than 100 percent juice, shall not bear any other percentage declaration that describes the juice content of the beverage in its label or in its labeling (e.g., “100 percent natural” or “100 percent pure”). However, the label or labeling may bear percentage statements clearly unrelated to juice content (e.g., “provides 100 percent of U.S. RDA of vitamin C”).

(m) Products purporting to be beverages that contain fruit or vegetable juices are exempted from the provisions of this section until May 8, 1994. All products that are labeled on or after that date shall comply with this section.

(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.

(b) The declaration of nutrition information on the label and in labeling shall contain the following information, using the subheadings and the format specified in paragraph (e) of this section.

(1) Serving size. (i) The subheading “Serving Size” shall be placed under the heading “Supplement Facts” and aligned on the left side of the nutrition label. The serving size shall be determined in accordance with §§ 101.9(b) and 101.12(b), Table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as “tablets,” “capsules,” “packets,” or “teaspoonfuls.”

(ii) The subheading “Servings Per Container” shall be placed under the subheading “Serving Size” and aligned on the left side of the nutrition label, except that this information need not be provided when it is stated in the net quantity of contents declaration.

(2) Information on dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in § 101.9(c) and their subcomponents (hereinafter referred to as “(b)(2)-dietary ingredients”). (i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.

(A) The names and the quantitative amounts by weight of each (b)(2)-dietary ingredient shall be presented under the heading “Amount Per Serving.” When the quantitative amounts by weight are presented in a separate column, the heading may be centered over a column of quantitative amounts, described by paragraph (b)(2)(ii) of this section, if space permits. A heading consistent with the declaration of the serving size, such as “Each Tablet Contains,” or “Amount Per 2 Tablets” may be used in place of the heading “Amount Per Serving.” Other appropriate terms, such as capsule, packet, or teaspoonful, also may be used in place of the term “Serving.”

(B) The names of dietary ingredients that are declared under paragraph (b)(2)(i) of this section shall be presented in a column aligned on the left side of the nutritional label in the order and manner of indentation specified in § 101.9(c), except that calcium and iron shall follow choline, and sodium and potassium shall follow chloride. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate and folic acid, vitamin B12, biotin, pantothenic acid, choline, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, potassium, and fluoride. The (b)(2)-dietary ingredients shall be listed according to the nomenclature specified in § 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.

(1) When “Calories” are declared, they shall be listed first in the column of names, beneath a light bar separating the heading “Amount Per Serving” from the list of names. When “Calories from saturated fat” are declared, they shall be indented under “Calories.”

(2) The following synonyms may be added in parentheses immediately following the name of these (b)(2)-dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), and calories (energy). Energy content per serving may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content.

(3) Beta-carotene may be declared as the percent of vitamin A that is present as beta-carotene, except that the declaration is required when a claim is made about beta-carotene. When declared, the percent shall be declared to the nearest whole percent, immediately adjacent to or beneath the name vitamin A (e.g., “Vitamin A (90% as beta-carotene)”). The amount of beta-carotene in terms of micrograms (mcg) may be included in the parentheses following the percent statement (e.g., “Vitamin A (90% (810 mcg) as beta-carotene)”).

(ii) The number of calories, if declared, and the quantitative amount by weight per serving of each dietary ingredient required to be listed under paragraph (b)(2)(i) of this section shall be presented either in a separate column aligned to the right of the column of names or immediately following the listing of names within the same column. The quantitative amounts by weight shall represent the weight of the dietary ingredient rather than the weight of the source of the dietary ingredient (e.g., the weight of calcium rather than that of calcium carbonate).

(A) The amounts shall be expressed in the increments specified in § 101.9(c)(1) through (7), which includes increments for sodium.

(B) The amounts of vitamins and minerals, excluding sodium, shall be the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and the levels of significance given in § 101.9(c)(8)(iv), except that zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams (mg), but the quantitative amount may be declared in tenths of a mg). The amount of vitamin D may, but is not required to, be expressed in IUs, in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IUs must appear in parentheses after the declaration of the amount of vitamin D in mcg.

(iii) The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent Daily Value for protein, when present, shall be calculated using the corrected amount of protein as specified in § 101.9(c)(7)(ii); no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., total sugars). Additionally, the percentage of the RDI for protein shall be omitted when a food is purported to be for infants through 12 months of age.

(A) When information on the percent of Daily Values is listed, this information shall be presented in one column aligned under the heading of “% Daily Value” and to the right of the column of amounts. The headings “% Daily Value (DV),” “% DV,” “Percent Daily Value,” or “Percent DV” may be substituted for “% Daily Value.” The heading “% Daily Value” shall be placed on the same line as the heading “Amount Per Serving.” When the acronym “DV” is unexplained in the heading and a footnote is required under (b)(2)(iii)(D), (b)(2)(iii)(F), or (b)(3)(iv) of this section, the footnote shall explain the acronym (e.g. “Daily Value (DV) not established”).

(B) The percent of Daily Value shall be calculated by dividing the quantitative amount by weight of each (b)(2)-dietary ingredient by the RDI as established in § 101.9(c)(8)(iv) or the DRV as established in § 101.9(c)(9) for the specified dietary ingredient and multiplying by 100, except that the percent of Daily Value for protein, when present, shall be calculated as specified in § 101.9(c)(7)(ii). The quantitative amount by weight of each dietary ingredient in this calculation shall be the unrounded amount, except that for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber, the quantitative amount by weight declared on the label (i.e, rounded amount) may be used. The numerical value shall be followed by the symbol for percent (i.e., %).

(C) The percentages based on RDI's and on DRV's shall be expressed to the nearest whole percent, except that for dietary ingredients for which DRV's have been established, “Less than 1%” or “<1%” shall be used to declare the “% Daily Value” when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the “% Daily Value” when rounded to the nearest percent is zero (e.g., a product that contains 1 gram of total carbohydrate would list the percent Daily Value as “Less than 1%” or “<1%”).

(D) If the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein, or added sugars, a symbol shall follow the value listed for those nutrients that refers to the same symbol that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement “Percent Daily Values are based on a 2,000 calorie diet.” If the product is represented or purported to be for use by children 1 through 3 years of age, and if the percent of Daily Value is declared for total fat, total carbohydrate, dietary fiber, or protein, or added sugars, a symbol shall follow the value listed for those nutrients that refers to the same symbol that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement “Percent Daily Values are based on a 1,000 calorie diet.”

(E) The percent of Daily Value shall be based on RDI or DRV values for adults and children 4 or more years of age, unless the product is represented or purported to be specifically for infants through 12 months of age, children 1 through 3 years of age, pregnant women, or lactating women, in which case the column heading shall clearly state the intended group. If the product is for persons within more than one group, the percent of Daily Value for each group shall be presented in separate columns as shown in paragraph (e)(11)(ii) of this section.

(F) For declared subcomponents that have no DRVs or RDIs, a symbol (e.g., an asterisk) shall be placed in the “Percent Daily Value” column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by a statement “Daily Value not established.”

(G) When calories or calories from saturated fat are declared, the space under the “% DV” column shall be left blank for these items. When there are no other (b)(2)-dietary ingredients listed for which a value must be declared in the “% DV” column, the column may be omitted as shown in paragraph (e)(11)(vii) of this section. When the “% DV” column is not required, but the dietary ingredients listed are subject to paragraph (b)(2)(iii)(F) of this section, the symbol required in that paragraph shall immediately follow the quantitative amount by weight for each dietary ingredient listed under “Amount Per Serving.”

(3) Information on dietary ingredients for which RDI's and DRV's have not been established. (i) Dietary ingredients for which FDA has not established RDI's or DRV's and that are not subject to regulation under paragraph (b)(2) of this section (hereinafter referred to as “other dietary ingredients”) shall be declared by their common or usual name when they are present in a dietary supplement, in a column that is under the column of names described in paragraph (b)(2)(i)(B) of this section or, as long as the constituents of an other dietary ingredient are not listed, in a linear display, under the heavy bar described in paragraph (e)(6) of this section, except that if no (b)(2)-dietary ingredients are declared, other dietary ingredients shall be declared directly beneath the heading “Amount Per Serving” described in paragraph (b)(2)(i)(A) of this section.

(ii) The quantitative amount by weight per serving of other dietary ingredients shall be presented in the same manner as the corresponding information required in paragraph (b)(2)(ii) of this section or, when a linear display is used, shall be presented immediately following the name of the other dietary ingredient. The quantitative amount by weight shall be the weight of the other dietary ingredient listed and not the weight of any component, or the source, of that dietary ingredient.

(A) These amounts shall be expressed using metric measures in appropriate units.

(B) For any dietary ingredient that is a liquid extract from which the solvent has not been removed, the quantity listed shall be the volume or weight of the total extract. Information on the condition of the starting material shall be indicated when it is fresh and may be indicated when it is dried. Information may be included on the concentration of the dietary ingredient and the solvent used, e.g., “fresh dandelion root extract, x (y:z) in 70% ethanol,” where x is the number of milliliters (mL) or mg of the entire extract, y is the weight of the starting material and z is the volume (mL) of solvent. Where the solvent has been partially removed (not to dryness), the final concentration, when indicated, shall be stated (e.g., if the original extract was 1:5 and 50 percent of the solvent was removed, then the final concentration shall be stated as 1:2.5). Where the name of the solvent used is not included in the nutrition label, it is required to be listed in the ingredient statement in accordance with § 101.4(g).

(C) For a dietary ingredient that is an extract from which the solvent has been removed, the weight of the ingredient shall be the weight of the dried extract.

(iii) The constituents of a dietary ingredient described in paragraph (b)(3)(i) of this section may be listed indented under the dietary ingredient and followed by their quantitative amounts by weight per serving, except that dietary ingredients described in paragraph (b)(2) of this section shall be listed in accordance with that section. When the constituents of a dietary ingredient described in paragraph (b)(3)(i) of this section are listed, all other dietary ingredients shall be declared in a column; however, the constituents themselves may be declared in a column or in a linear display.

(iv) Other dietary ingredients shall bear a symbol (e.g., an asterisk) in the column under the heading of “% Daily Value” that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “Daily Value not established,” except that when the heading “% Daily Value” is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed.

(c) A proprietary blend of dietary ingredients shall be included in the list of dietary ingredients described in paragraph (b)(3)(i) of this section and identified by the term “Proprietary Blend” or other appropriately descriptive term or fanciful name and may be highlighted by bold type. Except as specified in this paragraph, all other requirements for the listing of dietary ingredients in dietary supplements are applicable.

(1) Dietary ingredients contained in the proprietary blend that are listed under paragraph (b)(2) of this section shall be declared in accordance with paragraph (b)(2) of this section.

(2) Dietary ingredients contained in the proprietary blend that are listed under paragraph (b)(3) of this section (i.e., “other dietary ingredients”) shall be declared in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name.

(3) The quantitative amount by weight specified for the proprietary blend shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section. A symbol (e.g., asterisk), which refers to the same symbol placed at the bottom of the nutrition label that is followed by the statement “Daily Value not established,” shall be placed under the heading “% Daily Value,” if present, or immediately following the quantitative amount by weight for the proprietary blend.

(4) The sample label shown in paragraph (e)(11)(v) of this section illustrates one method of nutrition labeling a proprietary blend of dietary ingredients.

(d) The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words “as” or “from”, e.g., “Calcium (as calcium carbonate),” except that manner of presentation is unnecessary when the name of the dietary ingredient (e.g., Oriental ginseng) or its synonym (e.g., ascorbic acid) is itself the source ingredient. When a source ingredient is identified in parentheses within the nutrition label, or when the name of the dietary ingredient or its synonym is the source ingredient, it shall not be required to be listed again in the ingredient statement that appears outside of the nutrition label. When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement in accordance with § 101.4(g), which shall appear outside and immediately below the nutrition label or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label.

(1) Source ingredients shall be identified in accordance with § 101.4 (i.e., shall be listed by common or usual name, and the listing of botanicals shall specify the part of the plant from which the ingredient is derived) regardless of whether they are listed in an ingredient statement or in the nutrition label.

(2) When source ingredients are listed within the nutrition label, and two or more are used to provide a single dietary ingredient, all of the sources shall be listed within the parentheses in descending order by weight.

(3) Representations that the source ingredient conforms to an official compendium may be included either in the nutrition label or in the ingredient list (e.g., “Calcium (as calcium carbonate USP)”).

(e) Except as provided for small and intermediate sized packages under paragraph (h)(3)(i)(2) of this section, information other than the title, headings, and footnotes shall be in uniform type size no smaller than 8 point. Type size no smaller than 6 point may be used for column headings (e.g., “Amount Per Serving” and “% Daily Value”) and for footnotes (e.g., “Percent Daily Values are based on a 2,000 calorie diet”).

(1) The title, “Supplement Facts,” shall be set in a type size larger than all other print size in the nutrition label and, unless impractical, shall be set full width of the nutrition label. The title and all headings shall be bolded to distinguish them from other information.

(2) The nutrition information shall be enclosed in a box by using hairlines.

(3) All information within the nutrition label shall utilize:

(i) A single easy-to-read type style,

(ii) All black or one color type, printed on a white or other neutral contrasting background whenever practical,

(iii) Upper- and lowercase letters, except that all uppercase lettering may be utilized for packages that have a total surface area available to bear labeling of less than 12 square inches,

(iv) At least one point leading (i.e., space between lines of text), and

(v) Letters that do not touch.

(4) Except as provided for small and intermediate-sized packages under paragraph (i)(2) of this section, information other than the title, headings, and footnotes shall be in uniform type size no smaller than 8 point. Type size no smaller than 6 point may be used for column headings (e.g., “Amount Per Serving” and “% Daily Value”) and for footnotes (e.g., “Percent Daily Values are based on a 2,000 calorie diet”).

(5) A hairline rule that is centered between the lines of text shall separate each dietary ingredient required in paragraph (b)(2) and (b)(3) of this section from the dietary ingredient above and beneath it, as shown in paragraph (e)(10) of this section.

(6) A heavy bar shall be placed:

(i) Beneath the subheading “Servings Per Container” except that if “Servings Per Container” is not required and, as a result, not declared, the bar shall be placed beneath the subheading “Serving Size,”

(ii) Beneath the last dietary ingredient to be listed under paragraph (b)(2)(i) of this section, if any, and

(iii) Beneath the last other dietary ingredient to be listed under paragraph (b)(3) of this section, if any.

(7) A light bar shall be placed beneath the headings “Amount Per Serving” and “% Daily Value.”

(8) If the product contains two or more separately packaged dietary supplements that differ from each other (e.g., the product has a packet of supplements to be taken in the morning and a different packet to be taken in the afternoon), the quantitative amounts and percent of Daily Value may be presented as specified in this paragraph in individual nutrition labels or in one aggregate nutrition label as illustrated in paragraph (e)(11)(iii) of this section.

(9)(i) The quantitative amount by weight (or volume, if permitted) and the percent of Daily Value of each dietary ingredient may be presented on a “per unit” basis in addition to the “per serving” basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for other dietary ingredients. If “per unit” information is provided, it must be presented in additional columns to the right of the “per serving” information and be clearly identified by appropriate headings.

(ii) Alternatively, if a recommendation is made in other parts of the label that a dietary supplement be consumed more than once per day, the total quantitative amount by weight (or volume, if permitted) and the percent of Daily Value of each dietary ingredient may be presented on a “per day” basis in addition to the “per serving” basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for other dietary ingredients. If “per day” information is provided, it must be presented in additional columns to the right of the “per serving” information and be clearly identified by appropriate headings and/or be presented in a parenthetical statement as part of the “Serving Size” declaration. A sample illustration for “per day” information in a column format is provided in paragraph (e)(11)(viii) of this section. As illustrated, the additional “Per Day” column heading is followed parenthetically by the number of servings recommended per day in other parts of the label (e.g., “Per Day (3 Caplets)”). When the parenthetical statement format following the “Serving Size” declaration is used as an alternative to the column format, the statement must provide no more than simple instructions regarding how to calculate the “per day” amount for the number of servings per day recommended in other parts of the label (e.g., “Serving Size: 1 Caplet (Multiply amounts by 3 for total daily amount)”). When the parenthetical statement format following the “Serving Size” declaration is used in addition to the column format, the statement must provide no more than a simple declaration of the number of servings recommended in other parts of the label (e.g., “Serving Size: 1 Caplet (Total daily amount: 3 caplets per day)”).

(10) In the interest of uniformity of presentation, FDA urges that the information be presented using the graphic specifications set forth in appendix B to part 101, as applicable.

(11) The following sample labels are presented for the purpose of illustration:

(ii) Multiple vitamins for children and adults (excludes Servings Per Container which is stated in the net quantity of contents declaration):

(iv) Dietary supplement containing dietary ingredients with and without RDIs and DRVs:

(12) If space is not adequate to list the required information as shown in the sample labels in paragraph (e)(11) of this section, the list may be split and continued to the right as long as the headings are repeated. The list to the right must be set off by a line that distinguishes it and sets it apart from the dietary ingredients and percent of Daily Value information given to the left. The following sample label illustrates this display:

(f)(1) Compliance with this section will be determined in accordance with § 101.9(g)(1) through (g)(8), (g)(10), and (g)(11), except that the sample for analysis shall consist of a composite of 12 subsamples (consumer packages) or 10 percent of the number of packages in the same inspection lot, whichever is smaller, randomly selected to be representative of the lot. The criteria on class I and class II nutrients given in § 101.9(g)(3) and (g)(4) also are applicable to other dietary ingredients described in paragraph (b)(3)(i) of this section. Reasonable excesses over labeled amounts are acceptable within current good manufacturing practice.

(2) When it is not technologically feasible, or some other circumstance makes it impracticable, for firms to comply with the requirements of this section, FDA may permit alternative means of compliance or additional exemptions to deal with the situation in accordance with § 101.9(g)(9). Firms in need of such special allowances shall make their request in writing to the Office of Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(g) Except as provided in paragraphs (i)(2) and (i)(5) of this section, the location of nutrition information on a label shall be in compliance with § 101.2.

(h) Dietary supplements are subject to the exemptions specified as follows in:

(1) Section 101.9(j)(1) for foods that are offered for sale by a person who makes direct sales to consumers (i.e., a retailer) who has annual gross sales or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim;

(2) Section 101.9(j)(18) for foods that are low-volume products (that is, they meet the requirements for units sold in § 101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in § 101.9(j)(18)(iv), are the subject of a claim for an exemption that provides the information required under § 101.9(j)(18)(iv), that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in § 101.9(j)(18)(i) or (j)(18)(ii), and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim;

(3) Section 101.9(j)(9) for foods shipped in bulk form that are not for distribution to consumers in such form and that are for use solely in the manufacture of other dietary supplements or that are to be processed, labeled, or repacked at a site other than where originally processed or packed.

(i)(1) Dietary supplements are subject to the special labeling provisions specified in § 101.9(j)(5)(i) for foods other than infant formula, represented or purported to be specifically for infants through 12 months of age and children 1 through 3 years of age.

(2) Section 101.9(j)(13) for foods in small or intermediate-sized packages, except that:

(i) All information within the nutrition label on small-sized packages, which have a total surface area available to labeling of less than 12 square inches, shall be in type size no smaller than 4.5 point;

(ii) All information within the nutrition label on intermediate-sized packages, which have from 12 to 40 square inches of surface area available to bear labeling, shall be in type size no smaller than 6 point, except that type size no smaller than 4.5 point may be used on packages that have less than 20 square inches available for labeling and more than 8 dietary ingredients to be listed and on packages that have 20 to 40 square inches available for labeling and more than 16 dietary ingredients to be listed.

(iii) When the nutrition information is presented on any panel under § 101.9(j)(13)(ii)(D), the ingredient list shall continue to be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label as specified in § 101.4(g).

(iv) When it is not possible for a small or intermediate-sized package that is enclosed in an outer package to comply with these type size requirements, the type size of the nutrition label on the primary (inner) container may be as small as needed to accommodate all of the required label information provided that the primary container is securely enclosed in outer packaging, the nutrition labeling on the outer packaging meets the applicable type size requirements, and such outer packaging is not intended to be separated from the primary container under conditions of retail sale.

(v) Where there is not sufficient space on a small or intermediate-sized package for a nutrition label that meets minimum type size requirements of 4.5 points if hairlines are used in accordance with paragraph (e)(5) of this section, the hairlines may be omitted and replaced by a row of dots connecting the columns containing the name of each dietary ingredient and the quantitative amounts (by weight and as a percent of Daily Value).

(3) Section 101.9(j)(15) for foods in multiunit food containers;

(4) Section 101.9(j)(16) for foods sold in bulk containers; and

(5) Section 101.9(j)(17) for foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required label information, except that the ingredient list shall continue to be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label as specified in § 101.4(g).

(j) Dietary supplements shall be subject to the misbranding provisions of § 101.9(k).

(a) The Food and Drug Administration (FDA) urges food retailers to provide nutrition information, as provided in § 101.9(c), for raw fruit, vegetables, and fish at the point-of-purchase. If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines in § 101.45.

(b) In § 101.44, FDA has listed the 20 varieties of raw fruit, vegetables, and fish that are most frequently consumed during a year and to which the guidelines apply.

(c) FDA has also defined in § 101.43, the circumstances that constitute substantial compliance by food retailers with the guidelines.

(d) By May 8, 1993, FDA will issue a report on actions taken by food retailers to provide consumers with nutrition information for raw fruit, vegetables, and fish under the guidelines established in § 101.45.

(1) The report will include a determination of whether there is substantial compliance, as defined in § 101.43, with the guidelines.

(2) In evaluating substantial compliance, FDA will consider only the 20 varieties of raw fruit, vegetables, and fish most frequently consumed as identified in § 101.44.

(e) If FDA finds that there is substantial compliance with the guidelines for the nutrition labeling of raw fruit and vegetables or of fish, the agency will so state in the report, and the guidelines will remain in effect. FDA will reevaluate the market place for substantial compliance every 2 years.

(f) If FDA determines that there is not substantial compliance with the guidelines for raw fruit and vegetables or for raw fish, the agency will at that time issue proposed regulations requiring that any person who offers raw fruit and vegetables or fish to consumers provide, in a manner prescribed by regulations, the nutrition information required by § 101.9. Final regulations would have to be issued 6 months after issuance of proposed regulations, and they would become effective 6 months after the date of their promulgation.

(a) The Food and Drug Administration (FDA) will judge a food retailer who sells raw agricultural commodities or raw fish to be in compliance with the guidelines in § 101.45 with respect to raw agricultural commodities if the retailer displays or provides nutrition labeling for at least 90 percent of the raw agricultural commodities listed in § 101.44 that it sells, and with respect to raw fish if the retailer displays or provides nutrition labeling for at least 90 percent of the types of raw fish listed in § 101.44 that it sells. To be in compliance, the nutrition labeling shall:

(1) Be presented in the store or other type of establishment in a manner that is consistent with § 101.45(a)(1);

(2) Be presented in content and format that are consistent with § 101.45 (a)(2), (a)(3), and (a)(4); and

(3) Include data that have been provided by FDA in appendices C and D to part 101 of this chapter, except that the information on potassium is voluntary.

(b) To determine whether there is substantial compliance by food retailers with the guidelines in § 101.45 for the voluntary nutrition labeling of raw fruit and vegetables and of raw fish, FDA will select a representative sample of 2,000 stores, allocated by store type and size, for raw fruit and vegetables and for raw fish.

(c) FDA will find that there is substantial compliance with the guidelines in § 101.45 if it finds based on paragraph (a) of this section that at least 60 percent of all stores that are evaluated are in compliance.

(d) FDA will evaluate substantial compliance separately for raw agricultural commodities and for raw fish.

(a) The 20 most frequently consumed raw fruits are: Apple, avocado (California), banana, cantaloupe, grapefruit, grapes, honeydew melon, kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, tangerine, and watermelon.

(b) The 20 most frequently consumed raw vegetables are: Asparagus, bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green (snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet potato, and tomato.

(c) The 20 most frequently consumed raw fish are: Blue crab, catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon (Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish, tilapia, and tuna.

(a) Nutrition labeling for raw fruits, vegetables, and fish listed in § 101.44 should be presented to the public in the following manner:

(1) Nutrition labeling information should be displayed at the point of purchase by an appropriate means such as by a label affixed to the food or through labeling including shelf labels, signs, posters, brochures, notebooks, or leaflets that are readily available and in close proximity to the foods. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media.

(2) Serving sizes should be determined, and nutrients declared, in accordance with § 101.9 (b) and (c), respectively, except that the nutrition labeling data should be based on the raw edible portion for fruits and vegetables and on the cooked edible portion for fish. The methods used to cook fish should be those that do not add fat, breading, or seasoning (e.g., salt or spices).

(3) When nutrition labeling information is provided for more than one raw fruit, vegetable, or fish on signs, posters, brochures, notebooks, or leaflets, it may be presented in charts with horizontal or vertical columns or as a compilation of individual nutrition labels. Nutrition labeling that is presented in a linear display (see § 101.9(j)(13)(ii)(A)(2)) will not be considered to be in compliance. The heading “Nutrition Facts” must be in a type size larger than all other print in the nutrition label. The required information (i.e., headings, serving sizes, list of nutrients, quantitative amounts by weight (except for vitamins and minerals), and percent of Daily Values (DV's) (except for sugars and protein) must be clearly presented and of sufficient type size and color contrast to be plainly legible, with numeric values for percent of DV highlighted in contrast to the quantitative amounts by weight and hairlines between all nutrients.

(i) Declaration of the number of servings per container need not be included in the nutrition labeling of raw fruits, vegetables, and fish.

(ii) Except for the statement “Percent Daily Values are based on a 2,000 calorie diet,” the footnote required in § 101.9(d)(9) is not required. However, when labeling is provided in brochures, notebooks, leaflets, or similar types of materials, retailers are encouraged to include the footnote.

(iii) When retailers provide nutrition labeling information for more than one raw fruit or vegetable on signs or posters or in brochures, notebooks, or leaflets, the listings for saturated fat, trans fat, and cholesterol may be omitted from the charts or individual nutrition labels if a footnote states that most fruits and vegetables provide negligible amounts of these nutrients, but that avocados contain 0.5 gram (g) of saturated fat per ounce (e.g., “Most fruits and vegetables provide negligible amounts of saturated fat, trans fat, and cholesterol; avocados provide 0.5 g of saturated fat per ounce”). The footnote also may contain information about the polyunsaturated and monounsaturated fat content of avocados.

(iv) When retailers provide nutrition labeling information for more than one raw fish on signs or posters or in brochures, notebooks, or leaflets, the listings for trans fat, dietary fiber, and sugars may be omitted from the charts or individual nutrition labels if the following footnote is used, “Fish provide negligible amounts of trans fat, dietary fiber, and sugars.”

(4) When nutrition labeling is provided for individual raw fruits, vegetables, or fish on packages or on signs, posters, brochures, notebooks, or leaflets, it should be displayed in accordance with § 101.9, except that the declaration of the number of servings per container need not be included. For individual labels provided by retailers on signs and posters, the footnote required in § 101.9(d)(9) may be shortened to “Percent Daily Values are based on a 2,000 calorie diet.”

(b) Nutrition label values provided by the Food and Drug Administration (FDA) in Appendices C and D to part 101 for the 20 most frequently consumed raw fruits, vegetables, and fish listed in § 101.44 shall be used to ensure uniformity in declared values. FDA will publish proposed updates of the 20 most frequently consumed raw fruits, vegetables, and fish and nutrition label data for these foods (or a notice that the data sets have not changed from the previous publication) at least every 4 years in the Federal Register.

(1) The agency encourages the submission of data bases with new or additional nutrient data for any of the most frequently consumed raw fruits, vegetables, and fish to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, for review and evaluation. FDA may incorporate these data in the next revision of the nutrition labeling information for the top 20 raw fruits, vegetables, and fish.

(i) Guidance in the development of data bases may be found in the “FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases,” available from the FDA Office of Food Labeling.

(ii) The submission to FDA should include, but need not be limited to, information on the following: Source of the data (names of investigators, name of organization, place of analyses, dates of analyses), number of samples, sampling design, analytical methods, and statistical treatment of the data. Proposed quantitative label declarations may be included. The proposed values for declaration should be determined in accordance with the “FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases.”

(2) [Reserved]

(c) Data bases of nutrient values for raw fruits, vegetables, and fish that are not among the 20 most frequently consumed may be used to develop nutrition labeling values for these foods. This includes data bases of nutrient values for specific varieties, species, or cultivars of raw fruits, vegetables, and fish not specifically identified among the 20 most frequently consumed.

(1) The food names and descriptions for the fruits, vegetables, and fish should clearly identify these foods as distinct from foods among the most frequently consumed list for which FDA has provided data.

(2) Guidance in the development of data bases may be found in the “FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases.”

(3) Nutrition labeling values computed from data bases are subject to the compliance provisions of § 101.9(g).

(i) Compliance with the provisions of § 101.9(g) may be achieved by use of a data base that has been developed following FDA guideline procedures and approved by FDA.

(A) The submission to FDA for approval should include but need not be limited to information on the following: Source of the data (names of investigators, name of organization, place of analyses, dates of analyses), number of samples, sampling design, analytical methods, statistical treatment of the data, and proposed quantitative label declarations. The values for declaration should be determined in accordance with the “FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases.”

(B) FDA approval of a data base and nutrition labeling values shall not be considered granted until the Center for Food Safety and Applied Nutrition has agreed to all aspects of the data base in writing. Approvals will be in effect for a limited time, e.g., 10 years, and will be eligible for renewal in the absence of significant changes in agricultural or industry practices (e.g., a change occurs in a predominant variety produced). FDA will take steps to revoke its approval of the data base and nutrition labeling values if FDA monitoring suggests that the data base or nutrition labeling values are no longer representative of the item sold in this country. Approval requests shall be submitted in accordance with the provision of § 101.30 of this chapter.

(ii) [Reserved]

(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in § 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in § 101.9(c)(9), (excluding total carbohydrates) may only be made on the label or in labeling of the food if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and

(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable.

(b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label and in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (b)(1) of this section may be used on the label and in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., the serving of broccoli in this product is high in vitamin C).

(c) “Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label and in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that the food contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed.

(2) The terms defined in paragraph (c)(1) of this section may be used on the label and in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in 101.13(m), provided that:

(i) The product contains a food that meets the definition of “good source” in paragraph (c)(1) of this section; and

(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., the serving of sweet potatoes in this product is a “good source” of fiber).

(d) “Fiber” claims. (1) If a nutrient content claim is made with respect to the level of dietary fiber, that is, that the product is high in fiber, a good source of fiber, or that the food contains “more” fiber, and the food is not “low” in total fat as defined in § 101.62(b)(2) or, in the case of a meal product, as defined in § 101.13(l), or main dish product, as defined in § 101.13(m), is not “low” in total fat as defined in § 101.62(b)(3), then the label shall disclose the level of total fat per labeled serving.

(2) The disclosure shall appear in immediate proximity to such claim, be in a type size no less than one-half the size of the claim and precede any disclosure statement required under § 101.13(h) (e.g., “contains [x amount] of total fat per serving. See nutrition information for fat content”).

(e) “More” claims. (1) A relative claim using the terms “more,” “fortified,” “enriched,” “added,” “extra,” and “plus” may be used on the label or in labeling of foods to describe the level of protein, vitamins, minerals, dietary fiber, or potassium, except as limited by § 101.13(j)(1)(i) and except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 10 percent more of the RDI for vitamins or minerals or of the DRV for protein, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference food; and

(ii) Where the claim is based on a nutrient that has been added to the food, that fortification is in accordance with the policy on fortification of foods in § 104.20 of this chapter; and

(iii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber than white bread”); and

(B) Quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces (e.g., “Fiber content of white bread is 1 gram (g) per serving; (this product) 3.5 g per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(2) A relative claim using the terms “more,” “fortified,” “enriched,” “added,” “extra,” and “plus” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber or potassium, except as limited in § 101.13(j)(1)(i), in meal products as defined in § 101.13(l) or main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 10 percent more of the RDI for vitamins or minerals or of the DRV for protein, dietary fiber, or potassium (expressed as a percent of the Daily Value) per 100 g of food than an appropriate reference food.

(ii) Where the claim is based on a nutrient that has been added to the food, that fortification is in accordance with the policy on fortification of foods in § 104.20 of this chapter; and

(iii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percentage (or fraction) that the nutrient was increased relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber per 3 oz than does ‘X brand of product’ ”), and

(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference food that it replaces (e.g., “The fiber content of ‘X brand of product’ is 2 g per 3 oz. This product contains 4.5 g per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(f) “High potency” claims. (1)(i) The term “high potency” may be used on the label or in the labeling of foods to describe individual vitamins or minerals that are present at 100 percent or more of the RDI per reference amount customarily consumed.

(ii) When the term “high potency” is used to describe individual vitamins or minerals in a product that contains other nutrients or dietary ingredients, the label or labeling shall clearly identify which vitamin or mineral is described by the term “high potency” (e.g., “Botanical ‘X’ with high potency vitamin E”).

(2) The term “high potency” may be used on the label or in the labeling of a multiingredient food product to describe the product if the product contains 100 percent or more of the RDI for at least two-thirds of the vitamins and minerals that are listed in § 101.9(c)(8)(iv) and that are present in the product at 2 percent or more of the RDI (e.g., “High potency multivitamin, multimineral dietary supplement tablets”).

(3) Where compliance with paragraphs (f)(1)(i), (f)(1)(ii), or (f)(2) of this section is based on a nutrient that has been added to a food (other than a dietary supplement), that fortification shall be in accordance with the policy on fortification of foods in § 104.20 of this chapter.

(g) Nutrient content claims using the term “antioxidant.” A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when:

(1) An RDI has been established for each of the nutrients;

(2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions;

(3) The level of each nutrient that is the subject of the claim is sufficient to qualify for the § 101.54 (b), (c), or (e) claim (e.g., to bear the claim ”high in antioxidant vitamin C,” the product must contain 20 percent or more of the RDI for vitamin C). Beta-carotene may be a subject of the claim when the level of vitamin A present as beta-carotene in the food that bears the claim is sufficient to qualify for the claim. For example, for the claim “good source of antioxidant beta-carotene,” 10 percent or more of the RDI for vitamin A must be present as beta-carotene per reference amount customarily consumed; and

(4) The names of the nutrients that are the subject of the claim are included as part of the claim (e.g., “high in antioxidant vitamins C and E”). Alternatively, when used as part of a nutrient content claim, the term “antioxidant” or “antioxidants” (as in “high in antioxidants”) may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of a product label followed by the name or names of the nutrients with recognized antioxidant activity. The list of nutrients shall appear in letters of a type size height no smaller than the larger of one-half of the type size of the largest nutrient content claim or 1/16 inch.

(a) General requirements. A claim using the term light or lite to describe a food may only be made on the label or in labeling of the food if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and

(3) The food is labeled in accordance with § 101.9 or § 101.10, where applicable.

(b) “Light” claims. The terms “light” or “lite” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), without further qualification, provided that:

(1) If the food derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference food as specified in § 101.13(j)(1); or

(2) If the food derives less than 50 percent of its calories from fat:

(i) The number of calories is reduced by at least one-third (33 1/3 percent) per reference amount customarily consumed compared to an appropriate reference food; or

(ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the reference food that it resembles or for which it substitutes as specified in § 101.13(j)(1); and

(3) As required in § 101.13(j)(2) for relative claims:

(i) The identity of the reference food and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim, (e.g., “1/3 fewer calories and 50 percent less fat than our regular cheese cake”);

(ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference food that it replaces (e.g., “lite cheesecake - 200 calories, 4 grams (g) fat per serving; regular cheesecake - 300 calories, 8 g fat per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2; and

(iii) If the labeled food contains less than 40 calories or less than 3 g fat per reference amount customarily consumed, the percentage reduction for that nutrient need not be declared.

(4) A “light” claim may not be made on a food for which the reference food meets the definition of “low fat” and “low calorie.”

(c)(1)(i) A product for which the reference food contains 40 calories or less and 3 g fat or less per reference amount customarily consumed may use the term “light” or “lite” without further qualification if it is reduced by 50 percent or more in sodium content compared to the reference food; and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sodium was reduced shall be declared in immediate proximity to the most prominent such claim (e.g., 50 percent less sodium than our regular soy sauce); and

(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference food that it replaces (e.g., “lite soy sauce 500 milligrams (mg) sodium per serving; regular soy sauce 1,000 mg per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(2)(i) A product for which the reference food contains more than 40 calories or more than 3 g fat per reference amount customarily consumed may use the term “light in sodium” or “lite in sodium” if it is reduced by 50 percent or more in sodium content compared to the reference food, provided that “light” or “lite” is presented in immediate proximity with “in sodium” and the entire term is presented in uniform type size, style, color, and prominence; and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sodium was reduced shall be declared in immediate proximity to the most prominent such claim (e.g., 50 percent less sodium than our regular canned peas); and

(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference food that it replaces (e.g., “lite canned peas, 175 mg sodium per serving; regular canned peas 350 mg per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Except for meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), a “light in sodium” claim may not be made on a food for which the reference food meets the definition of “low in sodium”.

(d)(1) The terms “light” or “lite” may be used on the label or in the labeling of a meal product as defined in § 101.13(l) and a main dish product as defined in § 101.13(m), provided that:

(i) The food meets the definition of:

(A) “Low in calories” as defined in § 101.60(b)(3); or

(B) “Low in fat” as defined in § 101.62(b)(3); and

(ii)(A) A statement appears on the principal display panel that explains whether “light” is used to mean “low fat,” “low calories,” or both (e.g., “Light Delight, a low fat meal”); and

(B) The accompanying statement is no less than one-half the type size of the “light” or “lite” claim.

(2)(i) The term “light in sodium” or “lite in sodium” may be used on the label or in the labeling of a meal product as defined in § 101.13(l) and a main dish product as defined in § 101.13(m), provided that the food meets the definition of “low in sodium” as defined in § 101.61(b)(5)(i); and

(ii) “Light” or “lite” and “in sodium” are presented in uniform type size, style, color, and prominence.

(e) Except as provided in paragraphs (b) through (d) of this section, the term “light” or “lite” may not be used to refer to a food that is not reduced in fat by 50 percent, or, if applicable, in calories by 1/3 or, when properly qualified, in sodium by 50 percent unless:

(1) It describes some physical or organoleptic attribute of the food such as texture or color and the information (e.g., “light in color” or “light in texture”) so stated, clearly conveys the nature of the product; and

(2) The attribute (e.g., “color” or “texture”) is in the same style, color, and at least one-half the type size as the word “light” and in immediate proximity thereto.

(f) If a manufacturer can demonstrate that the word “light” has been associated, through common use, with a particular food to reflect a physical or organoleptic attribute (e.g., light brown sugar, light corn syrup, or light molasses) to the point where it has become part of the statement of identity, such use of the term “light” shall not be considered a nutrient content claim subject to the requirements in this part.

(g) The term “lightly salted” may be used on a product to which has been added 50 percent less sodium than is normally added to the reference food as described in § 101.13(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not “low in sodium” as defined in § 101.61(b)(4), the statement “not a low sodium food,” shall appear adjacent to the nutrition label of the food bearing the claim, or, if the nutrition label is on the information panel, it may appear elsewhere on the information panel in accordance with § 101.2 and the information required to accompany a relative claim shall appear on the label or labeling as specified in § 101.13(j)(2).

(a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling of a food if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13;

(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable; and

(4) For dietary supplements, claims regarding calories may not be made on products that meet the criteria in § 101.60(b)(1) or (b)(2) for “calorie free” or “low calorie” claims except when an equivalent amount of a similar dietary supplement (e.g., another protein supplement) that the labeled food resembles and for which it substitutes, normally exceeds the definition for “low calorie” in § 101.60(b)(2).

(b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in the labeling of foods, provided that:

(i) The food contains less than 5 calories per reference amount customarily consumed and per labeled serving.

(ii) As required in § 101.13(e)(2), if the food meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to disclose that calories are not usually present in the food (e.g., “cider vinegar, a calorie free food”).

(2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i)(A) The food has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons and does not provide more than 40 calories per reference amount customarily consumed; or

(B) The food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and does not provide more than 40 calories per reference amount customarily consumed and, except for sugar substitutes, per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50 g criterion refers to the “as prepared” form).

(ii) If a food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to vary the caloric content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “celery, a low calorie food”).

(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of meal products as defined in § 101.13(l) or main dish products as defined in § 101.13(m), provided that:

(i) The product contains 120 calories or less per 100 g; and

(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the calorie content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which it attaches.

(4) The terms “reduced calorie,” “reduced in calories,” “calorie reduced,” “fewer calories,” “lower calorie,” or “lower in calories” may be used on the label or in the labeling of foods, except as limited by § 101.13(j)(1)(i) and except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the calories differ between the two foods are declared in immediate proximity to the most prominent such claim (e.g., reduced calorie cupcakes “33 1/3 percent fewer calories than regular cupcakes”); and

(B) Quantitative information comparing the level of the nutrient per labeled serving size with that of the reference food that it replaces (e.g., “Calorie content has been reduced from 150 to 100 calories per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or labeling of foods if the reference food meets the definition for “low calorie.”

(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent fewer calories per 100 g of food than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the calories differ between the two foods are declared in immediate proximity to the most prominent such claim (e.g., Larry's Reduced Calorie Lasagna, “25 percent fewer calories per oz (or 3 oz) than our regular Lasagna”); and

(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference food that it replaces (e.g., “Calorie content has been reduced from 108 calories per 3 oz to 83 calories per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or labeling of food if the reference food meets the definition for “low calorie.”

(c) Sugar content claims - (1) Use of terms such as “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” or “dietarily insignificant source of sugar.” Consumers may reasonably be expected to regard terms that represent that the food contains no sugars or sweeteners e.g., “sugar free,” or “no sugar,” as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (c)(2) of this section, a food may not be labeled with such terms unless:

(i) The food contains less than 0.5 g of sugars, as defined in § 101.9(c)(6)(ii), per reference amount customarily consumed and per labeled serving or, in the case of a meal product or main dish product, less than 0.5 g of sugars per labeled serving; and

(ii) The food contains no ingredient that is a sugar or that is generally understood by consumers to contain sugars unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietarily insignificant amount of sugar;” and

(iii)(A) It is labeled “low calorie” or “reduced calorie” or bears a relative claim of special dietary usefulness labeled in compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this section, or, if a dietary supplement, it meets the definition in paragraph (b)(2) of this section for “low calorie” but is prohibited by §§ 101.13(b)(5) and 101.60(a)(4) from bearing the claim; or

(B) Such term is immediately accompanied, each time it is used, by either the statement “not a reduced calorie food,” “not a low calorie food,” or “not for weight control.”

(2) The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if:

(i) No amount of sugars, as defined in § 101.9(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging; and

(ii) The product does not contain an ingredient containing added sugars such as jam, jelly, or concentrated fruit juice; and

(iii) The sugars content has not been increased above the amount present in the ingredients by some means such as the use of enzymes, except where the intended functional effect of the process is not to increase the sugars content of a food, and a functionally insignificant increase in sugars results; and

(iv) The food that it resembles and for which it substitutes normally contains added sugars; and

(v) The product bears a statement that the food is not “low calorie” or “calorie reduced” (unless the food meets the requirements for a “low” or “reduced calorie” food) and that directs consumers' attention to the nutrition panel for further information on sugar and calorie content.

(3) Paragraph (c)(1) of this section shall not apply to a factual statement that a food, including foods intended specifically for infants and children less than 2 years of age, is unsweetened or contains no added sweeteners in the case of a food that contains apparent substantial inherent sugar content, e.g., juices.

(4) The claims provided for in paragraph (c)(1) and (c)(2) of this section may be used on labels or in labeling of dietary supplements of vitamins or minerals that are intended specifically for use by infants and children less than 2 years of age.

(5) The terms “reduced sugar,” “reduced in sugar,” “sugar reduced,” “less sugar,” “lower sugar” or “lower in sugar” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l), main dish products as defined in § 101.13(m), and dietary supplements of vitamins or minerals, provided that:

(i) The food contains at least 25 percent less sugar per reference amount customarily consumed than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sugar differs between the two foods are declared in immediate proximity to the most prominent such claim (e.g., “these corn flakes contain 25 percent less sugar than our sugar coated corn flakes”); and

(B) Quantitative information comparing the level of the sugar in the product per labeled serving with that of the reference food that it replaces (e.g., “Sugar content has been lowered from 8 g to 6 g per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(6) The terms defined in paragraph (c)(5) of this section may be used on the label or in the labeling of a meal product as defined in § 101.13(l) and a main dish product as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less sugars per 100 g of food than an appropriate reference food as described in § 101.13(j)(1), and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sugars differ between the two foods are declared in immediate proximity to the most prominent such claim (e.g., reduced sweet and sour shrimp dinner, “25 percent less sugar per 3 oz than our regular sweet and sour shrimp dinner”); and

(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference food that it replaces (e.g., “Sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and

(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable.

(b) Sodium content claims. (1) The terms “sodium free,” “free of sodium,” “no sodium,” “zero sodium,” “without sodium,” “trivial source of sodium,” “negligible source of sodium,” or “dietary insignificant source of sodium” may be used on the label or in the labeling of foods, provided that:

(i) The food contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving or, in the case of a meal product or a main dish product, less than 5 mg of sodium per labeled serving; and

(ii) The food contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium;” and

(iii) As required in § 101.13(e)(2) if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to disclose that sodium is not usually present in the food (e.g., “leaf lettuce, a sodium free food”).

(2) The terms “very low sodium,” or “very low in sodium,” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i)(A) The food has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons and contains 35 mg or less sodium per reference amount customarily consumed; or

(B) The food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contains 35 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form);

(ii) If the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to vary the sodium content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “potatoes, a very low-sodium food”).

(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The product contains 35 mg or less of sodium per 100 g of product; and

(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches.

(4) The terms “low sodium,” or “low in sodium,” “little sodium,” “contains a small amount of sodium,” or “low source of sodium” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i)(A) The food has a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons and contains 140 mg or less sodium per reference amount customarily consumed; or

(B) The food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contains 140 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form); and

(ii) If the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to vary the sodium content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “fresh spinach, a low sodium food”); and

(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The product contains 140 mg or less sodium per 100 g; and

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches.

(6) The terms “reduced sodium,” “reduced in sodium,” “sodium reduced,” “less sodium,” “lower sodium,” or “lower in sodium” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less sodium per reference amount customarily consumed than an appropriate reference food as described in § 101.13(j)(1).

(ii) As required for § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sodium differs from the labeled food are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ___, 50 percent less sodium than regular ___”); and

(B) Quantitative information comparing the level of the sodium in the product per labeled serving with that of the reference food that it replaces (e.g., “Sodium content has been lowered from 300 to 150 mg per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(6) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low sodium.”

(7) The terms defined in paragraph (b)(6) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less sodium per 100 g of food than an appropriate reference food as described in § 101.13(j)(1), and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the sodium differs from the reference food are declared in immediate proximity to the most prominent such claim (e.g., reduced sodium eggplant parmigiana dinner “30 percent less sodium per oz (or 3 oz) than our regular eggplant parmigiana dinner”).

(B) Quantitative information comparing the level of sodium in the product per specified weight with that of the reference food that it replaces (e.g., “Sodium content has been reduced from 217 mg per 3 oz to 150 mg per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(7) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low sodium.”

(c) The term “salt” is not synonymous with “sodium.” Salt refers to sodium chloride. However, references to salt content such as “unsalted,” “no salt,” “no salt added” are potentially misleading.

(1) The term “salt free” may be used on the label or in labeling of foods only if the food is “sodium free” as defined in paragraph (b)(1) of this section.

(2) The terms “unsalted,” “without added salt,” and “no salt added” may be used on the label or in labeling of foods only if:

(i) No salt is added during processing;

(ii) The food that it resembles and for which it substitutes is normally processed with salt; and

(iii) If the food is not sodium free, the statement, “not a sodium free food” or “not for control of sodium in the diet” appears adjacent to the nutrition label of the food bearing the claim, or, if the nutrition label is on the information panel, it may appear elsewhere on the information panel in accordance with § 101.2.

(3) Paragraph (c)(2) of this section shall not apply to a factual statement that a food intended specifically for infants and children less than 2 years of age is unsalted, provided such statement refers to the taste of the food and is not otherwise false and misleading.

(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if:

(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13;

(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable; and

(4) For dietary supplements, claims for fat, saturated fat, and cholesterol may not be made on products that meet the criteria in § 101.60(b)(1) or (b)(2) for “calorie free” or “low calorie” claims.

(b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “negligible source of fat,” or “dietarily insignificant source of fat” or, in the case of milk products, “skim” may be used on the label or in labeling of foods, provided that:

(i) The food contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving or, in the case of a meal product or main dish product, less than 0.5 g of fat per labeled serving; and

(ii) The food contains no added ingredient that is a fat or is generally understood by consumers to contain fat unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states “adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat;” and

(iii) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to disclose that fat is not usually present in the food (e.g., “broccoli, a fat free food”).

(2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i)(A) The food has a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons and contains 3 g or less of fat per reference amount customarily consumed; or

(B) The food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contains 3 g or less of fat per reference amount customarily consumed and per 50 g of food (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form); and

(ii) If the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “frozen perch, a low fat food”).

(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of meal products as defined in § 101.13(l) or main dish products as defined in § 101.13(m), provided that:

(i) The product contains 3 g or less of total fat per 100 g and not more than 30 percent of calories from fat; and

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches.

(4) The terms “reduced fat,” “reduced in fat,” “fat reduced,” “less fat,” “lower fat,” or “lower in fat” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less fat per reference amount customarily consumed than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the fat differs between the two foods and are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat - 50 percent less fat than our regular brownies”); and

(B) Quantitative information comparing the level of fat in the product per labeled serving with that of the reference food that it replaces (e.g., “Fat content has been reduced from 8 g to 4 g per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low fat.”

(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less fat per 100 g of food than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the fat differs between the two foods are declared in immediate proximity to the most prominent such claim (e.g., reduced fat spinach souffle, “33 percent less fat per 3 oz than our regular spinach souffle”); and

(B) Quantitative information comparing the level of fat in the product per specified weight with that of the reference food that it replaces (e.g., “Fat content has been reduced from 7.5 g per 3 oz to 5 g per 3 oz.”) is declared adjacent to the most prominent claim, to the nutrition label, or, if the nutrition label is located on the information panel, it may appear elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low fat.”

(6) The term “_ percent fat free” may be used on the label or in the labeling of foods, provided that:

(i) The food meets the criteria for “low fat” in paragraph (b)(2) or (b)(3) of this section;

(ii) The percent declared and the words “fat free” are in uniform type size; and

(iii) A “100 percent fat free” claim may be made only on foods that meet the criteria for “fat free” in paragraph (b)(1) of this section, that contain less than 0.5 g of fat per 100 g, and that contain no added fat.

(c) Fatty acid content claims. The label or labeling of foods that bear claims with respect to the level of saturated fat shall disclose the level of total fat and cholesterol in the food in immediate proximity to such claim each time the claim is made and in type that shall be no less than one-half the size of the type used for the claim with respect to the level of saturated fat. Declaration of cholesterol content may be omitted when the food contains less than 2 milligrams (mg) of cholesterol per reference amount customarily consumed or in the case of a meal or main dish product less than 2 mg of cholesterol per labeled serving. Declaration of total fat may be omitted with the term defined in paragraph (c)(1) of this section when the food contains less than 0.5 g of total fat per reference amount customarily consumed or, in the case of a meal product or a main dish product, when the product contains less than 0.5 g of total fat per labeled serving. The declaration of total fat may be omitted with the terms defined in paragraphs (c)(2) through (c)(5) of this section when the food contains 3 g or less of total fat per reference amount customarily consumed or in the case of a meal product or a main dish product, when the product contains 3 g or less of total fat per 100 g and not more than 30 percent calories from fat.

(1) The terms “saturated fat free,” “free of saturated fat,” “no saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of saturated fat,” “negligible source of saturated fat,” or “dietarily insignificant source of saturated fat” may be used on the label or in the labeling of foods, provided that:

(i) The food contains less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid per reference amount customarily consumed and per labeled serving, or in the case of a meal product or main dish product, less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid per labeled serving; and

(ii) The food contains no ingredient that is generally understood by consumers to contain saturated fat unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients which states, “adds a trivial amount of saturated fat,” “adds a negligible amount of saturated fat,” or “adds a dietarily insignificant amount of saturated fat;” and

(iii) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to disclose that saturated fat is not usually present in the food.

(2) The terms “low in saturated fat,” “low saturated fat,” “contains a small amount of saturated fat,” “low source of saturated fat,” or “a little saturated fat” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains 1 g or less of saturated fatty acids per reference amount customarily consumed and not more than 15 percent of calories from saturated fatty acids; and

(ii) If a food meets these conditions without benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “raspberries, a low saturated fat food”).

(3) The terms defined in paragraph (c)(2) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The product contains 1 g or less of saturated fatty acids per 100 g and less than 10 percent calories from saturated fat; and

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches.

(4) The terms “reduced saturated fat,” “reduced in saturated fat,” “saturated fat reduced,” “less saturated fat,” “lower saturated fat,” or “lower in saturated fat” may be used on the label or in the labeling of foods, except as limited by § 101.13(j)(1)(i) and except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less saturated fat per reference amount customarily consumed than an appropriate reference food as described in § 101.13(j)(1); and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food and the percent (or fraction) that the saturated fat differs between the two foods are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat. Contains 50 percent less saturated fat than the national average for nondairy creamers”); and

(B) Quantitative information comparing the level of saturated fat in the product per labeled serving with that of the reference food that it replaces (e.g., “Saturated fat reduced from 3 g to 1.5 g per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (c)(4) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low saturated fat.”

(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) The food contains at least 25 percent less saturated fat per 100 g of food than an appropriate reference food as described in § 101.13(j)(1), and

(ii) As required in § 101.13(j)(2) for relative claims:

(A) The identity of the reference food, and the percent (or fraction) that the fat differs between the two foods are declared in immediate proximity to the most prominent such claim (e.g., reduced saturated fat Macaroni and Cheese, “33 percent less saturated fat per 3 oz than our regular Macaroni and Cheese”).

(B) Quantitative information comparing the level of saturated fat in the product per specified weight with that of the reference food that it replaces (e.g., “Saturated fat content has been reduced from 2.5 g per 3 oz to 1.7 g per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label in on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low saturated fat.”

(d) Cholesterol content claims. (1) The terms “cholesterol free,” “free of cholesterol,” “zero cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of cholesterol,” “negligible source of cholesterol,” or “dietarily insignificant source of cholesterol” may be used on the label or in the labeling of foods, provided that:

(i) For foods that contain 13 g or less of total fat per reference amount customarily consumed, per labeled serving, and per 50 g if the reference amount customarily consumed is 30 g or less or 2 tablespoons or less (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form), or, in the case of meal products, 26.0 g or less total fat per labeled serving, or, in the case of main dish products, 19.5 g or less total fat per labeled serving:

(A) The food contains less than 2 mg of cholesterol per reference amount customarily consumed and per labeling serving or, in the case of a meal product or main dish product, less than 2 mg of cholesterol per labeled serving; and

(B) The food contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states “adds a trivial amount of cholesterol,” “adds a negligible amount of cholesterol,” or “adds a dietarily insignificant amount of cholesterol;” and

(C) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed or, in the case of a meal product or main dish product, 2 g or less of saturated fatty acids per labeled serving; and

(D) As required in § 101.13(e)(2), if the food contains less than 2 mg of cholesterol per reference amount customarily consumed or in the case of a meal product or main dish product, less than 2 mg of cholesterol per labeled serving without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to disclose that cholesterol is not usually present in the food (e.g., “applesauce, a cholesterol-free food”).

(ii) For food that contain more than 13 g of total fat per reference amount customarily consumed, per labeling serving, or per 50 g if the reference amount customarily consumed is 30 g or less or 2 tablespoons or less (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form), or in the case of a meal product, more than 26 g of total fat per labeled serving, or, in the case of a main dish product more than 19.5 g of total fat per labeled serving:

(A) The food contains less than 2 mg of cholesterol per reference amount customarily consumed and per labeling serving or, in the case of a meal product or main dish product, less than 2 mg of cholesterol per labeled serving; and

(B) The food contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states “adds a trivial amount of cholesterol,” “adds a negligible amount of cholesterol,” or “adds a dietarily insignificant amount of cholesterol;” and

(C) The food contains 2 g or less of saturated fatty acids per reference amount cutomarily consumed or, in the case of a meal product or main dish product less than 2 g of saturated fatty acids per labeled serving; and

(D) The label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. Such disclosure shall appear in immediate proximity to such claim preceding any disclosure statement required under § 101.13(h) in type that shall be no less than one-half the size of the type used for such claim. If the claim appears on more than one panel, the disclosure shall be made on each panel except for the panel that bears nutrition labeling. If the claim appears more than once on a panel, the disclosure shall be made in immediate proximity to the claim that is printed in the largest type; and

(E) As required in § 101.13(e)(2), if the food contains less than 2 mg of cholesterol per reference amount customarily consumed or in the case of a meal product or main dish product less than 2 mg of cholesterol per labeled serving without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to disclose that cholesterol is not usually present in the food (e.g., “canola oil, a cholesterol-free food, contains 14 g of fat per serving”); or

(F) If the food contains less than 2 mg of cholesterol per reference amount customarily consumed or in the case of a meal product or main dish product less than 2 mg of cholesterol per labeled serving only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is substantially less (i.e., meets requirements of paragraph (d)(4)(ii)(A) of this section) than the food for which it substitutes as specified in § 101.13(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol was reduced are declared in immediate proximity to the most prominent such claim (e.g., “cholesterol-free margarine, contains 100 percent less cholesterol than butter”); and

(2) Quantitative information comparing the level of cholesterol in the product per labeled serving with that of the reference food that it replaces (e.g., “Contains no cholesterol compared with 30 mg cholesterol in one serving of butter. Contains 13 g of fat per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(2) The terms “low in cholesterol,” “low cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” or “little cholesterol” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) For foods that have a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons and contain 13 g or less of total fat per reference amount customarily consumed and per labeled serving:

(A) The food contains 20 mg or less of cholesterol per reference amount customarily consumed;

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed; and

(C) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all foods of that type and not merely to the particular brand to which the label attaches (e.g., “low fat cottage cheese, a low cholesterol food.”).

(ii) For foods that have a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contain 13 g or less of total fat per reference amount customarily consumed, per labeled serving, and per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form);

(A) The food contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form);

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed; and

(C) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all foods of that type and not merely to the particular brand to which the label attaches (e.g., “low fat cottage cheese, a low cholesterol food”).

(iii) For foods that have a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons and contain more than 13 g of total fat per reference amount customarily consumed or per labeled serving,

(A) The food contains 20 mg or less of cholesterol per reference amount customarily consumed;

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed;

(C) The label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. Such disclosure shall appear in immediate proximity to such claim preceding any disclosure statement required under § 101.13(h) in type that shall be no less than one-half the size of the type used for such claim. If the claim appears on more than one panel, the disclosure shall be made on each panel except for the panel that bears nutrition labeling. If the claim is made more than once on a panel, the disclosure shall be made in immediate proximity to the claim that is printed in the largest type; and

(D) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all foods of that type and not merely to the particular brand to which the label attaches; or

(E) If the food contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is substantially less (i.e., meets requirements of paragraph (d)(4)(ii)(A) of this section) than the food for which it substitutes as specified in § 101.13(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “low-cholesterol peanut butter sandwich crackers, contains 83 percent less cholesterol than our regular peanut butter sandwich crackers”); and

(2) Quantitative information comparing the level of cholesterol in the product per labeled serving with that of the reference food that it replaces (e.g., “Cholesterol lowered from 30 mg to 5 mg per serving; contains 13 g of fat per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iv) For foods that have a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contain more than 13 g of total fat per reference amount customarily consumed, per labeled serving, or per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form),

(A) The food contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form),

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed;

(C) The label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. Such disclosure shall appear in immediate proximity to such claim preceding any disclosure statement required under § 101.13(h) in type that shall be no less than one-half the size of the type used for such claim. If the claim appears on more than one panel, the disclosure shall be made on each panel except for the panel that bears nutrition labeling. If the claim is made more than once on a panel, the disclosure shall be made in immediate proximity to the claim that is printed in the largest type; and

(D) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all foods of that type and not merely to the particular brand to which the label attaches; or

(E) If the food contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is substantially less (i.e., meets requirements of paragraph (d)(4)(ii)(A) of this section) than the food for which it substitutes as specified in § 101.13(d) that has a significant (i.e., 5 percent or more of a national or regional market) market share. As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “low-cholesterol peanut butter sandwich crackers, contains 83 percent less cholesterol than our regular peanut butter sandwich crackers”); and

(2) Quantitative information comparing the level of cholesterol in the product per labeled serving with that of the reference food that it replaces (e.g., “Cholesterol lowered from 30 mg to 5 mg per serving; contains 13 g of fat per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(3) The terms defined in paragraph (d)(2) of this section may be used on the label and in labeling of meal products as defined in § 101.13(l) or a main dish product as defined in § 101.13(m) provided that the product meets the requirements of paragraph (d)(2) of this section except that the determination as to whether paragraph (d)(2)(i) or (d)(2)(iii) of this section applies to the product will be made only on the basis of whether the meal product contains 26 g or less of total fat per labeled serving or the main dish product contain 19.5 g or less of total fat per labeled serving, the requirement in paragraphs (d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20 mg of cholesterol per 100 g, and the requirement in paragraphs (d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to require that the food contain 2 g or less of saturated fat per 100 g rather than per reference amount customarily consumed.

(4) The terms “reduced cholesterol,” “reduced in cholesterol,” “cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in cholesterol” except as limited by § 101.13(j)(1)(i) may be used on the label or in labeling of foods or foods that substitute for those foods as specified in § 101.13(d), excluding meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) For foods that contain 13 g or less of total fat per reference amount customarily consumed, per labeled serving, and per 50 g if the reference amount customarily consumed is 30 g or less or 2 tablespoons or less (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form):

(A) The food has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference food it resembles as defined in § 101.13(j)(1) and for which it substitutes as specified in § 101.13(d) that has a significant (i.e., 5 percent or more) market share; and

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed; and

(C) As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim; and

(2) Quantitative information comparing the level of cholesterol in the product per labeled serving with that of the reference food that it replaces (e.g., “[labeled product] 50 mg cholesterol per serving; [reference product] 30 mg cholesterol per serving”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(ii) For foods that contain more than 13 g of total fat per reference amount customarily consumed, per labeled serving, or per 50 g if the reference amount customarily consumed is 30 g or less or 2 tablespoons or less (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the “as prepared” form):

(A) The food has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference food it resembles as defined in § 101.13(j)(1) and for which it substitutes as specified in § 101.13(d) that has a significant (i.e., 5 percent or more of a national or regional market) market share;

(B) The food contains 2 g or less of saturated fatty acids per reference amount customarily consumed;

(C) The label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. Such disclosure shall appear in immediate proximity to such claim preceding any disclosure statement required under § 101.13(h) in type that shall be no less than one-half the size of the type used for such claim. If the claim appears on more than one panel, the disclosure shall be made on each panel except for the panel that bears nutrition labeling. If the claim is made more than once on a panel, the disclosure shall be made in immediate proximity to the claim that is printed in the largest type; and

(D) As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., 25 percent less cholesterol than ___); and

(2) Quantitative information comparing the level of cholesterol in the product per labeled serving with that of the reference food that it replaces (e.g., “Cholesterol lowered from 55 mg to 30 mg per serving. Contains 13 g of fat per serving.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (d)(4) of this section may not be made on the label or in labeling of a food if the nutrient content of the reference food meets the definition for “low cholesterol.”

(5) The terms defined in paragraph (d)(4) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that:

(i) For meal products that contain 26.0 g or less of total fat per labeled serving or for main dish products that contain 19.5 g or less of total fat per labeled serving;

(A) The food has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference food it resembles as defined in § 101.13(j)(1) and for which it substitutes as specified in § 101.13(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;

(B) The food contains 2 g or less of saturated fatty acids per 100 g; and

(C) As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food, and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25% less cholesterol per 3 oz than ___); and

(2) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference food that it replaces (e.g., “Cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(ii) For meal products that contain more than 26.0 g of total fat per labeled serving or for main dish products that contain more than 19.5 g of total fat per labeled serving:

(A) The food has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference food it resembles as defined in § 101.13(j)(1) and for which it substitutes as specified in § 101.13(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share.

(B) The food contains 2 g or less of saturated fatty acids per 100 g;

(C) The label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. Such disclosure shall appear in immediate proximity to such claim preceding any disclosure statement required under § 101.13(h) in type that shall be no less than one-half the size of the type used for such claim. If the claim appears on more than one panel the disclosure shall be made on each panel except for the panel that bears nutrition labeling. If the claim is made more than once on a panel, the disclosure shall be made in immediate proximity to the claim that is printed in the largest type; and

(D) As required in § 101.13(j)(2) for relative claims:

(1) The identity of the reference food and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., 25 percent less cholesterol than ___); and

(2) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference food that it replaces (e.g., “Cholesterol lowered from 30 mg to 22 mg per 3 oz of product.”) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with § 101.2.

(iii) Claims described in paragraph (d)(5) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for “low cholesterol.”

(e) “Lean” and “extra lean” claims. (1) The term “lean” may be used on the label or in labeling of foods except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m) provided that the food is a seafood or game meat product and as packaged contains less than 10 g total fat, 4.5 g or less saturated fat, and less than 95 mg cholesterol per reference amount customarily consumed and per 100 g;

(2) The term defined in paragraph (e)(1) of this section may be used on the label or in labeling of a mixed dish not measurable with a cup as defined in § 101.12(b) in table 2, provided that the food contains less than 8 g total fat, 3.5 g or less saturated fat and less than 80 mg cholesterol per reference amount customarily consumed;

(3) The term defined in paragraph (e)(1) of this section may be used on the label or in the labeling of meal products as defined in § 101.13(l) or main dish products as defined in § 101.13(m) provided that the food contains less than 10 g total fat, 4.5 g or less saturated fat, and less than 95 mg cholesterol per 100 g and per labeled serving;

(4) The term “extra lean” may be used on the label or in the labeling of foods except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m) provided that the food is a discrete seafood or game meat product and as packaged contains less than 5 g total fat, less than 2 g saturated fat, and less than 95 mg cholesterol per reference amount customarily consumed and per 100 g; and

(5) The term defined in paragraph (e)(4) of this section may be used on the label or in labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m) provided that the food contains less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of cholesterol per 100 g and per labeled serving.

(f) Misbranding. Any label or labeling containing any statement concerning fat, fatty acids, or cholesterol that is not in conformity with this section shall be deemed to be misbranded under sections 201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.

(a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food if:

(1) The claim uses one of the terms described in this section in accordance with the definition for that term;

(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and

(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable.

(b) Label statements that are not implied claims. Certain label statements about the nature of a product are not nutrient content claims unless such statements are made in a context that would make them an implied claim under § 101.13(b)(2). The following types of label statements are generally not implied nutrient content claims and, as such, are not subject to the requirements of § 101.13 and this section:

(1) A claim that a specific ingredient or food component is absent from a product, provided that the purpose of such claim is to facilitate avoidance of the substances because of food allergies (see § 105.62 of this chapter), food intolerance, religious beliefs, or dietary practices such as vegetarianism or other nonnutrition related reason, e.g., “100 percent milk free;”

(2) A claim about a substance that is nonnutritive or that does not have a nutritive function, e.g., “contains no preservatives,” “no artificial colors;”

(3) A claim about the presence of an ingredient that is perceived to add value to the product, e.g., “made with real butter,” “made with whole fruit,” or “contains honey,” except that claims about the presence of ingredients other than vitamins or minerals or that are represented as a source of vitamins and minerals are not allowed on labels or in labeling of dietary supplements of vitamins and minerals that are not in conventional food form.

(4) A statement of identity for a food in which an ingredient constitutes essentially 100 percent of a food (e.g., “corn oil,” “oat bran,” “dietary supplement of vitamin C 60 mg tablet”).

(5) A statement of identity that names as a characterizing ingredient, an ingredient associated with a nutrient benefit (e.g., “corn oil margarine,” “oat bran muffins,” or “whole wheat bagels”), unless such claim is made in a context in which label or labeling statements, symbols, vignettes, or other forms of communication suggest that a nutrient is absent or present in a certain amount; and

(6) A label statement made in compliance with a specific provision of part 105 of this chapter, solely to note that a food has special dietary usefulness relative to a physical, physiological, pathological, or other condition, where the claim identifies the special diet of which the food is intended to be a part.

(c) Particular implied nutrient content claims. (1) Claims about the food or an ingredient therein that suggest that a nutrient or an ingredient is absent or present in a certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with paragraph (a) of this section.

(2) The phrases “contains the same amount of [nutrient] as a [food]” and “as much [nutrient] as a [food]” may be used on the label or in the labeling of foods, provided that the amount of the nutrient in the reference food is enough to qualify that food as a “good source” of that nutrient, and the labeled food, on a per serving basis, is an equivalent, good source of that nutrient (e.g., “as much fiber as an apple,” “Contains the same amount of Vitamin C as an 8 oz glass of orange juice.”).

(3) Claims may be made that a food contains or is made with an ingredient that is known to contain a particular nutrient, or is prepared in a way that affects the content of a particular nutrient in the food, if the finished food is either “low” in or a “good source” of the nutrient that is associated with the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that level of the nutrient must be present in the food. For example, a claim that a food contains oat bran is a claim that it is a good source of dietary fiber; that a food is made only with vegetable oil is a claim that it is low in saturated fat; and that a food contains no oil is a claim that it is fat free.

(d) General nutritional claims. (1) This paragraph covers labeling claims that are implied nutrient content claims because they:

(i) Suggest that a food because of its nutrient content may help consumers maintain healthy dietary practices; and

(ii) Are made in connection with an explicit or implicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams of fat”).

(2) You may use the term “healthy” or related terms (e.g., “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if:

(i) The food meets the following conditions for fat, saturated fat, cholesterol, and other nutrients:

(ii) The food meets the following conditions for sodium:

(iii) The food complies with the definition and declaration requirements in this part 101 for any specific nutrient content claim on the label or in labeling, and

(iv) If you add a nutrient to the food specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foods in § 104.20 of this chapter.

(a) Claims may be made to characterize the level of nutrients, including fat, in butter if:

(1) The claim complies with the requirements of § 101.13 and with the requirements of the regulations in this subpart that define the particular nutrient content claim that is used and how it is to be presented. In determining whether a claim is appropriate, the calculation of the percent fat reduction in milkfat shall be based on the 80 percent milkfat requirement provided by the statutory standard for butter (21 U.S.C. 321a);

(2) The product contains cream or milk, including milk constituents (including, but not limited to, whey, casein, modified whey, and salts of casein), or both, with or without added salt, with or without safe and suitable colorings, with or without nutrients added to comply with paragraph (a)(3) of this section, and with or without safe and suitable bacterial cultures. The product may contain safe and suitable ingredients to improve texture, prevent syneresis, add flavor, extend shelf life, improve appearance, and add sweetness. The product may contain water to replace milkfat although the amount of water in the product shall be less than the amount of cream, milk, or milk constituents;

(3) The product is not nutritionally inferior, as defined in § 101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and

(4) If the product would violate 21 U.S.C. 321a but for the nutrient content claim that characterizes the level of nutrients, that claim shall be an explicit claim that is included as part of the common or usual name of the product.

(b) Deviations from the ingredient provisions of 21 U.S.C. 321a must be the minimum necessary to achieve similar performance characteristics as butter as produced under 21 U.S.C. 321a, or the food will be deemed to be adulterated under section 402(b) of the act. The performance characteristics (e.g., physical properties, organoleptic characteristics, functional properties, shelf life) of the product shall be similar to butter as produced under 21 U.S.C. 321a. If there is a significant difference in performance characteristics (that materially limits the uses of the product compared to butter,) the label shall include a statement informing the consumer of such difference (e.g., if appropriate, “not recommended for baking purposes”). Such statement shall comply with the requirements of § 101.13(d). The modified product shall perform at least one of the principal functions of butter substantially as well as butter as produced under 21 U.S.C. 321a.

(c)(1) Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of this part.

(2) Safe and suitable ingredients added to improve texture, prevent syneresis, add flavor, extend shelf life, improve appearance, or add sweetness and water added to replace milkfat shall be identified with an asterisk in the ingredient statement. The statement “*Ingredients not in regular butter” shall immediately follow the ingredient statement in the same type size.

(a) This section pertains to petitions for claims, expressed or implied, that:

(1) Characterize the level of any nutrient which is of the type required to be in the label or labeling of food by section 403(q)(1) or (q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and

(2) That are not exempted under section 403(r)(5)(A) through (r)(5)(C) of the act from the requirements for such claims in section 403(r)(2).

(b) Petitions included in this section are:

(1) Petitions for a new (heretofore unauthorized) nutrient content claim;

(2) Petitions for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient; and

(3) Petitions for the use of an implied claim in a brand name.

(c) An original and one copy of the petition to be filed under the provisions of section 403(r)(4) of the act shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. Petitioners interested in submitting a disk should contact the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition for details. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's post office address to which published notices as required by section 403 of the act may be sent.

(d) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of FDA. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(e) If nonclinical laboratory studies are included in a petition submitted under section 403(r)(4) of the act, the petition shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(f) If clinical investigations are included in a petition submitted under section 403(r)(4) of the act, the petition shall include a statement regarding each such clinical investigation relied upon in the petition that the study either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter or was not subject to such requirements in accordance with § 56.104 or § 56.105 of this chapter, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.

(g) The availability for public disclosure of petitions submitted to the agency under this section will be governed by the rules specified in § 10.20(j) of this chapter.

(h) All petitions submitted under this section shall include either a claim for a categorical exclusion under § 25.30 or 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter.

(i) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application from the petitioner, the present petition may incorporate it by specific reference to the earlier petition.

(j) The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.

(k) The petition shall include a statement signed by the person responsible for the petition, that to the best of his knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him pertinent to the evaluation of the petition.

(l) All applicable provisions of part 10 - Administrative Practices and Procedures, may be used by FDA, the petitioner or any outside party with respect to any agency action on the petition.

(m)(1) Petitions for a new nutrient content claim shall include the following data and be submitted in the following form.

(2) Within 15 days of receipt of the petition, the petitioner will be notified by letter of the date on which the petition was received by the agency. Such notice will inform the petitioner:

(i) That the petition is undergoing agency review (in which case a docket number will be assigned to the petition), and the petitioner will subsequently be notified of the agency's decision to file or deny the petition; or

(ii) That the petition is incomplete, e.g., it lacks any of the data required by this part, it presents such data in a manner that is not readily understood, or it has not been submitted in quadruplicate, in which case the petition will be denied, and the petitioner will be notified as to what respect the petition is incomplete.

(3) Within 100 days of the date of receipt of the petition, FDA will notify the petitioner by letter that the petition has either been filed or denied. If denied, the notification shall state the reasons therefor. If filed, the date of the notification letter becomes the date of filing for the purposes of section 403(r)(4)(A)(i) of the act. If FDA does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the FDA and the petitioner. A petition that has been denied, or has been deemed to be denied, without filing shall not be made available to the public. A filed petition shall be available to the public as provided under paragraph (g) of this section.

(4) Within 90 days of the date of filing FDA will by letter of notification to the petitioner:

(i) Deny the petition; or

(ii) Inform the petitioner that a proposed regulation to provide for the requested use of the new term will be published in the Federal Register. FDA will publish the proposal to amend the regulations to provide for the requested use of the nutrient content claim in the Federal Register within 90 days of the date of filing. The proposal will also announce the availability of the petition for public disclosure.

(iii) If FDA does not act within 90 days of the date of filing, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.

(5) If FDA issues a proposal, the rulemaking shall be completed within 540 days of the date of receipt of the petition.

(n)(1) Petitions for a synonymous term shall include the following data and be submitted in the following form.

(2) Within 15 days of receipt of the petition the petitioner will be notified by letter of the date on which the petition was received. Such notice will inform the petitioner:

(i) That the petition is undergoing agency review (in which case a docket number will be assigned to the petition) and the petitioner will subsequently be notified of the agency's decision to grant the petitioner permission to use the proposed term or to deny the petition; or

(ii) That the petition is incomplete, e.g., it lacks any of the data required by this part, it presents such data in a manner that is not readily understood, or it has not been submitted in quadruplicate, in which case the petition will be denied, and the petitioner will be notified as to what respect the petition is incomplete.

(3) Within 90 days of the date of receipt of the petition that is accepted for review (i.e., that has not been found to be incomplete and consequently denied, FDA will notify the petitioner by letter of the agency's decision to grant the petitioner permission to use the proposed term, with any conditions or limitations on such use specified, or to deny the petition, in which case the letter shall state the reasons therefor. Failure of the petition to fully address the requirements of this section shall be grounds for denial of the petition.

(4) As soon as practicable following the agency's decision to either grant or deny the petition, FDA will publish a notice in the Federal Register informing the public of his decision. If the petition is granted the Food and Drug Administration will list, the approved synonymous term in the regulations listing terms permitted for use in nutrient content claims.

(o)(1) Petitions for the use of an implied nutrient content claim in a brand name shall include the following data and be submitted in the following form:

(2) Within 15 days of receipt of the petition the petitioner will be notified by letter of the date on which the petition was received. Such notice will inform the petitioner:

(i) That the petition is undergoing agency review (in which case a docket number will be assigned to the petition); or

(ii) That the petition is incomplete, e.g., it lacks any of the data required by this part, it presents such data in a manner that is not readily understood, or it has not been submitted in quadruplicate, in which case the petition will be denied, and the petitioner will be notified as to what respect the petition is incomplete.

(3) FDA will publish a notice of the petition in the Federal Register announcing its availability to the public and seeking comment on the petition. The petition shall be available to the public to the extent provided under paragraph (g) of this section. The notice shall allow 30 days for comments.

(4) Within 100 days of the date of receipt of the petition that is accepted for review (i.e., that has not been found to be incomplete and subsequently returned to the petitioner), FDA will:

(i) Notify the petitioner by letter of the agency's decision to grant the petitioner permission to use the proposed brand name if such use is not misleading, with any conditions or limitations on such use specified; or

(ii) Deny the petition, in which case the letter shall state the reasons therefor. Failure of the petition to fully address the requirements of this section shall be grounds for denial of the petition. Should FDA not notify the petitioner of his decision on the petition within 100 days, the petition shall be considered to be granted.

(5) As soon as practicable following the granting of a petition, the Commissioner of Food and Drugs will publish a notice in the Federal Register informing the public of such fact.

(a) Any interested person may petition the Food and Drug Administration (FDA) to issue a regulation regarding a health claim. An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.) If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's post office address to which any correspondence required by section 403 of the Federal Food, Drug, and Cosmetic Act may be sent.

(b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of FDA. Such information may include any findings, along with the basis of the findings, of an outside panel with expertise in the subject area. Any reference to published information shall be accompanied by reprints, or easily readable copies of such information.

(c) If nonclinical laboratory studies are included in a petition, the petition shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(d) If clinical or other human investigations are included in a petition, the petition shall include a statement that they were either conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or were not subject to such requirements in accordance with § 56.104 or § 56.105, and a statement that they were conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.

(e) All data and information in a health claim petition are available for public disclosure after the notice of filing of petition is issued to the petitioner, except that clinical investigation reports, adverse reaction reports, product experience reports, consumer complaints, and other similar data and information shall only be available after deletion of:

(1) Names and any information that would identify the person using the product.

(2) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(f) Petitions for a health claim shall include the following data and be submitted in the following form:

(g) The data specified under the several lettered headings should be submitted on separate pages or sets of pages, suitably identified. If such data have already been submitted with an earlier application from the petitioner or any other final petition, the present petition may incorporate it by specific reference to the earlier petition.

(h) The petition shall include a statement signed by the person responsible for the petition that, to the best of his/her knowledge, it is a representative and balanced submission that includes unfavorable information as well as favorable information, known to him/her to be pertinent to the evaluation of the proposed health claim.

(i) The petition shall be signed by the petitioner or by his/her attorney or agent, or (if a corporation) by an authorized official.

(j) Agency action on the petition. (1) Within 15 days of receipt of the petition, the petitioner will be notified by letter of the date on which the petition was received. Such notice will inform the petitioner that the petition is undergoing agency review and that the petitioner will subsequently be notified of the agency's decision to file for comprehensive review or deny the petition.

(2) Within 100 days of the date of receipt of the petition, FDA will notify the petitioner by letter that the petition has either been filed for comprehensive review or denied. The agency will deny a petition without reviewing the information contained in “B. Summary of Scientific Data” if the information in “A. Preliminary Requirements” is inadequate in explaining how the substance conforms to the requirements of § 101.14(b). If the petition is denied, the notification will state the reasons therefor, including justification of the rejection of any report from an authoritative scientific body of the U.S. Government. If filed, the date of the notification letter becomes the date of filing for the purposes of this regulation. If FDA does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner. A petition that has been denied, or has been deemed to be denied, without filing will not be made available to the public. A filed petition will be available to the public to the extent provided under paragraph (e) of this section.

(3) Within 90 days of the date of filing, FDA will by letter of notification to the petitioner:

(i) Deny the petition, or

(ii) Inform the petitioner that a proposed regulation to provide for the requested use of the health claim will be published in the Federal Register. If the petition is denied, the notification will state the reasons therefor, including justification for the rejection of any report from an authoritative scientific body of the U.S. Government. FDA will publish the proposal to amend the regulations to provide for the requested use of the health claim in the Federal Register within 90 days of the date of filing. The proposal will also announce the availability of the petition for public review.

(iii) If FDA does not act within 90 days of the date of filing, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner.

(4)(i) Within 270 of the date of publication of the proposal, FDA will publish a final rule that either authorizes use of the health claim or explains why the agency has decided not to authorize one.

(ii) For cause, FDA may extend, no more than twice, the period in which it will publish a final rule; each such extension will be for no more than 90 days. FDA will publish a notice of each extension in the Federal Register. The document will state the basis for the extension, the length of the extension, and the date by which the final rule will be published, which date shall be within 540 days of the date of receipt of the petition.

Health claims not authorized for foods in conventional food form or for dietary supplements of vitamins, minerals, herbs, or other similar substances:

(a) Dietary fiber and cardiovascular disease.

(b) Zinc and immune function in the elderly.

(a) Relationship between calcium, vitamin D, and osteoporosis. An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Peak bone mass is the total quantity of bone present at maturity, and experts believe that it has the greatest bearing on whether a person will be at risk of developing osteoporosis and related bone fractures later in life. Another factor that influences total bone mass and susceptibility to osteoporosis is the rate of bone loss after skeletal maturity. Vitamin D is required for normal absorption of calcium and to prevent the occurrence of high serum parathyroid hormone (PTH) concentration, which stimulates mobilization of calcium from the skeleton and can lower bone mass. Calcium, along with vitamin D and several other nutrients, is required for normal bone mineralization. While vitamin D is required for optimal bone mineralization, it is more effective when calcium intake is adequate. An adequate intake of calcium and vitamin D is thought to exert a positive effect during adolescence and early adulthood in optimizing the amount of bone that is laid down. However, the upper limit of peak bone mass is genetically determined. The mechanism through which adequate intakes of calcium and vitamin D and optimal peak bone mass reduce the risk of osteoporosis is thought to be as follows. All persons lose bone with age. Hence, those with higher bone mass at maturity take longer to reach the critically reduced mass at which bones can fracture easily. The rate of bone loss after skeletal maturity also influences the amount of bone present at old age and can influence an individual's risk of developing osteoporosis. Maintenance of adequate intakes of calcium and vitamin D later in life is thought to be important in reducing the rate of bone loss particularly in the elderly and in women during the first decade following menopause, but a significant protective effect is also seen among men and younger women.

(b) Significance of calcium or calcium and vitamin D. Adequate calcium intake, or adequate calcium and vitamin D intake, is not the only recognized risk factor in the development of osteoporosis, which is a multifactorial bone disease. Maintenance of adequate calcium and vitamin D intakes throughout life is necessary to achieve optimal peak bone mass and to reduce the risk of osteoporosis in later life. However, vitamin D is most effective in this regard when calcium intake is adequate. Increasing intake of calcium has been shown to have beneficial effects on bone health independent of dietary vitamin D.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating calcium or, when appropriate, calcium and vitamin D with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraphs (c)(2)(ii) and (d)(1) of this section, provided that:

(A) The claim makes clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, throughout life, in a healthful diet, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis;

(B) The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropriate, an adequate dietary calcium and vitamin D intake, throughout life.

(ii) Nature of the food. (A) The food shall meet or exceed the requirements for a “high” level of calcium as defined in § 101.54(b);

(B) The calcium content of the product shall be assimilable;

(C) Dietary supplements shall meet the United States Pharmacopeia (USP) standards for disintegration and dissolution applicable to their component calcium salts, except that dietary supplements for which no USP standards exist shall exhibit appropriate assimilability under the conditions of use stated on the product label;

(D) A food or total daily recommended supplement intake shall not contain more phosphorus than calcium on a weight per weight basis.

(d) Optional information. (1) The claim may include the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in § 101.54(b);

(2) The claim may include information from paragraphs (a) and (b) of this section.

(3) The claim may make reference to physical activity.

(4) The claim may include information on the number of people in the United States, including the number of people in certain subpopulations in the United States, who have osteoporosis or low bone density. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation.

(5) The claim may state that the role of adequate calcium intake, or when appropriate, the role of adequate calcium and vitamin D intake, throughout life is linked to reduced risk of osteoporosis through the mechanism of optimizing peak bone mass during adolescence and early adulthood. The phrase “build and maintain good bone health” may be used to convey the concept of optimizing peak bone mass. The claim may also state that adequate intake of calcium, or when appropriate, adequate intake of calcium and vitamin D, is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss for persons with a family history of the disease, post-menopausal women, and elderly men and women.

(e) Model health claims. The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis:

(f) Model additional health claims for calcium and vitamin D. The following model health claims may be used in food labeling to describe the relationship between calcium, vitamin D, and osteoporosis:

(a) Relationship between fat and cancer. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include a family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(2) Among dietary factors, the strongest positive association has been found between total fat intake and risk of some types of cancer. Based on the totality of the publicly available scientific evidence, there is significant scientific agreement among experts, qualified by training and experience to evaluate such evidence, that diets high in total fat are associated with an increased cancer risk. Research to date, although not conclusive, demonstrates that the total amount of fats, rather than any specific type of fat, is positively associated with cancer risk. The mechanism by which total fat affects cancer has not yet been established.

(3) A question that has been the subject of considerable research is whether the effect of fat on cancer is site-specific. Neither human nor animal studies are consistent in the association of fat intake with specific cancer sites.

(4) Another question that has been raised is whether the association of total fat intake to cancer risk is independently associated with energy intakes, or whether the association of fat with cancer risk is the result of the higher energy (caloric) intake normally associated with high fat intake. FDA has concluded that evidence from both animal and human studies indicates that total fat intake alone, independent of energy intake, is associated with cancer risk.

(b) Significance of the relationship between fat intake and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high.

(2) U.S. diets tend to be high in fat and high in calories. The average U.S. diet is estimated to contain 36 to 37 percent of calories from total fat. Current dietary guidelines from the Federal Government and other national health professional organizations recommend that dietary fat intake be reduced to a level of 30 percent or less of energy (calories) from total fat. In order to reduce intake of total fat, individuals should choose diets which are high in vegetables, fruits, and grain products (particularly whole grain products), choose lean cuts of meats, fish, and poultry, substitute low-fat dairy products for higher fat products, and use fats and oils sparingly.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets low in fat with reduced risk of cancer may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in fat “may” or “might” reduce the risk of some cancers;

(B) In specifying the disease, the claim uses the following terms: “some types of cancer” or “some cancers”;

(C) In specifying the nutrient, the claim uses the term “total fat” or “fat”;

(D) The claim does not specify types of fat or fatty acid that may be related to the risk of cancer;

(E) The claim does not attribute any degree of cancer risk reduction to diets low in fat; and

(F) The claim indicates that the development of cancer depends on many factors.

(ii) Nature of the food. The food shall meet all of the nutrient content requirements of § 101.62 for a “low fat” food; except that fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, geese, ostrich) may meet the requirements for “extra lean” in § 101.62.

(d) Optional information. (1) The claim may identify one or more of the following risk factors for development of cancer: Family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(2) The claim may include information from paragraphs (a) and (b) of this section which summarize the relationship between dietary fat and cancer and the significance of the relationship.

(3) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office.

(4) The claim may include information on the number of people in the United States who have cancer. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, Government Printing Office.

(e) Model health claims. The following model health claims may be used in food labeling to describe the relationship between dietary fat and cancer:

(1) Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.

(2) Eating a healthful diet low in fat may help reduce the risk of some types of cancers. Development of cancer is associated with many factors, including a family history of the disease, cigarette smoking, and what you eat.

(a) Relationship between sodium and hypertension (high blood pressure). (1) Hypertension, or high blood pressure, generally means a systolic blood pressure of greater than 140 millimeters of mercury (mm Hg) or a diastolic blood pressure of greater than 90 mm Hg. Normotension, or normal blood pressure, is a systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is specified here as the chemical entity or electrolyte “sodium” and is distinguished from sodium chloride, or salt, which is 39 percent sodium by weight.

(2) The scientific evidence establishes that diets high in sodium are associated with a high prevalence of hypertension or high blood pressure and with increases in blood pressure with age, and that diets low in sodium are associated with a low prevalence of hypertension or high blood pressure and with a low or no increase of blood pressure with age.

(b) Significance of sodium in relation to high blood pressure. (1) High blood pressure is a public health concern primarily because it is a major risk factor for mortality from coronary heart disease and stroke. Early management of high blood pressure is a major public health goal that can assist in reducing mortality associated with coronary heart disease and stroke. There is a continuum of mortality risk that increases as blood pressures rise. Individuals with high blood pressure are at greatest risk, and individuals with moderately high, high normal, and normal blood pressure are at steadily decreasing risk. The scientific evidence indicates that reducing sodium intake lowers blood pressure and associated risks in many but not all hypertensive individuals. There is also evidence that reducing sodium intake lowers blood pressure and associated risks in many but not all normotensive individuals as well.

(2) The populations at greatest risk for high blood pressure, and those most likely to benefit from sodium reduction, include those with family histories of high blood pressure, the elderly, males because they develop hypertension earlier in life than females, and black males and females. Although some population groups are at greater risk than others, high blood-pressure is a disease of public health concern for all population groups. Sodium intake, alcohol consumption, and obesity are identified risk factors for high blood pressure.

(3) Sodium intakes exceed recommended levels in almost every group in the United States. One of the major public health recommendations relative to high blood pressure is to decrease consumption of salt. On a population-wide basis, reducing the average sodium intake would have a small but significant effect on reducing the average blood pressure, and, consequently, reducing mortality from coronary heart disease and stroke.

(4) Sodium is an essential nutrient, and experts have recommended a safe minimum level of 500 milligrams (mg) sodium per day and an upper level of 2,400 mg sodium per day, the FDA Daily Value for sodium.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets low in sodium with reduced risk of high blood pressure may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in sodium “may” or “might” reduce the risk of high blood pressure;

(B) In specifying the disease, the claim uses the term “high blood pressure”;

(C) In specifying the nutrient, the claim uses the term “sodium”;

(D) The claim does not attribute any degree of reduction in risk of high blood pressure to diets low in sodium; and

(E) The claim indicates that development of high blood pressure depends on many factors.

(ii) Nature of the food. The food shall meet all of the nutrient content requirements of § 101.61 for a “low sodium” food.

(d) Optional information. (1) The claim may identify one or more of the following risk factors for development of high blood pressure in addition to dietary sodium consumption: Family history of high blood pressure, growing older, alcohol consumption, and excess weight.

(2) The claim may include information from paragraphs (a) and (b) of this section, which summarizes the relationship between dietary sodium and high blood pressure and the significance of the relationship.

(3) The claim may include information on the number of people in the United States who have high blood pressure. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Health and Human Services (DHHS) and U.S. Department of Argiculture (USDA), Government Printing Office.

(4) The claim may indicate that it is consistent with “Nutrition and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, Government Printing Office.

(5) In specifying the nutrient, the claim may include the term “salt” in addition to the term “sodium.”

(6) In specifying the disease, the claim may include the term “hypertension” in addition to the term “high blood pressure.”

(7) The claim may state that individuals with high blood pressure should consult their physicians for medical advice and treatment. If the claim defines high or normal blood pressure, then the health claim must state that individuals with high blood pressure should consult their physicians for medical advice and treatment.

(e) Model health claims. The following are model health claims that may be used in food labeling to describe the relationship between dietary sodium and high blood pressure:

(1) Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.

(2) Development of hypertension or high blood pressure depends on many factors. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure.

(a) Relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease is the most common and serious form of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total- and low density lipoprotein (LDL)- cholesterol levels are major modifiable risk factors in the development of coronary heart disease. High coronary heart disease rates occur among people with high blood cholesterol levels of 240 milligrams/decaliter (mg/dL) (6.21 millimoles per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), and monounsaturated and polyunsaturated fat (fatty acids containing one or more double bonds).

(2) The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of coronary heart disease. Diets low in saturated fat and cholesterol are associated with decreased levels of blood total- and LDL-cholesterol, and thus, with decreased risk of developing coronary heart disease.

(b) Significance of the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. (1) Coronary heart disease is a major public health concern in the United States, primarily because it accounts for more deaths than any other disease or group of diseases. Early management of risk factors for coronary heart disease is a major public health goal that can assist in reducing risk of coronary heart disease. There is a continuum of mortality risk from coronary heart disease that increases with increasing levels of blood LDL-cholesterol. Individuals with high blood LDL-cholesterol are at greatest risk. A larger number of individuals with more moderately elevated cholesterol also have increased risk of coronary events; such individuals comprise a substantial proportion of the adult U.S. population. The scientific evidence indicates that reducing saturated fat and cholesterol intakes lowers blood LDL-cholesterol and risk of heart disease in most individuals. There is also evidence that reducing saturated fat and cholesterol intakes in persons with blood cholesterol levels in the normal range also reduces risk of heart disease.

(2) Other risk factors for coronary heart disease include a family history of heart disease, high blood pressure, diabetes, cigarette smoking, obesity (body weight 30 percent greater than ideal body weight), and lack of regular physical exercise.

(3) Intakes of saturated fat exceed recommended levels in many people in the United States. Intakes of cholesterol are, on average, at or above recommended levels. One of the major public health recommendations relative to coronary heart disease risk is to consume less than 10 percent of calories from saturated fat, and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 mg or less per day.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met, except § 101.14(e)(6) with respect to a raw fruit or vegetable.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets low in saturated fat and cholesterol with reduced risk of coronary heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section provided that:

(A) The claim states that diets low in saturated fat and cholesterol “may” or “might” reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the terms “heart disease” or “coronary heart disease;”

(C) In specifying the nutrient, the claim uses the terms “saturated fat” and “cholesterol” and lists both;

(D) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in dietary saturated fat and cholesterol; and

(E) The claim states that coronary heart disease risk depends on many factors.

(ii) Nature of the food. (A) The food shall meet all of the nutrient content requirements of § 101.62 for a “low saturated fat” and “low cholesterol” food.

(B) The food shall meet the nutrient content requirements of § 101.62 for a “low fat” food, unless it is a raw fruit or vegetable; except that fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may meet the requirements for “extra lean” in § 101.62.

(d) Optional information. (1) The claim may identify one or more of the following risk factors in addition to saturated fat and cholesterol about which there is general scientific agreement that they are major risk factors for this disease: A family history of coronary heart disease, elevated blood total and LDL-cholesterol, excess body weight, high blood pressure, cigarette smoking, diabetes, and physical inactivity.

(2) The claim may indicate that the relationship of saturated fat and cholesterol to heart disease is through the intermediate link of “blood cholesterol” or “blood total- and LDL cholesterol.”

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease, and the significance of the relationship.

(4) In specifying the nutrients, the claim may include the term “total fat” in addition to the terms “saturated fat” and “cholesterol”.

(5) The claim may include information on the number of people in the United States who have coronary heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Health and Human Services (DHHS) and U.S. Department of Agriculture (USDA), Government Printing Office.

(6) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” DHHS and USDA, Government Printing Office.

(7) The claim may state that individuals with elevated blood total- or LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total- or LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment.

(e) Model health claims.The following are model health claims that may be used in food labeling to describe the relationship between dietary saturated fat and cholesterol and risk of heart disease:

(1) While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease;

(2) Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles;

(3) Development of heart disease depends upon many factors, including a family history of the disease, high blood LDL-cholesterol, diabetes, high blood pressure, being overweight, cigarette smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in saturated fat, total fat, and cholesterol, as part of a healthy lifestyle, may lower blood cholesterol levels and may reduce the risk of heart disease;

(4) Many factors, such as a family history of the disease, increased blood- and LDL-cholesterol levels, high blood pressure, cigarette smoking, diabetes, and being overweight, contribute to developing heart disease. A diet low in saturated fat, cholesterol, and total fat may help reduce the risk of heart disease; and

(5) Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood LDL-cholesterol levels, and physical inactivity.

(a) Relationship between diets low in fat and high in fiber-containing grain products, fruits, and vegetables and cancer risk. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include: A family history of a specific type of cancer, cigarette smoking, overweight and obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(2) The scientific evidence establishes that diets low in fat and high in fiber-containing grain products, fruits, and vegetables are associated with a reduced risk of some types of cancer. Although the specific role of total dietary fiber, fiber components, and the multiple nutrients and other substances contained in these foods are not yet fully understood, many studies have shown that diets low in fat and high in fiber-containing foods are associated with reduced risk of some types of cancer.

(b) Significance of the relationship between consumption of diets low in fat and high in fiber-containing grain products, fruits, and vegetables and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high.

(2) U.S. diets tend to be high in fat and low in grain products, fruits, and vegetables. Studies in various parts of the world indicate that populations who habitually consume a diet high in plant foods have lower risks of some cancers. These diets generally are low in fat and rich in many nutrients, including, but not limited to, dietary fiber. Current dietary guidelines from Federal government agencies and nationally recognized health professional organizations recommend decreased consumption of fats (less than 30 percent of calories), maintenance of desirable body weight, and increased consumption of fruits and vegetables (five or more servings daily), and grain products (six or more servings daily).

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets low in fat and high in fiber-containing grain products, fruits, and vegetables with reduced risk of cancer may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in fat and high in fiber-containing grain products, fruits, and vegetables “may” or “might” reduce the risk of some cancers;

(B) In specifying the disease, the claim uses the following terms: “some types of cancer,” or “some cancers”;

(C) The claim is limited to grain products, fruits, and vegetables that contain dietary fiber;

(D) The claim indicates that development of cancer depends on many factors;

(E) The claim does not attribute any degree of cancer risk reduction to diets low in fat and high in fiber-containing grain products, fruits, and vegetables;

(F) In specifying the dietary fiber component of the labeled food, the claim uses the term “fiber”, “dietary fiber” or “total dietary fiber”; and

(G) The claim does not specify types of dietary fiber that may be related to risk of cancer.

(ii) Nature of the food. (A) The food shall be or shall contain a grain product, fruit, or vegetable.

(B) The food shall meet the nutrient content requirements of § 101.62 for a “low fat” food.

(C) The food shall meet, without fortification, the nutrient content requirements of § 101.54 for a “good source” of dietary fiber.

(d) Optional information. (1) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets low in fat and high in fiber-containing grain products, fruits, and vegetables, and some types of cancer and the significance of the relationship.

(2) The claim may identify one or more of the following risk factors for development of cancer: Family history of a specific type of cancer, cigarette smoking, overweight and obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to cancer causing chemicals, and dietary factors.

(3) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office.

(4) The claim may include information on the number of people in the United States who have cancer. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, Government Printing Office.

(e) Model health claims. The following model health claims may be used in food labeling to characterize the relationship between diets low in fat and high in fiber-containing grain products, fruits, and vegetables and cancer risk:

(1) Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.

(2) Development of cancer depends on many factors. Eating a diet low in fat and high in grain products, fruits, and vegetables that contain dietary fiber may reduce your risk of some cancers.

(a) Relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease is the most common and serious form of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total- and low density lipoprotein (LDL)- cholesterol levels are major modifiable risk factors in the development of coronary heart disease. High coronary heart disease rates occur among people with high blood cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), and monounsaturated and polyunsaturated fat (fatty acids containing one or more double bonds).

(2) The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of coronary heart disease. Diets low in saturated fat and cholesterol are associated with decreased levels of blood total- and LDL-cholesterol, and thus, with decreased risk of developing coronary heart disease.

(3) Populations with relatively low blood cholesterol levels tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in fruits, vegetables, and grain products. Although the specific roles of these plant foods are not yet fully understood, many studies have shown that diets high in plant foods are associated with reduced risk of coronary heart disease. These studies correlate diets rich in fruits, vegetables, and grain products and nutrients from these diets, such as some types of fiber, with reduced coronary heart disease risk. Persons consuming these diets frequently have high intakes of dietary fiber, particularly soluble fibers. Currently, there is not scientific agreement as to whether a particular type of soluble fiber is beneficial, or whether the observed protective effects of fruits, vegetables, and grain products against heart disease are due to other components, or a combination of components, in these diets, including, but not necessarily limited to, some types of soluble fiber, other fiber components, other characteristics of the complex carbohydrate content of these foods, other nutrients in these foods, or displacement of saturated fat and cholesterol from the diet.

(b) Significance of the relationship between diets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (1) Coronary heart disease is a major public health concern in the United States, primarily because it accounts for more deaths than any other disease or group of diseases. Early management of risk factors for coronary heart disease is a major public health goal that can assist in reducing risk of coronary heart disease. There is a continuum of mortality risk from coronary heart disease that increases with increasing levels of blood LDL-cholesterol. Individuals with high blood LDL-cholesterol are at greatest risk. A larger number of individuals with more moderately elevated cholesterol also have increased risk of coronary events; such individuals comprise a substantial proportion of the adult U.S. population. The scientific evidence indicates that reducing saturated fat and cholesterol intakes lowers blood LDL-cholesterol and risk of heart disease in most individuals, including persons with blood cholesterol levels in the normal range. Additionally, consuming diets high in fruits, vegetables, and grain products, foods that contain soluble fiber, may be a useful adjunct to a low saturated fat and low cholesterol diet.

(2) Other risk factors for coronary heart disease include a family history of heart disease, high blood pressure, diabetes, cigarette smoking, obesity (body weight 30 percent greater than ideal body weight), and lack of regular physical exercise.

(3) Intakes of saturated fat exceed recommended levels in many people in the United States. Intakes of cholesterol are, on average, at or above recommended levels. Intakes of fiber-containing fruits, vegetables, and grain products are about half of recommended intake levels. One of the major public health recommendations relative to coronary heart disease risk is to consume less than 10 percent of calories from saturated fat, and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 mg or less per day. Recommended total dietary fiber intakes are about 25 grams (g) daily, of which about 25 percent (about 6 g) should be soluble fiber.

(4) Current dietary guidance recommendations encourage decreased consumption of dietary fat, especially saturated fat and cholesterol, and increased consumption of fiber-rich foods to help lower blood LDL-cholesterol levels. Results of numerous studies have shown that fiber-containing fruits, vegetables, and grain products can help lower blood LDL-cholesterol.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber “may” or “might” reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease;”

(C) The claim is limited to those fruits, vegetables, and grains that contain fiber;

(D) In specifying the dietary fiber, the claim uses the term “fiber,” “dietary fiber,” “some types of dietary fiber,” “some dietary fibers,” or “some fibers;” the term “soluble fiber” may be used in addition to these terms;

(E) In specifying the fat component, the claim uses the terms “saturated fat” and “cholesterol;” and

(F) The claim indicates that development of heart disease depends on many factors; and

(G) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber.

(ii) Nature of the food. (A) The food shall be or shall contain a fruit, vegetable, or grain product.

(B) The food shall meet the nutrient content requirements of § 101.62 for a “low saturated fat,” “low cholesterol,” and “low fat” food.

(C) The food contains, without fortification, at least 0.6 g of soluble fiber per reference amount customarily consumed;

(D) The content of soluble fiber shall be declared in the nutrition information panel, consistent with § 101.9(c)(6)(i)(A).

(d) Optional information. (1) The claim may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of coronary heart disease, elevated blood-, total- and LDL-cholesterol, excess body weight, high blood pressure, cigarette smoking, diabetes, and physical inactivity.

(2) The claim may indicate that the relationship of diets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain fiber to heart disease is through the intermediate link of “blood cholesterol” or “blood total- and LDL-cholesterol.”

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber and coronary heart disease, and the significance of the relationship.

(4) In specifying the nutrients, the claim may include the term “total fat” in addition to the terms “saturated fat” and “cholesterol.”

(5) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO).

(6) The claim may state that individuals with elevated blood total- and LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total- and LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment.

(7) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, GPO.

(e) Model health claims. The following model health claims may be used in food labeling to characterize the relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain soluble fiber:

(1) Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.

(2) Development of heart disease depends on many factors. Eating a diet low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease.

(a) Relationship between substances in diets low in fat and high in fruits and vegetables and cancer risk. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include a family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(2) Although the specific roles of the numerous potentially protective substances in plant foods are not yet understood, many studies have shown that diets high in plant foods are associated with reduced risk of some types of cancers. These studies correlate diets rich in fruits and vegetables and nutrients from these diets, such as vitamin C, vitamin A, and dietary fiber, with reduced cancer risk. Persons consuming these diets frequently have high intakes of these nutrients. Currently, there is not scientific agreement as to whether the observed protective effects of fruits and vegetables against cancer are due to a combination of the nutrient components of diets rich in fruits and vegetables, including but not necessarily limited to dietary fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of fat from such diets, or to intakes of other substances in these foods which are not nutrients but may be protective against cancer risk.

(b) Significance of the relationship between consumption of diets low in fat and high in fruits and vegetables and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high.

(2) U.S. diets tend to be high in fat and low in fruits and vegetables. Studies in various parts of the world indicate that populations who habitually consume a diet high in plant foods have lower risks of some cancers. These diets generally are low in fat and rich in many nutrients, including, but not limited to, dietary fiber, vitamin A (as beta-carotene), and vitamin C. Current dietary guidelines from Federal Government agencies and nationally recognized health professional organizations recommend decreased consumption of fats (less than 30 percent of calories), maintenance of desirable body weight, and increased consumption of fruits and vegetables (5 or more servings daily), particularly those fruits and vegetables which contain dietary fiber, vitamin A, and vitamin C.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating substances in diets low in fat and high in fruits and vegetables with reduced risk of cancer may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in fat and high in fruits and vegetables “may” or “might” reduce the risk of some cancers;

(B) In specifying the disease, the claim uses the following terms: “some types of cancer”, or “some cancers”;

(C) The claim characterizes fruits and vegetables as foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber;

(D) The claim characterizes the food bearing the claim as containing one or more of the following, for which the food is a good source under § 101.54: dietary fiber, vitamin A, or vitamin C;

(E) The claim does not attribute any degree of cancer risk reduction to diets low in fat and high in fruits and vegetables;

(F) In specifying the fat component of the labeled food, the claim uses the term “total fat” or “fat”;

(G) The claim does not specify types of fats or fatty acids that may be related to risk of cancer;

(H) In specifying the dietary fiber component of the labeled food, the claim uses the term “fiber”, “dietary fiber”, or “total dietary fiber”;

(I) The claim does not specify types of dietary fiber that may be related to risk of cancer; and

(J) The claim indicates that development of cancer depends on many factors.

(ii) Nature of the food. (A) The food shall be or shall contain a fruit or vegetable.

(B) The food shall meet the nutrient content requirements of § 101.62 for a “low fat” food.

(C) The food shall meet, without fortification, the nutrient content requirements of § 101.54 for a “good source” of at least one of the following: vitamin A, vitamin C, or dietary fiber.

(d) Optional information. (1) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets low in fat and high in fruits and vegetables and some types of cancer and the significance of the relationship.

(2) The claim may identify one or more of the following risk factors for development of cancer: Family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(3) The claim may use the word “beta-carotene” in parentheses after the term vitamin A, provided that the vitamin A in the food bearing the claim is beta-carotene.

(4) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS), Government Printing Office.

(5) The claim may include information on the number of people in the United States who have cancer. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, Government Printing Office.

(e) Model health claims. The following model health claims may be used in food labeling to characterize the relationship between substances in diets low in fat and high in fruits and vegetables and cancer:

(1) Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber.

(2) Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may reduce your risk of some cancers. Oranges, a food low in fat, are a good source of fiber and vitamin C.

(a) Relationship between folate and neural tube defects - (1) Definition. Neural tube defects are serious birth defects of the brain or spinal cord that can result in infant mortality or serious disability. The birth defects anencephaly and spina bifida are the most common forms of neural tube defects and account for about 90 percent of these defects. These defects result from failure of closure of the covering of the brain or spinal cord during early embryonic development. Because the neural tube forms and closes during early pregnancy, the defect may occur before a woman realizes that she is pregnant.

(2) Relationship. The available data show that diets adequate in folate may reduce the risk of neural tube defects. The strongest evidence for this relationship comes from an intervention study by the Medical Research Council of the United Kingdom that showed that women at risk of recurrence of a neural tube defect pregnancy who consumed a supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic acid daily before conception and continuing into early pregnancy had a reduced risk of having a child with a neural tube defect. (Products containing this level of folic acid are drugs). In addition, based on its review of a Hungarian intervention trial that reported periconceptional use of a multivitamin and multimineral preparation containing 800 mcg (0.8 mg) of folic acid, and its review of the observational studies that reported periconceptional use of multivitamins containing 0 to 1,000 mcg of folic acid, the Food and Drug Administration concluded that most of these studies had results consistent with the conclusion that folate, at levels attainable in usual diets, may reduce the risk of neural tube defects.

(b) Significance of folate - (1) Public health concern. Neural tube defects occur in approximately 0.6 of 1,000 live births in the United States (i.e., approximately 6 of 10,000 live births; about 2,500 cases among 4 million live births annually). Neural tube defects are believed to be caused by many factors. The single greatest risk factor for a neural tube defect-affected pregnancy is a personal or family history of a pregnancy affected with a such a defect. However, about 90 percent of infants with a neural tube defect are born to women who do not have a family history of these defects. The available evidence shows that diets adequate in folate may reduce the risk of neural tube defects but not of other birth defects.

(2) Populations at risk. Prevalence rates for neural tube defects have been reported to vary with a wide range of factors including genetics, geography, socioeconomic status, maternal birth cohort, month of conception, race, nutrition, and maternal health, including maternal age and reproductive history. Women with a close relative (i.e., sibling, niece, nephew) with a neural tube defect, those with insulin-dependent diabetes mellitus, and women with seizure disorders who are being treated with valproic acid or carbamazepine are at significantly increased risk compared with women without these characteristics. Rates for neural tube defects vary within the United States, with lower rates observed on the west coast than on the east coast.

(3) Those who may benefit. Based on a synthesis of information from several studies, including those which used multivitamins containing folic acid at a daily dose level of ≥400 mcg (≥0.4 mg), the Public Health Service has inferred that folate alone at levels of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects. The protective effect found in studies of lower dose folate measured by the reduction in neural tube defect incidence, ranges from none to substantial; a reasonable estimate of the expected reduction in the United States is 50 percent. It is expected that consumption of adequate folate will avert some, but not all, neural tube defects. The underlying causes of neural tube defects are not known. Thus, it is not known what proportion of neural tube defects will be averted by adequate folate consumption. From the available evidence, the Public Health Service estimates that there is the potential for averting 50 percent of cases that now occur (i.e., about 1,250 cases annually). However, until further research is done, no firm estimate of this proportion will be available.

(c) Requirements. The label or labeling of food may contain a folate/neural tube defect health claim provided that:

(1) General requirements. The health claim for a food meets all of the general requirements of § 101.14 for health claims, except that a food may qualify to bear the health claim if it meets the definition of the term “good source.”

(2) Specific requirements - (i) Nature of the claim - (A) Relationship. A health claim that women who are capable of becoming pregnant and who consume adequate amounts of folate daily during their childbearing years may reduce their risk of having a pregnancy affected by spina bifida or other neural tube defects may be made on the label or labeling of food provided that:

(B) Specifying the nutrient. In specifying the nutrient, the claim shall use the terms “folate,” “folic acid,” “folacin,” “folate, a B vitamin,” “folic acid, a B vitamin,” or “folacin, a B vitamin.”

(C) Specifying the condition. In specifying the health- related condition, the claim shall identify the birth defects as “neural tube defects,” “birth defects spina bifida or anencephaly,” “birth defects of the brain or spinal cord anencephaly or spina bifida,” “spina bifida and anencephaly, birth defects of the brain or spinal cord,” “birth defects of the brain or spinal cord;” or “brain or spinal cord birth defects.”

(D) Multifactorial nature. The claim shall not imply that folate intake is the only recognized risk factor for neural tube defects.

(E) Reduction in risk. The claim shall not attribute any specific degree of reduction in risk of neural tube defects from maintaining an adequate folate intake throughout the childbearing years. The claim shall state that some women may reduce their risk of a neural tube defect pregnancy by maintaining adequate intakes of folate during their childbearing years. Optional statements about population-based estimates of risk reduction may be made in accordance with paragraph (c)(3)(vi) of this section.

(F) Safe upper limit of daily intake. Claims on foods that contain more than 100 percent of the Daily Value (DV) (400 mcg) when labeled for use by adults and children 4 or more years of age, or 800 mcg when labeled for use by pregnant or lactating women) shall identify the safe upper limit of daily intake with respect to the DV. The safe upper limit of daily intake value of 1,000 mcg (1 mg) may be included in parentheses.

(G) The claim shall state that folate needs to be consumed as part of a healthful diet.

(ii) Nature of the food - (A) Requirements. The food shall meet or exceed the requirements for a “good source” of folate as defined in § 101.54;

(B) Dietary supplements. Dietary supplements shall meet the United States Pharmacopeia (USP) standards for disintegration and dissolution, except that if there are no applicable USP standards, the folate in the dietary supplement shall be shown to be bioavailable under the conditions of use stated on the product label.

(iii) Limitation. The claim shall not be made on foods that contain more than 100 percent of the RDI for vitamin A as retinol or preformed vitamin A or vitamin D per serving or per unit.

(iv) Nutrition labeling. The nutrition label shall include information about the amount of folate in the food. This information shall be declared after the declaration for iron if only the levels of vitamin A, vitamin C, calcium, and iron are provided, or in accordance with § 101.9 (c)(8) and (c)(9) if other optional vitamins or minerals are declared.

(3) Optional information - (i) Risk factors. The claim may specifically identify risk factors for neural tube defects. Where such information is provided, it may consist of statements from § 101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those with a personal history of a neural tube defect-affected pregnancy, those with a close relative (i.e., sibling, niece, nephew) with a neural tube defect; those with insulin-dependent diabetes mellitus; those with seizure disorders who are being treated with valproic acid or carbamazepine) or from other parts of this paragraph (c)(3)(i).

(ii) Relationship between folate and neural tube defects. The claim may include statements from paragraphs (a) and (b) of this section that summarize the relationship between folate and neural tube defects and the significance of the relationship except for information specifically prohibited from the claim.

(iii) Personal history of a neural tube defect-affected pregnancy. The claim may state that women with a history of a neural tube defect pregnancy should consult their physicians or health care providers before becoming pregnant. If such a statement is provided, the claim shall also state that all women should consult a health care provider when planning a pregnancy.

(iv) Daily value. The claim may identify 100 percent of the DV (100% DV; 400 mcg) for folate as the target intake goal.

(v) Prevalence. The claim may provide estimates, expressed on an annual basis, of the number of neural tube defect-affected births among live births in the United States. Current estimates are provided in § 101.79(b)(1), and are approximately 6 of 10,000 live births annually (i.e., about 2,500 cases among 4 million live births annually). Data provided in § 101.79(b)(1) shall be used, unless more current estimates from the U.S. Public Health Service are available, in which case the latter may be cited.

(vi) Reduction in risk. An estimate of the reduction in the number of neural tube defect-affected births that might occur in the United States if all women consumed adequate folate throughout their childbearing years may be included in the claim. Information contained in paragraph (b)(3) of this section may be used. If such an estimate (i.e., 50 percent) is provided, the estimate shall be accompanied by additional information that states that the estimate is population-based and that it does not reflect risk reduction that may be experienced by individual women.

(vii) Diets adequate in folate. The claim may identify diets adequate in folate by using phrases such as “Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements.” or “Adequate amounts of folate can be obtained from diets rich in fruits, dark green leafy vegetables, legumes, whole grain products, fortified cereals, or dietary supplements.” or “Adequate amounts of folate can be obtained from diets rich in fruits, including citrus fruits and juices, vegetables, including dark green leafy vegetables, legumes, whole grain products, including breads, rice, and pasta, fortified cereals, or a dietary supplement.”

(d) Model health claims. The following are examples of model health claims that may be used in food labeling to describe the relationship between folate and neural tube defects:

(1) Examples 1 and 2. Model health claims appropriate for foods containing 100 percent or less of the DV for folate per serving or per unit (general population). The examples contain only the required elements:

(i) Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect.

(ii) Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect.

(2) Example 3. Model health claim appropriate for foods containing 100 percent or less of the DV for folate per serving or per unit. The example contains all required elements plus optional information: Women who consume healthful diets with adequate folate throughout their childbearing years may reduce their risk of having a child with a birth defect of the brain or spinal cord. Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements.

(3) Example 4. Model health claim appropriate for foods intended for use by the general population and containing more than 100 percent of the DV of folate per serving or per unit: Women who consume healthful diets with adequate folate may reduce their risk of having a child with birth defects of the brain or spinal cord. Folate intake should not exceed 250% of the DV (1,000 mcg).

(a) Relationship between dietary carbohydrates and dental caries. (1) Dental caries, or tooth decay, is a disease caused by many factors. Both environmental and genetic factors can affect the development of dental caries. Risk factors include tooth enamel crystal structure and mineral content, plaque quantity and quality, saliva quantity and quality, individual immune response, types and physical characteristics of foods consumed, eating behaviors, presence of acid producing oral bacteria, and cultural influences.

(2) The relationship between consumption of fermentable carbohydrates, i.e., dietary sugars and starches, and tooth decay is well established. Sucrose, also known as sugar, is one of the most, but not the only, cariogenic sugars in the diet. Bacteria found in the mouth are able to metabolize most dietary carbohydrates, producing acid and forming dental plaque. The more frequent and longer the exposure of teeth to dietary sugars and starches, the greater the risk for tooth decay.

(3) Dental caries continues to affect a large proportion of Americans. Although there has been a decline in the prevalence of dental caries among children in the United States, the disease remains widespread throughout the population, imposing a substantial burden on Americans. Recent Federal government dietary guidelines recommend that Americans choose diets that are moderate in sugars and avoid excessive snacking. Frequent between-meal snacks that are high in sugars and starches may be more harmful to teeth than eating such foods at meals and then brushing.

(4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols, can be used to replace dietary sugars, such as sucrose and corn sweeteners, in foods such as chewing gums and certain confectioneries. Noncariogenic carbohydrate sweeteners are significantly less cariogenic than dietary sugars and other fermentable carbohydrates.

(b) Significance of the relationship between noncariogenic carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate sweeteners do not promote dental caries. The noncariogenic carbohydrate sweeteners listed in paragraph (c)(2)(ii) of this section are slowly metabolized by bacteria to form some acid. The rate and amount of acid production is significantly less than that from sucrose and other fermentable carbohydrates and does not cause the loss of important minerals from tooth enamel.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met, except that noncariogenic carbohydrate sweetener-containing foods listed in paragraph (c)(2)(ii) of this section are exempt from § 101.14(e)(6).

(2) Specific requirements - (i) Nature of the claim. A health claim relating noncariogenic carbohydrate sweeteners, compared to other carbohydrates, and the nonpromotion of dental caries may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim shall state that frequent between-meal consumption of foods high in sugars and starches can promote tooth decay.

(B) The claim shall state that the noncariogenic carbohydrate sweetener present in the food “does not promote,” “may reduce the risk of,” “useful [or is useful] in not promoting,” or “expressly [or is expressly] for not promoting” dental caries.

(C) In specifying the nutrient, the claim shall state “sugar alcohol,” “sugar alcohols,” or the name or names of the substances listed in paragraph (c)(2)(ii) of this section, e.g., “sorbitol.” D-tagatose may be identified as “tagatose.”

(D) In specifying the disease, the claim uses the following terms: “dental caries” or “tooth decay.”

(E) The claim shall not attribute any degree of the reduction in risk of dental caries to the use of the noncariogenic carbohydrate sweetener-containing food.

(F) The claim shall not imply that consuming noncariogenic carbohydrate sweetener-containing foods is the only recognized means of achieving a reduced risk of dental caries.

(G) Packages with less than 15 square inches of surface area available for labeling are exempt from paragraphs (A) and (C) of this section.

(H) When the substance that is the subject of the claim is a noncariogenic sugar, the claim shall identify the substance as a sugar that, unlike other sugars, does not promote the development of dental caries.

(ii) Nature of the substance. Eligible noncariogenic carbohydrate sweeteners are:

(A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, and erythritol, or a combination of these.

(B) The sugars D-tagatose and isomaltulose.

(C) Sucralose.

(iii) Nature of the food. (A) The food shall meet the requirement in § 101.60(c)(1)(i) with respect to sugars content, except that the food may contain D-tagatose or isomaltulose.

(B) A food whose labeling includes a health claim under this section shall contain one or more of the noncariogenic carbohydrate sweeteners listed in paragraph (c)(2)(ii) of this section.

(C) When carbohydrates other than those listed in paragraph (c)(2)(ii) of this section are present in the food, the food shall not lower plaque pH below 5.7 by bacterial fermentation either during consumption or up to 30 minutes after consumption, as measured by the indwelling plaque pH test found in “Identification of Low Caries Risk Dietary Components,” dated 1983, by T. N. Imfeld, in Volume 11, Monographs in Oral Science, 1983. The Director of the Office of the Federal Register has approved the incorporation by reference of this material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel, Switzerland, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Optional information. (1) The claim may include information from paragraphs (a) and (b) of this section, which describe the relationship between diets containing noncariogenic carbohydrate sweeteners and dental caries.

(2) The claim may indicate that development of dental caries depends on many factors and may identify one or more of the following risk factors for dental caries: Frequent consumption of fermentable carbohydrates, such as dietary sugars and starches; presence of oral bacteria capable of fermenting carbohydrates; length of time fermentable carbohydrates are in contact with the teeth; lack of exposure to fluoride; individual susceptibility; socioeconomic and cultural factors; and characteristics of tooth enamel, saliva, and plaque.

(3) The claim may indicate that oral hygiene and proper dental care may help to reduce the risk of dental disease.

(4) The claim may indicate that a substance listed in paragraph (c)(2)(ii) of this section serves as a sweetener.

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between noncariogenic carbohydrate sweetener-containing foods and dental caries.

(1) Examples of the full claim:

(i) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries.

(ii) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay.

(iii) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries.

(iv) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar in [name of food], unlike other sugars, does not promote tooth decay.

(v) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay.

(2) Example of the shortened claim for small packages:

(i) Does not promote tooth decay.

(ii) May reduce the risk of tooth decay.

(iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar does not promote tooth decay.

(iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar may reduce the risk of tooth decay.

(a) Relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease (CHD) is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing coronary heart disease. High CHD rates occur among people with high total cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of CHD.

(2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL-cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in fiber-containing fruits, vegetables, and grain products, such as whole oat products.

(3) Scientific evidence demonstrates that diets low in saturated fat and cholesterol may reduce the risk of CHD. Other evidence demonstrates that the addition of soluble fiber from certain foods to a diet that is low in saturated fat and cholesterol may also help to reduce the risk of CHD.

(b) Significance of the relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any other disease or group of diseases. Early management of risk factors for CHD is a major public health goal that can assist in reducing risk of CHD. High blood total and LDL-cholesterol are major modifiable risk factors in the development of CHD.

(2) Intakes of saturated fat exceed recommended levels in the diets of many people in the United States. One of the major public health recommendations relative to CHD risk is to consume less than 10 percent of calories from saturated fat and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 milligrams (mg) or less per day. Scientific evidence demonstrates that diets low in saturated fat and cholesterol are associated with lower blood total- and LDL-cholesterol levels. Soluble fiber from certain foods, when included in a low saturated fat and cholesterol diet, also helps to lower blood total- and LDL-cholesterol levels.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met. The label and labeling of foods containing psyllium husk shall be consistent with the provisions of § 101.17(f).

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim states that diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods “may” or “might” reduce the risk of heart disease.

(B) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease”;

(C) In specifying the substance, the claim uses the term “soluble fiber” qualified by the name of the eligible source of soluble fiber (provided in paragraph (c)(2)(ii)) of this section. Additionally, the claim may use the name of the food product that contains the eligible source of soluble fiber;

(D) In specifying the fat component, the claim uses the terms “saturated fat” and “cholesterol”;

(E) The claim does not attribute any degree of risk reduction for CHD to diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section; and

(F) The claim does not imply that consumption of diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section is the only recognized means of achieving a reduced risk of CHD.

(G) The claim specifies the daily dietary intake of the soluble fiber source that is necessary to reduce the risk of coronary heart disease and the contribution one serving of the product makes to the specified daily dietary intake level. Daily dietary intake levels of soluble fiber sources listed in paragraph (c)(2)(ii) of this section that have been associated with reduced risk coronary heart disease are:

(1) 3 g or more per day of β-glucan soluble fiber from either whole oats or barley, or a combination of whole oats and barley.

(2) 7 g or more per day of soluble fiber from psyllium seed husk.

(ii) Nature of the substance - Eligible sources of soluble fiber. (A) Beta (β) glucan soluble fiber from the whole oat and barley sources listed below. β-glucan soluble fiber will be determined by method No. 992.28 from the “Official Methods of Analysis of the AOAC INTERNATIONAL,” 16th ed. (1995), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html;

(1) Oat bran. Oat bran is produced by grinding clean oat groats or rolled oats and separating the resulting oat flour by suitable means into fractions such that the oat bran fraction is not more than 50 percent of the original starting material and provides at least 5.5 percent (dry weight basis (dwb)) β-glucan soluble fiber and a total dietary fiber content of 16 percent (dwb), and such that at least one-third of the total dietary fiber is soluble fiber;

(2) Rolled oats. Rolled oats, also known as oatmeal, produced from 100 percent dehulled, clean oat groats by steaming, cutting, rolling, and flaking, and provides at least 4 percent (dwb) of β-glucan soluble fiber and a total dietary fiber content of at least 10 percent.

(3) Whole oat flour. Whole oat flour is produced from 100 percent dehulled, clean oat groats by steaming and grinding, such that there is no significant loss of oat bran in the final product, and provides at least 4 percent (dwb) of β-glucan soluble fiber and a total dietary fiber content of at least 10 percent (dwb).

(4) Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour, also known as oatrim. Oatrim is produced from either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of this section or whole oat flour as defined in paragraph (c)(2)(ii)(A)(3) of this section by solubilization of the starch in the starting material with an alpha-amylase hydrolysis process, and then removal by centrifugation of the insoluble components consisting of a high portion of protein, lipid, insoluble dietary fiber, and the majority of the flavor and color components of the starting material. Oatrim shall have a beta-glucan soluble fiber content up to 10 percent (dwb) and not less than that of the starting material (dwb).

(5) Whole grain barley and dry milled barley. Dehulled and hull-less whole grain barley with a β-glucan soluble fiber content of at least 4 percent (dwb) and a total dietary fiber content of at least 10 percent (dwb). Dry milled barley grain products include barley bran, barley flakes, barley grits, pearl barley, barley flour, barley meal, and sieved barley meal that are produced from clean, sound dehulled or hull-less barley grain using standard dry milling techniques, which may include steaming or tempering, and that contain at least 4 percent (dwb) of β-glucan soluble fiber and at least 8 percent (dwb) of total dietary fiber, except barley bran and sieved barley meal for which the minimum β-glucan soluble fiber content is 5.5 percent (dwb) and minimum total dietary fiber content is 15 percent (dwb). Dehulled barley, hull-less barley, barley bran, barley flakes, barley grits, pearl barley, and barley flour are as defined in the Barley Glossary (AACC Method 55-99), published in Approved Methods of the American Association of Cereal Chemists, 10th ed. (2000), pp. 1 and 2, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Association of Cereal Chemists, Inc., 3340 Pilot Knob Rd., St. Paul, Minnesota, 55121, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Barley meal is unsifted, ground barley grain not subjected to any processing to separate the bran, germ, and endosperm. Sieved barley meal is an endosperm cell wall-enriched fraction of ground barley separated from meal by sieving or by air classification.

(6) Barley betafiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole grain barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is separated from the insoluble material by centrifugation, and after removal of the insoluble material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.

(B)(1) Psyllium husk from the dried seed coat (epidermis) of the seed of Plantago (P.) ovata, known as blond psyllium or Indian psyllium, P. indica, or P. psyllium. To qualify for this claim, psyllium seed husk, also known as psyllium husk, shall have a purity of no less than 95 percent, such that it contains 3 percent or less protein, 4.5 percent or less of light extraneous matter, and 0.5 percent or less of heavy extraneous matter, but in no case may the combined extraneous matter exceed 4.9 percent, as determined by U.S. Pharmacopeia (USP) methods described in USP's “The National Formulary,” USP 23, NF 18, p. 1341, (1995), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html;

(2) FDA will determine the amount of soluble fiber that is provided by psyllium husk by using a modification of the Association of Official Analytical Chemists' International (AOAC's) method for soluble dietary fiber (991.43) described by Lee et al., “Determination of Soluble and Insoluble Dietary Fiber in Psyllium-containing Cereal Products,” Journal of the AOAC International, 78 (No. 3):724-729, 1995, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html;

(iii) Nature of the food eligible to bear the claim. (A) The food product shall include:

(1) One or more of the whole oat or barley foods from paragraphs (c)(2)(ii)(A)(1), (2), (3), and (5) of this section, and the whole oat or barley foods shall contain at least 0.75 gram (g) of soluble fiber per reference amount customarily consumed of the food product; or

(2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6) of this section shall contain at least 0.75 g of beta-glucan soluble fiber per reference amount customarily consumed of the food product; or

(3) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of this section, and the psyllium food shall contain at least 1.7 g of soluble fiber per reference amount customarily consumed of the food product;

(B) The amount of soluble fiber shall be declared in the nutrition label, consistent with § 101.9(c)(6)(i)(A).

(C) The food shall meet the nutrient content requirement in § 101.62 for a “low saturated fat” and “low cholesterol” food; and

(D) The food shall meet the nutrient content requirement in § 101.62(b)(2) for a “low fat” food, unless the food exceeds this requirement due to fat content derived from whole oat sources listed in paragraph (c)(2)(ii)(A) of this section.

(d) Optional information. (1) The claim may state that the development of heart disease depends on many factors and may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of CHD; elevated blood total and LDL-cholesterol; excess body weight; high blood pressure; cigarette smoking; diabetes; and physical inactivity. The claim may also provide additional information about the benefits of exercise and management of body weight to help lower the risk of heart disease;

(2) The claim may state that the relationship between intake of diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section and reduced risk of heart disease is through the intermediate link of “blood cholesterol” or “blood total- and LDL-cholesterol;”

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and coronary heart disease and the significance of the relationship;

(4) The claim may specify the name of the eligible soluble fiber;

(5) The claim may state that a diet low in saturated fat and cholesterol that includes soluble fiber from whole oats or barley is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO);

(6) The claim may state that individuals with elevated blood total- and LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total- and LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment;

(7) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, GPO.

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and reduced risk of heart disease:

(1) Soluble fiber from foods such as [name of soluble fiber source from paragraph (c)(2)(ii) of this section and, if desired, the name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [ name of food] supplies ____ grams of the [grams of soluble fiber specified in paragraph (c)(2)(i)(G) of this section] soluble fiber from [name of the soluble fiber source from paragraph (c)(2)(ii) of this section] necessary per day to have this effect.

(2) Diets low in saturated fat and cholesterol that include [____ grams of soluble fiber specified in paragraph (c)(2)(i)(G) of this section] of soluble fiber per day from [name of soluble fiber source from paragraph (c)(2)(ii) of this section and, if desired, the name of the food product] may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber.

(a) Relationship between diets that are low in saturated fat and cholesterol and that include soy protein and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. CHD is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing CHD. High CHD rates occur among people with high total cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 millimole per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total and LDL-cholesterol and, thus, with increased risk of CHD.

(2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL-cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in plant foods that contain dietary fiber and other components.

(3) Scientific evidence demonstrates that diets low in saturated fat and cholesterol may reduce the risk of CHD. Other evidence demonstrates that the addition of soy protein to a diet that is low in saturated fat and cholesterol may also help to reduce the risk of CHD.

(b) Significance of the relationship between diets that are low in saturated fat and cholesterol and that include soy protein and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any other disease or group of diseases. Early management of risk factors for CHD is a major public health goal that can assist in reducing risk of CHD. High blood total and LDL-cholesterol are major modifiable risk factors in the development of CHD.

(2) Intakes of saturated fat exceed recommended levels in the diets of many people in the United States. One of the major public health recommendations relative to CHD risk is to consume less than 10 percent of calories from saturated fat and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 mg or less per day. Scientific evidence demonstrates that diets low in saturated fat and cholesterol are associated with lower blood total and LDL-cholesterol levels. Soy protein, when included in a low saturated fat and cholesterol diet, also helps to lower blood total and LDL-cholesterol levels.

(c) Requirements. (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets that are low in saturated fat and cholesterol and that include soy protein with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim states that diets that are low in saturated fat and cholesterol and that include soy protein “may” or “might” reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease”;

(C) In specifying the substance, the claim uses the term “soy protein”;

(D) In specifying the fat component, the claim uses the terms “saturated fat” and “cholesterol”;

(E) The claim does not attribute any degree of risk reduction for CHD to diets that are low in saturated fat and cholesterol and that include soy protein;

(F) The claim does not imply that consumption of diets that are low in saturated fat and cholesterol and that include soy protein is the only recognized means of achieving a reduced risk of CHD; and

(G) The claim specifies the daily dietary intake of soy protein that is necessary to reduce the risk of coronary heart disease and the contribution one serving of the product makes to the specified daily dietary intake level. The daily dietary intake level of soy protein that has been associated with reduced risk of coronary heart disease is 25 grams (g) or more per day of soy protein.

(ii) Nature of the substance. (A) Soy protein from the legume seed Glycine max.

(B) FDA will assess qualifying levels of soy protein in the following fashion: FDA will measure total protein content by the appropriate method of analysis given in the “Official Methods of Analysis of the AOAC International,” as described at § 101.9(c)(7). For products that contain no sources of protein other than soy, FDA will consider the amount of soy protein as equivalent to the total protein content. For products that contain a source or sources of protein in addition to soy, FDA will, using the measurement of total protein content, calculate the soy protein content based on the ratio of soy protein ingredients to total protein ingredients in the product. FDA will base its calculation on information identified and supplied by manufacturers, such as nutrient data bases or analyses, recipes or formulations, purchase orders for ingredients, or any other information that reasonably substantiates the ratio of soy protein to total protein. Manufacturers must maintain records sufficient to substantiate the claim for as long as the products are marketed and provide these records, on written request, to appropriate regulatory officials.

(iii) Nature of the food eligible to bear the claim. (A) The food product shall contain at least 6.25 g of soy protein per reference amount customarily consumed of the food product;

(B) The food shall meet the nutrient content requirements in § 101.62 for a “low saturated fat” and “low cholesterol” food; and

(C) The food shall meet the nutrient content requirement in § 101.62 for a “low fat” food, unless it consists of or is derived from whole soybeans and contains no fat in addition to the fat inherently present in the whole soybeans it contains or from which it is derived.

(d) Optional information. (1) The claim may state that the development of heart disease depends on many factors and may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of CHD; elevated blood total and LDL-cholesterol; excess body weight; high blood pressure; cigarette smoking; diabetes; and physical inactivity. The claim may also provide additional information about the benefits of exercise and management of body weight to help lower the risk of heart disease;

(2) The claim may state that the relationship between intake of diets that are low in saturated fat and cholesterol and that include soy protein and reduced risk of heart disease is through the intermediate link of “blood cholesterol” or “blood total and LDL-cholesterol”;

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets that are low in saturated fat and cholesterol and that include soy protein and CHD and the significance of the relationship;

(4) The claim may state that a diet low in saturated fat and cholesterol that includes soy protein is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO);

(5) The claim may state that individuals with elevated blood total and LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total and LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment;

(6) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” USDA and DHHS, GPO;

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between diets that are low in saturated fat and cholesterol and that include soy protein and reduced risk of heart disease:

(1) 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.

(2) Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein.

(a) Relationship between diets that include plant sterol/stanol esters and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease (CHD) is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL) cholesterol levels are associated with increased risk of developing coronary heart disease. High CHD rates occur among people with high total cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 millimole per liter (mmol/l)) or above and LDL cholesterol levels of 160 mg/dL (4.13 mmol/l) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/l) for total cholesterol, and 130 to 159 mg/dL (3.36 to 4.11 mmol/l) of LDL cholesterol.

(2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in plant foods that contain dietary fiber and other components.

(3) Scientific evidence demonstrates that diets that include plant sterol/stanol esters may reduce the risk of CHD.

(b) Significance of the relationship between diets that include plant sterol/stanol esters and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any other disease or group of diseases. Early management of risk factors for CHD is a major public health goal that can assist in reducing risk of CHD. High blood total and LDL cholesterol are major modifiable risk factors in the development of CHD.

(2) The scientific evidence establishes that including plant sterol/stanol esters in the diet helps to lower blood total and LDL cholesterol levels.

(c) Requirements - (1) General. All requirements set forth in § 101.14 shall be met, except § 101.14(a)(4) with respect to the disqualifying level for total fat per 50 grams (g) in dressings for salad and spreads and § 101.14(e)(6) with respect to dressings for salad.

(2) Specific requirements - (i) Nature of the claim. A health claim associating diets that include plant sterol/stanol esters with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim states that plant sterol/stanol esters should be consumed as part of a diet low in saturated fat and cholesterol;

(B) The claim states that diets that include plant sterol/stanol esters “may” or “might” reduce the risk of heart disease;

(C) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease”;

(D) In specifying the substance, the claim uses the term “plant sterol esters” or “plant stanol esters,” except that if the sole source of the plant sterols or stanols is vegetable oil, the claim may use the term “vegetable oil sterol esters” or “vegetable oil stanol esters”;

(E) The claim does not attribute any degree of risk reduction for CHD to diets that include plant sterol/stanol esters;

(F) The claim does not imply that consumption of diets that include plant sterol/stanol esters is the only recognized means of achieving a reduced risk of CHD; and

(G) The claim specifies the daily dietary intake of plant sterol or stanol esters that is necessary to reduce the risk of CHD and the contribution one serving of the product makes to the specified daily dietary intake level. Daily dietary intake levels of plant sterol and stanol esters that have been associated with reduced risk of are:

(1) 1.3 g or more per day of plant sterol esters.

(2) 3.4 g or more per day of plant stanol esters.

(H) The claim specifies that the daily dietary intake of plant sterol or stanol esters should be consumed in two servings eaten at different times of the day with other foods.

(ii) Nature of the substance - (A) Plant sterol esters. (1) Plant sterol esters prepared by esterifying a mixture of plant sterols from edible oils with food-grade fatty acids. The plant sterol mixture shall contain at least 80 percent beta-sitosterol, campesterol, and stigmasterol (combined weight).

(2) FDA will measure plant sterol esters by the method entitled “Determination of the Sterol Content in Margarines, Halvarines, Dressings, Fat Blends and Sterol Fatty Acid Ester Concentrates by Capillary Gas Chromatography,” developed by Unilever United States, Inc., dated February 1, 2000. The method, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, may be obtained from the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(B) Plant stanol esters. (1) Plant stanol esters prepared by esterifying a mixture of plant stanols derived from edible oils or byproducts of the kraft paper pulping process with food-grade fatty acids. The plant stanol mixture shall contain at least 80 percent sitostanol and campestanol (combined weight).

(2) FDA will measure plant stanol esters by the following methods developed by McNeil Consumer Heathcare dated February 15, 2000: “Determination of Stanols and Sterols in Benecol Tub Spread”; “Determination of Stanols and Sterols in Benecol Dressing”; “Determination of Stanols and Sterols in Benecol Snack Bars”; or “Determination of Stanols and Sterols in Benecol Softgels.” These methods are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(iii) Nature of the food eligible to bear the claim. (A) The food product shall contain:

(1) At least 0.65 g of plant sterol esters that comply with paragraph (c)(2)(ii)(A)(1) of this section per reference amount customarily consumed of the food products eligible to bear the health claim, specifically spreads and dressings for salad, or

(2) At least 1.7 g of plant stanol esters that comply with paragraph (c)(2)(ii)(B)(1) of this section per reference amount customarily consumed of the food products eligible to bear the health claim, specifically spreads, dressings for salad, snack bars, and dietary supplements in softgel form.

(B) The food shall meet the nutrient content requirements in § 101.62 for a “low saturated fat” and “low cholesterol” food; and

(C) The food must meet the limit for total fat in § 101.14(a)(4), except that spreads and dressings for salad are not required to meet the limit for total fat per 50 g if the label of the food bears a disclosure statement that complies with § 101.13(h); and

(D) The food must meet the minimum nutrient contribution requirement in § 101.14(e)(6) unless it is a dressing for salad.

(d) Optional information. (1) The claim may state that the development of heart disease depends on many factors and may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of CHD; elevated blood total and LDL cholesterol; excess body weight; high blood pressure; cigarette smoking; diabetes; and physical inactivity. The claim may also provide additional information about the benefits of exercise and management of body weight to help lower the risk of heart disease.

(2) The claim may state that the relationship between intake of diets that include plant sterol/stanol esters and reduced risk of heart disease is through the intermediate link of “blood cholesterol” or “blood total and LDL cholesterol.”

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets that include plant sterol/stanol esters and the risk of CHD and the significance of the relationship.

(4) The claim may include information from the following paragraph on the relationship between saturated fat and cholesterol in the diet and the risk of CHD: The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total and LDL cholesterol and, thus, with increased risk of CHD. Intakes of saturated fat exceed recommended levels in the diets of many people in the United States. One of the major public health recommendations relative to CHD risk is to consume less than 10 percent of calories from saturated fat and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 mg or less per day. Scientific evidence demonstrates that diets low in saturated fat and cholesterol are associated with lower blood total and LDL cholesterol levels.

(5) The claim may state that diets that include plant sterol or stanol esters and are low in saturated fat and cholesterol are consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO).

(6) The claim may state that individuals with elevated blood total and LDL cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total and LDL cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment.

(7) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO).

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between diets that include plant sterol or stanol esters and reduced risk of heart disease:

(1) For plant sterol esters: (i) Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters.

(ii) Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 1.3 g of vegetable oil sterol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters.

(2) For plant stanol esters: (i) Foods containing at least 1.7 g per serving of plant stanol esters, eaten twice a day with meals for a total daily intake of at least 3.4 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of plant stanol esters.

(ii) Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 g of vegetable oil stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil stanol esters.

(a) Definitions. (1) The term “gluten-containing grain” means any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):

(i) Wheat, including any species belonging to the genus Triticum;

(ii) Rye, including any species belonging to the genus Secale; or

(iii) Barley, including any species belonging to the genus Hordeum.

(2) The term “gluten” means the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).

(3) The labeling claim “gluten-free” means:

(i) That the food bearing the claim in its labeling:

(A) Does not contain any one of the following:

(1) An ingredient that is a gluten-containing grain (e.g., spelt wheat);

(2) An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or

(3) An ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or

(B) Inherently does not contain gluten; and

(ii) Any unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food).

(b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.

(2) A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.

(3) A food that bears the term “wheat” in the ingredient list or in a separate “Contains wheat” statement in its labeling, as required by 21 U.S.C. 343(w)(1)(A), and also bears the claim “gluten-free” or a claim identified in paragraph (b)(2) of this section will be deemed misbranded unless the word “wheat” in the ingredient list or in the “Contains wheat” statement is followed immediately by an asterisk (or other symbol) that refers to another asterisk (or other symbol) in close proximity to the ingredient statement that immediately precedes the following: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”

(c) Compliance. When compliance with paragraph (b) of this section is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.

(d) Preemption. A State or political subdivision of a State may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in this section for the definition and use of the claim “gluten-free,” as well as the claims “no gluten,” “free of gluten,” or “without gluten.”

(a)(1) No later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403(r)(6) or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, that it has included such a statement on the label or in the labeling of its product. An original and two copies of this notification shall be submitted.

(2) The notification shall include the following:

(i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;

(ii) The text of the statement that is being made;

(iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and

(iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears.

(3) The notice shall be signed by a responsible individual or the person who can certify the accuracy of the information presented and contained in the notice. The individual shall certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

(b) Disclaimer. The requirements in this section apply to the label or labeling of dietary supplements where the dietary supplement bears a statement that is provided for by section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer, or distributor wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6) of the act.

(c) Text for disclaimer. (1) Where there is one statement, the disclaimer shall be placed in accordance with paragraph (d) of this section and shall state:

(2) Where there is more than one such statement on the label or in the labeling, each statement shall bear the disclaimer in accordance with paragraph (c)(1) of this section, or a plural disclaimer may be placed in accordance with paragraph (d) of this section and shall state:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

(d) Placement. The disclaimer shall be placed adjacent to the statement with no intervening material or linked to the statement with a symbol (e.g., an asterisk) at the end of each such statement that refers to the same symbol placed adjacent to the disclaimer specified in paragraphs (c)(1) or (c)(2) of this section. On product labels and in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on each panel or page where there such is a statement. The disclaimer shall be set off in a box where it is not adjacent to the statement in question.

(e) Typesize. The disclaimer in paragraph (c) of this section shall appear in boldface type in letters of a typesize no smaller than one-sixteenth inch.

(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of this section, bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims under paragraph (g) of this section. If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.

(g) Disease claims. (1) For purposes of 21 U.S.C. 343(r)(6), a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.

(2) FDA will find that a statement about a product claims to diagnose, mitigate, treat, cure, or prevent disease (other than a classical nutrient deficiency disease) under 21 U.S.C. 343(r)(6) if it meets one or more of the criteria listed below. These criteria are not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment. In determining whether a statement is a disease claim under these criteria, FDA will consider the context in which the claim is presented. A statement claims to diagnose, mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product:

(i) Has an effect on a specific disease or class of diseases;

(ii) Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology;

(iii) Has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm;

(iv) Has an effect on a disease or diseases through one or more of the following factors:

(A) The name of the product;

(B) A statement about the formulation of the product, including a claim that the product contains an ingredient (other than an ingredient that is an article included in the definition of “dietary supplement” under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease;

(C) Citation of a publication or reference, if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease, e.g., through placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims;

(D) Use of the term “disease” or “diseased,” except in general statements about disease prevention that do not refer explicitly or implicitly to a specific disease or class of diseases or to a specific product or ingredient; or

(E) Use of pictures, vignettes, symbols, or other means;

(v) Belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease;

(vi) Is a substitute for a product that is a therapy for a disease;

(vii) Augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases;

(viii) Has a role in the body's response to a disease or to a vector of disease;

(ix) Treats, prevents, or mitigates adverse events associated with a therapy for a disease, if the adverse events constitute diseases; or

(x) Otherwise suggests an effect on a disease or diseases.

The terms defined in this section may be used on the label or in labeling of a food in conformity with the provisions of this section. The requirements of the section pertain to any use of the subject terms as described in paragraphs (a) and (b) of this section that expressly or implicitly refers to the food on labels or labeling, including use in a brand name and use as a sensory modifier. However, the use of the term “fresh” on labels or labeling is not subject to the requirements of paragraph (a) of this section if the term does not suggest or imply that a food is unprocessed or unpreserved. For example, the term “fresh” used to describe pasteurized whole milk is not subject to paragraph (a) of this section because the term does not imply that the food is unprocessed (consumers commonly understand that milk is nearly always pasteurized). However, the term “fresh” to describe pasta sauce that has been pasteurized or that contains pasteurized ingredients would be subject to paragraph (a) of this section because the term implies that the food is not processed or preserved. Uses of fresh not subject to this regulation will be governed by the provisions of 403(a) of the Federal Food, Drug, and Cosmetic Act (the act).

(a) The term “fresh,” when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation, except as provided in paragraph (c) of this section.

(b) The terms “fresh frozen” and “frozen fresh,” when used on the label or in labeling of a food, mean that the food was quickly frozen while still fresh (i.e., the food had been recently harvested when frozen). Blanching of the food before freezing will not preclude use of the term “fresh frozen” to describe the food. “Quickly frozen” means frozen by a freezing system such as blast-freezing (sub-zero Fahrenheit temperature with fast moving air directed at the food) that ensures the food is frozen, even to the center of the food, quickly and that virtually no deterioration has taken place.

(c) Provisions and restrictions. (1) The following do not preclude the food from use of the term “fresh:”

(i) The addition of approved waxes or coatings;

(ii) The post-harvest use of approved pesticides;

(iii) The application of a mild chlorine wash or mild acid wash on produce; or

(iv) The treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1 kiloGray in accordance with § 179.26 of this chapter.

(2) A food meeting the definition in paragraph (a) of this section that is refrigerated is not precluded from use of “fresh” as provided by this section.

(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).

(1) An assortment of different items of food, when variations in the items that make up different packages packed from such assortment normally occur in good packing practice and when such variations result in variations in the ingredients in different packages, with respect to any ingredient that is not common to all packages. Such exemption, however, shall be on the condition that the label shall bear, in conjunction with the names of such ingredients as are common to all packages, a statement (in terms that are as informative as practicable and that are not misleading) indicating by name other ingredients which may be present.

(2) A food having been received in bulk containers at a retail establishment, if displayed to the purchaser with either:

(i) The labeling of the bulk container plainly in view, provided ingredient information appears prominently and conspicuously in lettering of not less than one-fourth of an inch in height; or

(ii) A counter card, sign, or other appropriate device bearing prominently and conspicuously, but in no case with lettering of less than one-fourth of an inch in height, the information required to be stated on the label pursuant to section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (the act).

(3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are:

(i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect.

(ii) Processing aids, which are as follows:

(a) Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form.

(b) Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constitutents naturally found in the food.

(c) Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food that are not food additives as defined in section 201(s) of the act; or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act.

(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) that has been added to any food or to any ingredient in any food and that has no technical effect in that food will be considered to be present in an insignificant amount only if no detectable amount of the agent is present in the finished food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food. Compliance with this paragraph will be determined using sections 20.123-20.125, “Total Sulfurous Acid,” in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 14th Ed. (1984), which is incorporated by reference and the refinements of the “Total Sulfurous Acid” procedure in the “Monier-Williams Procedure (with Modifications) for Sulfites in Foods,” which is appendix A to part 101. A copy of sections 20.123-20-125 of the Official Methods of Analysis of the Association of Official Analytical Chemists” is available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) A food repackaged in a retail establishment is exempt from the following provisions of the act if the conditions specified are met.

(1) Section 403(e)(1) of the act (requiring a statement on the label of the name and place of business of the manufacturer, packer, or distributor).

(2) Section 403(g)(2) of the act (requiring the label of a food which purports to be or is represented as one for which a definition and standard of identity has been prescribed to bear the name of the food specified in the definition and standard and, insofar as may be required by the regulation establishing the standard the common names of the optional ingredients present in the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other appropriate device bearing prominently and conspicuously the information required by these provisions.

(3) Section 403(i)(1) of the act (requiring the label to bear the common or usual name of the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other appropriate device bearing prominently and conspicuously the common or usual name of the food, or if the common or usual name of the food is clearly revealed by its appearance.

(c) An open container (a container of rigid or semirigid construction, which is not closed by lid, wrapper, or otherwise other than by an uncolored transparent wrapper which does not obscure the contents) of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than 1 dry quart, shall be exempt from the labeling requirements of sections 403(e), (g)(2) (with respect to the name of the food specified in the definition and standard), and (i)(1) of the act; but such exemption shall be on the condition that if two or more such containers are enclosed in a crate or other shipping package, such crate or package shall bear labeling showing the number of such containers enclosed therein and the quantity of the contents of each.

(d) Except as provided by paragraphs (e) and (f) of this section, a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of section 403 (c), (e), (g), (h), (i), (k), and (q) of the act if:

(1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or

(2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such food in such establishment as will ensure, if such specifications are followed, that such food will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such food from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(3) The article is an egg product subject to a standard of identity promulgated in part 160 of this chapter, is to be shipped under the conditions specified in paragraph (d) (1) or (2) of this section and for the purpose of pasteurization or other treatment as required in such standard, and each container of such egg product bears a conspicuous tag or label reading “Caution - This egg product has not been pasteurized or otherwise treated to destroy viable Salmonella microorganisms”. In addition to safe and suitable bactericidal processes designed specifically for Salmonella destruction in egg products, the term “other treatment” in the first sentence of this paragraph shall include use in acidic dressings in the processing of which the pH is not above 4.1 and the acidity of the aqueous phase, expressed as acetic acid, is not less than 1.4 percent, subject also to the conditions that:

(i) The agreement required in paragraph (d)(2) of this section shall also state that the operator agrees to utilize such unpasteurized egg products in the processing of acidic dressings according to the specifications for pH and acidity set forth in this paragraph, agrees not to deliver the acidic dressing to a user until at least 72 hours after such egg product is incorporated in such acidic dressing, and agrees to maintain for inspection adequate records covering such processing for 2 years after such processing.

(ii) In addition to the caution statement referred to above, the container of such egg product shall also bear the statement “Unpasteurized ___ for use in acidic dressings only”, the blank being filled in with the applicable name of the eggs or egg product.

(e) Conditions affecting expiration of exemptions:

(1) An exemption of a shipment or other delivery of a food under paragraph (d) (1) or (3) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment become void ab initio if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(2) An exemption of a shipment or other delivery of a food under paragraph (d) (2) or (3) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by paragraph (d) (2) or (3) of this section.

(3) An exemption of a shipment or other delivery of a food under paragraph (d) (2) or (3) of this section shall expire:

(i) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the food constituting such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(ii) Upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such paragraph.

(f) The word “processed” as used in this paragraph shall include the holding of cheese in a suitable warehouse at a temperature of not less than 35 °F for the purpose of aging or curing to bring the cheese into compliance with requirements of an applicable definition and standard of identity. The exemptions provided for in paragraph (d) of this section shall apply to cheese which is, in accordance with the practice of the trade, shipped to a warehouse for aging or curing, on condition that the cheese is identified in the manner set forth in one of the applicable following paragraphs, and in such case the provisions of paragraph (e) of this section shall also apply:

(1) In the case of varieties of cheese for which definitions and standards of identity require a period of aging whether or not they are made from pasteurized milk, each such cheese shall bear on the cheese a legible mark showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each cheese, on its wrapper or immediate container, shall be affixed a removable tag bearing the statement “Uncured ___ cheese for completion of curing and proper labeling”, the blank being filled in with the applicable name of the variety of cheese. In the case of swiss cheese, the date at which the preliminary manufacturing process had been completed and at which date curing commences is the date on which the shaped curd is removed from immersion in saturated salt solution as provided in the definition and standard of identity for swiss cheese, and such cheese shall bear a removable tag reading, “To be cured and labeled as ‘swiss cheese,’ but if eyes do not form, to be labeled as ‘swiss cheese for manufacturing’ ”.

(2) In the case of varieties of cheeses which when made from unpasteurized milk are required to be aged for not less than 60 days, each such cheese shall bear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or its wrapper or immediate container shall be affixed a removable tag reading, “___ cheese made from unpasteurized milk. For completion of curing and proper labeling”, the blank being filled in with the applicable name of the variety of cheese.

(3) In the case of cheddar cheese, washed curd cheese, colby cheese, granular cheese, and brick cheese made from unpasteurized milk, each such cheese shall bear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or its wrapper or immediate container shall be affixed a removable tag reading “___ cheese made from unpasteurized milk. For completion of curing and proper labeling, or for labeling as ___ cheese for manufacturing”, the blank being filled in with the applicable name of the variety of cheese.

(g) The label declaration of a harmless marker used to identify a particular manufacturer's product may result in unfair competition through revealing a trade secret. Exemption from the label declaration of such a marker is granted, therefore, provided that the following conditions are met:

(1) The person desiring to use the marker without label declaration of its presence has submitted to the Commissioner of Food and Drugs full information concerning the proposed usage and the reasons why he believes label declaration of the marker should be subject to this exemption; and

(2) The person requesting the exemption has received from the Commissioner of Food and Drugs a finding that the marker is harmless and that the exemption has been granted.

(h) Wrapped fish fillets of nonuniform weight intended to be unpacked and marked with the correct weight at or before the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirement of section 403(e)(2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing and marking:

(1) Provided, That (i) The outside container bears a label declaration of the total net weight; and

(ii) The individual packages bear a conspicuous statement “To be weighed at or before time of sale” and a correct statement setting forth the weight of the wrapper;

(2) Provided further, That it is the practice of the retail establishment to weigh and mark the individual packages with a correct net-weight statement prior to or at the point of retail sale. A statement of the weight of the wrapper shall be set forth so as to be readily read and understood, using such term as “wrapper tare - ounce”, the blank being filled in with the correct average weight of the wrapper used.

(3) The act of delivering the wrapped fish fillets during the retail sale without the correct net-weight statement shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this paragraph shall be construed as requiring net-weight statements for wrapped fish fillets delivered into institutional trade provided the outside container bears the required information.

(i) Wrapped clusters (consumer units) of bananas of nonuniform weight intended to be unpacked from a master carton or container and weighed at or before the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirements of section 403(e)(2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing:

(1) Provided, That (i) The master carton or container bears a label declaration of the total net weight; and

(ii) The individual packages bear a conspicuous statement “To be weighed at or before the time of sale” and a correct statement setting forth the weight of the wrapper; using such term as “wrapper tare _ ounce”, the blank being filled in with the correct average weight of the wrapper used;

(2) Provided further, That it is the practice of the retail establishment to weigh the individual packages either prior to or at the time of retail sale.

(3) The act of delivering the wrapped clusters (consumer units) during the retail sale without an accurate net weight statement or alternatively without weighing at the time of sale shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this paragraph shall be construed as requiring net-weight statements for clusters (consumer units) delivered into institutional trade, provided that the master container or carton bears the required information.

(a) The food industry is encouraged to experiment voluntarily, under controlled conditions and in collaboration with the Food and Drug Administration, with and other formats for presenting nutrition and other related food labeling information that is consistent with the current quantitative system in §§ 101.9 and 105.66 of this chapter.

(b) Any firm that intends to undertake a labeling experiment that requires exemptions from certain requirements of §§ 101.9 and 105.66 of this chapter should submit a written proposal containing a thorough discussion of each of the following information items that apply to the particular experiment:

(1) A description of the labeling format to be tested;

(2) A statement of the criteria to be used in the experiment for assigning foods to categories, e.g., nutrient or other values defining “low” and “reduced”;

(3) A draft of the material to be used in the store, e.g., shelf tags, booklets, posters, etc.;

(4) The dates on which the experiment will begin and end and on which a written report of analysis of the experimental data will be submitted to FDA, together with a commitment not to continue the experiment beyond the proposed ending date without FDA approval;

(5) The geographic area or areas in which the experiment is to be conducted;

(6) The mechanism to measure the effectiveness of the experiment;

(7) The method for conveying to consumers the required nutrition and other labeling information that is exempted from the label during the experiment;

(8) The method that will be or has been used to determine the actual nutritional characteristics of foods for which a claim is made; and

(9) A statement of the sections of the regulations for which an exemption is sought.

(c) The written proposal should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The proposal should be clearly identified as a request for a temporary exemption for purposes of conducting authorized food labeling experiments and submitted as a citizen petition under § 10.30 of this chapter.

(d) Approval for food labeling experiments will be given by FDA in writing. Foods labeled in violation of existing regulations will be subject to regulatory action unless an FDA-approved exemption to the specific regulation has been granted for that specific product.

(e) Reporting requirements contained in § 101.108(b) have been approved by this Office of Management and Budget and assigned number 0910-0151.

(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. Each class or subclass of food shall be given its own common or usual name that states, in clear terms, what it is in a way that distinguishes it from different foods.

(b) The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case. The following requirements shall apply unless modified by a specific regulation in subpart B of this part.

(1) The percentage of a characterizing ingredient or component shall be declared on the basis of its quantity in the finished product (i.e., weight/weight in the case of solids, or volume/volume in the case of liquids).

(2) The percentage of a characterizing ingredient or component shall be declared by the words “containing (or contains) _ percent (or %) ___” or “_ percent (or %) ___” with the first blank filled in with the percentage expressed as a whole number not greater than the actual percentage of the ingredient or component named and the second blank filled in with the common or usual name of the ingredient or component. The word “containing” (or “contains”), when used, shall appear on a line immediately below the part of the common or usual name of the food required by paragraph (a) of this section. For each characterizing ingredient or component, the words “_ percent or %) ___” shall appear following or directly below the word “containing” (or contains), or directly below the part of the common or usual name of the food required by paragraph (a) of this section when the word “containing” (or contains) is not used, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(i) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(ii) Not less than one-half the height of the largest type appearing in the part of the common or usual name of the food required by paragraph (a) of this section.

(c) The common or usual name of a food shall include a statement of the presence or absence of any characterizing ingredient(s) or component(s) and/or the need for the user to add any characterizing ingredient(s) or component(s) when the presence or absence of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present when it is not, and consumers may otherwise be misled about the presence or absence of the ingredient(s) or component(s) in the food. The following requirements shall apply unless modified by a specific regulation in subpart B of this part.

(1) The presence or absence of a characterizing ingredient or component shall be declared by the words “containing (or contains) ___” or “containing (or contains) no ___” or “no ___” or “does not contain ___”, with the blank being filled in with the common or usual name of the ingredient or component.

(2) The need for the user of a food to add any characterizing ingredient(s) or component(s) shall be declared by an appropriate informative statement.

(3) The statement(s) required under paragraph (c)(1) and/or (2) of this section shall appear following or directly below the part of the common or usual name of the food required by paragraphs (a) and (b) of this section, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the alternatives established under paragraphs (b)(2) (i) and (ii) of this section.

(d) A common or usual name of a food may be established by common usage or by establishment of a regulation in subpart B of this part, in part 104 of this chapter, in a standard of identity, or in other regulations in this chapter.

(a) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to issue, amend, or revoke, under this part, a regulation prescribing a common or usual name for a food, pursuant to part 10 of this chapter.

(b) If the principal display panel of a food for which a common or usual name regulation is established is too small to accommodate all mandatory requirements, the Commissioner may establish by regulation an acceptable alternative, e.g., a smaller type size. A petition requesting such a regulation, which would amend the applicable regulation, shall be submitted pursuant to part 10 of this chapter.

The common or usual name of a protein hydrolysate shall be specific to the ingredient and shall include the identity of the food source from which the protein was derived.

(a) “Hydrolyzed wheat gluten,” “hydrolyzed soy protein,” and “autolyzed yeast extract” are examples of acceptable names. “Hydrolyzed casein” is also an example of an acceptable name, whereas “hydrolyzed milk protein” is not an acceptable name for this ingredient because it is not specific to the ingredient (hydrolysates can be prepared from other milk proteins). The names “hydrolyzed vegetable protein” and “hydrolyzed protein” are not acceptable because they do not identify the food source of the protein.

(b) [Reserved]

(a) The common or usual name of a spreadable peanut product that does not conform to § 164.150 of this chapter, and more than 10 percent of which consists of nonpeanut ingredients, shall consist of the term “peanut spread” and a statement of the percentage by weight of peanuts in the product in the manner set forth in § 102.5(b), except that peanut percentages shall be based on the amount of peanuts used to make the finished food and shall be declared in 5-percent increments expressed as a multiple of 5, not to exceed the actual percentage of peanuts in the products.

(b) A spreadable peanut product that is nutritionally inferior to peanut butter shall be labeled as an imitation of peanut butter under § 101.3(e)(2) of this chapter; a spreadable peanut product shall be considered nutritionally equivalent to peanut butter if it meets all of the following conditions:

(1) Protein. (i) The protein content of the product is at least 24 percent by weight of the finished product, and the overall biological quality of the protein contained in the product is at least 68 percent that of casein; or

(ii) The protein content of the product is at least 16.6 percent by weight of the finished product, and the overall biological quality of the protein contained in the product is equal to or greater than that of casein.

(2) Other nutrients. The product contains the following levels of nutrients per 100 grams of product:

(c) Compliance with the requirements of paragraph (b) of this section shall be determined by methods described in the following references except that in determining protein quantity in products with mixed protein sources a nitrogen conversion factor of 6.25 may be used.

(1) Protein quantity: “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980), using the method described in section 27.007, which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Biological quality of protein: AOAC, 13th Ed. (1980), using the method described in sections 43.212-43.216, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(3) Niacin: AOAC, 13th Ed. (1980), using the method described in sections 43.044-43.046, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(4) Vitamin B6: AOAC, 13th Ed. (1980), using the method described in sections 43.188-43.193, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(5) Folic acid: Using the method described in U.S. Department of Agriculture Handbook No. 29, modified by use of ascorbate buffer as described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968), which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(6) Iron: AOAC, 13th Ed. (1980), using the method described in sections 43.217-43.219, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(7) Zinc: AOAC, 13th Ed. (1980), using the method described in sections 25.150-25.153, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(8) Copper: AOAC, 13th Ed. (1980), using the method described in sections 25.038-25.043, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(9) Magnesium: AOAC, 13th Ed. (1980), using the method described in sections 2.109-2.113, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(a) A frozen “heat and serve” dinner:

(1) Shall contain at least three components, one of which shall be a significant source of protein and each of which shall consist of one or more of the following: meat, poultry, fish, cheese, eggs, vegetables, fruit, potatoes, rice, or other cereal based products (other than bread or rolls).

(2) May also contain other servings of food (e.g., soup, bread or rolls, beverage, dessert).

(b) The common or usual name of the food consists of all of the following:

(1) The phrase “frozen ‘heat and serve’ dinner,” except that the name of the predominant characterizing ingredient or other appropriately descriptive term may immediately precede the word “dinner” (e.g., “frozen chicken dinner” or “frozen heat and serve beef dinner”). The words “heat and serve” are optional. The word “frozen” is also optional, provided that the words “Keep Frozen” or the equivalent are prominently and conspicuously placed on the principal display panel in type size not less than that specified in § 102.5(b)(2)(i).

(2) The phrase “containing (or contains) ___” the blank to be filled in with an accurate description of each of the three or more dish components listed in paragraph (a)(1) of this section in their order of descending predominance by weight (e.g., ham, mashed potatoes, and peas), followed by any of the other servings specified in paragraph (a)(2) of this section contained in the package (e.g., onion soup, enriched white bread, and artificially flavored vanilla pudding) in their order of descending predominance by weight. This part of the name shall be placed immediately following or directly below the part specified in paragraph (b)(1) of this section in the manner set forth in § 102.5(c)(3). The words “contains” or “containing” are optional.

(3) If the labeling implies that the package contains other foods and these foods are not present in the package, e.g., if a vignette on the package depicts a “serving suggestion” which includes any foods not present in the package, the principal display panel shall bear a statement that such foods are not present, in type size not less than that specified in § 102.5(b)(2)(i).

(a) The common or usual name of a packaged food which is represented on the principal display panel by word or vignette to be used in the preparation of a “main dish”, “dinner”, or other such food serving, and to which some other important characterizing ingredient(s) or component(s) not present in the package must be added, consists of all the following:

(1) The common or usual name of each important ingredient or component in the package, in descending order of predominance by weight (e.g., “noodles and tomato sauce”).

(2) An appropriate informative statement identifying the food to be prepared by use of the package contents (e.g., “for preparation of chicken casserole”).

(3) An appropriate informative statement that additional characterizing ingredient(s) or component(s) must be added and which names the additional characterizing ingredient(s) or component(s) (e.g., “you must add ___ to complete the recipe,” the blank to be filled in with the name(s) of the important characterizing ingredient(s) or component(s) that must be added).

(b) The labeling required by paragraph (a) of this section shall appear on the principal display panel.

(1) No word in the statement required by paragraph (a)(2) of this section may appear on the principal display panel more conspicuously or in larger type than the smallest and least conspicuous type employed on the panel for any word, phrase or statement within the scope of paragraph (a)(1) of this section.

(2) Every word in the statement required by paragraph (a)(3) of this section shall appear on the principal display panel in easily legible bold face print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(i) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(ii) Not less than one-half the height of the largest type appearing in the part of the common or usual name of the food required by paragraphs (a) (1) and (2) of this section.

(c) Any vignette which shows any food or characterizing ingredient(s) or component(s) not included in the package shall be accompanied either by the statement required by paragraph (a)(3) of this section or by a separate statement specifying the food or characterizing ingredient(s) or component(s) shown in the vignette but not included in the package.

(d) If the statement specified in paragraph (a)(2) of this section is used on any panel in addition to the principal display panel as a product identification statement, the complete common or usual name shall appear on such panel in the manner specified in paragraph (b) of this section.

(e) When a brand name or other prominent product designation contains a word or words that includes or suggests an important characterizing ingredient(s) or component(s) that must be added, or otherwise states or implies that the package contains a complete main dish, dinner, or other food serving, the part of the common or usual name of the food required by paragraph (a)(3) of this section shall appear in direct conjunction with such brand name or other designation and in type size not less than one-half the height of the largest type appearing in such brand name or other designation.

(a) For a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable juice, the common or usual name shall be a descriptive name that meets the requirements of § 102.5(a) and, if the common or usual name uses the word “juice,” shall include a qualifying term such as “beverage,” “cocktail,” or “drink” appropriate to advise the consumer that the product is less than 100 percent juice (e.g., “diluted grape juice beverage” or “grape juice drink”).

(b) If the product is a diluted multiple-juice beverage or blend of single-strength juices and names, other than in the ingredient statement, more than one juice, then the names of those juices, except in the ingredient statement, must be in descending order of predominance by volume unless the name specifically shows that the juice with the represented flavor is used as a flavor (e.g., raspberry-flavored apple and pear juice drink). In accordance with § 101.22(i)(1)(iii) of this chapter, the presence of added natural flavors is not required to be declared in the name of the beverage unless the declared juices alone do not characterize the product before the addition of the added flavors.

(c) If a diluted multiple-juice beverage or blend of single-strength juices contains a juice that is named or implied on the label or labeling other than in the ingredient statement (represented juice), and also contains a juice other than the named or implied juice (nonrepresented juice), then the common or usual name for the product shall indicate that the represented juice is not the only juice present (e.g., “Apple blend; apple juice in a blend of two other fruit juices.”)

(d) In a diluted multiple-juice beverage or blend of single-strength juices where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice, the common or usual name for the product shall:

(1) Indicate that the named juice is present as a flavor or flavoring (e.g., “Raspcranberry”; raspberry and cranberry flavored juice drink); or

(2) Include the amount of the named juice, declared in a 5- percent range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10- to 15-percent cranberry juice and 3- to 8-percent raspberry juice). The 5-percent range, when used, shall be declared in the manner set forth in § 102.5(b)(2).

(e) The common or usual name of a juice that has been modified shall include a description of the exact nature of the modification (e.g., “acid-reduced cranberry juice,” “deflavored, decolored grape juice”).

(f) If the product is a beverage that contains a juice whose color, taste, or other organoleptic properties have been modified to the extent that the original juice is no longer recognizable at the time processing is complete, or if its nutrient profile has been diminished to a level below the normal nutrient range for the juice, then the source fruits or vegetables from which the modified juice was derived may not be depicted on the label by vignette or other pictorial representation.

(g)(1) If one or more juices in a juice beverage is made from concentrate, the name of the juice must include a term indicating that fact, such as “from concentrate,” or “reconstituted.” Such terms must be included in the name of each individual juice or it may be stated once adjacent to the product name so that it applies to all the juices, (e.g., “cherry juice (from concentrate) in a blend of two other juices” or “cherry juice in a blend of 2 other juices (from concentrate)”). The term shall be in a type size no less than one-half the height of the letters in the name of the juice.

(2) If the juice is 100 percent single species juice consisting of juice directly expressed from a fruit or vegetable whose Brix level has been raised by the addition of juice concentrate from the same fruit or vegetable, the name of the juice need not include a statement that the juice is from concentrate. However, if water is added to this 100 percent juice mixture to adjust the Brix level, the product shall be labeled with the term “from concentrate” or “reconstituted.”

The common or usual name of a mixture of edible fats and oils containing less than 100 percent and more than 0 percent olive oil shall be as follows:

(a) A descriptive name for the product meeting the requirements of § 102.5(a), e.g., “cottonseed oil and olive oil” or another descriptive phrase, and

(b) When the label bears any representation, other than in the ingredient listing, of the presence of olive oil in the mixture, the descriptive name shall be followed by a statement of the percentage of olive oil contained in the product in the manner set forth in § 102.5(b)(2).

(a) The common or usual name of the food product that resembles and is of the same composition as onion rings, except that it is composed of comminuted onions, shall be as follows:

(1) When the product is composed of dehydrated onions, the name shall be “onion rings made from dried diced onions.”

(2) When the product is composed of any form of onion other than dehydrated, the name shall be “onion rings made from diced onions.”

(b) The words “made from dried diced onions” or “made from diced onions” shall immediately follow or appear on a line(s) immediately below the words “onion rings” in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(2) Not less than one-half the height of the largest type used in the words “onion rings.”

(a) The common or usual name of the food product that resembles and is of the same composition as potato chips, except that it is composed of dehydrated potatoes (buds, flakes, granules, or other form), shall be “potato chips made from dried potatoes.”

(b) The words “made from dried potatoes” shall immediately follow or appear on a line(s) immediately below the words “potato chips” in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(2) Not less than one-half the height of the largest type used in the words “potato chips.”

(a) The common or usual name of the food product that resembles and is of the same composition as fish sticks or fish portions, except that it is composed of comminuted fish flesh, shall be “fish ___ made from minced fish,” the blank to be filled in with the word “sticks” or “portions” as the case may be.

(b) The words “made from minced fish” shall immediately follow or appear on a line(s) immediately below the words “fish ___” in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(2) Not less than one-half the height of the largest type used in the words “fish ___.”

“Pacific whiting” or “North Pacific whiting” is the common or usual name of the food fish Merluccius productus.

“Bonito” or “bonito fish” is the common or usual name of the following food fishes:

(a) The common or usual name of the food product that resembles and is of the same composition as fried clams, except that it is composed of comminuted clams, shall be “fried clams made from minced clams.”

(b) The words “made from minced clams” shall immediately follow or appear on a line(s) immediately below the words “fried clams” and in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(2) Not less than one-half the height of the largest type used in the words “fried clams.”

The common or usual name of crabmeat derived from each of the following designated species of crabs shall be as follows:

The common or usual name of a seafood cocktail in package form fabricated with one or more seafood ingredients shall be:

(a) When the cocktail contains only one seafood ingredient, the name of the seafood ingredient followed by the word “cocktail” (e.g., shrimp cocktail, crabmeat cocktail) and a statement of the percentage by weight of that seafood ingredient in the product in the manner set forth in § 102.5(b).

(b) When the cocktail contains more than one seafood ingredient, the term “seafood cocktail” and a statement of the percentage by weight of each seafood ingredient in the product in the manner set forth in § 102.5(b).

(a) The common on usual name of the food product that conforms to the definition and standard of identity described by § 161.175(c)(6) of this chapter, except that the food is made from comminuted shrimp and is not in raw frozen form, shall be “___ made from minced shrimp,” the blank to be filled in with the words “breaded shrimp sticks” or “breaded shrimp cutlets” depending upon the shape of the product, or if prepared in a shape other than that of sticks or cutlets “breaded shrimp ___ made from minced shrimp,” the blank to be filled by a word or phrase that accurately describes the shape and that is not misleading.

(b) The words “made from minced shrimp” shall immediately follow or appear on a line(s) immediately below the other words required by this section in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and no less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or

(2) Not less than one-half the height of the largest type used in the words “breaded shrimp sticks” or the other comparable words required by this section.

“Greenland turbot” is the common or usual name of the food fish Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye flounders. The term “halibut” may be associated only with Atlantic halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus stenolepis).

(a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food.

(b) Labeling for a product which complies with all of the requirements of the nutritional quality guideline established for its class of food may state “This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Government,” except that the words “this product” are optional. This statement, if used, shall be printed on the principal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by § 101.7 of this chapter. Labeling of noncomplying products may not include any such statement or otherwise represent, suggest, or imply the product as being, in whole or in part, in compliance with a guideline.

(c) A product bearing the statement provided for in paragraph (b) of this section, in addition to meeting the requirements of the applicable nutritional quality guideline, shall comply with the following requirements:

(1) The label of the product shall bear the common or usual name of the food in accordance with the provisions of the guideline and §§ 101.3 and 102.5(a) of this chapter.

(2) The label of the product shall bear nutrition labeling in accordance with §§ 101.2 and 101.9 of this chapter and all other labeling required by applicable sections of part 101 of this chapter.

(d) No claim or statement may be made on the label or in labeling representing, suggesting, or implying any nutritional or other differences between a product to which nutrient addition has or has not been made in order to meet the guideline, except that a nutrient addition shall be declared in the ingredient statement.

(e) Compliance with a nutrient level specified in a nutritional quality guideline shall be determined by the procedures and requirements established in § 101.9(g) of this chapter.

(f) A product within a class of food for which a nutritional quality guideline has been established and to which has been added a discrete nutrient either for which no minimum nutrient level or nutrient range or other allowance has been established as appropriate in the nutritional quality guideline, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph (b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the following prominent and conspicuous statement: “The addition of ___ to (or “The addition of ___ at the level contained in) this product has been determined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food,” the blank to be filled in with the common or usual name of the nutrient(s) involved.

(a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nation's food supply is an important public health objective. The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food. It is reasonable to anticipate that the Reference Daily Intakes (RDI's) as delineated in § 101.9 of this chapter and in paragraph (d) of this section will be amended from time to time to list additional nutrients and/or to change the levels of specific RDI's as improved knowledge about human nutrient requirements and allowances develops. The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable in other countries.

(b) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if:

(1) Sufficient information is available to identify the nutritional problem and the affected population groups, and the food is suitable to act as a vehicle for the added nutrients. Manufacturers contemplating using this principle are urged to contact the Food and Drug Administration before implementing a fortification plan based on this principle.

(2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions. (Other Federal regulations include, but are not limited to, standards of identity promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act, nutritional quality guidelines established in subpart C of this part, and common or usual name regulations established in part 102 of this chapter.)

(c) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to restore such nutrient(s) to a level(s) representative of the food prior to storage, handling, and processing, when:

(1) The nutrient is shown by adequate scientific documentation to have been lost in storage, handling, or processing in a measurable amount equal to at least 2 percent of the Daily Reference Value (DRV) of protein and of potassium and 2 percent of the Reference Daily Intake (RDI) in a normal serving of the food.

(2) Good manufacturing practices and normal storage and handling procedures cannot prevent the loss of such nutrient(s),

(3) All nutrients, including protein, iodine and vitamin D, that are lost in a measurable amount are restored and all ingredients of the food product that contribute nutrients are considered in determining restoration levels; and

(4) The food is not the subject of any other Federal regulation that requires or prohibits nutrient addition(s), or the food has not been fortified in accordance with any other Federal regulation that permits voluntary nutrient additions.

(d) A nutrient(s) listed in paragraph (d)(3) of this section may be added to a food in proportion to the total caloric content of the food, to balance the vitamin, mineral, and protein content if:

(1) A normal serving of the food contains at least 40 kilocalories (that is, 2 percent of a daily intake of 2,000 kilocalories);

(2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions; and

(3) The food contains all of the following nutrients per 100 calories based on 2,000 calorie total intake as a daily standard:

(e) A nutrient(s) may appropriately be added to a food that replaces traditional food in the diet to avoid nutritional inferiority in accordance with § 101.3(e)(2) of this chapter.

(f) Nutrient(s) may be added to foods as permitted or required by applicable regulations established elsewhere in this chapter.

(g) A nutrient added to a food is appropriate only when the nutrient:

(1) Is stable in the food under customary conditions of storage, distribution, and use;

(2) Is physiologically available from the food;

(3) Is present at a level at which there is a reasonable assurance that consumption of the food containing the added nutrient will not result in an excessive intake of the nutrient, considering cumulative amounts from other sources in the diet; and

(4) Is suitable for its intended purpose and is in compliance with applicable provisions of the act and regulations governing the safety of substances in food.

(h) Any claims or statements in the labeling of food about the addition of a vitamin, mineral, or protein to a food shall be made only if the claim or statement is not false or misleading and otherwise complies with the act and any applicable regulations. The following label claims are acceptable:

(1) The labeling claim “fully restored with vitamins and minerals” or “fully restored with vitamins and minerals to the level of unprocessed ___” (the blank to be filled in with the common or usual name of the food) may be used to describe foods fortified in accordance with the principles established in paragraph (c) of the section.

(2) The labeling claim, “vitamins and minerals (and “protein” when appropriate) added are in proportion to caloric content” may be used to describe food fortified in accordance with the principles established in paragraph (d) of this section.

(3) When labeling claims are permitted, the term “enriched,” “fortified,” “added,” or similar terms may be used interchangeably to indicate the addition of one or more vitamins or minerals or protein to a food, unless an applicable Federal regulation requires the use of specific words or statements.

(i) It is inappropriate to make any claim or statement on a label or in labeling, other than in a listing of the nutrient ingredients as part of the ingredient statement, that any vitamin, mineral, or protein has been added to a food to which nutrients have been added pursuant to paragraph (e) of this section.

(a) A product, for which a common or usual name is established in § 102.26 of this chapter, in order to be eligible to bear the guideline statement set forth at § 104.5(b), shall contain at least the following three components:

(1) One or more sources of protein derived from meat, poultry, fish, cheese, or eggs.

(2) One or more vegetables or vegetable mixtures other than potatoes, rice, or cereal-based product.

(3) Potatoes, rice, or cereal-based product (other than bread or rolls) or another vegetable or vegetable mixture.

(b) The three or more components named in paragraph (a) of this section, including their sauces, gravies, breading, etc.:

(1) Shall contribute not less than the minimum levels of nutrients prescribed in paragraph (d) of this section.

(2) Shall be selected so that one or more of the listed protein sources of paragraph (a)(1) of this section, excluding their sauces, gravies, breading, etc., shall provide not less than 70 percent of the total protein supplied by the components named in paragraph (a) of this section.

(c) If it is necessary to add any nutrient(s) in order to meet the minimum nutrient levels prescribed in paragraph (d) of this section, the addition of each such nutrient may not result in a total nutrient level exceeding 150 percent of the minimum level prescribed. Nutrients used for such addition shall be biologically available in the final product.

(d) Minimum levels of nutrients for a frozen “heat and serve” dinner are as follows:

(1) A frozen “heat and serve” dinner prepared from conventional food ingredients listed in paragraph (a) of this section will also contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels for these nutrients cannot be established at the present time but may be specified as additional data are obtained.

(2) The minimum levels for pantothenic acid, vitamin B-6, and vitamin B-12 are tentative. Final levels will be established when sufficient data are available. Until final levels are established, a product containing less than the tentative levels will not be deemed to be misbranded when labeled in accordance with § 104.5(b).

(3) When technologically practicable, iodized salt shall be used or iodine shall be present at a level equivalent to that which would be present if iodized salt were used in the manufacture of the product.

(4) When technologically practicable, product components and ingredients shall be selected to obtain the desirable calcium to phosphorous ratio of 1:1. Technological addition of phosphates shall be minimized and shall not exceed the amount necessary for the intended effect.

(e) If the product includes servings of food which are not prescribed by paragraph (a) of this section (e.g., soup, bread or rolls, beverage, or dessert), their contribution shall not be considered in determining compliance with the nutrient levels established in paragraph (d) of this section but shall be included in any nutrition labeling.

(f) For the purposes of labeling, an “average serving” shall be one entire frozen “heat and serve” dinner.

The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter “the act”) shall be applicable with the following additions:

(a)(1) The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows:

(i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight;

(ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood;

(iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use.

(2) The use of an artificial sweetener in a food, except when specifically and solely used for achieving a physical characteristic in the food which cannot be achieved with sugar or other nutritive sweetener, shall be considered a use for regulation of the intake of calories and available carbohydrate, or for use in the diets of diabetics and is therefore a special dietary use.

(b)-(d) [Reserved]

(e) For the purposes of the regulations in this part, the terms infant, child, and adult mean persons not more than 12 months old, more than 12 months but less than 12 years old, and 12 years or more old, respectively.

If a food purports to be or is represented for special dietary use by reason of the decrease or absence of any allergenic property or by reason of being offered as food suitable as a substitute for another food having an allergenic property, the label shall bear:

(a) The common or usual name and the quantity or proportion of each ingredient (including spices, flavoring, and coloring) in case the food is fabricated from two or more ingredients.

(b) A qualification of the name of the food, or the name of each ingredient thereof in case the food is fabricated from two or more ingredients, to reveal clearly the specific plant or animal that is the source of such food or of such ingredient, if such food or such ingredient consists in whole or in part of plant or animal matter and such name does not reveal clearly the specific plant or animal that is such a source.

(c) An informative statement of the nature and effect of any treatment or processing of the food or any ingredient thereof, if the changed allergenic property results from such treatment or processing.

(a) If a food (other than a dietary supplement of vitamins and/or minerals alone) purports to be or is represented for special dietary use for infants, the label shall bear, if such food is fabricated from two or more ingredients, the common or usual name of each ingredient, including spices, flavoring, and coloring.

(b) If such food, or any ingredient thereof, consists in whole or in part of plant or animal matter and the name of such food or ingredient does not clearly reveal the specific plant or animal which is its source, such name shall be so qualified as to reveal clearly the specific plant or animal that is such source.

(a) General requirements. Any food that purports to be or is represented for special dietary use because of usefulness in reducing or maintaining body weight shall bear:

(1) Nutrition labeling in conformity with § 101.9, or, where applicable, § 101.36 of this chapter, unless exempt under that section; and

(2) A conspicuous statement of the basis upon which the food claims to be of special dietary usefulness.

(b) Nonnutritive ingredients. (1) Any food subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.

(2) A special dietary food may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the food under the applicable law and regulations of this chapter. Any food that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener, e.g., “Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).”

(c) “Low calorie” foods. A food purporting to be “low calorie” must comply with the criteria set forth for such foods in § 101.60(b)(2) and (b)(3) of this chapter.

(d) “Reduced calorie” foods and other comparative calorie claims. A food purporting to be “reduced calorie” or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such food in § 101.60(b)(4) and (b)(5) of this chapter.

(e) Label terms suggesting usefulness as low calorie or reduced calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, and in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if the claim is not false and misleading, and the food is labeled “low calorie” or “reduced calorie” or bears another comparative calorie claim in compliance with part 101 of this chapter and this section.

(2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body weight, e.g., “for low-sodium diets.”

(3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on foods.

(f) “Sugar free,” and “no added sugar.” Criteria for the use of the terms “sugar free” and “no added sugar” are provided for in § 101.60(c) of this chapter.

(a) The criteria set forth in subparts B, C, and D of this part prescribe the steps that manufacturers shall take under section 412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(2) and (b)(3)) in processing infant formula. If the processing of the formula does not comply with any regulation in subparts B, C, or D of this part, the formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act.

(b) The criteria set forth in subpart E of this part prescribe the requirements for quality factors that infant formula shall meet under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the formula fails to comply with any regulation in subpart E of this part, it will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act.

(c) The criteria set forth in subpart F of this part prescribe records requirements for quality factors under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act and for good manufacturing practices and quality control procedures, including distribution and audit records, under section 412(b)(2). If an infant formula manufacturer fails to comply with the quality factor record requirements in subpart F of this part with respect to an infant formula, the formula will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. If an infant formula manufacturer fails to comply with the good manufacturing practices or quality control procedures record requirements in subpart F of this part with respect to an infant formula, the infant formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. The criteria set forth in subpart F of this part also implement record retention requirements under section 412(b)(4) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart F of this part is a violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)).

(d) The criteria set forth in subpart G of this part describe, in part, certain good manufacturing practices, quality control procedures, and quality factor records requirements under section 412(b)(1) and (b)(2) of the Federal Food, Drug and Cosmetic Act. If an infant formula manufacturer fails to comply with such records requirements with respect to an infant formula, the infant formula will be deemed to be adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, and Cosmetic Act, as applicable. The criteria set forth in subpart G of this part also describe the circumstances in which an infant formula manufacturer is required to register with, submit to, or notify the Food and Drug Administration, and the content of a registration, submission, or notification, under section 412(c), (d), and (e) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart G of this part is a violation of section 301(s) of the Federal Food, Drug, and Cosmetic Act.

The definitions in this section and the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) shall apply to infant formula requirements in 21 CFR parts 106 and 107 of this chapter.

Eligible infant formula means an infant formula that could be lawfully distributed in the United States on December 8, 2014.

Final product stage means the point in the manufacturing process, before distribution of an infant formula, at which the infant formula is homogeneous and is not subject to further degradation due to processing.

Indicator nutrient means a nutrient whose concentration is measured during the manufacture of an infant formula to confirm complete addition and uniform distribution of a premix or other substance of which the indicator nutrient is a part.

Infant means a person not more than 12 months of age.

Infant formula means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

In-process production aggregate means a combination of ingredients at any point in the manufacturing process before packaging.

Major change in an infant formula means any new formulation, or any change of ingredients or processes where experience or theory would predict a possible significant adverse impact on levels of nutrients or bioavailability of nutrients, or any change that causes an infant formula to differ fundamentally in processing or in composition from any previous formulation produced by the manufacturer. Examples of infant formulas deemed to differ fundamentally in processing or in composition include:

(1) Any infant formula produced by a manufacturer who is entering the U.S. market;

(2) Any infant formula powder processed and distributed by a manufacturer who previously only produced liquids (or vice versa);

(3) Any infant formula having a significant revision, addition, or substitution of a macronutrient (i.e., protein, fat, or carbohydrate), with which the manufacturer has not had previous experience;

(4) Any infant formula manufactured on a new processing line or in a new plant;

(5) Any infant formula manufactured containing a new constituent not listed in section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)), such as taurine or L-carnitine;

(6) Any infant formula processed by a manufacturer on new equipment that utilizes a new technology or principle (e.g., from terminal sterilization to aseptic processing); or

(7) An infant formula for which there has been a fundamental change in the type of packaging used (e.g., changing from metal cans to plastic pouches).

Manufacturer means a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person.

Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance.

New infant formula means:

(1) An infant formula manufactured by a person that has not previously manufactured an infant formula, and

(2) An infant formula manufactured by a person that has previously manufactured infant formula and in which there is a major change in processing or formulation from a current or any previous formulation produced by such manufacturer, or which has not previously been the subject of a submission under section 412(c) of the Federal Food, Drug, and Cosmetic Act for the U.S. market.

Nutrient means any vitamin, mineral, or other substance or ingredient that is required in accordance with the “Nutrients” table set out in section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act or by regulations issued under section 412(i)(2) or that is identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or that has been identified as essential for infants by the Food and Drug Administration through a Federal Register publication.

Nutrient premix means a combination of ingredients containing two or more nutrients received from a supplier or prepared by an infant formula manufacturer.

Production aggregate means a quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, within specified limits, and is produced according to a master manufacturing order.

Production unit means a specific quantity of an infant formula produced during a single cycle of manufacture that has uniform composition, character, and quality, within specified limits.

Production unit number or production aggregate number means any distinctive combination of letters, numbers, symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a production aggregate or a production unit of infant formula can be determined.

Quality factors means those factors necessary to demonstrate the safety of the infant formula and the bioavailability of its nutrients, as prepared for market and when fed as the sole source of nutrition, to ensure the healthy growth of infants.

Representative sample means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.

Shall is used to state mandatory requirements.

(a) The regulations set forth in this subpart define the minimum current good manufacturing practices that are to be used in, and the facilities or controls that are to be used for, the manufacture, processing, packing, or holding of an infant formula. Compliance with these provisions is necessary to ensure that such infant formula provides the nutrients required under § 107.100 of this chapter and is manufactured in a manner designed to prevent its adulteration. A liquid infant formula that is a thermally processed low-acid food packaged in a hermetically sealed container is also subject to the regulations in part 113 of this chapter, and an infant formula that is an acidified food, as defined in § 114.3(b) of this chapter, is also subject to the regulations in part 114 of this chapter.

(b) The failure to comply with any regulation in this subpart in the manufacture, processing, packing, or holding of an infant formula shall render such infant formula adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)); the failure to comply with any regulation in part 113 of this chapter in the manufacture, processing, packing, or holding of a liquid infant formula shall render such infant formula adulterated under section 412(a)(3); and the failure to comply with any regulation in part 114 of this chapter in the manufacture, processing, packing, or holding of an infant formula that is an acidified food shall render such infant formula adulterated under section 412(a)(3).

(a) A manufacturer shall conform to the requirements of this subpart by implementing a system of production and in-process controls. This production and in-process control system shall cover all stages of processing, from the receipt and acceptance of the raw materials, ingredients, and components through the storage and distribution of the finished product and shall be designed to ensure that all the requirements of this subpart are met.

(b) The production and in-process control system shall be set out in a written plan or set of procedures that is designed to ensure that an infant formula is manufactured in a manner that will prevent adulteration of the infant formula.

(c) At any point, step, or stage in the production process where control is necessary to prevent adulteration, a manufacturer shall:

(1) Establish specifications to be met;

(2) Monitor the production and in-process control point, step, or stage;

(3) Establish a corrective action plan for use when a specification established in accordance with paragraph (c)(1) of this section is not met;

(4) Review the results of the monitoring required by paragraph (c)(2) of this section, and review and evaluate the public health significance of any deviation from specifications that have been established in accordance with paragraph (c)(1) of this section. For any specification established in accordance with paragraph (c)(1) of this section that a manufacturer fails to meet, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected article, to reprocess or otherwise recondition the affected article, or to approve and release the article for use or distribution; and

(5) Establish recordkeeping procedures, in accordance with § 106.100(e)(3), that ensure that compliance with the requirements of this section is documented.

(d) Any article that fails to meet a specification established in accordance with paragraph (c)(1) of this section shall be controlled under a quarantine system designed to prevent its use pending the completion of a documented review and material disposition decision.

(a) A manufacturer shall employ sufficient personnel, qualified by education, training, or experience, to perform all operations, including all required recordkeeping, in the manufacture, processing, packing, and holding of each infant formula and to supervise such operations to ensure that the operations are correctly and fully performed.

(b) Personnel working directly with infant formula, infant formula raw materials, infant formula packaging, or infant formula equipment or utensil contact surfaces shall practice good personal hygiene to protect the infant formula against contamination. Good personal hygiene includes:

(1) Wearing clean outer garments and, as necessary, protective apparel such as head, face, hand, and arm coverings; and

(2) Washing hands thoroughly in a hand washing facility with soap and running water at a suitable temperature before starting work, after each absence from the work station, and at any other time when the hands may become soiled or contaminated.

(c) Any person who reports that he or she has, or appears by medical examination or supervisory observation to have, an illness, open lesion (including boils, sores, or infected wounds), or any other source of microbial contamination that creates a reasonable possibility that the safety of an infant formula may be adversely affected, shall be excluded from direct contact with ingredients, containers, closures, in-process materials, equipment, utensils, and infant formula product until the condition is corrected or determined by competent medical personnel not to jeopardize the safety of the infant formula.

(a) Buildings used in the manufacture, processing, packing, or holding of infant formula shall be maintained in a clean and sanitary condition and shall have space for the separation of incompatible operations, such as the handling of raw materials, the manufacture of the product, and packaging and labeling operations.

(b) Separate areas or another system of separation, such as a computerized inventory control, a written card system, or an automated system of segregation, shall be used for holding raw materials, in-process materials, and final infant formula product at the following times:

(1) Pending release for use in infant formula production or pending release of the final product;

(2) After rejection for use in, or as, infant formula; and

(3) After release for use in infant formula production or after release of the final product.

(c) Lighting shall allow easy identification of raw materials, packaging, labeling, in-process materials, and finished products that have been released for use in infant formula production and shall permit the easy reading of instruments and controls necessary in processing, packaging, and laboratory analysis. Any lighting fixtures directly over or adjacent to exposed raw materials, in-process materials, or bulk (unpackaged) finished product shall be protected to prevent glass from contaminating the product in the event of breakage.

(d) A manufacturer shall provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate the infant formula; and shall minimize the potential for contamination of raw materials, in-process materials, final product infant formula, packing materials, and infant formula-contact surfaces, through the use of appropriate measures, which may include the use of air filtration.

(e) All rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents shall be stored and used in a manner that protects against contamination of infant formula.

(f) Potable water used in the manufacture of infant formula shall meet the standards prescribed in the Environmental Protection Agency's (EPA's) Primary Drinking Water regulations in 40 CFR part 141, except that the water used in infant formula manufacturing shall not be fluoridated or shall be defluoridated to a level as low as possible prior to use.

(1) The water shall be supplied under continuous positive pressure in a plumbing system that is free of defects that could contaminate an infant formula.

(2) A manufacturer shall test representative samples of the potable water drawn at a point in the system at which the water is in the same condition that it will be when it is used in infant formula manufacturing.

(3) A manufacturer shall conduct the tests required by paragraph (f)(2) of this section with sufficient frequency to ensure that the water meets the EPA's Primary Drinking Water Regulations but shall not conduct these tests less frequently than annually for chemical contaminants, every 4 years for radiological contaminants, and weekly for bacteriological contaminants.

(4) A manufacturer shall make and retain records, in accordance with § 106.100(f)(1), of the frequency and results of testing of the water used in the production of infant formula.

(g) There shall be no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for infant formula manufacturing.

(h) Only culinary steam shall be used at all direct infant formula product contact points. Culinary steam shall be in compliance with the 3-A Sanitary Standards, No. 60903, which is incorporated by reference at § 106.160. Boiler water additives in the steam shall be used in accordance with § 173.310 of this chapter.

(i) Each infant formula manufacturing site shall provide its employees with readily accessible toilet facilities and hand washing facilities that include hot and cold water, soap or detergent, single-service towels or air dryers in toilet facilities. These facilities shall be maintained in good repair and in a sanitary condition at all times. These facilities shall provide for proper disposal of the sewage. Doors to the toilet facility shall not open into areas where infant formula, ingredients, containers, or closures are processed, handled, or stored, except where alternate means have been taken to protect against contamination.

(a) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are of appropriate design and are installed to facilitate their intended function and their cleaning and maintenance.

(b) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are constructed so that surfaces that contact ingredients, in-process materials, or infant formula are made of nontoxic materials and are not reactive or absorptive. A manufacturer shall ensure that such equipment and utensils are designed to be easily cleanable and to withstand the environment of their intended use and that all surfaces that contact ingredients, in-process materials, or infant formula are cleaned and sanitized, as necessary, and are maintained to protect infant formula from being contaminated by any source. All sanitizing agents used on such equipment and utensils that are regulated as pesticide chemicals under 21 U.S.C. 346a(a) shall comply with the Environmental Protection Agency's regulations established under such section, and all other such sanitizers shall comply with all applicable Food and Drug Administration laws and regulations.

(c) A manufacturer shall ensure that any substance, such as a lubricant or a coolant, that is required for operation of infant formula manufacturing equipment and which would render the infant formula adulterated if such substance were to come in contact with the formula, does not come in contact with formula ingredients, containers, closures, in-process materials, or with infant formula product during the manufacture of an infant formula.

(d) A manufacturer shall ensure that each instrument used for measuring, regulating, or controlling mixing time and speed, temperature, pressure, moisture, water activity, or other parameter at any point, step, or stage where control is necessary to prevent adulteration of an infant formula during processing is accurate, easily read, properly maintained, and present in sufficient number for its intended use.

(1) The instruments and controls shall be calibrated against a known reference standard at the time of or before first use and thereafter at routine intervals, as specified in writing by the manufacturer of the instrument or control, or as otherwise deemed necessary to ensure the accuracy of the instrument or control. The known reference standard shall be certified for accuracy at the intervals specified in writing by the manufacturer of the instrument or control, or at routine intervals otherwise deemed necessary to ensure the accuracy of the instrument or control. A manufacturer shall make and retain records of the calibration activities in accordance with § 106.100(f)(2).

(2) Instruments and controls that cannot be adjusted to agree with the reference standard shall be repaired or replaced.

(3) If calibration of an instrument shows a failure to meet a specification for a point where control is deemed necessary to prevent adulteration of infant formula product, a written evaluation of all affected product, and of any actions that need to be taken with respect to that product, shall be made, in accordance with § 106.100(f)(2).

(e) The following provisions apply to thermal processing and cold storage of infant formulas:

(1) Equipment and procedures for thermal processing of infant formula packaged in hermetically sealed containers shall conform to the requirements in 21 CFR parts 108 and 113.

(2)(i) Except as provided in paragraph (e)(2)(ii) of this section, a manufacturer shall maintain all areas of cold storage at a temperature of 40 °F (4.4 °C) or below.

(ii) A manufacturer may maintain a cold storage area for an in-process infant formula or for a final infant formula at a temperature not to exceed 45 °F (7.2 °C) for a defined period of time provided that the manufacturer has scientific data and other information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product.

(3)(i) Cold storage compartments and thermal processing equipment shall be equipped with easily readable, accurate temperature-indicating devices.

(ii) A manufacturer shall ensure that the temperature of each cold storage compartment is maintained by:

(A) Monitoring the temperature of the cold storage compartment on a temperature-indicating device and recording this temperature in a record with such frequency as is necessary to ensure that temperature control is maintained;

(B) Equipping the cold storage compartment with one or more temperature-recording devices that will reflect, on a continuing basis, the true temperature, within the compartment;

(C) Equipping the cold storage compartment with a high temperature alarm that has been validated to function properly and recording the temperature in a record with such frequency as is necessary to ensure that temperature control is maintained; or

(D) Equipping the cold storage compartment with a maximum-indicating thermometer that has been validated to function properly and recording this temperature in a record with such frequency as is necessary to ensure that temperature control is maintained.

(iii) A manufacturer shall, in accordance with § 106.100(f)(3), make and retain records of the temperatures recorded in compliance with § 106.30(e)(3)(ii).

(4) When a manufacturer uses a temperature-recording device for a cold storage compartment, such device shall not read lower than the reference temperature-indicating device.

(5) A manufacturer shall monitor the temperature in thermal processing equipment at points where temperature control is necessary to prevent adulteration. Such monitoring shall be at such frequency as is required by regulation or is necessary to ensure that temperature control is maintained.

(f) A manufacturer shall ensure that equipment and utensils used in the manufacture of infant formula are cleaned, sanitized, and maintained at regular intervals to prevent adulteration of the infant formula.

(1) An individual qualified by education, training, or experience to conduct such a review shall review all cleaning, sanitizing, and maintenance to ensure that it has been satisfactorily completed.

(2) A manufacturer shall make and retain records on equipment cleaning, sanitizing, and maintenance, in accordance with § 106.100(f)(4).

(g) A manufacturer shall ensure that compressed air or other gases that are mechanically introduced into infant formula, that are used to clean any equipment, or that come into contact with any other surface that contacts ingredients, in-process materials, or infant formula product are treated in such a way that their use will not contaminate the infant formula with unlawful or other chemical, physical, or microbiological contaminants. When compressed gases are used at product filling machines to replace air removed from the headspace of containers, a manufacturer shall install, as close as practical to the end of the gas line that feeds gas into the space, a filter capable of retaining particles 0.5 micrometer or smaller.

(a) For the purposes of this section:

(1) “Hardware” means all automatic equipment, including mechanical and electronic equipment (such as computers), that is used in production or quality control of infant formula.

(2) “Software” means any programs, procedures, rules, and associated documentation used in the operation of a system.

(3) “System” means a collection of components (including software and hardware) organized to accomplish a specific function or set of functions in a specified environment.

(4) “Validation” means establishing documented evidence that provides a high degree of assurance that a system will consistently produce a product meeting its predetermined specifications and quality characteristics. Validation can be accomplished through any suitable means, such as verification studies or modeling.

(b) All systems shall be designed, installed, tested, and maintained in a manner that will ensure that they are capable of performing their intended function and of producing or analyzing infant formula in accordance with this subpart and subpart C of this part.

(1) A manufacturer shall ensure, at any point, step, or stage where control is necessary to prevent adulteration of the infant formula, that all hardware is routinely inspected and checked according to written procedures and that hardware that is capable of being calibrated is routinely calibrated according to written procedures.

(2) A manufacturer shall check and document the accuracy of input into, and output generated by, any system used in the production or quality control of an infant formula to ensure that the infant formula is not adulterated. The degree and frequency of input/output verification shall be based on the complexity and reliability of the system and the level of risk associated with the safe operation of the system.

(3) A manufacturer shall ensure that each system is validated prior to the release for distribution of any infant formula manufactured using the system.

(4) A manufacturer shall ensure that any system that is modified is revalidated following the modification and prior to the release for distribution of any infant formula manufactured using the modified system. All modifications to software shall be made by a designated individual and shall be checked by the infant formula manufacturer to ensure that infant formula that is produced or analyzed using the modified software complies with this subpart and with subpart C of this part.

(c) A manufacturer shall make and retain records, in accordance with § 106.100(f)(5), concerning mechanical or electronic equipment.

(a) The only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe (GRAS) for such use, or is authorized by a prior sanction.

(b) Infant formula containers and closures shall not be reactive or absorptive so as to affect the safety of the infant formula. The following substances may be used as packaging material that comes in contact with an infant formula:

(1) A food additive that is the subject of a regulation issued under section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) and is used consistent with the conditions of use of that regulation;

(2) A food contact substance that is the subject of an effective notification under section 409(h) of the Federal Food, Drug, and Cosmetic Act and is used consistent with the conditions of use in that notification;

(3) A substance that is exempt from regulation as a food additive under § 170.39 of this chapter and its use conforms to the use identified in the exemption letter;

(4) A substance that is generally recognized as safe for use in or on infant formula or for use in infant formula packaging;

(5) A substance the use of which is authorized by a prior sanction from the Food and Drug Administration or from the U.S. Department of Agriculture; and

(6) A substance that is not a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) because the substance is not reasonably expected to become a component of food or otherwise affect the characteristics of food.

(c) Ingredients, containers, and closures used in the manufacture of infant formula shall be identified with a lot number to be used in recording their disposition.

(d) A manufacturer shall develop written specifications for ingredients, containers, and closures used in manufacturing infant formula and shall develop and follow written procedures to determine whether all ingredients, containers, and closures meet these specifications. When any specification is not met, an individual qualified by education, training, or experience shall conduct a documented review, shall determine whether a failure to meet such a specification could result in an adulterated infant formula, and shall make and document a material disposition decision to reject the ingredient, container, or closure or the affected infant formula; to reprocess or otherwise recondition the ingredient, container, or closure or the affected infant formula; or to approve and release the ingredient, container, or closure or the affected infant formula for use.

(e) Ingredients, containers, and closures shall be stored in separate areas or separated by a system of segregation, such as a computerized inventory control, a written card system, or an automated system of segregation, clearly designated for materials pending release for use; materials released for use; or materials rejected for use in infant formula production.

(1) Any lot of an ingredient, a container, or a closure that does not meet the manufacturer's specifications shall be quarantined under a system designed to prevent its use in the manufacture of infant formula until an individual qualified by education, training, or experience has conducted a documented review, has determined whether such failure could result in an adulterated infant formula, and has made and documented a material disposition decision to reject the ingredient, container, closure, or the affected infant formula; to reprocess or otherwise recondition the ingredient, container, closure, or the affected infant formula; or to approve and release the ingredient, container, closure, or the affected infant formula for use.

(2) Any ingredient, container, or closure that has been reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use.

(3) A manufacturer shall not reprocess or otherwise recondition an ingredient, container, or closure rejected because it is contaminated with microorganisms of public health significance or other contaminants, such as heavy metals.

(f) If an ingredient, container, or closure that complies with a manufacturer's specifications, or that has been released for use following a material review and disposition decision, is subsequently exposed to air, heat, or other conditions that may adversely affect it, or if a manufacturer reasonably believes that an ingredient, container, or closure that complies with a manufacturer's specifications, or that has been released for use following a material review and disposition decision, has been exposed to air, heat, or other conditions that may adversely affect it, the ingredient, container, or closure shall be quarantined under a system designed to prevent its use in the manufacture of infant formula until an individual qualified by education, training, or experience has conducted a documented review and has made and documented a material disposition decision to reject the ingredient, container, or closure; to reprocess or otherwise recondition the ingredient, container, or closure; or to approve and release the ingredient, container, or closure for use.

(1) Any ingredient, container, or closure that is reprocessed or otherwise reconditioned shall be retested or reexamined and be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether the ingredient, container, or closure should be rejected, further reprocessed or otherwise further reconditioned, or approved and released for use.

(2) Any rejected ingredient, container, or closure shall be clearly identified as having been rejected for use in infant formula manufacturing or processing operations and shall be controlled under a quarantine system designed to prevent its use in infant formula manufacturing or processing operations.

(3) Any ingredient, container, or closure that has not been manufactured, packaged, labeled, or held under conditions to prevent adulteration under section 402(a)(1) through (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved and released for use.

(g) A manufacturer shall make and retain records, in accordance with § 106.100(f)(6), on the ingredients, containers, and closures used in the manufacture of infant formula.

(a) A manufacturer shall prepare and follow a written master manufacturing order that establishes controls and procedures for the production of an infant formula.

(1) The manufacturer shall make and retain records, in accordance with § 106.100(e), that include complete information relating to the production and control of the production aggregate. An individual qualified by education, training, or experience shall conduct an investigation of any deviations from the master manufacturing order and document any corrective action taken.

(2) Changes made to the master manufacturing order shall be reviewed and approved by a responsible official and include an evaluation of the effect of the change on the nutrient content and the suitability of the formula for infants.

(b) A manufacturer shall establish controls to ensure that each raw or in-process ingredient required by the master manufacturing order is examined by one person and checked by a second person or system. This checking shall ensure that the correct ingredient is added during the manufacturing process, that the ingredient has been released for use in infant formula, and that the correct weight or measure of the ingredient is added to the production unit.

(c) A manufacturer shall establish a system of identification for the contents of all compounding and storage containers, processing lines, and major equipment used during the manufacture of a production aggregate of an infant formula. The system shall permit the identification of the processing stage and the unique identification number for the particular production unit or production aggregate of infant formula.

(d) A manufacturer shall establish controls to ensure that the nutrient levels required by § 107.100 of this chapter are maintained in the formula, and that the formula is not contaminated with microorganisms or other contaminants. Such controls shall include:

(1) The mixing time; the speed, temperature, and flow rate of product; and other critical parameters necessary to ensure the addition of required ingredients to, and the homogeneity of, the formula;

(2) The spray-drying process for powdered infant formula, including the filtering of the intake air before heating, to prevent microbial and other contamination;

(3) The removal of air from the finished product to ensure that nutrient deterioration does not occur;

(4) Ensuring that each container of finished product is properly sealed. Such controls shall involve use of established procedures, specifications, and intervals of examination that are designed by qualified individuals and are sufficient to:

(i) Detect visible closure or seal defects, and

(ii) Determine closure strength through destructive testing. A manufacturer of a liquid infant formula that is a thermally processed low-acid food packaged in a hermetically sealed container shall perform such closure integrity testing in accordance with § 113.60(a) of this chapter.

(e) A manufacturer shall establish controls that ensure that the equipment used at points where control is deemed necessary to prevent adulteration is monitored, so that personnel will be alerted to malfunctions.

(f) A manufacturer shall establish controls for in-process material as follows:

(1) For any specification established in accordance with § 106.6(c)(1) that a manufacturer fails to meet for in-process material, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected in-process material, to reprocess or otherwise recondition the affected in-process material, or to approve and release the affected in-process material for use or distribution;

(2) Pending a documented review and material disposition decision, any in-process material that fails to meet any specification established in accordance with § 106.6(c)(1) shall be clearly identified as such and shall be controlled under a quarantine system designed to prevent its use in manufacturing or processing operations until completion of the documented review and material disposition decision;

(3) Any in-process material that has been reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use; and

(4) Any rejected in-process material shall be clearly identified as having been rejected for use in infant formula and shall be controlled under a quarantine system designed to prevent its use in infant formula manufacturing or processing operations.

(a) A manufacturer of infant formula shall establish a system of process controls covering all stages of processing that is designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.

(b) A manufacturer of liquid infant formula shall comply, as appropriate, with the procedures specified in part 113 of this chapter for thermally processed low-acid foods packaged in hermetically sealed containers and part 114 of this chapter for acidified foods.

(c) A manufacturer of powdered infant formula shall test representative samples of each production aggregate of powdered infant formula at the final product stage, before distribution, to ensure that each production aggregate meets the microbiological quality standards in the table in paragraph (e) of this section.

(d) A manufacturer shall make and retain records, in accordance with § 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas for microorganisms.

(e) A powdered infant formula that contains any microorganism that exceeds the M value listed for that microorganism in the table in paragraph (e) of this section shall be deemed adulterated under sections 402(a)(1), 402(a)(4), and 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)). The Food and Drug Administration will determine compliance with the M values listed below using the latest edition of the Bacteriological Analytical Manual (BAM) (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm) (accessed April 8, 2013).

(a) A manufacturer shall examine packaged and labeled infant formula during finishing operations to ensure that all containers and packages in the production aggregate have the correct label, the correct use-by date, and the correct code established under § 106.80.

(b) Labels shall be designed, printed, and applied so that the labels remain legible and attached during the conditions of processing, storage, handling, distribution, and use.

(c) Packaging used to hold multiple containers of an infant formula product shall be labeled as follows:

(1) Where all containers are the same infant formula product and all bear the same code established under § 106.80, the packaging label shall include the product name, the name of the manufacturer, distributor, or shipper, and the code established under § 106.80.

(2) Where the containers are not the same infant formula product or do not all bear the same code established under § 106.80, the packaging label shall:

(i) Include the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and a “use by” date that is no later than the “use by” date of the container exhibiting the closest “use by” date applied to satisfy the requirement of § 107.20(c) of this chapter; or

(ii) Include a unique identification number assigned by the packager, provided that the distributor of the package maintains a record linked to such unique number that identifies the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and the “use by” date for each product applied to satisfy the requirement of § 107.20(c) of this chapter.

(a) A manufacturer shall control under a quarantine system designed to prevent use or distribution of each production aggregate of infant formula until it determines that the production aggregate meets all of the manufacturer's specifications, including those adopted to meet the standards of § 106.55 on microbiological contamination and of § 106.91(a) on quality control procedures, or until the documented review of the failure to meet any of the manufacturer's specifications finds that the failure does not result in, or could not lead to, adulteration of the product.

(b) Any production aggregate of infant formula that fails to meet any of the manufacturer's specifications shall be quarantined under a system designed to prevent its use in the manufacture of infant formula or its distribution until an individual qualified by education, training, or experience has conducted a documented review and has made and documented a material disposition decision to reject the infant formula; to reprocess or otherwise recondition the infant formula; or to approve and release the infant formula. Any production aggregate of infant formula that is reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use or distribution.

(c) Any rejected infant formula shall be clearly identified as having been rejected for use and shall be controlled under a quarantine system designed to prevent its release or distribution.

(d) A production aggregate of infant formula, including a reprocessed or reconditioned production aggregate, that does not meet the nutrient requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) or that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration under sections 402(a)(1) through (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved and released for distribution.

Each production aggregate of infant formula shall be coded with a sequential number that identifies the product and the establishment where the product was packed and that permits tracing of all stages of manufacture of that production aggregate, including the year, the days of the year, and the period during those days that the product was packed, and the receipt and handling of raw materials used.

(a) A manufacturer of an infant formula, or an agent of such manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the current good manufacturing practice regulations in this subpart. Such audits shall be conducted at a frequency that is required to ensure compliance with such regulations.

(b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the Agency's regulations concerning current good manufacturing practice that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit.

(a) During manufacture, a manufacturer shall test each production aggregate for nutrients as follows:

(1) Each nutrient premix used in the manufacture of an infant formula shall be tested for each nutrient (required under § 107.100 of this chapter or otherwise added by the manufacturer) that the manufacturer is relying on the premix to provide, to ensure that the premix is in compliance with the manufacturer's specifications;

(2) During the manufacturing process, after the addition of the premix, or at the final product stage but before distribution, each production aggregate of infant formula shall be tested for at least one indicator nutrient for each of the nutrient premixes used in the infant formula to confirm that the nutrients supplied by each of the premixes are present, in the proper concentration, in the production aggregate of infant formula.

(3) At the final product stage, before distribution of an infant formula, each production aggregate shall be tested for vitamins A, C, E, and thiamin.

(4) During the manufacturing process or at the final product stage, before distribution, each production aggregate shall be tested for all nutrients required to be included in such formula under § 107.100 of this chapter for which testing is not conducted for compliance with paragraphs (a)(1) or (a)(3) of this section and for any nutrient added by the manufacturer for which testing is not conducted for compliance with paragraph (a)(1) of this section.

(b) A manufacturer shall test each production aggregate of finished product for nutrients as follows:

(1)(i) For an infant formula that is a new infant formula the manufacturer shall collect, from each manufacturing site and at the final product stage, a representative sample of the first production aggregate of packaged, finished formula in each physical form (powder, ready-to-feed, or concentrate) and evaluate the levels of all nutrients required under § 107.100 of this chapter and all other nutrients added by the manufacturer. The manufacturer shall repeat such testing every 4 months thereafter throughout the shelf life of the product.

(ii) The Food and Drug Administration will exempt the manufacturer from the requirements of paragraph (b)(1)(i) of this section if the manufacturer of a new infant formula requests an exemption and provides analytical data, as required under § 106.120(b)(7), that demonstrates that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. A manufacturer exempt from the requirements of paragraph (b)(1)(i) of this section would be required to test the first production aggregate according to the requirements of § 106.91(b)(2).

(2) The manufacturer shall collect, from each manufacturing site and at the final product stage, a representative sample of each subsequent production aggregate of packaged, finished formula in each physical form (powder, ready-to-feed, or concentrate) and evaluate the levels of all nutrients required under § 107.100 of this chapter and all other nutrients added by the manufacturer. The manufacturer shall repeat such testing at the end of the shelf life of the product.

(3) If the results of the testing required by paragraph (b)(1) of this section do not substantiate the shelf life of the infant formula, the manufacturer shall address, as appropriate, all production aggregates of formula released and pending release for distribution that are implicated by the testing results, such as by conducting the testing required by paragraph (b)(1) of this section on a subsequently produced production aggregate to substantiate the shelf life of the infant formula or revising the use by date for such product so that such date is substantiated by the stability testing results.

(4) If results of the testing required by paragraph (b)(2) of this section show that any required nutrient is not present in the production aggregate of infant formula at the level required by § 107.100 of this chapter or that any nutrient added by the manufacturer is not present at the level declared on the label of the production aggregate of infant formula, the manufacturer shall:

(i) Investigate the cause of such variance in the level of any required or added nutrient;

(ii) Evaluate the significance, if any, of the results for other production aggregates of the same formula that have been released for distribution;

(iii) Address, as appropriate, all production aggregates of formula released and pending release for distribution that are implicated by the testing results; and

(iv) Determine whether it is necessary to conduct the testing required by paragraph (b)(1) of this section.

(5) The testing required by paragraphs (b)(1) and (b)(2) of this section is not required to evaluate the level of minerals present in the infant formula.

(c) All quality control testing shall be conducted using appropriate, scientifically valid test methods.

(d) A manufacturer shall make and retain quality control records in accordance with § 106.100(e)(5)(i).

(a) A manufacturer of an infant formula, or an agent of such a manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the requirements for quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with section 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b) and (i)) and is manufactured in a manner designed to prevent adulteration of the infant formula under section 412(a)(1) and (a)(3) of the Federal Food, Drug, and Cosmetic Act. Such audits shall be conducted at a frequency that is required to ensure compliance with the requirements for quality control procedures.

(b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the regulations concerning quality control procedures that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit.

(a) A manufacturer shall develop and follow a written audit plan that is available at the manufacturing facility for Food and Drug Administration inspection.

(b) The audit plan shall include audit procedures that set out the methods the manufacturer uses to determine whether the facility is operating in accordance with current good manufacturing practice, with the quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with sections 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act, and in a manner designed to prevent adulteration of the infant formula.

(c) The audit procedures shall include:

(1) An evaluation of the production and in-process control system established under § 106.6(b) by:

(i) Observing the production of infant formula and comparing the observed process to the written production and in-process control plan required under § 106.6(b);

(ii) Reviewing records of the monitoring of points, steps, or stages where control is deemed necessary to prevent adulteration; and

(iii) Reviewing records of how deviations from any specification at points, steps, or stages where control is deemed necessary to prevent adulteration were handled; and

(2) A review of a representative sample of all records maintained in accordance with § 106.100(e) and (f).

The regulations set forth in this subpart define the minimum requirements for quality factors for infant formulas:

(a) An infant formula shall meet the quality factor of normal physical growth.

(b) A manufacturer of an infant formula that is not an eligible infant formula shall demonstrate that a formula supports normal physical growth in infants when fed as a sole source of nutrition by conducting, in accordance with good clinical practice, an adequate and well-controlled growth monitoring study of the infant formula that:

(1) Is no less than 15 weeks in duration, enrolling infants no more than 2 weeks old at time of entry into the study;

(2) Includes the collection and maintenance of data on formula intake and anthropometric measures of physical growth, including body weight, recumbent length, head circumference, average daily weight increment, and average daily recumbent length increment;

(3) Includes anthropometric measurements made at the beginning and end of the study, and at least four additional measurements made at intermediate time points with three of the six total measurements made within the first 4 weeks of the study and three measurements made at approximately 4-week intervals over the remaining 11 weeks of the study;

(4) Compares the anthropometric data for the test group to a concurrent control group or groups at each time point and compares the anthropometric data for each infant (body weight for age, body length for age, head circumference for age, and weight for length) in the test group and the control group to the 2009 CDC growth charts, which are incorporated by reference at § 106.160; and

(5) Compares the data on formula intake of the test group with a concurrent control group or groups and a scientifically appropriate reference.

(c) The Food and Drug Administration will exempt a manufacturer from the requirements of paragraph (b) of this section, if:

(1) The manufacturer requests an exemption and provides assurances, as required under § 106.121(b), that the changes made by the manufacturer to an existing infant formula are limited to changing the type of packaging of an existing infant formula (e.g., changing from metal cans to plastic pouches); or

(2) The manufacturer requests an exemption and provides assurances, as required under § 106.121, which demonstrate that:

(i) An alternative method or study design that is based on sound scientific principles is available to show that the formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition;

(ii) The change made by the manufacturer to an existing formula does not affect the ability of the formula to support normal physical growth; or

(iii) The manufacturer markets a formulation in more than one form (e.g., liquid and powdered forms) and the quality factor requirements are met by the form of the formula that is processed using the method that has the greatest potential for adversely affecting nutrient content and bioavailability.

(d) A manufacturer of a new infant formula that is not an eligible infant formula shall, in accordance with § 106.100(p)(1), make and retain records demonstrating that the formula meets the quality factor of normal physical growth.

(e) An infant formula shall meet the quality factor of sufficient biological quality of protein.

(f) A manufacturer of an infant formula that is not an eligible infant formula shall demonstrate that a formula meets the quality factor of sufficient biological quality of protein by establishing the biological quality of the protein in the infant formula when fed as the sole source of nutrition using an appropriate modification of the Protein Efficiency Ratio (PER) rat bioassay described in the “Official Methods of Analysis of AOAC International,” 18th ed., sections 45.3.04 and 45.3.05, “AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay,” which is incorporated by reference at § 106.160. The PER rat bioassay shall be conducted on a formula and the results evaluated prior to the initiation of a growth monitoring study of the formula that is required under paragraph (b) of this section.

(g) The Food and Drug Administration will exempt a manufacturer from the requirements of paragraph (f) of this section, if:

(1) The manufacturer requests an exemption and provides assurances as required under § 106.121(g) that the changes made by the manufacturer to an existing infant formula are limited to changing the type of packaging of an existing infant formula (e.g., changing from metal cans to plastic pouches); or

(2) The manufacturer requests an exemption and provides assurances, as required under § 106.121(h), that demonstrate that the change made by the manufacturer to an existing formula does not affect the bioavailability of the protein.

(3) The manufacturer requests an exemption and provides assurances, as required under § 106.121(i), that demonstrate that an alternative method to the PER that is based on sound scientific principles is available to demonstrate that the formula supports the quality factor for the biological quality of the protein.

(h) A manufacturer of a new infant formula that is not an eligible infant formula shall, in accordance with § 106.100(q), make and retain records demonstrating that the formula meets the quality factor of sufficient biological quality of protein.

(i) The following provisions for requirements for quality factors apply only to an “eligible infant formula” as defined in § 106.3:

(1) An eligible infant formula that fulfills one or more of the following criteria meets the quality factor of normal physical growth:

(i) The scientific evidence on such infant formula meets the requirements of paragraph (b) of this section that apply to infant formula that is not an eligible infant formula;

(ii) The scientific evidence on such infant formula meets the following provisions:

(A) The evidence is an adequate and well-controlled growth study, conducted in accordance with good clinical practice, to determine whether an infant formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition;

(B) The growth study is no less than 4 months in duration, enrolling infants no more than 1 month old at time of entry into the study;

(C) The growth study collects from the study subjects data on anthropometric measures of physical growth, including body weight, recumbent length, head circumference, and average daily weight increment, and plots the data on the following charts from “Physical Growth: National Center for Health Statistics Percentiles” for body weight, body length, and head circumference, which are incorporated by reference at § 106.160:

(1) Figure 1. Length by age percentiles for girls aged birth-36 months (p. 609);

(2) Figure 2. Length by age percentiles for boys aged birth-36 months (p. 610);

(3) Figure 3. Weight by age percentiles for girls aged birth-36 months (p. 611);

(4) Figure 4. Weight by age percentiles for boys aged birth-36 months (p. 612);

(5) Figure 5. Head circumference by age percentiles for girls aged birth-36 months (p. 613);

(6) Figure 6. Weight by length percentiles for girls aged birth-36 months (p. 613);

(7) Figure 7. Head circumference by age percentiles for boys aged birth-36 months (p. 614); and

(8) Figure 8. Weight by length percentiles for boys aged birth-36 months (p. 614); and

(D) The growth study collects anthropometric measurements at the beginning of the growth study, at 2 weeks, at 4 weeks, at least monthly thereafter, and at the conclusion of the study; or

(iii) The scientific evidence on such infant formula otherwise demonstrates that such formula supports normal physical growth.

(2) An eligible infant formula that fulfills one or more of the following criteria meets the quality factor of sufficient biological quality of the protein:

(i) The scientific evidence on such infant formula meets the requirements of paragraph (f) of this section that apply to infant formula that is not an eligible infant formula;

(ii) The scientific evidence on such infant formula is a study that establishes the biological quality of the protein in an infant formula by demonstrating that the protein source supports adequate growth using the Protein Efficiency Ratio (PER) rat bioassay described in sections 45.3.04 and 45.3.05 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 16th ed., which are incorporated by reference at § 106.160; or

(iii) The scientific evidence on such infant formula otherwise demonstrates that the protein in such infant formula is of sufficient biological quality.

(3) The manufacturer of an eligible infant formula may, not later than November 12, 2015, submit a petition to the Food and Drug Administration under § 10.30 of this chapter that:

(i) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(1) of this section; or

(ii) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(2) of this section.

(4) A petition filed under paragraph (i)(3) of this section shall address only one infant formula formulation and shall contain all data and information relied upon by the manufacturer to demonstrate that such formulation fulfills one or more of the criteria in paragraph (i)(1) or in paragraph (i)(2) of this section. A manufacturer may combine petitions submitted under paragraphs (i)(3)(i) and (i)(3)(ii) of this section that relate to the same formulation.

(5) The manufacturer of each eligible infant formula shall make and retain, in accordance with § 106.100(p)(2), records to demonstrate that such formula supports normal physical growth in infants when fed as the sole source of nutrition and shall make and retain, in accordance with § 106.100(q)(2), records to demonstrate that that the protein in such infant formula is of sufficient biological quality. The records required by this paragraph shall include all relevant scientific data and information and a narrative explanation of why the data and information demonstrate that the formula supports normal physical growth and a narrative explanation of why the data and information demonstrate that the protein in such infant formula is of sufficient biological quality.

(a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the Food and Drug Administration to determine whether each manufacturer is in compliance with section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a)).

(b) The manufacturer shall maintain all records that pertain to food-packaging materials subject to § 174.5 of this chapter and that bear on whether such materials would cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)).

(c) The manufacturer shall maintain all records that pertain to nutrient premix testing that it generates or receives. Such records shall include, but are not limited to:

(1) Any results of testing conducted to ensure that each nutrient premix is in compliance with the premix certificate and guarantee and specifications that have been provided to the manufacturer by the premix supplier, including tests conducted when nutrients exceed their expiration date or shelf life (retest date).

(2) All certificates and guarantees given by premix suppliers concerning the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act and § 107.100 of this chapter.

(d) The premix supplier shall maintain the results of all testing conducted to provide all certificates and guarantees concerning nutrient premixes for infant formulas. Such records shall include but are not limited to:

(1) The results of tests conducted to determine the purity of each nutrient required by section 412(i) of the Federal Food, Drug, and Cosmetic Act or § 107.100 of this chapter and any other nutrient listed in the certificate and guarantee;

(2) The weight of each nutrient added;

(3) The results of any quantitative tests conducted to determine the amount of each nutrient certified or guaranteed; and

(4) The results of any quantitative tests conducted to identify the nutrient levels present when nutrient premixes exceed their expiration date or shelf life (retest date).

(e) For each production aggregate of infant formula, a manufacturer shall prepare and maintain records that include complete information relating to the production and control of the production aggregate. These records shall include:

(1) The master manufacturing order. The master manufacturing order shall include:

(i) The significant steps in the production of the production aggregate and the date on which each significant step occurred;

(ii) For a manufacturing facility that has more than one set of equipment or more than one processing line, the identity of equipment and processing lines for which the manufacturer has identified points, steps, or stages in the production process where control is necessary to prevent adulteration;

(iii) The identity of each lot of ingredients, containers, and closures used in producing the production aggregate of formula;

(iv) The amount of each ingredient to be added to the production aggregate of infant formula and a check (verification) that the correct amount was added; and

(v) A copy of each infant formula label used on a finished production aggregate of infant formula and the results of examinations conducted during the finishing operations to provide assurance that the containers and packages have the correct label.

(2) Any deviations from the master manufacturing order and any corrective actions taken because of the deviations.

(3) Documentation, in accordance with § 106.6(c), of the monitoring at any point, step, or stage in the manufacturer 's production process where control is deemed necessary to prevent adulteration. These records shall include:

(i) A list of the specifications established at each point, step, or stage in the production process where control is deemed necessary to prevent adulteration, in accordance with § 106.6(c)(1), including documentation of the scientific basis for each specification;

(ii) The actual values obtained during the monitoring operation, any deviations from established specifications, and any corrective actions taken; and

(iii) Identification of the person monitoring each point, step, or stage in the production process where control is deemed necessary to prevent adulteration.

(4) The conclusions and followup, along with the identity of the individual qualified by education, training, or experience who investigated:

(i) Any deviation from the master manufacturing order and any corrective actions taken;

(ii) A finding that a production aggregate or any of its ingredients failed to meet the infant formula manufacturer's specifications; and

(iii) A failure to meet any specification at any point, step, or stage in the production process where control is deemed necessary to prevent adulteration.

(5) The results of all testing performed on the production aggregate of infant formula, including testing on the in-process production aggregate, at the final product stage, and on finished product throughout the shelf life of the product. The results recorded shall include:

(i) The results of all quality control testing conducted in accordance with § 106.91(a) and (b) to verify that each nutrient required by § 107.100 of this chapter is present in each production aggregate of infant formula at the level required by § 107.100 of this chapter, and that all other nutrients added by the manufacturer are present at the appropriate level. The record of the results of the quality control testing shall include:

(A) A summary document identifying the stages of the manufacturing process at which the nutrient analysis for each required nutrient is conducted as required under § 106.91(a); and

(B) A summary document on the stability testing program conducted under § 106.91(b), including the nutrients tested and the frequency of nutrient testing throughout the shelf life of the product.

(ii) For powdered infant formula, the results of any testing conducted in accordance with § 106.55(c) to verify compliance with the microbiological quality standards in § 106.55(e).

(f) A manufacturer shall make and retain all records described in subparts B and C of this part, including:

(1) Records, in accordance with § 106.20(f)(4), of the frequency and results of testing of the water used in the production of infant formula;

(2) Records, in accordance with § 106.30(d), of accuracy checks of instruments and controls. A certification of accuracy of any known reference standard used and a history of recertification shall be maintained. At a minimum, such records shall specify the instrument or control being checked, the date of the accuracy check, the standard used, the calibration method used, the results found, any actions taken if the instrument is found to be out of calibration, and the initials or name of the individual performing the test. If calibration of an instrument shows that a specification at a point, step, or stage in the production process where control is deemed necessary to prevent adulteration has not been met, a written evaluation of all affected product, and any actions that need to be taken with respect to that product, shall be made.

(3) Records, in accordance with § 106.30(e)(3)(iii).

(4) Records, in accordance with § 106.30(f), on equipment cleaning, sanitizing, and maintenance that show the date and time of such cleaning, sanitizing, and maintenance and the production aggregate number of each infant formula processed between equipment startup and shutdown for cleaning, sanitizing, and maintenance. The person performing and checking the cleaning, sanitizing, and maintenance shall date and sign or initial the record indicating that the work was performed.

(5) Records, in accordance with § 106.35(c), on all mechanical and electronic equipment used in the production or quality control of infant formula. These records shall include:

(i) A list of all systems used with a description of the computer files and the defined capabilities and inherent limitations of each system;

(ii) A copy of all software used;

(iii) Records that document installation, calibration, testing or validation, and maintenance of the systems used;

(iv) A list of all persons authorized to create or modify software;

(v) Records that document modifications to software, including the identity of the person who modified the software;

(vi) Records that document retesting or revalidation of modified systems; and

(vii) A backup file of data entered into a computer or related system. The backup file shall consist of a hard copy or alternative system, such as duplicate electronic records, tapes, or microfilm, designed to ensure that backup data are exact and complete, and that they are secure from alteration, inadvertent erasures, or loss.

(6) Records, in accordance with § 106.40(g), on ingredients, containers, and closures used in the manufacture of infant formula. These records shall include:

(i) The identity and quantity of each lot of ingredients, containers, and closures;

(ii) The name of the supplier;

(iii) The supplier's lot numbers;

(iv) The name and location of the manufacturer of the ingredient, container, or closure, if different from the supplier;

(v) The date of receipt;

(vi) The receiving code as specified; and

(vii) The results of any test or examination (including retesting and reexamination) performed on the ingredients, containers, or closures and the conclusions derived there from and the disposition of all ingredients, containers, or closures.

(7) A full description of the methodology used to test powdered infant formula to verify compliance with the microbiological quality standards of § 106.55(c) and the methodology used to do quality control testing, in accordance with § 106.91(a).

(g) A manufacturer shall maintain all records pertaining to distribution of the infant formula, including records that show that formula produced for export only is exported. Such records shall include all information and data necessary to effect and monitor recalls of the manufacturer's infant formula products in accordance with subpart E of part 107 of this chapter.

(h) The manufacturer shall maintain all records pertaining to the microbiological quality and purity of raw materials and finished powdered infant formula.

(i) [Reserved]

(j) The manufacturer shall make and retain records pertaining to regularly scheduled audits, including the audit plans and procedures, the findings of the audit, and a listing of any changes made in response to these findings. The manufacturer shall make readily available for authorized inspection the audit plans and procedures and a statement of assurance that the regularly scheduled audits are being conducted. The findings of the audit and any changes made in response to these findings shall be maintained for the time period required under paragraph (n) of this section, but need not be made available to the Food and Drug Administration.

(k) The manufacturer shall maintain procedures describing how all written and oral complaints regarding infant formula will be handled. The manufacturer shall follow these procedures and shall include in them provisions for the review of any complaint involving an infant formula and for determining the need for an investigation of the possible existence of a hazard to health.

(1) For purposes of this section, every manufacturer shall interpret a “complaint” as any communication that contains any allegation, written or oral, expressing dissatisfaction with a product for any reason, including concerns about the possible existence of a hazard to health and about appearance, taste, odor, and quality. Correspondence about prices, package size or shape, or other matters that could not possibly reveal the existence of a hazard to health shall not, for compliance purposes, be considered a complaint and therefore need not be made available to a Food and Drug Administration investigator.

(2) When a complaint shows that a hazard to health possibly exists, the manufacturer shall conduct an investigation into the validity of the complaint. Where such an investigation is conducted, the manufacturer shall include in its file on the complaint the determination as to whether a hazard to health exists and the basis for that determination. No investigation is necessary when the manufacturer determines that there is no possibility of a hazard to health. When no investigation is necessary, the manufacturer shall include in the record the reason that an investigation was found to be unnecessary and the name of the responsible person making that determination.

(3) When there is a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant's death, the manufacturer shall, within 15 days of receiving such information, conduct an investigation and notify the Agency as required in § 106.150.

(4) The manufacturer shall maintain in designated files all records pertaining to the complaints it receives. The manufacturer shall separate the files into two classes:

(i) Those complaints that allege that the infant became ill from consuming the product or required treatment by a physician or health care provider and

(ii) Those complaints that may involve a possible existence of a hazard to health but do not refer to an infant becoming ill or the need for treatment by physician or a health care provider.

(5) The manufacturer shall include in a complaint file the following information concerning the complaint:

(i) The name of the infant formula;

(ii) The production aggregate number;

(iii) The name of complainant;

(iv) A copy of the complaint or a memo of the telephone conversation or meeting and all correspondence with the complainant;

(v) By reference or copy, all the associated manufacturing records and complaint investigation records needed to evaluate the complaint. When copies of such records are not maintained in the complaint file, they must be available within 24 hours when requested by a Food and Drug Administration official.

(vi) All actions taken to followup on the complaint; and

(vii) All findings and evaluations of the complaint.

(6) The manufacturer should maintain the files regarding infant formula complaints at the establishment where the infant formula was manufactured, processed, or packed. When the manufacturer wishes to maintain all consumer complaints for the entire firm at one location other than at the facility where an infant formula was manufactured, processed, or packed, the manufacturer may do so as long as all records required by this section are available within 24 hours of request for inspection at that facility. However, all records of consumer complaints, including summaries, any reports, and any files, maintained at the manufacturing facility or at any other facility shall be made available to investigators for review and copying upon request.

(l) The manufacturer shall make readily available for authorized inspection all records required under this part or copies of such records. Records shall be available at any reasonable time at the establishment where the activities described in such records occurred. (Infant formula complaint files may be maintained at one facility, as provided in paragraph (k)(6) of this section, if all required records are readily available at that facility.) These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by electronic means shall be considered as meeting the requirements of this paragraph.

(m) A manufacturer shall maintain all records required under this part in a manner that ensures that both the manufacturer and the Food and Drug Administration can be provided with access to such records within 24 hours. The manufacturer may maintain the records required under this part as original records, as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records, or as electronic records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. All electronic records maintained under this part shall comply with part 11 of this chapter.

(n) Production control, product testing, testing results, complaints, and distribution records necessary to verify compliance with parts 106, 107, 109, 110, 113, and 117 of this chapter, or with other appropriate regulations, shall be retained for 1 year after the expiration of the shelf life of the infant formula or 3 years from the date of manufacture, whichever is greater.

(o) The manufacturer shall maintain quality control records that contain sufficient information to permit a public health evaluation of any production aggregate of infant formula.

(p) A manufacturer shall make and retain records that demonstrate that the formula meets the quality factor of normal physical growth.

(1) For an infant formula that is not an eligible infant formula, in accordance with § 106.96(d), these records shall include:

(i) Records demonstrating compliance with the requirements in § 106.96(b), including records made in compliance with § 106.121; or

(ii) Records demonstrating satisfaction of an applicable exemption under § 106.96(c), including records made in compliance with § 106.121.

(2) For an eligible infant formula, in accordance with § 106.96(i)(5), these records shall include records demonstrating that the formula fulfills one or more of the criteria listed in § 106.96(i)(1).

(q) A manufacturer shall make and retain records that demonstrate that a formula meets the quality factor of sufficient biological quality of protein.

(1) For an infant formula that is not an eligible infant formula, in accordance with § 106.96(h), these records shall include:

(i) Records demonstrating compliance with the requirements in § 106.96(f), including records made in compliance with § 106.121; or

(ii) Records demonstrating satisfaction of an applicable exemption under § 106.96(g), including records made in compliance with § 106.121.

(2) For an eligible infant formula, in accordance with § 106.96(i)(5), these records shall include records demonstrating that the formula fulfills one or more of the criteria listed in § 106.96(i)(2).

(r) The failure to comply with the records requirements in this section applicable to the quality factors shall render the formula adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. The failure to comply with the records requirements in this section applicable to the good manufacturing practices and quality control procedures, including distribution and audit records requirements, with respect to an infant formula shall render the formula adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. A failure to retain or make available records applicable to the quality factor requirements, quality control procedures, or current good manufacturing practices requirements in compliance with paragraph (l), (m), or (n) of this section with respect to a formula shall render the formula adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, and Cosmetic Act, as applicable.

(a) Before a new infant formula may be introduced or delivered for introduction into interstate commerce, including a new infant formula for export only, the manufacturer of the formula shall register with the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., College Park, MD 20740-3835.

(b) The new infant formula registration shall include:

(1) The name of the new infant formula;

(2) The name of the manufacturer;

(3) The street address of the place of business of the manufacturer; and

(4) The name and street address of each establishment at which the manufacturer intends to manufacture such new infant formula.

(a) At least 90 days before a new infant formula is introduced or delivered for introduction into interstate commerce, a manufacturer shall submit notice of its intent to do so to the Food and Drug Administration at the address given in § 106.110(a). An original and two paper copies of such notice of intent shall be submitted, unless the notice is submitted in conformance with part 11 of this chapter, in which case a single copy shall be sufficient.

(b) The new infant formula submission shall include:

(1) The name and description of the physical form (e.g., powder, ready-to feed, or concentrate) of the infant formula;

(2) An explanation of why the formula is a new infant formula;

(3) The quantitative formulation of each form of the infant formula that is the subject of the notice in units per volume or units per weight for liquid formulas, specified either as sold or as fed, and units per dry weight for powdered formulas, and the weight of powder to be reconstituted with a specified volume of water, and, when applicable, a description of any reformulation of the infant formula, including a listing of each new or changed ingredient and a discussion of the effect of such changes on the nutrient levels in the formulation;

(4) A description, when applicable, of any change in processing of the infant formula. Such description shall identify the specific change in processing, including side-by-side, detailed schematic diagrams comparing the new processing to the previous processing and processing times and temperatures;

(5) Assurance that the infant formula will not be marketed unless the formula meets the requirements for quality factors of section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(1)) and the nutrient content requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act.

(i) Assurance that the formula meets the requirements for quality factors, which are set forth in § 106.96, shall be provided by a submission that complies with § 106.121;

(ii) Assurance that the formula complies with the nutrient content requirements, which are set forth in § 107.100 of this chapter, shall be provided by a statement that the formula will not be marketed unless it meets the nutrient requirements of § 107.100 of this chapter, as demonstrated by testing required under subpart C of this part; and

(6) Assurance that the processing of the infant formula complies with section 412(b)(2) of the Federal Food, Drug, and Cosmetic Act. Such assurance shall include:

(i) A statement that the formula will be produced in accordance with subparts B and C of this part; and

(ii) The basis on which each ingredient meets the requirements of § 106.40(a), e.g. that it is an approved food additive, that it is authorized by a prior sanction, or that it is generally recognized as safe (GRAS) for its intended use. Any claim that an ingredient is GRAS shall be supported by a citation to the Agency's regulations or by an explanation, including a list of published studies and a copy of those publications, for why, based on the published studies, there is general recognition of the safety of the use of the ingredient in infant formula.

(7) If the manufacturer is requesting an exemption under § 106.91(b)(1)(ii), the manufacturer shall include the scientific evidence that the manufacturer is relying on to demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data.

(c) For a new infant formula for export only, a manufacturer may submit, in lieu of the information required under paragraphs (b)(5) and (b)(6) of this section, a statement certifying that the infant formula meets the specifications of the foreign purchaser, the infant formula does not conflict with the laws of the country to which it is intended for export, the infant formula is labeled on the outside of the shipping package to indicate that it is intended for export only, and the infant formula will not be sold or offered for sale in domestic commerce. Such manufacturer shall also submit a statement certifying that it has adequate controls in place to ensure that such formula is actually exported.

(d) The submission will not constitute notice under section 412 of the Federal Food, Drug, and Cosmetic Act unless it complies fully with paragraph (b) of this section, as applicable, and the information that it contains is set forth in a manner that is readily understandable. The Agency will notify the manufacturer if the notice is not complete because it does not meet the requirements in section 412(c) and (d) of the Federal Food, Drug, and Cosmetic Act.

(e) If a new infant formula submission contains all the information required by paragraph (b) of this section, as applicable, the Food and Drug Administration will acknowledge its receipt and notify the manufacturer of the date of receipt. The date that the Agency receives a new infant formula submission that is complete is the filing date for such submission. The manufacturer shall not market the new infant formula before the date that is 90 days after the filing date. If the information in the submission does not provide the assurances required under section 412(d)(1) of the Federal Food, Drug, and Cosmetic Act and the regulations of this chapter, the Food and Drug Administration will so notify the manufacturer before the expiration of the 90th day.

(f) If the manufacturer provides additional information in support of a new infant formula submission, the Agency will determine whether the additional information is a substantive amendment to the new infant formula submission. If the Agency determines that the new submission is a substantive amendment, the Food and Drug Administration will assign the new infant formula submission a new filing date. The Food and Drug Administration will acknowledge receipt of the additional information and, when applicable, notify the manufacturer of the new filing date, which is the date of receipt by the Food and Drug Administration of the information that constitutes the substantive amendment to the new infant formula submission.

(g) Submissions relating to exempt infant formulas are subject to the provisions of § 107.50 of this chapter.

To provide assurance that an infant formula meets the requirements for quality factors set forth in § 106.96, the manufacturer shall submit the following data and information:

(a) Unless the manufacturer of a new infant formula can claim an exemption under § 106.96(c)(1) or (c)(2), the following assurances shall be provided to ensure that the requirements of § 106.96(a) and (b) have been met:

(1) An explanation, in narrative form, setting forth how requirements for quality factors in § 106.96(b) have been met;

(2) Records that contain the information required by § 106.96(b) to be collected during the study for each infant enrolled in the study. The records shall be identified by subject number, age, feeding group, gender, and study day of collection.

(3) Data, which shall include:

(i) Statistical evaluation for all measurements, including group means, group standard deviations, and measures of statistical significance for all measurements for each feeding group at the beginning of the study and at every point where measurements were made throughout the study, and

(ii) Calculations of the statistical power of the study before study initiation and at study completion.

(4) A report on attrition and on all occurrences of adverse events during the study, which shall include:

(i) Identification of the infant by subject number and feeding group and a complete description of the adverse event, including comparisons of the frequency and nature of occurrence in each feeding group and information on the health of the infant during the course of the study, including the occurrence and duration of any illness;

(ii) A clinical assessment by a health care provider of the infant's health during each suspected adverse event; and

(iii) A list of all subjects who did not complete the study, including the subject number and the reason that each subject did not complete the study.

(b) If the manufacturer is requesting an exemption from the growth monitoring study requirements under § 106.96(c)(1), the manufacturer shall include a detailed description of the change made by the manufacturer to an existing infant formula and an explanation of why the change made by the manufacturer to an existing infant formula satisfies the criteria of § 106.96(c)(1).

(c) If the manufacturer is requesting an exemption under § 106.96(c)(2)(i), the manufacturer shall include a detailed description of the alternative method or alternative study design, an explanation of why the method or study design is based on sound scientific principles, and data that demonstrate that the formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition.

(d) If the manufacturer is requesting an exemption under § 106.96(c)(2)(ii), the manufacturer shall include a detailed description of the change and an explanation of why the change made by the manufacturer to an existing infant formula does not the affect the ability of the formula to support normal physical growth.

(e) If the manufacturer is requesting an exemption under § 106.96(c)(2)(iii), the manufacturer shall include a detailed description of the two formulations and an explanation of why the quality factor requirement of normal physical growth is met by the form of the formula that is processed using the method that has the greatest potential for adversely affecting nutrient content and bioavailability.

(f) Unless the manufacturer of a new infant formula is requesting an exemption under § 106.96(g), the results of the Protein Efficiency Ratio bioassay shall be provided in accordance with § 106.96(f).

(g) If the manufacturer is requesting an exemption under § 106.96(g)(1), the manufacturer shall include a detailed description of the change made by the manufacturer to an existing infant formula and an explanation of why the change made by the manufacturer to an existing infant formula satisfies the criteria listed in § 106.96(g)(1).

(h) If the manufacturer is requesting an exemption under § 106.96(g)(2), the manufacturer shall include a detailed description of the change and an explanation of why the change made by the manufacturer to an existing infant formula does not affect the bioavailability of the protein.

(i) If the manufacturer is requesting an exemption under § 106.96(g)(3), the manufacturer shall include a detailed explanation of the alternative method, an explanation of why the method is based on sound scientific principles, and the data that demonstrate that the quality factor for the biological quality of the protein has been met.

(j) A statement certifying that the manufacturer has collected and considered all information and data concerning the ability of the infant formula to meet the requirements for quality factors and that the manufacturer is not aware of any information or data that would show that the formula does not meet the requirements for quality factors.

(a) A manufacturer shall, after the first production and before the introduction into interstate commerce of a new infant formula (except for a new infant formula that is for export only for which a submission is received in compliance with § 106.120(c)), verify in a written submission to the Food and Drug Administration at the address given in § 106.110(a) that the infant formula complies with the requirements of the Federal Food, Drug, and Cosmetic Act and is not adulterated.

(b) The verification submission shall include the following information:

(1) The name of the new infant formula; the filing date for the new infant formula submission, in accordance with § 106.120, for the subject formula; and the identification number assigned by the Agency to the new infant formula submission:

(2) A statement that the infant formula to be introduced into interstate commerce is the same as the infant formula that was the subject of the new infant formula notification and for which the manufacturer provided assurances in accordance with the requirements of § 106.120;

(3) A summary of test results of the level of each nutrient required by § 107.100 of this chapter and any nutrient added by the manufacturer in the formula, presented in units per 100 kilocalories at the final product stage.

(4) A certification that the manufacturer has established current good manufacturing practices, including quality control procedures and in-process controls, and testing required by current good manufacturing practice, designed to prevent adulteration of this formula in accordance with subparts B and C of this part.

(c) The submission shall not constitute written verification under section 412(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)(2)) when any data prescribed in paragraph (b) of this section are lacking or are not set forth so as to be readily understood. In such circumstances, the Agency will notify the manufacturer that the notice is not adequate.

(a) When a manufacturer makes a change in the formulation or processing of the formula that may affect whether the formula is adulterated under section 412(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)), the manufacturer shall, before the first processing of such formula, make a submission to the Food and Drug Administration at the address given in § 106.110(a). An original and two copies shall be submitted.

(b) The submission shall include:

(1) The name and physical form of the infant formula (i.e., powder, ready-to-feed, or concentrate);

(2)(i) An explanation of why the change in formulation or processing may affect whether the formula is adulterated; and

(ii) What steps will be taken to ensure that, before the formula is introduced into interstate commerce, the formula will not be adulterated; and

(3) A statement that the submission complies with § 106.120(b)(3), (b)(4), (b)(5), and (b)(6). When appropriate, a statement to the effect that the information required by § 106.120(b)(3), (b)(4), (b)(5), or (b)(6) has been provided to the Agency previously and has not been affected by the changes that are the subject of the current submission, together with the identification number assigned by the Agency to the relevant infant formula submission, may be provided in lieu of such statement.

(c) The submission shall not constitute notice under section 412 of the Federal Food, Drug, and Cosmetic Act unless it complies fully with paragraph (b) of this section, and the information that it contains is set forth in a manner that is readily understandable. The Agency will notify the manufacturer if the notice is not adequate because it does not meet the requirements of section 412(d)(3) of the Federal Food, Drug, and Cosmetic Act.

(a) A manufacturer shall promptly notify the Food and Drug Administration in accordance with paragraph (b) of this section when the manufacturer has knowledge (that is, actual knowledge that the manufacturer had, or the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer:

(1) May not provide the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 350d(i)) or by regulations issued under section 412(i)(2); or

(2) May be otherwise adulterated or misbranded.

(b) The notification made according to paragraph (a) of this section shall be made by telephone, to the Director of the appropriate Food and Drug Administration district office. After normal business hours (8 a.m. to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-866-300-4374 shall be used. The manufacturer shall promptly send written confirmation of the notification to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., College Park, MD 20740, and to the appropriate Food and Drug Administration district office.

(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Food and Drug Administration must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Food and Drug Administration library at 10903 New Hampshire Ave., Building 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and is available from the sources listed below. This material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) 3-A Sanitary Standards, Inc., 6888 Elm St., Suite 2D, McLean, VA 22101-3829, 703-790-0295, and may be ordered online at http://www.3-a.org/:

(1) 3-A Sanitary Standards, No. 609-03: A Method of Producing Culinary Steam, adopted November 21, 2004, into § 106.20(h).

(2) [Reserved]

(c) American Society for Nutrition, 9650 Rockville Pike, Bethesda, MD 20814-3998, 301-634-7279, http://www.nutrition.org:

(1) Physical growth: National Center for Health Statistics percentiles, Hamill, P.V.V., T.A. Drizd, C.L. Johnson, R.B. Reed, A.F. Roche, and W.M. Moore, American Journal of Clinical Nutrition, vol. 32, pp. 607-614, dated March 1979, into § 106.96(i)(1)(ii)(c).

(2) [Reserved]

(d) AOAC International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7078:

(1) Official Methods of Analysis of AOAC International, 16th ed., dated 1995, into § 106.96(i)(2)(ii):

(i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay, and

(ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency Ratio Calculation Method.

(2) Official Methods of Analysis of AOAC International, 18th ed., dated 2005, into § 106.96(f):

(i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay, and

(ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency Ratio Calculation Method.

(e) Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333, 1-800-232-4636, http://www.cdc.gov/growthcharts/who_charts.htm.

(1) Birth to 24 months: Boys Head circumference-for-age and Weight-for-length percentiles, dated November 1, 2009, into § 106.96(b)(4).

(2) Birth to 24 months: Boys Length-for-age and Weight-for-age percentiles, dated November 1, 2009, into § 106.96(b)(4).

(3) Birth to 24 months: Girls Head circumference-for-age and Weight-for-length percentiles, dated November 1, 2009, into § 106.96(b)(4).

(4) Birth to 24 months: Girls Length-for-age and Weight-for-age percentiles, dated November 1, 2009, into § 106.96(b)(4).

(a) The criteria in subpart B of this part describe the labeling requirements applicable to infant formula under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply with any regulation in subpart B of this part will render an infant formula misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.

(b) The criteria in subpart C of this part describe the terms and conditions for the exemption of an infant formula from the requirements of section 412(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply with any regulations in subpart C of this part will result in withdrawal of the exemption given under section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act.

(c) Subpart D of this part contains the nutrient requirements for infant formula under section 412(i) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart D of this part will render an infant formula adulterated under section 412(a)(1) of the Federal Food, Drug, and Cosmetic Act.

(d) An exempt infant formula is subject to the provisions of § 107.50 and other applicable Food and Drug Administration food regulations.

The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act):

Exempt formula. An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.

Manufacturer. A person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person.

References. References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(a) The labeling of infant formulas, as defined in section 201(z) of the Federal Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format, the following information regarding the product as prepared in accordance with label directions for infant consumption:

(1) A statement of the number of fluid ounces supplying 100 kilocalories (in case of food label statements, a kilocalorie is represented by the word “Calorie”); and

(2) A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer:

(b) In addition the following apply:

(1) Vitamin A content may also be declared on the label in units of microgram retinol equivalents, vitamin D content in units of micrograms cholecalciferol, vitamin E content in units of milligram alpha-tocopherol equivalents, and sodium, potassium, and chloride content in units of millimoles, micromoles, or milliequivalents. When these declarations are made they shall appear in parentheses immediately following the declarations in International Units for vitamins A, D, and E, and immediately following the declarations in milligrams for sodium, potassium, and chloride.

(2) Biotin, choline, and inositol content shall be declared except when they are not added to milk-based infant formulas.

(3) Each of the listed nutrients, and the caloric density, may also be declared on the label on other bases, such as per 100 milliliters or per liter, as prepared for infant consumption.

(4) One of the following statements shall appear on the principal display panel, as appropriate:

(i) The statement “Infant Formula With Iron”, or a similar statement, if the product contains 1 milligram or more of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.

(ii) The statement “Additional Iron May Be Necessary”, or a similar statement, if the product contains less than 1 milligram of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.

(5) Any additional vitamin may be declared at the bottom of the vitamin list and any additional minerals may be declared between iodine and sodium, provided that any additionally declared nutrient:

(i) Has been identified as essential by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or has been identified as essential by the Food and Drug Administration through a Federal Register publication; and

(ii) Is provided at a level considered in these publications as having biological significance, when these levels are known.

In addition to the applicable labeling requirements in parts 101 and 105 of this chapter, the product label shall bear:

(a) Under the heading “Directions For Preparation and Use”, directions for:

(1) Storage of infant formula before and after the container has been opened, including a statement indicating that prolonged storage at excessive temperatures should be avoided;

(2) Agitating liquid infant formula before opening the container, such as “Shake Well Before Opening”;

(3) “Sterilization” of water, bottle, and nipples when necessary for preparing infant formula for use;

(4) Dilution of infant formula, when appropriate. Directions for powdered infant formula shall contain the weight and volume of powdered formula to be reconstituted.

(b) In close proximity to the “Directions for Preparation and Use” a pictogram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula):

(c) A “Use by ___” date, the blank to be filled in with the month and year selected by the manufacturer, packer, or distributor of the infant formula on the basis of tests or other information showing that the infant formula, until that date, under the conditions of handling, storage, preparation, and use prescribed by label directions, will: (1) when consumed, contain not less than the quantity of each nutrient, as set forth on its label; and (2) otherwise be of an acceptable quality (e.g., pass through an ordinary bottle nipple).

(d) The statement “Add Water” or “Do Not Add Water”, as appropriate, to appear on the principal display panel of concentrated or ready-to-feed infant formulas. In close proximity to the statement “Add Water”, a symbol such as

(e) A warning statement beneath or in close proximity to the “Directions For Preparation and Use” that cautions against improper preparation or use of an infant formula, such as “THE HEALTH OF YOUR INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND USE”.

(f) A statement indicating that parents should consult their physicians about the use of infant formulas, such as “USE AS DIRECTED BY A PHYSICIAN”.

When containers of ready-to-feed infant formula, to be sold at the retail level, are contained within a multiunit package, the labels of the individual containers shall contain all of the label information required by section 403 of the Federal Food, Drug, and Cosmetic Act (the act), §§ 107.10 and 107.20, and all appropriate sections of part 101 of this chapter, except that the labels of the individual containers contained within the outer package shall be exempt from compliance with the requirements of section 403 (e)(1) and (i)(2) of the act; and §§ 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that (a) the multiunit package meets all the requirements of this part; (b) individual containers are securely enclosed within and are not intended to be separated from the retail package under conditions of retail sale; and (c) the label on each individual container includes the statement “This Unit Not Intended For Individual Sale” in type size not less than one-sixteenth inch in height. The word “Retail” may be used in lieu of or immediately following the word “Individual” in the statement.

(a) Terms and conditions. Section 412(f)(1) of the act exempts from the requirements of section 412(a), (b), and (c)(1)(A) of the act infant formulas that are represented and labeled for use by an infant who has an inborn error of metabolism or low brith weight or who otherwise has an unusual medical or dietary problem, if such formulas comply with regulations prescribed by the Secretary. The regulations in this subpart establish the terms and conditions that a manufacturer must meet with respect to such infant formulas.

(b) Infant formulas generally available at the retail level. (1) These exempt infant formulas can generally be purchased from retail store shelves that are readily available to the public. Such formulas are also typically represented and labeled for use to provide dietary management for diseases or conditions that are not clinically serious or life-threatening, even though such formulas may also be represented and labeled for use in clinically serious or life-threatening disorders.

(2) Except as provided in paragraphs (b)(4) and (5) of this section, an infant formula manufacturer shall, with respect to each formula covered by this paragraph, comply with the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act, the quality control procedure requirements of part 106, and the labeling requirements of subpart B of this part.

(3) To retain the exempt status of an infant formula covered by this paragraph, the manufacturer shall submit to the Food and Drug Administration (FDA), at the address specified in paragraph (e)(1) of this section, on or before May 21, 1986, or on or before the 90th day before the first processing of the infant formula for commercial or charitable distribution, whichever occurs later, the label and other labeling of the infant formula, a complete quantitative formulation for the infant formula, and a detailed description of the medical conditions for which the infant formula is represented. FDA will review the information under paragraph (d) of this section.

(4) To retain the exempt status of an infant formula covered by this paragraph, when any change in ingredients or processes that may result in an adverse impact on levels of nutrients or availability of nutrients is instituted, the manufacturer shall submit to FDA at the address specified in paragraph (e)(1) of this section, before the first processing of the infant formula, the label and other labeling of the infant formula, a complete quantitative formulation for the infant formula, a detailed description of the reformulation and the rationale for the reformulation, a complete description of the change in processing, and a detailed description of the medical conditions for which the infant formula is represented. FDA will review that information under paragraph (d) of this section.

(5) A manufacturer may deviate from the requirements of paragraph (b)(2) of this section only with respect to those specific requirements for which it submits to FDA, at the address specified in paragraph (e)(1) of this section, the medical, nutritional, scientific, or technological rationale (including any appropriate animal or human clinical studies). FDA will review that information under paragraph (d) of this section.

(c) Infant formulas not generally available at the retail level. (1) These exempt infant formulas are not generally found on retail shelves for general consumer purchase. Such formulas typically are prescribed by a physician, and must be requested from a pharmacist or are distributed directly to institutions such as hospitals, clinics, and State or Federal agencies. Such formulas are also generally represented and labeled solely to provide dietary management for specific diseases or conditions that are clinically serious or life-threatening and generally are required for prolonged periods of time. Exempt infant formulas distributed directly to institutions such as hospitals, clinics, and State or Federal agencies that are of the same formulation as those generally available at the retail level are subject to the requirements of paragraph (b) of this section rather than to the requirements of this paragraph.

(2) Except as provided for in paragraph (c)(5) of this section, an infant formula manufacturer shall, with respect to each formula covered by this paragraph, comply with the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act, and the labeling requirements of subpart B of this part.

(3) Each manufacturer of an infant formula covered by this paragraph shall establish quality control procedures designed to ensure that the infant formula meets applicable nutrient requirements of this section, including any special nutritional characteristics for the specific disorders or conditions for which the formula is represented for use. Each manufacturer shall maintain records of such quality control procedures sufficient to permit a public health evaluation of each manufactured batch of infant formula and shall permit any authorized FDA employee at all reasonable times to have access to and to copy and verify the records referred to in this paragraph.

(4) To retain the exempt status of an infant formula covered by this paragraph, the manufacturer shall submit the information required by paragraphs (b)(3) and (4) of this section.

(5) A manufacturer may deviate from the requirements of paragraph (c)(2) of this section only with respect to those specific requirements for which it submits to FDA, at the address specified in paragraph (e)(1) of this section, the medical, nutritional, scientific, or technological rationale (including any appropriate animal or human clinical studies). FDA will review that information under paragaraph (d) of this section.

(6) The requirements of this section do not apply to an infant formula specially and individually prepared for one or more specific infants on a physician's request.

(d) FDA review of exempt status. (1) FDA's Center for Food Safety and Applied Nutrition will review information submitted by infant formula manufacturers under paragraph (b) (3), (b) (4), or (c)(4) of this section. On the basis of such review and other information available to the agency, the Center for Food Safety and Applied Nutrition may impose additional conditions on, or modify requirements for, the quality control procedures, nutrient specifications, or labeling of an infant formula, or withdraw a product's exempt status. Such determinations will be made by the Director of the Center for Food Safety and Applied Nutrition.

(2)(i) If after completing its review of all information submitted, the Center for Food Safety and Applied Nutrition concludes that additional or modified quality control, nutrient, or labeling requirements are needed, or that a product's exempt status is withdrawn, the Center for Food Safety and Applied Nutrition will so notify the manufacturer and this notification will specify the reasons therefor. Upon receipt of this notification, the manufacturer has 10 working days to have the decision reviewed under § 10.75 by the office of the Commissioner of Food and Drugs. A determination by the Director of the Center for Food Safety and Applied Nutrition that is not appealed becomes a final agency decision.

(ii) After a final decision by the Director or by the office of the Commissioner that a product's exempt status is withdrawn, the manufacturer shall comply with the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act, the quality control requirements of part 106, and the labeling requirements of subpart B of this part.

(iii) The compliance date for the withdrawal of a product's exempt status or the imposition of additional or modified quality control, nutrient, or labeling requirements is 60 calendar days after issuance of the final decision except as otherwise provided for reasons stated in the decision. If the agency determines that a health hazard may exist and so notifies the manufacturer, withdrawal of a product's exempt status shall be effective on the date of receipt of notification from the Director of the Center for Food Safety and Applied Nutrition. Additional or modified requirements, or the withdrawal of an exemption, apply only to those formulas that are manufactured after the compliance date. A postponement of the compliance date may be granted for good cause.

(3) FDA may decide that withdrawal of an exemption is necessary when, on the basis of its review under paragraph (d)(1) of this section, it concludes that quality control procedures are not adequate to ensure that the formula contains all required nutrients, that deviations in nutrient levels are not supported by generally accepted scientific, nutritional, or medical rationale, or that deviations from subpart B of this part are not necessary to provide appropriate directions for preparation and use of the infant formula, or that additional labeling information is necessary.

(4) FDA will use the following criteria in determining whether deviations from the requirements of this subpart are necessary and will adequately protect the public health:

(i) A deviation from the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act is necessary to provide an infant formula that is appropriate for the dietary management of a specific disease, disorder, or medical condition;

(ii) For exempt infant formulas subject to paragraph (b) of this section, a deviation from the quality control procedures requirements of part 106 is necessary because of unusal or difficult technological problems in manufacturing the infant formula; and

(iii) A deviation from the labeling requirements of subpart B of this part is necessary because label information, including pictograms and symbols required by those regulations, could lead to inappropriate use of the product.

(e) Notification requirements. (1) Information required by paragraphs (b) and (c) of this section shall be submitted to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula and Medical Foods Staff (HFS-850), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(2) The manufacturer shall promptly notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of the Federal Food, Drug, and Cosmetic Act) that reasonably supports the conclusion that an exempt infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by paragraph (b) or (c) of this section, or when there is an exempt infant formula that may be otherwise adulterated or misbranded and if so adulterated or misbranded presents a risk of human health. This notification shall be made, by telephone, to the Director of the appropriate Food and Drug Administration district office specified in part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the Food and Drug Administration Emergency Call Center at 866-300-4374. The manufacturer shall send a followup written confirmation to the Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and to the appropriate FDA district office specified in part 5, subpart M of this chapter.

(a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container:

(b) Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E per gram of linoleic acid.

(c) Any vitamin K added shall be in the form of phylloquinone.

(d) Vitamin B6 shall be present at a level of at least 15 micrograms of vitamin B6 for each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container.

(e) The ratio of calcium to phosphorus in infant formula in the form prepared for consumption as directed on the container shall be no less than 1.1 and not more than 2.0.

(f) Protein shall be present in an amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container when its biological quality is equivalent to or better than that of casein. If the biological quality of the protein is less than that of casein, the minimum amount of protein shall be increased proportionately to compensate for its lower biological quality. For example, an infant formula containing protein with a biological quality of 75 percent of casein shall contain at least 2.4 grams of protein (1.8/0.75). No protein with a biological quality less than 70 percent of casein shall be used.

When the Food and Drug Administration determines that an adulterated or misbranded infant formula presents a risk to human health, a manufacturer shall immediately take all actions necessary to recall that formula, extending to and including the retail level, consistent with the requirements of this subpart.

(a) If a manufacturer has determined to recall voluntarily from the market an infant formula that is not subject to § 107.200 but that otherwise violates the laws and regulations administered by the Food and Drug Administration (FDA) and that would be subject to legal action, the manufacturer, upon prompt notification to FDA, shall administer such voluntary recall consistent with the requirements of this subpart.

(b) If a manufacturer has determined to withdraw voluntarily from the market an infant formula that is adulterated or misbranded in only a minor way and that would not be subject to legal action, such removal from the market is deemed to be a market withdrawal, as defined in § 7.3(j) of this chapter. As required by § 107.240(a), the manufacturer shall promptly notify FDA of such violative formula and may, but is not required to, conduct such market withdrawal consistent with the requirements of this subpart pertaining to product recalls.

(a) The requirements of this subpart apply:

(1) When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Administration and that poses a risk to human health; or

(2) When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that:

(i) Is no longer subject to the manufacturer's control;

(ii) Is in violation of the laws and regulations administered by the Food and Drug Administration and against which the agency could initiate legal or regulatory action; and

(iii) Does not present a human risk.

(b) The Food and Drug Administration will monitor continually the recall action and will take appropriate actions to ensure that the violative infant formula is removed from the market.

A recalling firm shall conduct an infant formula recall with the following elements:

(a) The recalling firm shall evaluate in writing the hazard to human health associated with the use of the infant formula. This health hazard evaluation shall include consideration of any disease, injury, or other adverse physiological effect that has been or that could be caused by the infant formula and of the seriousness, likelihood, and consequences of the diseases, injury, or other adverse physiological effect. The Food and Drug Administration will conduct its own health hazard evaluation and promptly notify the recalling firm of the results of that evaluation if the criteria for recall under § 107.200 have been met.

(b) The recalling firm shall devise a written recall strategy suited to the individual circumstances of the particular recall. The recall strategy shall take into account the health hazard evaluation and specify the following: The extent of the recall; if necessary, the public warning to be given about any hazard presented by the infant formula; the disposition of the recalled infant formula; and the effectiveness checks that will be made to determine that the recall is carried out.

(c) The recalling firm shall promptly notify each of its affected direct accounts about the recall. The format of a recall communication shall be distinctive, and the content and extent of a recall communication shall be commensurate with the hazard of the infant formula being recalled and the strategy developed for the recall. The recall communication shall instruct consignees to report back quickly to the recalling firm about whether they are in possession of the recalled infant formula and shall include a means of doing so. The recalled communication shall also advise consignees how to return the recall infant formula to the manufacturer or otherwise dispose of it. The recalling firm shall send a followup recall communication to any consignee that does not respond to the initial recall communication.

(d) If the infant formula presents a risk to human health, the recalling firm shall request that each establishment, at which such infant formula is sold or available for sale, post at the point of purchase of such formula a notice of such recall at such establishment. The notice shall be provided by the recalling firm after approval of the notice by the Food and Drug Administration. The recalling firm shall also request that each retail establishment maintain such notice on display until such time as the Food and Drug Administration notifies the recalling firm that the agency considers the recall completed.

(e) The recalling firm shall furnish promptly to the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chapter, as they are available, copies of the health hazard evaluation, the recall strategy, and all recall communications (including, for a recall under § 107.200, the notice to be displayed at retail establishments) directed to consignees, distributors, retailers, and members of the public.

(a) Telephone report. When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formula that is to be recalled.

(b) Initial written report. Within 14 days after the recall has begun, the recalling firm shall provide a written report to the appropriate FDA district office. The report shall contain relevant information, including the following cumulative information concerning the infant formula that is being recalled:

(1) Number of consignees notified of the recall and date and method of notification, including recalls required by § 107.200, information about the notice provided for retail display, and the request for its display.

(2) Number of consignees responding to the recall communication and quantity of recalled infant formula on hand at each consignee at the time the communication was received.

(3) Quantity of recalled infant formula returned or corrected by each consignee contacted and the quantity of recalled infant formula accounted for.

(4) Number and results of effectiveness checks that were made.

(5) Estimated timeframes for completion of the recall.

(c) Status reports. The recalling firm shall submit to the appropriate FDA district office a written status report on the recall at least every 14 days until the recall is terminated. The status report shall describe the steps taken by the recalling firm to carry out the recall since the last report and the results of these steps.

The recalling firm may submit a recommendation for termination of the recall to the appropriate FDA district office for transmittal to the Recall Coordinator, Division of Enforcement (HFS-605), Office of Compliance, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, or by email to CFSAN.RECALL@fda.hhs.gov, for action. Any such recommendation shall contain information supporting a conclusion that the recall strategy has been effective. The Agency will respond within 15 days of receipt by the Division of Enforcement of the request for termination. The recalling firm shall continue to implement the recall strategy until it receives final written notification from the Agency that the recall has been terminated. The Agency will send such notification, unless the Agency has information from FDA's own audits or from other sources demonstrating that the recall has not been effective. The Agency may conclude that a recall has not been effective if:

(a) The recalling firm's distributors have failed to retrieve the recalled infant formula; or

(b) Stocks of the recalled infant formula remain in distribution channels that are not in direct control of the recalling firm.

If after a review of the recalling firm's recall strategy or periodic reports or other monitoring of the recall, the Food and Drug Administration concludes that the actions of the recalling firm are deficient, the agency shall notify the recalling firm of any serious deficiency. The agency may require the firm to:

(a) Change the extent of the recall, if the agency concludes on the basis of available data that the depth of the recall is not adequate in light of the risk to human health presented by the infant formula.

(b) Carry out additional effectiveness checks, if the agency's audits, or other information, demonstrate that the recall has not been effective.

(c) Issue additional notifications to the firm's direct accounts, if the agency's audits, or other information demonstrate that the original notifications were not received, or were disregarded in a significant number of cases.

A recalling firm may satisfy the requirements of this subpart by any means reasonable calculated to meet the obligations set forth in this Subpart E. The recall guidance in subpart C of part 7 of this chapter specify procedures that may be useful to a recalling firm in determining how to comply with these regulations.

Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least 1 year after the expiration of the shelf life of the infant formula.

(a) The definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part.

(b) Commissioner means the Commissioner of Food and Drugs.

(c) Act means the Federal Food, Drug, and Cosmetic Act, as amended.

(d) Permit means an emergency permit issued by the Commissioner pursuant to section 404 of the act for such temporary period of time as may be necessary to protect the public health.

(e) Manufacture, processing, or packing of food in any locality means activities conducted in a single plant or establishment, a series of plants under a single management, or all plants in an industry or region, by a manufacturer, processor, or packer.

(a) Whenever the Commissioner determines after investigation that a manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of this part does not meet the mandatory conditions and requirements established in such regulation, he shall issue to such manufacturer, processor, or packer an order determining that a permit shall be required before the food may be introduced or delivered for introduction into interstate commerce by that person. The order shall specify the mandatory conditions and requirements with which there is a lack of compliance.

(1) The manufacturer, processor, or packer shall have 3 working days after receipt of such order within which to file objections. Such objections may be filed by telegram, telex, or any other mode of written communication addressed to the Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-605), 5001 Campus Dr., College Park, MD 20740. If such objections are filed, the determination is stayed pending a hearing to be held within 5 working days after the filing of objections on the issues involved unless the Commissioner determines that the objections raise no genuine and substantial issue of fact to justify a hearing.

(2) If the Commissioner finds that there is an imminent hazard to health, the order shall contain this finding and the reasons therefor, and shall state that the determination of the need for a permit is effective immediately pending an expedited hearing.

(b) A hearing under this section shall be conducted by the Commissioner or his designee at a location agreed upon by the objector and the Commissioner or, if such agreement cannot be reached, at a location designated by the Commissioner. The manufacturer, processor, or packer shall have the right to cross-examine the Food and Drug Administration's witnesses and to present witnesses on his own behalf.

(c) Within 5 working days after the hearing, and based on the evidence presented at the hearing, the Commissioner shall determine whether a permit is required and shall so inform the manufacturer, processor, or packer in writing, with the reasons for his decision.

(d) The Commissioner's determination of the need for a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay a determination of the need for a permit pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

(a) A permit shall be required only during such temporary period as is necessary to protect the public health.

(b) Whenever the Commissioner has reason to believe that a permit holder is in compliance with the mandatory requirements and conditions established in subpart B of this part and is likely to remain in compliance, he shall, on his own initiative or on the application of the permit holder, revoke both the determination of need for a permit and the permit that had been issued. If denied, the applicant shall, upon request, be afforded a hearing conducted in accordance with § 108.5 (b) and (c) as soon as practicable. Such revocation is without prejudice to the initiation of further permit proceedings with respect to the same manufacturer, processor, or packer should later information again show the need for a permit.

(a) After a determination and notification by the Commissioner in accordance with the provisions of § 108.5 that a manufacturer, processor, or packer requires a permit, such manufacturer, processor, or packer may not thereafter introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by him unless he holds a permit issued by the Commissioner or obtains advance written approval of the Food and Drug Administration pursuant to § 108.12(a).

(b) Any manufacturer, processor, or packer for whom the Commissioner has made a determination that a permit is necessary may apply to the Commissioner for the issuance of such a permit. The application shall contain such data and information as is necessary to show that all mandatory requirements and conditions for the manufacturer, processing or packing of a food for which regulations are established in subpart B of this part are met and, in particular, shall show that the deviations specified in the Commissioner's determination of the need for a permit have been corrected or suitable interim measures established. Within 10 working days after receipt of such application, (except that the Commissioner may extend such time an additional 10 working days where necessary), the Commissioner shall issue a permit, deny the permit, or offer the applicant a hearing conducted in accordance with § 108.5 (b) and (c) as to whether the permit should be issued. The Commissioner shall issue such a permit to which shall be attached, in addition to the mandatory requirements and conditions of subpart B of this part, any additional requirements or conditions which may be necessary to protect the public health if he finds that all mandatory requirements and conditions of subpart B of this part are met or suitable interim measures are established.

(c) Denial of a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay such denial pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

(a) Whenever the Commissioner finds that a permit holder is not in compliance with the mandatory requirements and conditions established by the permit, he shall immediately suspend the permit and so inform the permit holder, with the reasons for the suspension.

(b) Upon application for reinstatement of a permit, the Commissioner shall, within 10 working days, reinstate the permit if he finds that the person is in compliance with the mandatory requirements and conditions established by the permit or deny the application.

(c) Any person whose permit has been suspended or whose application for reinstatement has been denied may request a hearing. The hearing shall be conducted by the Commissioner or his designee within 5 working days of receipt of the request at a location agreed upon by the objector and the Commissioner or, if an agreement cannot be reached, at a location designated by the Commissioner. The permit holder shall have the right to present witnesses on his own behalf and to cross-examine the Food and Drug Administration's witnesses.

(d) Within 5 working days after the hearing, and based on the evidence presented at the hearing, the Commissioner shall determine whether the permit shall be reinstated and shall so inform the permit holder, with the reasons for his decision.

(e) Denial of an application for reinstatement of a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay such denial pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

(a) A manufacturer, processor, or packer may continue at his own risk to manufacture, process, or pack without a permit a food for which the Commissioner has determined that a permit is required. All food so manufactured, processed, or packed during such period without a permit shall be retained by the manufacturer, processor, or packer and may not be introduced or delivered for introduction into interstate commerce without the advance written approval of the Food and Drug Administration. Such approval may be granted only upon an adequate showing that such food is free from microorganisms of public health significance. The manufacturer, processor, or packer may provide to the Commissioner, for his consideration in making any such determination, an evaluation of the potential public health significance of such food by a competent authority in accordance with procedures recognized as being adequate to detect any potential hazard to public health. Within 20 working days after receipt of a written request for such written approval the Food and Drug Administration shall either issue such written approval or deny the request. If the request is denied, the applicant shall, upon request, be afforded a prompt hearing conducted in accordance with § 108.5 (b) and (c).

(b) Except as provided in paragraph (a) of this section, no manufacturer, processor, or packer may introduce or deliver for introduction into interstate commerce without a permit or in violation of a permit a food for which the Commissioner has determined that a permit is required. Where a manufacturer, processor, or packer utilizes a consolidation warehouse or other storage facility under his control, interstate shipment of any such food from the point of production to that warehouse or storage facility shall not violate this paragraph, provided that no further introduction or delivery for introduction into interstate commerce is made from that consolidated warehouse or storage facility except as provided in paragraph (a) of this section.

(a) Whenever the Commissioner finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with microorganisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he shall promulgate regulations in Subpart B of this part establishing requirements and conditions governing the manufacture, processing, or packing of the food necessary to protect the public health. Such regulations may be proposed by the Commissioner on his own initiative or in response to a petition from any interested person pursuant to part 10 of this chapter.

(b) A manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of this part shall be exempt from the requirement for a permit only if he meets all of the mandatory requirements and conditions established in that regulation.

(a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate commerce. The Commissioner of Food and Drugs therefore finds that, to protect the public health, it may be necessary to require any commericial processor, in any establishment engaged in the manufacture, processing, or packing of acidified foods, to obtain and hold a temporary emergency permit provided for under section 404 of the Federal Food, Drug, and Cosmetic Act. Such a permit may be required whenever the Commissioner finds, after investigation, that the commercial processor has failed to fulfill all the requirements of this section, including registration and filing of process information, and the mandatory portions of §§ 114.10, 114.80(a) (1) and (2), and (b), 114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as they relate to acidified foods. These requirements are intended to ensure safe manufacturing, processing, and packing processes and to permit the Food and Drug Administration to verify that these processes are being followed. Failure to meet these requirements shall constitute a prima facie basis for the immediate application of the emergency permit control provisions of section 404 of the act to that establishment, under the procedures established in subpart A of this part.

(b) The definitions in § 114.3 of this chapter are applicable when those terms are used in this section.

(c)(1) Registration. A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods in any State, as defined in section 201(a)(1) of the act, shall, not later than 10 days after first so engaging, register and file with the Food and Drug Administration on Form FDA 2541 (food canning establishment registration) information including, but not limited to, the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method in terms of acidity and pH control, and a list of foods so processed in each establishment. These forms are available from the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form shall be submitted to the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. These forms also are available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go to FDA's Industry Systems Web site at www.access.fda.gov. Foreign processors shall register before any offering of foods for import into the United States. Commercial processors duly registered under this section shall notify the Food and Drug Administration not later than 90 days after the commercial processor ceases or discontinues the manufacture, processing, or packing of the foods in any establishment, except that this notification shall not be required for temporary cessations due to the seasonal character of an establishment's production or by temporary conditions including, but not limited to, labor disputes, fire, or acts of God.

(2) Process filing. A commercial processor engaged in the processing of acidified foods shall, not later than 60 days after registration, and before packing any new product, provide the Food and Drug Administration information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Filing of this information does not constitute approval of the information by the Food and Drug Administration, and information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). Forms are available from the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. These forms also are available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go to FDA's Industry Systems Web site at www.access.fda.gov.

(3) Process adherence and information - (i) Scheduling. A commercial processor engaged in processing acidified foods in any registered establishment shall process each food in conformity with at least the scheduled processes filed under paragraph (c)(2) of this section.

(ii) Process and pH information availability. When requested by the Food and Drug Administration in writing, a commercial processor engaged in the processing of acidified foods shall provide the Food and Drug Administration with any process and procedure information that the Food and Drug Administration deems necessary to determine the adequacy of the process. Furnishing of this information does not constitute approval by the Food and Drug Administration of the content of the information filed, and the information concerning processes and other data so furnished shall be considered trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905 (to the extent that they qualify under those provisions).

(d) A commercial processor engaged in the processing of acidified foods shall promptly report to the Food and Drug Administration any instance of spoilage, process deviation, or contamination with microorganisms, the nature of which has potential health-endangering significance, where any lot of such food has in whole or in part entered distribution in commerce.

(e) A commercial processor engaged in the processing of acidified foods shall prepare and maintain files on a current procedure for use for products under the processor's control, which that processor will ask the distributor to follow, including plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying the Food and Drug Administration of any recalls; and for implementing recall programs.

(f) All plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses presented under § 108.35 and part 113 of this chapter before March 16, 1979, as having satisfactorily completed the prescribed course of instruction under this section and part 114 of this chapter. The Commissioner will not withhold approval of any school qualified to give such instruction.

(g) A commercial processor engaged in the processing of acidified foods shall prepare, review, and retain at the processing plant or other reasonably accessible location for a period of 3 years from the date of manufacture, all records of processing, deviations in processing, pH, and other records specified in part 114 of this chapter. Upon written demand during the course of a factory inspection under section 704 of the act by a duly authorized employee of the Food and Drug Administration, a commercial processor shall permit the inspection and copying by that employee of these records to verify the pH and the adequacy of processing.

(h) This section shall not apply to the commercial processing of any food processed under the continuous inspection of the meat and poultry inspection program of the Food Safety and Inspection Service of the Department of Agriculture under the Federal Meat Inspection Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 791 (21 U.S.C. 451 et seq.)).

(i) Wherever the Commissioner finds that any State regulates the commercial processing of acidified foods under effective regulations specifying at least the requirements of part 114 of this chapter, the Commissioner shall issue a notice stating that compliance with such State regulations shall constitute compliance with this section, if the State through its regulatory agency or each processor of acidified foods in the State files with the Food and Drug Administration the registration information and the processing information prescribed in paragraph (c) of this section.

(j) Imports. (1) This section applies to any foreign commercial processor engaged in the processing of acidified foods and offering those foods for import into the United States except that, in lieu of providing for the issuance of an emergency permit under paragraph (a) of this section, the Commissioner will request the Secretary of the Treasury to refuse admission into the United States, under section 801 of the act, to any acidified foods which the Commissioner determines, after investigation, may result in the distribution in interstate commerce of processed foods that may be injurious to health as set forth in paragraph (a) of this section.

(2) Any acidified food so refused admission shall not be admitted until the Commissioner determines that the commercial processor offering the food for import has complied with the requirements of this section and that the food is not injurious to health. To assist the Commissioner in making this determination, a duly authorized employee of the Food and Drug Administration shall be permitted to inspect the commercial processor's manufacturing, processing, and packing facilities.

(k) The following information submitted to the Food and Drug Administration under this section is not available for public disclosure unless it has been previously disclosed to the public as defined in § 20.81 of this chapter or it relates to a product or ingredient that has been abandoned and no longer represents a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter:

(1) Manufacturing methods or processes, including quality control information.

(2) Production, sales, distribution, and similar information, except that any compilation of the information aggregated and prepared in a way that does not reveal information which is not available for public disclosure under this provision is available for public disclosure.

(3) Quantitative or semiquantitative formulas.

(a) Inadequate or improper manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate commerce. The Commissioner of Food and Drugs therefore finds that, in order to protect the public health, it may be necessary to require any commercial processor, in any establishment engaged in the manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers, to obtain and hold a temporary emergency permit provided for under section 404 of the Federal Food, Drug, and Cosmetic Act. Such a permit may be required whenever the Commissioner finds, after investigation, that the commercial processor has failed to fulfill all the requirements of this section, including registration and the filing of process information, and the mandatory portions of part 113 of this chapter. These requirements are intended to ensure safe manufacture, processing, and packing procedures and to permit the Food and Drug Administration to verify that these procedures are being followed. Such failure shall constitute a prima facie basis for the immediate application of the emergency permit control provisions of section 404 of the act to that establishment, pursuant to the procedures established in subpart A of this part.

(b) The definitions in § 113.3 of this chapter are applicable when such terms are used in this section.

(c) Registration and process filing - (1) Registration. A commercial processor when first engaging in the manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers in any State, as defined in section 201(a)(1) of the act, shall, not later than 10 days after first so engaging, register with the Food and Drug Administration on Form FDA 2541 (food canning establishment registration) information including (but not limited to) his name, principal place of business, the location of each establishment in which such processing is carried on, the processing method in terms of the type of processing equipment employed, and a list of the low-acid foods so processed in each such establishment. These forms are available from the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. These forms also are available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm. For electronic submission go to FDA's Industry Systems Web site at www.access.fda.gov. Commercial processors duly registered in accordance with this section shall notify the Food and Drug Administration not later than 90 days after such commercial processor ceases or discontinues the manufacture, processing, or packing of thermally processed foods in any establishment: Provided, that such notification shall not be required as to the temporary cessation necessitated by the seasonal character of the particular establishment's production or caused by temporary conditions including but not limited to strikes, lockouts, fire, or acts of God.

(2) Process filing. A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size: Provided, that the filing of such information does not constitute approval of the information by the Food and Drug Administration, and that information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on the following forms as appropriate: Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method), Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method), or Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems). These forms are available from the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form(s) shall be submitted to the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. These forms also are available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm. For electronic submission, go to FDA's Industry Systems Web site at www.access.fda.gov.

(i) If all the necessary information is not available for existing products, the processor shall, at the time the existing information is provided to the Food and Drug Administration request in writing an extension of time for submission of such information, specifying what additional information is to be supplied and the date by which it is to be submitted. Within 30 working days after receipt of such request the Food and Drug Administration shall either grant or deny such request in writing.

(ii) If a packer intentionally makes a change in a previously filed scheduled process by reducing the initial temperature or retort temperature, reducing the time of processing, or changing the product formulation, the container, or any other condition basic to the adequacy of scheduled process, he shall prior to using such changed process obtain substantiation by qualified scientific authority as to its adequacy. Such substantiation may be obtained by telephone, telegram, or other media, but must be promptly recorded, verified in writing by the authority, and contained in the packer's files for review by the Food and Drug Administration. Within 30 days after first use, the packer shall submit to the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 a complete description of the modifications made and utilized, together with a copy of his file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process. Any intentional change of a previously filed scheduled process or modification thereof in which the change consists solely of a higher initial temperature, a higher retort temperature, or a longer processing time, shall not be considered a change subject to this paragraph, but if that modification is thereafter to be regularly scheduled, the modified process shall be promptly filed as a scheduled process, accompanied by full information on the specified forms as provided in this paragraph.

(iii) Many packers employ an “operating” process in which retort operators are instructed to use retort temperatures and/or processing times slightly in excess of those specified in the scheduled process as a safety factor to compensate for minor fluctuations in temperature or time to assure that the minimum times and temperatures in the scheduled process are always met. This would not constitute a modification of the scheduled process.

(3) Process adherence and information. (i) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers in any registered establishment shall process each low-acid food in each container size in conformity with at least the scheduled processes and modifications filed pursuant to paragraph (c)(2) of this section.

(ii) Process information availability: When requested by the Food and Drug Administration in writing, a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall provide the Food and Drug Administration with any information concerning processes and procedures which is deemed necessary by the Food and Drug Administration to determine the adequacy of the process: Provided, That the furnishing of such information does not constitute approval of the information by the Food and Drug Administration, and that the information concerning processes and other data so furnished shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905.

(d) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance of spoilage or process deviation the nature of which indicates potential health significance where any lot of such food has in whole or in part entered distribution.

(e) A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance wherein any lot of such food, which may be injurious to health by reason of contamination with microorganisms, has in whole or in part entered distribution.

(f) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his files a current procedure which he will use for products under his control and which he will ask his distributor to follow, including plans for effecting recalls of any product that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness of such recall; for notifying the Food and Drug Administration of any such recall; and for implementing such recall program.

(g) All operators of retorts, thermal processing systems, aseptic processing and packaging systems, or other thermal processing systems, and container closure inspectors shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction in retort operations, aseptic processing and packaging systems operations or other thermal processing systems operations, and container closure inspections, and has satisfactorily completed the prescribed course of instruction: Provided, That this requirement shall not apply in the State of California as listed in paragraph (j) of this section. The Commissioner will not withhold approval of any school qualified to give such instruction.

(h) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall prepare, review, and retain at the processing plant for a period of not less than one year, and at the processing plant or other reasonably accessible location for an additional two years, all records of processing, deviations in processing, container closure inspections, and other records specified in part 113 of this chapter. If during the first year of the three-year record retention period the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack. Upon written demand during the course of a factory inspection pursuant to section 704 of the act by a duly authorized employee of the Food and Drug Administration, a commercial processor shall permit the inspection and copying by such employee of these records to verify the adequacy of processing, the integrity of container closures, and the coding of the products.

(i) This section shall not apply to the commercial processing of any food processed under the continuous inspection of the meat and poultry inspection program of the Food Safety and Inspection Service of the Department of Agriculture under the Federal Meat Inspection Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 791 (21 U.S.C. 451 et seq.)).

(j) Compliance with State regulations. (1) Wherever the Commissioner finds that any State regulates the commercial thermal processing of low-acid foods in accordance with effective regulations specifying at least the requirements of part 113 of this chapter, he shall issue a notice stating that compliance with such State regulations shall constitute compliance with part 113 of this chapter. However, the provisions of this section shall remain applicable to the commercial processing of low-acid foods in any such State, except that, either the State through its regulatory agency or each processor of low-acid foods in such State shall file with the Center for Food Safety and Applied Nutrition the registration information and the processing information prescribed in paragraph (c) of this section.

(2) The Commissioner finds that the regulations adopted by the State of California under the laws relating to cannery inspections governing thermal processing of low-acid foods packaged in hermetically sealed containers satisfy the requirements of part 113 of this chapter.

(k) Imports. (1) This section shall apply to any foreign commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers and offering such foods for import into the United States except that, in lieu of providing for the issuance of an emergency permit under paragraph (a) of this section, the Commissioner will request the Secretary of the Treasury to refuse admission into the United States, pursuant to section 801 of the act, of any such low-acid foods which the Commissioner determines, after investigation, may result in the distribution in interstate commerce of processed foods that may be injurious to health as set forth in paragraph (a) of this section.

(2) Any such food refused admission shall not be admitted until such time as the Commissioner may determine that the commercial processor offering the food for import is in compliance with the requirements and conditions of this section and that such food is not injurious to health. For the purpose of making such determination, the Commissioner reserves the right for a duly authorized employee of the Food and Drug Administration to inspect the commercial processor's manufacturing, processing, and packing facilities.

(l) The following data and information submitted to the Food and Drug Administration pursuant to this section are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.81 of this chapter:

(1) Manufacturing methods or processes, including quality control information.

(2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(3) Quantitative or semiquantitative formulas.

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) The definitions of terms contained in section 201 of the act are applicable to such terms when used in this part unless modified in this section.

(c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

(e) Food includes human food and substances migrating to food from food-contact articles.

(a) When appropriate under the criteria of § 109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food.

(b) When appropriate under the criteria of § 109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart C of this part under the provisions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act.

(c)(1) When appropriate under the criteria of § 109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated.

(2) Whenever an action level is established or changed, a notice shall be published in the Federal Register as soon as practicable thereafter. The notice shall call attention to the material supporting the action level which shall be on file with the Division of Dockets Management before the notice is published. The notice shall invite public comment on the action level.

(d) A regulation may be established in subpart D of this part to identify a food containing a naturally occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a)(1) of the act. These regulations do not constitute a complete list of such foods.

(a) Use of an added poisonous or deleterious substance, other than a pesticide chemical, that is also a food additive, will be controlled by a regulation issued under section 409 of the act when possible. When such a use cannot be approved under the criteria of section 409 of the act, or when the added poisonous or deleterious substance is not a food additive, a tolerance, regulatory limit, or action level may be established pursuant to the criteria in paragraphs (b), (c), or (d) of this section. Residues resulting from the use of an added poisonous or deleterious substance that is also a pesticide chemical will ordinarily be controlled by a tolerance established in a regulation issued under sections 406, 408, or 409 of the act by the U.S. Environmental Protection Agency (EPA). When such a regulation has not been issued, an action level for an added poisonous or deleterious substance that is also a pesticide chemical may be established by the Food and Drug Administration. The Food and Drug Administration will request EPA to recommend such an action level pursuant to the criteria established in paragraph (d) of this section.

(b) A tolerance for an added poisonous or deleterious substance in any food may be established when the following criteria are met:

(1) The substance cannot be avoided by good manufacturing practice.

(2) The tolerance established is sufficient for the protection of the public health, taking into account the extent to which the presence of the substance cannot be avoided and the other ways in which the consumer may be affected by the same or related poisonous or deleterious substances.

(3) No technological or other changes are foreseeable in the near future that might affect the appropriateness of the tolerance established. Examples of changes that might affect the appropriateness of the tolerance include anticipated improvements in good manufacturing practice that would change the extent to which use of the substance is unavoidable and anticipated studies expected to provide significant new toxicological or use data.

(c) A regulatory limit for an added poisonous or deleterious substance in any food may be established when each of the following criteria is met:

(1) The substance cannot be avoided by current good manufacturing practices.

(2) There is no tolerance established for the substance in the particular food under sections 406, 408, or 409 of the act.

(3) There is insufficient information by which a tolerance may be established for the substance under section 406 of the act or technological changes appear reasonably possible that may affect the appropriateness of a tolerance. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act.

(d) An action level for an added poisonous or deleterious substance in any food may be established when the criteria in paragraph (b) of this section are met, except that technological or other changes that might affect the appropriateness of the tolerance are foreseeable in the near future. An action level for an added poisonous or deleterious substance in any food may be established at a level at which the Food and Drug Administration may regard the food as adulterated within the meaning of section 402(a)(1) of the act, without regard to the criteria in paragraph (b) of this section or in section 406 of the act. An action level will be withdrawn when a tolerance or regulatory limit for the same substance and use has been established.

(e) Tolerances will be established under authority appropriate for action levels (sections 306, 402(a), and 701(a) of the act, together with section 408 or 409 of the act, if appropriate) as well as under authority appropriate for tolerances (sections 406 and 701 of the act). In the event the effectiveness of a tolerance is stayed pursuant to section 701(e)(2) of the act by the filing of an objection, the order establishing the tolerance shall be deemed to be an order establishing an action level until final action is taken upon such objection.

(a) Tolerances and action levels in this part are established at levels based on the unavoidability of the poisonous or deleterious substance concerned and do not establish a permissible level of contamination where it is avoidable.

(b) Compliance with tolerances, regulatory limits, and action levels does not excuse failure to observe either the requirement in section 402(a)(4) of the act that food may not be prepared, packed, or held under insanitary conditions or the other requirements in this chapter that food manufacturers must observe current good manufacturing practices. Evidence obtained through factory inspection or otherwise indicating such a violation renders the food unlawful, even though the amounts of poisonous or deleterious substances are lower than the currently established tolerances, regulatory limits, or action levels. The manufacturer of food must at all times utilize quality control procedures which will reduce contamination to the lowest level currently feasible.

(a) Polychlorinated biphenyls (PCB's) represent a class of toxic industrial chemicals manufactured and sold under a variety of trade names, including: Aroclor (United States); Phenoclor (France); Colphen (Germany); and Kanaclor (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's include, or did include in the past, their use as electrical transformer and capacitor fluids, heat transfer fluids, hydraulic fluids, and plasticizers, and in formulations of lubricants, coatings, and inks. Their unique physical and chemical properties and widespread, uncontrolled industrial applications have caused PCB's to be a persistent and ubiquitous contaminant in the environment, causing the contamination of certain foods. In addition, incidents have occurred in which PCB's have directly contaminated animal feeds as a result of industrial accidents (leakage or spillage of PCB fluids from plant equipment). These accidents in turn caused the contamination of food products intended for human consumption (meat, milk and eggs). Investigations by the Food and Drug Administration have revealed that a significant percentage of paper food-packaging material contains PCB's which can migrate to the packaged food. The origin of PCB's in such material is not fully understood. Reclaimed fibers containing carbonless copy paper (contains 3 to 5 percent PCB's) have been identified as a primary source of PCB's in paper products. Some virgin paper products have also been found to contain PCB's, the source of which is generally attributed to direct contamination from industrial accidents from the use of PCB-containing equipment and machinery in food packaging manufacturing establishments. Since PCB's are toxic chemicals, the PCB contamination of food-packaging materials as a result of industrial accidents, which can cause the PCB contamination of food, represents a hazard to public health. It is therefore necessary to place certain restrictions on the industrial uses of PCB's in establishments manufacturing food-packaging materials.

(b) The following special provisions are necessary to preclude the accidental PCB contamination of food-packaging materials:

(1) New equipment or machinery for manufacturing food-packaging materials shall not contain or use PCB's.

(2) On or before September 4, 1973, the management of establishments manufacturing food-packaging materials shall:

(i) Have the heat exchange fluid used in existing equipment for manufacturing food-packaging materials sampled and tested to determine whether it contains PCB's or verify the absence of PCB's in such formulations by other appropriate means. On or before Sept. 4, 1973, any such fluid formulated with PCB's must to the fullest extent possible commensurate with current good manufacturing practices be replaced with a heat exchange fluid that does not contain PCB's.

(ii) Eliminate to the fullest extent possible commensurate with current good manufacturing practices from the establishment any other PCB-containing equipment, machinery and materials wherever there is a reasonable expectation that such articles could cause food-packaging materials to become contaminated with PCB's either as a result of normal use or as a result of accident, breakage, or other mishap.

(iii) The toxicity and other characteristics of fluids selected as PCB replacements must be adequately determined so that the least potentially hazardous replacement is used. In making this determination with respect to a given fluid, consideration should be given to (a) its toxicity; (b) the maximum quantity that could be spilled onto a given quantity of food before it would be noticed, taking into account its color and odor; (c) possible signaling devices in the equipment to indicate a loss of fluid, etc.; and (d) its environmental stability and tendency to survive and be concentrated through the food chain. The judgment as to whether a replacement fluid is sufficiently non-hazardous is to be made on an individual installation and operation basis.

(c) The provisions of this section do not apply to electrical transformers and condensers containing PCB's in sealed containers.

(a) Lead is a toxic metal that is used as a component of glazes and decorative decals on ceramics, including some ornamental and decorative ceramicware. The use of ornamental or decorative ceramicware to prepare, serve, or hold food may result in the leaching of lead from the glaze or decoration into the food. The provisions of paragraph (b) of this section are necessary to ensure that ornamental or decorative ceramicware bear adequate indications that they are not to be used for food-handling purposes.

(b) Ornamental or decorative ceramicware initially introduced or initially delivered for introduction into interstate commerce on or after July 13, 1994 appears to be suitable for food use will be considered to be for food use unless:

(1) It bears:

(i) A conspicuous stick-on label on a surface clearly visible to consumers that states in legible script in letters at least 3.2 millimeters (0.125 inch) in height one of the following messages: “Not for Food Use. May Poison Food,” “Not for Food Use. Glaze contains lead. Food Use May Result in Lead Poisoning,” and “Not for Food Use - Food Consumed from this Vessel May be Harmful,” and

(ii) A conspicuous and legible permanent statement of the message selected from paragraph (b)(1)(i) of this section molded or fired onto the exterior surface of the base or, when the ceramicware is not fired after decoration, permanently painted onto the exterior surface of the base. This permanent statement shall be in letters at least 3.2 millimeters (0.125 inch) in height, except that if insufficient space exists for the permanent statement in letters of such height, the statement shall be in the largest letters that will allow it to fit on the base of the piece, provided that the letters are at least 1.6 millimeters (0.062 inch) in height; or

(2) A hole is bored through the potential food-contact surface.

(c) In addition to steps required under paragraphs (b)(1) and (b)(2) of this section, the following optional information may be provided on the ware:

(1) A further explanatory statement concerning the decorative nature of the piece, such as “Decorative” or “For Decorative Purposes Only,” may be used; however, such additional statement shall be placed after the required statement.

(2) A symbol may be used to advise that a piece of ornamental or decorative ceramicware is not to be used with food, as illustrated below.

(a) Polychlorinated biphenyls (PCB's) are toxic, industrial chemicals. Because of their widespread, uncontrolled industrial applications, PCB's have become a persistent and ubiquitous contaminant in the environment. As a result, certain foods and animal feeds, principally those of animal and marine origin, contain PCB's as unavoidable, environmental contaminants. PCB's are transmitted to the food portion (meat, milk, and eggs) of food-producing animals ingesting PCB-contaminated animal feed. In addition, a significant percentage of paper food-packaging materials contain PCB's which may migrate to the packaged food. The source of PCB's in paper food-packaging materials is primarily of certain types of carbonless copy paper (containing 3 to 5 percent PCB's) in waste paper stocks used for manufacturing recycled paper. Therefore, temporary tolerances for residues of PCB's as unavoidable environmental or industrial contaminants are established for a sufficient period of time following the effective date of this paragraph to permit the elimination of such contaminants at the earliest practicable time. For the purposes of this paragraph, the term “polychlorinated biphenyls (PCB's)” is applicable to mixtures of chlorinated biphenyl compounds, irrespective of which mixture of PCB's is present as the residue. The temporary tolerances for residues of PCB's are as follows:

(1) 1.5 parts per million in milk (fat basis).

(2) 1.5 parts per million in manufactured dairy products (fat basis).

(3) 3 parts per million in poultry (fat basis).

(4) 0.3 parts per million in eggs.

(5) 0.2 parts per million in finished animal feed for food-producing animals (except the following finished animal feeds: feed concentrates, feed supplements, and feed premixes).

(6) 2 parts per million in animal feed components of animal origin, including fishmeal and other by-products of marine origin and in finished animal feed concentrates, supplements, and premixes intended for food producing animals.

(7) 2 parts per million in fish and shellfish (edible portion). The edible portion of fish excludes head, scales, viscera, and inedible bones.

(8) 0.2 parts per million in infant and junior foods.

(9) 10 parts per million in paper food-packaging material intended for or used with human food, finished animal feed and any components intended for animal feeds. The tolerance shall not apply to paper food-packaging material separated from the food therein by a functional barrier which is impermeable to migration of PCB's.

(b) A compilation entitled “Analytical Methodology for Polychlorinated Biphenyls, June 1979” for determining compliance with the tolerances established in this section is available from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(c) A barrier is functional for purposes of paragraph (a)(9) of this section if the barrier limits migration of PCB's from the packaging material to food to a level not exceeding the migration which occurs under the same test conditions from packaging material containing 10 parts per million PCB without the use of a barrier. A class of barrier material is functional for purposes of paragraph (a)(9) of this section if a representative barrier of the class limits migration of PCB's from the packaging material to food to a level not exceeding the migration which occurs under the same test conditions from packaging material containing 10 parts per million PCB without the use of a barrier. Migration levels shall be determined for purpose of this paragraph solely by use of testing conditions described in “Test Procedures for Determination of PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised May 1983”, which is incorporated by reference. Copies are available from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. A class of barrier material shall be deemed functional only if the definition of the class and the designation of one or more representative barriers has been approved by the Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration. In the event that the Director, Center for Food Safety and Applied Nutrition, does not approve a proposal made to the Center regarding the definition of a class of barrier material or the designation of representative barriers, the Director shall advise the person making the proposal of the reasons for the Center's disapproval within 90 days of receipt of the proposal. All proposals for definition of classes and determinations of the Food and Drug Administration regarding such proposals shall be on file with the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(d) Any person who asserts that a barrier or class of barriers is functional shall submit the results of tests conducted to determine the functionality of the barrier or class of barriers to Center for Food Safety and Applied Nutrition (HFS-308), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. All barriers or classes of barriers shall be tested with the four solid food receptors specified in “Test Procedures for Determination of PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised May 1983”, which is incorporated by reference. The availability of this reference is given in paragraph (c) of this section. The test results as to each barrier shall be accompanied by (1) a description of the barrier's composition adequate to enable identification; and (2) a specific definition of the barrier by relevant technical characteristics. The Center for Food Safety and Applied Nutrition shall review submitted test results promptly. Within 60 days of the receipt of test results, the Director, Center for Food Safety and Applied Nutrition, shall notify the person submitting the test results whether the tests were conducted in accordance with the “Analytical Methodology for Polychlorinated Biphenyls; June 1979”, which is incorporated by reference, or the “Test Procedures for Determination of PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised May 1983” and whether, therefore, the barrier or class of barriers is deemed functional within the meaning of paragraph (c) of this section. The test results and any response of the Food and Drug Administration shall be placed on file with the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following definitions shall also apply:

(a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below.

(b) Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.

(c) Batter means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

(d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.

(e) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food.

(f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients.

(g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” includes utensils and food-contact surfaces of equipment.

(h) Lot means the food produced during a period of time indicated by a specific code.

(i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regulations, FDA used the adjective “microbial” instead of using an adjectival phrase containing the word microorganism.

(j) Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae.

(k) Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food.

(l) Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act.

(m) Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.

(n) Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.

(o) Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

(p) Shall is used to state mandatory requirements.

(q) Should is used to state recommended or advisory procedures or identify recommended equipment.

(r) Water activity (aw) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

(b) Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.

The plant management shall take all reasonable measures and precautions to ensure the following:

(a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.

(b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:

(1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials.

(2) Maintaining adequate personal cleanliness.

(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.

(4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.

(5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.

(6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.

(7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.

(8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.

(9) Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

(c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.

(d) Supervision. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel.

(a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more “raw agricultural commodities,” as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.

(b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations.

(a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.

(3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.

(4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed.

(b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall:

(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.

(2) Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means.

(3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including:

(i) Using protective coverings.

(ii) Controlling areas over and around the vessels to eliminate harborages for pests.

(iii) Checking on a regular basis for pests and pest infestation.

(iv) Skimming the fermentation vessels, as necessary.

(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.

(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.

(6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.

(7) Provide, where necessary, adequate screening or other protection against pests.

(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.

(b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed:

(i) Those required to maintain clean and sanitary conditions;

(ii) Those necessary for use in laboratory testing procedures;

(iii) Those necessary for plant and equipment maintenance and operation; and

(iv) Those necessary for use in the plant's operations.

(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed.

(c) Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.

(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food.

(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.

(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.

(3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.

(4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces.

(5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.

(e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination.

Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to:

(a) Water supply. The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.

(b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to:

(1) Carry sufficient quantities of water to required locations throughout the plant.

(2) Properly convey sewage and liquid disposable waste from the plant.

(3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

(5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.

(c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means.

(d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by:

(1) Maintaining the facilities in a sanitary condition.

(2) Keeping the facilities in good repair at all times.

(3) Providing self-closing doors.

(4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-flow systems).

(e) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:

(1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.

(2) Effective hand-cleaning and sanitizing preparations.

(3) Sanitary towel service or suitable drying devices.

(4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.

(5) Readily understandable signs directing employees handling unprotected food, unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces.

(6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food.

(f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces.

(a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.

(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.

(c) Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.

(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.

(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.

(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses.

(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

(a) Raw materials and other ingredients. (1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

(2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

(3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.

(4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.

(5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.

(6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.

(7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

(b) Manufacturing operations. (1) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

(2) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.

(3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including:

(i) Maintaining refrigerated foods at 45 °F (7.2 °C) or below as appropriate for the particular food involved.

(ii) Maintaining frozen foods in a frozen state.

(iii) Maintaining hot foods at 140 °F (60 °C) or above.

(iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

(4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.

(5) Work-in-process shall be handled in a manner that protects against contamination.

(6) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.

(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

(8) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

(9) Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food.

(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.

(11) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality.

(12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:

(i) Using ingredients free of contamination.

(ii) Employing adequate heat processes where applicable.

(iii) Using adequate time and temperature controls.

(iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.

(v) Cooling to an adequate temperature during manufacturing.

(vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.

(13) Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:

(i) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.

(ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers.

(iii) Using materials for food containers and food- packaging materials that are safe and suitable, as defined in § 130.3(d) of this chapter.

(iv) Providing physical protection from contamination, particularly airborne contamination.

(v) Using sanitary handling procedures.

(14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the aw of food.

(ii) Controlling the soluble solids-water ratio in finished food.

(iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level.

(15) Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the pH of raw materials, food in process, and finished food.

(ii) Controlling the amount of acid or acidified food added to low-acid food.

(16) When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.

(17) Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container.

(a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.

(b) Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information.

(c) Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

(d) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food.

(e) A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply:

Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement.

Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time period according to a single manufacturing record during the same cycle of manufacture.

Batch number, lot number, or control number means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined.

Component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients.

Contact surface means any surface that contacts a component or dietary supplement, and those surfaces from which drainage onto the component or dietary supplement, or onto surfaces that contact the component or dietary supplement, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging.

Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act.

In-process material means any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement.

Lot means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, and other similar microscopic organisms having public health or sanitary concern. This definition includes species that:

(1) May have public health significance;

(2) May cause a component or dietary supplement to decompose;

(3) Indicate that the component or dietary supplement is contaminated with filth; or

(4) Otherwise may cause the component or dietary supplement to be adulterated.

Must is used to state a requirement.

Pest means any objectionable insect or other animal including birds, rodents, flies, mites, and larvae.

Physical plant means all or any part of a building or facility used for or in connection with manufacturing, packaging, labeling, or holding a dietary supplement.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead).

Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.

Quality control means a planned and systematic operation or procedure for ensuring the quality of a dietary supplement.

Quality control personnel means any person, persons, or group, within or outside of your organization, who you designate to be responsible for your quality control operations.

Representative sample means a sample that consists of an adequate number of units that are drawn based on rational criteria, such as random sampling, and that are intended to ensure that the sample accurately portrays the material being sampled.

Reprocessing means using, in the manufacture of a dietary supplement, clean, uncontaminated components or dietary supplements that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a dietary supplement.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other microorganisms, but without adversely affecting the product or its safety for the consumer.

Theoretical yield means the quantity that would be produced at any appropriate step of manufacture or packaging of a particular dietary supplement, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production.

Water activity (aw) is a measure of the free moisture in a component or dietary supplement and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

We means the U.S. Food and Drug Administration (FDA).

You means a person who manufactures, packages, labels, or holds dietary supplements.

In addition to this part, you must comply with other applicable statutory provisions and regulations under the act related to dietary supplements. For importers of dietary supplements and dietary supplement components, the regulation on foreign supplier verification programs can be found in subpart L of part 1 of this chapter.

You must establish and follow written procedures for fulfilling the requirements of this subpart.

(a) Preventing microbial contamination. You must take measures to exclude from any operations any person who might be a source of microbial contamination, due to a health condition, where such contamination may occur, of any material, including components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. Such measures include the following:

(1) Excluding from working in any operations that may result in contamination any person who, by medical examination, the person's acknowledgement, or supervisory observation, is shown to have, or appears to have, an illness, infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial contamination of components, dietary supplements, or contact surfaces, until the health condition no longer exists; and

(2) Instructing your employees to notify their supervisor(s) if they have or if there is a reasonable possibility that they have a health condition described in paragraph (a)(1) of this section that could result in microbial contamination of any components, dietary supplements, or any contact surface.

(b) Hygienic practices. If you work in an operation during which adulteration of the component, dietary supplement, or contact surface could occur, you must use hygienic practices to the extent necessary to protect against such contamination of components, dietary supplements, or contact surfaces. These hygienic practices include the following:

(1) Wearing outer garments in a manner that protects against the contamination of components, dietary supplements, or any contact surface;

(2) Maintaining adequate personal cleanliness;

(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility:

(i) Before starting work; and

(ii) At any time when the hands may have become soiled or contaminated;

(4) Removing all unsecured jewelry and other objects that might fall into components, dietary supplements, equipment, or packaging, and removing hand jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand. If hand jewelry cannot be removed, it must be covered by material that is maintained in an intact, clean, and sanitary condition and that effectively protects against contamination of components, dietary supplements, or contact surfaces;

(5) Maintaining gloves used in handling components or dietary supplements in an intact, clean, and sanitary condition. The gloves must be of an impermeable material;

(6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints;

(7) Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact surfaces are exposed or where contact surfaces are washed;

(8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed; and

(9) Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials, including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

(a) You must have qualified employees who manufacture, package, label, or hold dietary supplements.

(b) You must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.

(c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions.

(a) You must assign qualified personnel to supervise the manufacturing, packaging, labeling, or holding of dietary supplements.

(b) Each supervisor whom you use must be qualified by education, training, or experience to supervise.

(a) You must make and keep records required under this subpart B in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart B; and

(2) Documentation of training, including the date of the training, the type of training, and the person(s) trained.

(a) Grounds. You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. The methods for adequate ground maintenance include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding;

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed;

(3) Adequately draining areas that may contribute to the contamination of components, dietary supplements, or contact surfaces by seepage, filth or any other extraneous materials, or by providing a breeding place for pests;

(4) Adequately operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed; and

(5) If your plant grounds are bordered by grounds not under your control, and if those other grounds are not maintained in the manner described in this section, you must exercise care in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth or any other extraneous materials that may be a source of contamination.

(b) Physical plant facilities. (1) You must maintain your physical plant in a clean and sanitary condition; and

(2) You must maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.

(c) Cleaning compounds, sanitizing agents, pesticides, and other toxic materials. (1) You must use cleaning compounds and sanitizing agents that are free from microorganisms of public health significance and that are safe and adequate under the conditions of use.

(2) You must not use or hold toxic materials in a physical plant in which components, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary as follows:

(i) To maintain clean and sanitary conditions;

(ii) For use in laboratory testing procedures;

(iii) For maintaining or operating the physical plant or equipment; or

(iv) For use in the plant's operations.

(3) You must identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, and other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.

(d) Pest control. (1) You must not allow animals or pests in any area of your physical plant. Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces;

(2) You must take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests; and

(3) You must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precautions to protect against the contamination of components, dietary supplements, or contact surfaces.

(e) Water supply. (1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement.

(2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.

(f) Plumbing. The plumbing in your physical plant must be of an adequate size and design and be adequately installed and maintained to:

(1) Carry sufficient amounts of water to required locations throughout the physical plant;

(2) Properly convey sewage and liquid disposable waste from your physical plant;

(3) Avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition;

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and

(5) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.

(g) Sewage disposal. You must dispose of sewage into an adequate sewage system or through other adequate means.

(h) Bathrooms. You must provide your employees with adequate, readily accessible bathrooms. The bathrooms must be kept clean and must not be a potential source of contamination to components, dietary supplements, or contact surfaces.

(i) Hand-washing facilities. You must provide hand-washing facilities that are designed to ensure that an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.

(j) Trash disposal. You must convey, store, and dispose of trash to:

(1) Minimize the development of odors;

(2) Minimize the potential for the trash to attract, harbor, or become a breeding place for pests;

(3) Protect against contamination of components, dietary supplements, any contact surface, water supplies, and grounds surrounding your physical plant; and

(4) Control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces.

(k) Sanitation supervisors. You must assign one or more employees to supervise overall sanitation. Each of these supervisors must be qualified by education, training, or experience to develop and supervise sanitation procedures.

You must establish and follow written procedures for cleaning the physical plant and for pest control.

Any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must:

(a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations;

(b) Have adequate space for the orderly placement of equipment and holding of materials as is necessary for maintenance, cleaning, and sanitizing operations and to prevent contamination and mixups of components and dietary supplements during manufacturing, packaging, labeling, or holding;

(c) Permit the use of proper precautions to reduce the potential for mixups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material. Your physical plant must have, and you must use, separate or defined areas of adequate size or other control systems, such as computerized inventory controls or automated systems of separation, to prevent contamination and mixups of components and dietary supplements during the following operations:

(1) Receiving, identifying, holding, and withholding from use, components, dietary supplements, packaging, and labels that will be used in or during the manufacturing, packaging, labeling, or holding of dietary supplements;

(2) Separating, as necessary, components, dietary supplements, packaging, and labels that are to be used in manufacturing from components, dietary supplements, packaging, or labels that are awaiting material review and disposition decision, reprocessing, or are awaiting disposal after rejection;

(3) Separating the manufacturing, packaging, labeling, and holding of different product types including different types of dietary supplements and other foods, cosmetics, and pharmaceutical products;

(4) Performing laboratory analyses and holding laboratory supplies and samples;

(5) Cleaning and sanitizing contact surfaces;

(6) Packaging and label operations; and

(7) Holding components or dietary supplements.

(d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces.

(1) The design and construction must include:

(i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair;

(ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or contact surfaces by dripping or other leakage, or condensate;

(iii) Adequate ventilation or environmental control equipment such as airflow systems, including filters, fans, and other air-blowing equipment, that minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate components, dietary supplements, or contact surfaces;

(iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement; and

(v) Aisles or working spaces between equipment and walls that are adequately unobstructed and of adequate width to permit all persons to perform their duties and to protect against contamination of components, dietary supplements, or contact surfaces with clothing or personal contact.

(2) When fans and other air-blowing equipment are used, such fans and equipment must be located and operated in a manner that minimizes the potential for microorganisms and particulate matter to contaminate components, dietary supplements, or contact surfaces;

(e) Provide adequate light in:

(1) All areas where components or dietary supplements are examined, processed, or held;

(2) All areas where contact surfaces are cleaned; and

(3) Hand-washing areas, dressing and locker rooms, and bathrooms.

(f) Use safety-type light bulbs, fixtures, skylights, or other glass or glass-like materials when the light bulbs, fixtures, skylights or other glass or glass-like materials are suspended over exposed components or dietary supplements in any step of preparation, unless your physical plant is otherwise constructed in a manner that will protect against contamination of components or dietary supplements in case of breakage of glass or glass-like materials.

(g) Provide effective protection against contamination of components and dietary supplements in bulk fermentation vessels, by, for example:

(1) Use of protective coverings;

(2) Placement in areas where you can eliminate harborages for pests over and around the vessels;

(3) Placement in areas where you can check regularly for pests, pest infestation, filth or any other extraneous materials; and

(4) Use of skimming equipment.

(h) Use adequate screening or other protection against pests, where necessary.

(a) You must make and keep records required under this subpart C in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control.

(c) You must make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of § 111.15(e)(2).

You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for:

(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;

(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.

(a) You must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained.

(1) Equipment and utensils include the following:

(i) Equipment used to hold or convey;

(ii) Equipment used to measure;

(iii) Equipment using compressed air or gas;

(iv) Equipment used to carry out processes in closed pipes and vessels; and

(v) Equipment used in automated, mechanical, or electronic systems.

(2) You must use equipment and utensils of appropriate design and construction so that use will not result in the contamination of components or dietary supplements with:

(i) Lubricants;

(ii) Fuel;

(iii) Coolants;

(iv) Metal or glass fragments;

(v) Filth or any other extraneous material;

(vi) Contaminated water; or

(vii) Any other contaminants.

(3) All equipment and utensils you use must be:

(i) Installed and maintained to facilitate cleaning the equipment, utensils, and all adjacent spaces;

(ii) Corrosion-resistant if the equipment or utensils contact components or dietary supplements;

(iii) Made of nontoxic materials;

(iv) Designed and constructed to withstand the environment in which they are used, the action of components or dietary supplements, and, if applicable, cleaning compounds and sanitizing agents; and

(v) Maintained to protect components and dietary supplements from being contaminated by any source.

(4) Equipment and utensils you use must have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants.

(5) Each freezer, refrigerator, and other cold storage compartment you use to hold components or dietary supplements:

(i) Must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the temperature accurately within the compartment; and

(ii) Must have an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change in a manual operation.

(6) Instruments or controls used in the manufacturing, packaging, labeling, or holding of a dietary supplement, and instruments or controls that you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), water activity, or other conditions, to control or prevent the growth of microorganisms or other contamination must be:

(i) Accurate and precise;

(ii) Adequately maintained; and

(iii) Adequate in number for their designated uses.

(7) Compressed air or other gases you introduce mechanically into or onto a component, dietary supplement, or contact surface or that you use to clean any contact surface must be treated in such a way that the component, dietary supplement, or contact surface is not contaminated.

(b) You must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement. You must calibrate:

(1) Before first use; and

(2) At the frequency specified in writing by the manufacturer of the instrument and control; or

(3) At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control.

(c) You must repair or replace instruments or controls that cannot be adjusted to agree with the reference standard.

(d) You must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements.

(1) Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing.

(2) You must ensure that all contact surfaces, used for manufacturing or holding low-moisture components or dietary supplements, are in a dry and sanitary condition when in use. When the surfaces are wet-cleaned, they must be sanitized, when necessary, and thoroughly dried before subsequent use.

(3) If you use wet processing during manufacturing, you must clean and sanitize all contact surfaces, as necessary, to protect against the introduction of microorganisms into components or dietary supplements. When cleaning and sanitizing is necessary, you must clean and sanitize all contact surfaces before use and after any interruption during which the contact surface may have become contaminated. If you use contact surfaces in a continuous production operation or in consecutive operations involving different batches of the same dietary supplement, you must adequately clean and sanitize the contact surfaces, as necessary.

(4) You must clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements.

(5) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be:

(i) Stored in appropriate containers; and

(ii) Handled, dispensed, used, and disposed of in a manner that protects against contamination of components, dietary supplements, or any contact surface.

(6) Cleaning compounds and sanitizing agents must be adequate for their intended use and safe under their conditions of use;

(7) You must store cleaned and sanitized portable equipment and utensils that have contact surfaces in a location and manner that protects them from contamination.

For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, you must:

(a) Design or select equipment to ensure that dietary supplement specifications are consistently met;

(b) Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process;

(c) Routinely calibrate, inspect, or check the equipment to ensure proper performance. Your quality control personnel must periodically review these calibrations, inspections, or checks;

(d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other operations are approved by quality control personnel and instituted only by authorized personnel; and

(e) Establish and use appropriate controls to ensure that the equipment functions in accordance with its intended use. These controls must be approved by quality control personnel.

(a) You must make and keep records required under this subpart D in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart, including written procedures for:

(i) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;

(ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

(iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements;

(2) Documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, unless such documentation is kept with the batch record;

(3) Documentation of any calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. In your documentation, you must:

(i) Identify the instrument or control calibrated;

(ii) Provide the date of calibration;

(iii) Identify the reference standard used including the certification of accuracy of the known reference standard and a history of recertification of accuracy;

(iv) Identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating;

(v) Provide the calibration reading or readings found;

(vi) Identify the recalibration method used, and reading or readings found, if accuracy or precision or both accuracy and precision limits for instruments and controls were not met; and

(vii) Include the initials of the person who performed the calibration and any recalibration.

(4) Written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment;

(5) Backup file(s) of current software programs (and of outdated software that is necessary to retrieve records that you are required to keep in accordance with subpart P of this part, when current software is not able to retrieve such records) and of data entered into computer systems that you use to manufacture, package, label, or hold dietary supplements.

(i) Your backup file (e.g., a hard copy of data you have entered, diskettes, tapes, microfilm, or compact disks) must be an exact and complete record of the data you entered.

(ii) You must keep your backup software programs and data secure from alterations, inadvertent erasures, or loss; and

(6) Documentation of the controls that you use to ensure that equipment functions in accordance with its intended use.

You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and

(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.

You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

(b) For each component that you use in the manufacture of a dietary supplement, you must establish component specifications as follows:

(1) You must establish an identity specification;

(2) You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and

(3) You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(c) For the in-process production:

(1) You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement;

(2) You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and

(3) Quality control personnel must review and approve the documentation that you provide under paragraph (c)(2) of this section.

(d) You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order.

(g) You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label.

You must determine whether the specifications you establish under § 111.70 are met.

(a) Before you use a component, you must:

(1)(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;

(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under § 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and

(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with § 111.70(b) are met. To do so, you must either:

(i) Conduct appropriate tests or examinations; or

(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that:

(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations;

(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;

(C) You maintain documentation of how you qualified the supplier;

(D) You periodically re-confirm the supplier's certificate of analysis; and

(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.

(b) You must monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to:

(1) Determine whether the in-process specifications are met; and

(2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifications.

(c) For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. To do so:

(1) You must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (or only those product specifications not otherwise exempted from this provision by quality control personnel under paragraph (d) of this section);

(2) You must conduct appropriate tests or examinations to determine compliance with the specifications selected in paragraph (c)(1) of this section;

(3) You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph (c)(1) of this section, through the use of appropriate tests or examinations conducted under paragraph (c)(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and

(4) Your quality control personnel must review and approve the documentation that you provide under paragraph (c)(3) of this section.

(d)(1) You may exempt one or more product specifications from verification requirements in paragraph (c)(1) of this section if you determine and document that the specifications you select under paragraph (c)(1) of this section for determination of compliance with specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage. In such a case, you must document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch; and

(2) Your quality control personnel must review and approve the documentation that you provide under paragraph (d)(1) of this section.

(e) Before you package or label a product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must visually examine the product and have documentation to determine whether the specifications that you established under § 111.70 (f) are met.

(f)(1) Before you use packaging, you must, at a minimum, conduct a visual identification of the containers and closures and review the supplier's invoice, guarantee, or certification to determine whether the packaging specifications are met; and

(2) Before you use labels, you must, at a minimum, conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met.

(g) You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label.

(h)(1) You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods.

(2) The tests and examinations that you use must include at least one of the following:

(i) Gross organoleptic analysis;

(ii) Macroscopic analysis;

(iii) Microscopic analysis;

(iv) Chemical analysis; or

(v) Other scientifically valid methods.

(i) You must establish corrective action plans for use when an established specification is not met.

(a) For specifications established under § 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. No finished batch of dietary supplements may be released for distribution unless it complies with § 111.123(b).

(b) For specifications established under § 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement.

(c) For specifications established under § 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement.

The representative samples that you must collect include:

(a) Representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications established in accordance with § 111.70(b) and (d), and as applicable, § 111.70(a) (and, when you receive components, packaging, or labels from a supplier, representative samples of each unique shipment, and of each unique lot within each unique shipment);

(b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements to determine whether the in-process materials meet specifications established in accordance with § 111.70(c), and as applicable, § 111.70(a);

(c) Representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications established in accordance with § 111.70(e), and as applicable, § 111.70(a);

(d) Representative samples of each unique shipment, and of each unique lot within each unique shipment, of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) to determine whether the received product meets specifications established in accordance with § 111.70(f), and as applicable, § 111.70(a); and

(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with § 111.70(g), and as applicable, § 111.70(a).

(a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute.

(b) The reserve samples must:

(1) Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere;

(2) Be identified with the batch, lot, or control number;

(3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and

(4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.

Quality control personnel must conduct all required material reviews and make all required disposition decisions.

(a) You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless:

(1) Quality control personnel conduct a material review and make a disposition decision to approve the reprocessing, treatment, or in-process adjustment; and

(2) The reprocessing, treatment, or in-process adjustment is permitted by § 111.77;

(b) You must not reprocess any dietary supplement or treat or provide an in-process adjustment to a component to make it suitable for use in the manufacture of a dietary supplement, unless:

(1) Quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approves the reprocessing, treatment, or in-process adjustment; and

(2) The reprocessing, treatment or in-process adjustment is permitted by § 111.77;

(c) Any batch of dietary supplement that is reprocessed, that contains components that you have treated, or to which you have made in-process adjustments to make them suitable for use in the manufacture of the dietary supplement must be approved by quality control personnel and comply with § 111.123(b) before releasing for distribution.

(a) You must make and keep records required under this subpart E in accordance with subpart P of this part.

(b) Under this subpart E, you must make and keep the following records:

(1) The specifications established;

(2) Documentation of your qualification of a supplier for the purpose of relying on the supplier's certificate of analysis;

(3) Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and

(4) Documentation for why the results of appropriate tests or examinations for the product specifications selected under § 111.75(c)(1) ensure that the dietary supplement meets all product specifications;

(5) Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under § 111.75(d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under § 111.75 (c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.

(6) Documentation of FDA's response to a petition submitted under § 111.75(a)(1)(ii) providing for an exemption from the provisions of § 111.75(a)(1)(i).

You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.

Quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. To do so, quality control personnel must perform operations that include:

(a) Approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement;

(b) Reviewing and approving the documentation setting forth the basis for qualification of any supplier;

(c) Reviewing and approving the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met;

(d) Reviewing and approving the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification selected under § 111.75(c)(1) will ensure that the finished batch of the dietary supplement meets product specifications;

(e) Reviewing and approving the basis and the documentation for why any product specification is exempted from the verification requirements in § 111.75(c)(1), and for why any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specification is met without verification through periodic testing of the finished batch;

(f) Ensuring that required representative samples are collected;

(g) Ensuring that required reserve samples are collected and held;

(h) Determining whether all specifications established under § 111.70(a) are met; and

(i) Performing other operations required under this subpart.

Quality control operations for laboratory operations associated with the production and process control system must include:

(a) Reviewing and approving all laboratory control processes associated with the production and process control system;

(b) Ensuring that all tests and examinations required under § 111.75 are conducted; and

(c) Reviewing and approving the results of all tests and examinations required under § 111.75.

(a) Quality control personnel must conduct a material review and make a disposition decision if:

(1) A specification established in accordance with § 111.70 is not met;

(2) A batch deviates from the master manufacturing record, including when any step established in the master manufacturing record is not completed and including any deviation from specifications;

(3) There is any unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record;

(4) Calibration of an instrument or control suggests a problem that may have resulted in a failure to ensure the quality of a batch or batches of a dietary supplement; or

(5) A dietary supplement is returned.

(b)(1) When there is a deviation or unanticipated occurrence during the production and in-process control system that results in or could lead to adulteration of a component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record, quality control personnel must reject the component, dietary supplement, packaging, or label unless it approves a treatment, an in-process adjustment, or reprocessing to correct the applicable deviation or occurrence.

(2) When a specification established in accordance with § 111.70 is not met, quality control personnel must reject the component, dietary supplement, package or label, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in § 111.77.

(c) The person who conducts a material review and makes the disposition decision must, at the time of performance, document that material review and disposition decision.

Quality control operations for equipment, instruments, and controls must include:

(a) Reviewing and approving all processes for calibrating instruments and controls;

(b) Periodically reviewing all records for calibration of instruments and controls;

(c) Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and

(d) Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.

Quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement must include:

(a) Reviewing all receiving records for components, packaging, and labels;

(b) Determining whether all components, packaging, and labels conform to specifications established under § 111.70 (b) and (d);

(c) Conducting any required material review and making any required disposition decision;

(d) Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and

(e) Approving, and releasing from quarantine, all components, packaging, and labels before they are used.

(a) Quality control operations for the master manufacturing record, the batch production record, and manufacturing operations must include:

(1) Reviewing and approving all master manufacturing records and all modifications to the master manufacturing records;

(2) Reviewing and approving all batch production-related records;

(3) Reviewing all monitoring required under subpart E;

(4) Conducting any required material review and making any required disposition decision;

(5) Approving or rejecting any reprocessing;

(6) Determining whether all in-process specifications established in accordance with § 111.70(c) are met;

(7) Determining whether each finished batch conforms to product specifications established in accordance with § 111.70(e); and

(8) Approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch.

(b) Quality control personnel must not approve and release for distribution:

(1) Any batch of dietary supplement for which any component in the batch does not meet its identity specification;

(2) Any batch of dietary supplement, including any reprocessed batch, that does not meet all product specifications established in accordance with § 111.70(e);

(3) Any batch of dietary supplement, including any reprocessed batch, that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act; and

(4) Any product received from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for which sufficient assurance is not provided to adequately identify the product and to determine that the product is consistent with your purchase order.

Quality control operations for packaging and labeling operations must include:

(a) Reviewing the results of any visual examination and documentation to ensure that specifications established under § 111.70(f) are met for all products that you receive for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier);

(b) Approving, and releasing from quarantine, all products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) before they are used for packaging or labeling;

(c) Reviewing and approving all records for packaging and label operations;

(d) Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);

(e) Conducting any required material review and making any required disposition decision;

(f) Approving or rejecting any repackaging of a packaged dietary supplement;

(g) Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and

(h) Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.

Quality control operations for returned dietary supplements must include:

(a) Conducting any required material review and making any required disposition decision; including:

(1) Determining whether tests or examination are necessary to determine compliance with product specifications established in accordance with § 111.70(e); and

(2) Reviewing the results of any tests or examinations that are conducted to determine compliance with product specifications established in accordance with § 111.70(e);

(b) Approving or rejecting any salvage and redistribution of any returned dietary supplement;

(c) Approving or rejecting any reprocessing of any returned dietary supplement; and

(d) Determining whether the reprocessed dietary supplement meets product specifications and either approving for release, or rejecting, any returned dietary supplement that is reprocessed.

Quality control operations for product complaints must include reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and followup action of any investigation performed.

(a) You must make and keep the records required under this subpart F in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing;

(2) Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the following:

(i) Date that the review, approval, or rejection was performed; and

(ii) Signature of the person performing the review, approval, or rejection; and

(3) Documentation of any material review and disposition decision and followup. Such documentation must be included in the appropriate batch production record and must include:

(i) Identification of the specific deviation or the unanticipated occurrence;

(ii) Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence;

(iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement or a failure to package and label the dietary supplement as specified in the master manufacturing record;

(iv) Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence;

(v) Explanation of what you did with the component, dietary supplement, packaging, or label;

(vi) A scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected; and

(vii) The signature of the individual(s) designated to perform the quality control operation, who conducted the material review and made the disposition decision, and of each qualified individual who provides information relevant to that material review and disposition decision.

You must establish and follow written procedures for fulfilling the requirements of this subpart G.

(a) You must visually examine each immediate container or grouping of immediate containers in a shipment that you receive for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components;

(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment you receive to ensure the components are consistent with your purchase order;

(c) You must quarantine components before you use them in the manufacture of a dietary supplement until:

(1) You collect representative samples of each unique lot of components (and, for components that you receive, of each unique shipment, and of each unique lot within each unique shipment);

(2) Quality control personnel review and approve the results of any tests or examinations conducted on components; and

(3) Quality control personnel approve the components for use in the manufacture of a dietary supplement, including approval of any treatment (including in-process adjustments) of components to make them suitable for use in the manufacture of a dietary supplement, and releases them from quarantine.

(d)(1) You must identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement that you manufactured and distributed.

(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of components that you receive and any lot of components that you produce.

(e) You must hold components under conditions that will protect against contamination and deterioration, and avoid mixups.

(a) You must visually examine each immediate container or grouping of immediate containers in a shipment for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the packaging and labels.

(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment to ensure that the packaging or labels are consistent with your purchase order.

(c) You must quarantine packaging and labels before you use them in the manufacture of a dietary supplement until:

(1) You collect representative samples of each unique shipment, and of each unique lot within each unique shipment, of packaging and labels and, at a minimum, conduct a visual identification of the immediate containers and closures;

(2) Quality control personnel review and approve the results of any tests or examinations conducted on the packaging and labels; and

(3) Quality control personnel approve the packaging and labels for use in the manufacture of a dietary supplement and release them from quarantine.

(d)(1) You must identify each unique lot within each unique shipment of packaging and labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label (e.g., quarantined, approved, or rejected); and to the dietary supplement that you distributed; and

(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels.

(e) You must hold packaging and labels under conditions that will protect against contamination and deterioration, and avoid mixups.

(a) You must visually examine each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product.

(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment of the received product to ensure that the received product is consistent with your purchase order.

(c) You must quarantine the received product until:

(1) You collect representative samples of each unique shipment, and of each unique lot within each unique shipment, of received product;

(2) Quality control personnel review and approve the documentation to determine whether the received product meets the specifications that you established under § 111.70(f); and

(3) Quality control personnel approve the received product for packaging or labeling as a dietary supplement and release the received product from quarantine.

(d)(1) You must identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to the supplier, the date received, the name of the received product, the status of the received product (e.g., quarantined, approved, or rejected), and to the product that you packaged or labeled and distributed as a dietary supplement.

(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of the received product.

(e) You must hold the received product under conditions that will protect against contamination and deterioration, and avoid mixups.

You must clearly identify, hold, and control under a quarantine system for appropriate disposition any component, packaging, and label, and any product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), that is rejected and unsuitable for use in manufacturing, packaging, or labeling operations.

(a) You must make and keep records required under this subpart G in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart.

(2) Receiving records (including records such as certificates of analysis, suppliers' invoices, and suppliers' guarantees) for components, packaging, and labels and for products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and

(3) Documentation that the requirements of this subpart were met.

(i) The person who performs the required operation must document, at the time of performance, that the required operation was performed.

(ii) The documentation must include:

(A) The date that the components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement were received;

(B) The initials of the person performing the required operation;

(C) The results of any tests or examinations conducted on components, packaging, or labels, and of any visual examination of product that you receive for packaging or labeling as a dietary supplement; and

(D) Any material review and disposition decision conducted on components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement.

(a) You must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.

(b) The master manufacturing record must:

(1) Identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and

(2) Establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified in accordance with paragraph (b)(1) of this section.

(c) You must make and keep master manufacturing records in accordance with subpart P of this part.

The master manufacturing record must include:

(a) The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size;

(b) A complete list of components to be used;

(c) An accurate statement of the weight or measure of each component to be used;

(d) The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement;

(e) A statement of any intentional overage amount of a dietary ingredient;

(f) A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made;

(g) A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label;

(h) Written instructions, including the following:

(1) Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record;

(2) Procedures for sampling and a cross-reference to procedures for tests or examinations;

(3) Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

(i) Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component; and

(ii) For manual operations, such specific actions must include:

(A) One person weighing or measuring a component and another person verifying the weight or measure; and

(B) One person adding the component and another person verifying the addition.

(4) Special notations and precautions to be followed; and

(5) Corrective action plans for use when a specification is not met.

(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;

(b) Your batch production record must include complete information relating to the production and control of each batch;

(c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and

(d) You must make and keep batch production records in accordance with subpart P of this part.

The batch production record must include the following:

(a) The batch, lot, or control number:

(1) Of the finished batch of dietary supplement; and

(2) That you assign in accordance with § 111.415(f) for the following:

(i) Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement;

(ii) Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to another person for packaging or labeling;

(b) The identity of equipment and processing lines used in producing the batch;

(c) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;

(d) The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used;

(e) The identity and weight or measure of each component used;

(f) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;

(g) The actual results obtained during any monitoring operation;

(h) The results of any testing or examination performed during the batch production, or a cross-reference to such results;

(i) Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g);

(j) Documentation, at the time of performance, of the manufacture of the batch, including:

(1) The date on which each step of the master manufacturing record was performed; and

(2) The initials of the persons performing each step, including:

(i) The initials of the person responsible for weighing or measuring each component used in the batch;

(ii) The initials of the person responsible for verifying the weight or measure of each component used in the batch;

(iii) The initials of the person responsible for adding the component to the batch; and

(iv) The initials of the person responsible for verifying the addition of components to the batch;

(k) Documentation, at the time of performance, of packaging and labeling operations, including:

(1) The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels;

(2) An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record; and

(3) The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results;

(l) Documentation at the time of performance that quality control personnel:

(1) Reviewed the batch production record, including:

(i) Review of any monitoring operation required under subpart E of this part; and

(ii) Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements;

(2) Approved or rejected any reprocessing or repackaging; and

(3) Approved and released, or rejected, the batch for distribution, including any reprocessed batch; and

(4) Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement.

(m) Documentation at the time of performance of any required material review and disposition decision.

(n) Documentation at the time of performance of any reprocessing.

You must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met.

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether:

(a) Components that you use meet specifications;

(b) In-process specifications are met as specified in the master manufacturing record; and

(c) Dietary supplements that you manufacture meet specifications.

You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:

(a) Use of criteria for establishing appropriate specifications;

(b) Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:

(1) Components, packaging, and labels;

(2) In-process materials;

(3) Finished batches of dietary supplements;

(4) Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and

(5) Packaged and labeled dietary supplements.

(c) Use of criteria for selecting appropriate examination and testing methods;

(d) Use of criteria for selecting standard reference materials used in performing tests and examinations; and

(e) Use of test methods and examinations in accordance with established criteria.

(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.

(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.

(a) You must make and keep records required under this subpart J in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;

(2) Documentation that laboratory methodology established in accordance with this subpart J is followed.

(i) The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed.

(ii) The documentation for laboratory tests and examinations must include the results of the testing and examination.

You must establish and follow written procedures for manufacturing operations.

You must design or select manufacturing processes to ensure that product specifications are consistently met.

You must conduct all manufacturing operations in accordance with adequate sanitation principles.

You must take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements. These precautions include:

(a) Performing manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination;

(b) Washing or cleaning components that contain soil or other contaminants;

(c) Using water that, at a minimum, complies with the applicable Federal, State, and local requirements and does not contaminate the dietary supplement when the water may become a component of the finished batch of dietary supplement;

(d) Performing chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components;

(e) Sterilizing, pasteurizing, freezing, refrigerating, controlling hydrogen-ion concentration (pH), controlling humidity, controlling water activity (aw), or using any other effective means to remove, destroy, or prevent the growth of microorganisms and prevent decomposition;

(f) Holding components and dietary supplements that can support the rapid growth of microorganisms of public health significance in a manner that prevents the components and dietary supplements from becoming adulterated;

(g) Identifying and holding any components or dietary supplements, for which a material review and disposition decision is required, in a manner that protects components or dietary supplements that are not under a material review against contamination and mixups with those that are under a material review;

(h) Performing mechanical manufacturing steps (such as cutting, sorting, inspecting, shredding, drying, grinding, blending, and sifting) by any effective means to protect the dietary supplements against contamination, by, for example:

(1) Cleaning and sanitizing contact surfaces;

(2) Using temperature controls; and

(3) Using time controls.

(i) Using effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements, by, for example:

(1) Filters or strainers,

(2) Traps,

(3) Magnets, or

(4) Electronic metal detectors.

(j) Segregating and identifying all containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing; and

(k) Identifying all processing lines and major equipment used during manufacturing to indicate their contents, including the name of the dietary supplement and the specific batch or lot number and, when necessary, the phase of manufacturing.

You must clearly identify, hold, and control under a quarantine system for appropriate disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or labeling operations.

(a) You must make and keep records required under this subpart K in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for manufacturing operations.

You must establish and follow written procedures for packaging and labeling operations.

(a) You must take necessary actions to determine whether packaging for dietary supplements meets specifications so that the condition of the packaging will ensure the quality of your dietary supplements;

(b) You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies. Label reconciliation is not required for cut or rolled labels if a 100-percent examination for correct labels is performed by appropriate electronic or electromechanical equipment during or after completion of finishing operations; and

(c) You must examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record; and

(d) You must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution.

You must fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. You must do this using any effective means, including the following:

(a) Cleaning and sanitizing all filling and packaging equipment, utensils, and dietary supplement packaging, as appropriate;

(b) Protecting manufactured dietary supplements from contamination, particularly airborne contamination;

(c) Using sanitary handling procedures;

(d) Establishing physical or spatial separation of packaging and label operations from operations on other components and dietary supplements to prevent mixups;

(e) Identifying, by any effective means, filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mixups;

(f) Assigning a batch, lot, or control number to:

(1) Each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement; and,

(2) Each lot of dietary supplement, from a finished batch of dietary supplement, that you distribute to another person for packaging or labeling.

(g) Examining a representative sample of each batch of the packaged and labeled dietary supplement to determine whether the dietary supplement meets specifications established in accordance with § 111.70(g); and

(h) Suitably disposing of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations.

(a) You may repackage or relabel dietary supplements only after quality control personnel have approved such repackaging or relabeling.

(b) You must examine a representative sample of each batch of repackaged or relabeled dietary supplements to determine whether the repackaged or relabeled dietary supplements meet all specifications established in accordance with § 111.70(g).

(c) Quality control personnel must approve or reject each batch of repackaged or relabeled dietary supplement prior to its release for distribution.

You must clearly identify, hold, and control under a quarantine system for appropriate disposition any packaged and labeled dietary supplement that is rejected for distribution.

(a) You must make and keep records required under this subpart L in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for packaging and labeling operations.

You must establish and follow written procedures for holding and distributing operations.

(a) You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.

(b) You must hold packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected.

(c) You must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels.

(a) You must identify and hold in-process material under conditions that protect against mixup, contamination, and deterioration.

(b) You must hold in-process material under appropriate conditions of temperature, humidity, and light.

(a) You must hold reserve samples of dietary supplements in a manner that protects against contamination and deterioration. This includes:

(1) Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions; and

(2) Using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distribute the dietary supplement for packaging and labeling elsewhere.

(b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations.

You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration.

(a) You must make and keep records required under this subpart M in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for holding and distributing operations; and

(2) Records of product distribution.

You must establish and follow written procedures to fulfill the requirements of this subpart.

You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.

You must destroy, or otherwise suitably dispose of, any returned dietary supplement unless the outcome of a material review and disposition decision is that quality control personnel do the following:

(a) Approve the salvage of the returned dietary supplement for redistribution or

(b) Approve the returned dietary supplement for reprocessing.

You may salvage a returned dietary supplement only if quality control personnel conduct a material review and make a disposition decision to allow the salvage.

(a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance with § 111.70(e); and

(b) Quality control personnel must approve or reject the release for distribution of any returned dietary supplement that is reprocessed.

If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.

(a) You must make and keep records required under this subpart N in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart N.

(2) Any material review and disposition decision on a returned dietary supplement;

(3) The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and,

(4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with § 111.70(e).

You must establish and follow written procedures to fulfill the requirements of this subpart O.

(a) A qualified person must:

(1) Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and

(2) Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.

(b) Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed.

(c) The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and followup action of any investigation performed, must extend to all relevant batches and records.

(a) You must make and keep the records required under this subpart O in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart,

(2) A written record of every product complaint that is related to good manufacturing practice,

(i) The person who performs the requirements of this subpart must document, at the time of performance, that the requirement was performed.

(ii) The written record of the product complaint must include the following:

(A) The name and description of the dietary supplement;

(B) The batch, lot, or control number of the dietary supplement, if available;

(C) The date the complaint was received and the name, address, or telephone number of the complainant, if available;

(D) The nature of the complaint including, if known, how the product was used;

(E) The reply to the complainant, if any; and

(F) Findings of the investigation and followup action taken when an investigation is performed.

(a) You must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

(b) Records must be kept as original records, as true copies (such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records), or as electronic records.

(c) All electronic records must comply with part 11 of this chapter.

(a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.

(b) If you use reduction techniques, such as microfilming, you must make suitable reader and photocopying equipment readily available to FDA.

(a) Unless it is excluded from this part under § 112.2, food that is produce within the meaning of this part and that is a raw agricultural commodity (RAC) is covered by this part. This includes a produce RAC that is grown domestically and a produce RAC that will be imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) For the purpose of this part and subject to the exemptions and qualified exemptions therein, covered produce includes all of the following:

(1) Fruits and vegetables such as almonds, apples, apricots, apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes, carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly endive, currants, dandelion leaves, fennel-Florence, garlic, genip, gooseberries, grapes, green beans, guavas, herbs (such as basil, chives, cilantro, oregano, and parsley), honeydew, huckleberries, Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, lettuce, lychees, macadamia nuts, mangos, other melons (such as Canary, Crenshaw and Persian), mulberries, mushrooms, mustard greens, nectarines, onions, papayas, parsnips, passion fruit, peaches, pears, peas, peas-pigeon, peppers (such as bell and hot), pine nuts, pineapples, plantains, plums, plumcots, quince, radishes, raspberries, rhubarb, rutabagas, scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips (roots and tops), walnuts, watercress, watermelons, and yams; and

(2) Mixes of intact fruits and vegetables (such as fruit baskets).

(a) The following produce is not covered by this part:

(1) Produce that is rarely consumed raw, specifically the produce on the following exhaustive list: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts.

(2) Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management; and

(3) Produce that is not a raw agricultural commodity.

(b) Produce is eligible for exemption from the requirements of this part (except as noted in paragraphs (b)(1), (2), and (3) of this section) under the following conditions:

(1) The produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance. Examples of commercial processing that adequately reduces the presence of microorganisms of public health significance are processing in accordance with the requirements of part 113, 114, or 120 of this chapter, treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products; and

(2) You must disclose in documents accompanying the produce, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance;” and

(3) You must either:

(i) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of this section, from the customer that performs the commercial processing described in paragraph (b)(1) of this section that the customer has established and is following procedures (identified in the written assurance) that adequately reduce the presence of microorganisms of public health significance; or

(ii) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of this section, from your customer that an entity in the distribution chain subsequent to the customer will perform commercial processing described in paragraph (b)(1) of this section and that the customer:

(A) Will disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and

(B) Will only sell to another entity that agrees, in writing, it will either:

(1) Follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance; or

(2) Obtain a similar written assurance from its customer that the produce will receive commercial processing described in paragraph (b)(1) of this section, and that there will be disclosure in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and

(4) You must establish and maintain documentation of your compliance with applicable requirements in paragraphs (b)(2) and (3) in accordance with the requirements of subpart O of this part, including:

(i) Documents containing disclosures required under paragraph (b)(2) of this section; and

(ii) Annual written assurances obtained from customers required under paragraph (b)(3) of this section; and

(5) The requirements of this subpart and subpart Q of this part apply to such produce; and

(6) An entity that provides a written assurance under § 112.2(b)(3)(i) or (ii) must act consistently with the assurance and document its actions taken to satisfy the written assurance.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:

Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.

Adequately reduce microorganisms of public health significance means reduce the presence of such microorganisms to an extent sufficient to prevent illness.

Agricultural tea means a water extract of biological materials (such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table waste, or yard trimmings), excluding any form of human waste, produced to transfer microbial biomass, fine particulate organic matter, and soluble chemical components into an aqueous phase. Agricultural teas are held for longer than one hour before application. Agricultural teas are soil amendments for the purposes of this rule.

Agricultural tea additive means a nutrient source (such as molasses, yeast extract, or algal powder) added to agricultural tea to increase microbial biomass.

Agricultural water means water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce).

Animal excreta means solid or liquid animal waste.

Application interval means the time interval between application of an agricultural input (such as a biological soil amendment of animal origin) to a growing area and harvest of covered produce from the growing area where the agricultural input was applied.

Biological soil amendment means any soil amendment containing biological materials such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea, or yard trimmings, alone or in combination.

Biological soil amendment of animal origin means a biological soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts including animal mortalities, or table waste, alone or in combination. The term “biological soil amendment of animal origin” does not include any form of human waste.

Composting means a process to produce stabilized compost in which organic material is decomposed by the actions of microorganisms under thermophilic conditions for a designated period of time (for example, 3 days) at a designated temperature (for example, 131 °F (55 °C)), followed by a curing stage under cooler conditions.

Covered activity means growing, harvesting, packing, or holding covered produce on a farm. Covered activity includes manufacturing/processing of covered produce on a farm, but only to the extent that such activities are performed on raw agricultural commodities and only to the extent that such activities are within the meaning of “farm” as defined in this chapter. Providing, acting consistently with, and documenting actions taken in compliance with written assurances as described in § 112.2(b) are also covered activities. This part does not apply to activities of a facility that are subject to part 117 of this chapter.

Covered produce means produce that is subject to the requirements of this part in accordance with §§ 112.1 and 112.2. The term “covered produce” refers to the harvestable or harvested part of the crop.

Curing means the final stage of composting, which is conducted after much of the readily metabolized biological material has been decomposed, at cooler temperatures than those in the thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition. Curing may or may not involve insulation, depending on environmental conditions.

Direct water application method means using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces during use of the water.

Farm means:

(1) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term “farm” includes operations that, in addition to these activities:

(i) Pack or hold raw agricultural commodities;

(ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

(iii) Manufacture/process food, provided that:

(A) All food used in such activities is consumed on that farm or another farm under the same management; or

(B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and

(3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

(2) Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in paragraphs (1)(ii) and (iii) of this definition.

Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes seeds and beans used to grow sprouts.

Food contact surfaces means those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food contact surfaces” includes food contact surfaces of equipment and tools used during harvest, packing and holding.

Ground water means the supply of fresh water found beneath the Earth's surface, usually in aquifers, which supply wells and springs. Ground water does not include any water that meets the definition of surface water.

Growth media means material that acts as a substrate during the growth of covered produce (such as mushrooms and some sprouts) that contains, may contain, or consists of components that may include any animal waste (such as stabilized compost, manure, non-fecal animal byproducts or table waste).

Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.

Hazard means any biological agent that has the potential to cause illness or injury in the absence of its control.

Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

Known or reasonably foreseeable hazard means a biological hazard that is known to be, or has the potential to be, associated with the farm or the food.

Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.

Manure means animal excreta, alone or in combination with litter (such as straw and feathers used for animal bedding) for use as a soil amendment.

Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species having public health significance. The term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.

Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but that also conducts activities outside the farm definition that require the establishment to be registered.

Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point or procedure is under control and, when required, to produce an accurate record of the observation or measurement.

Non-fecal animal byproduct means solid waste (other than manure) that is animal in origin (such as meat, fat, dairy products, eggs, carcasses, blood meal, bone meal, fish meal, shellfish waste (such as crab, shrimp, and lobster waste), fish emulsions, and offal) and is generated by commercial, institutional, or agricultural operations.

Packing means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.

Pest means any objectionable animals or insects, including birds, rodents, flies, and larvae.

Pre-consumer vegetative waste means solid waste that is purely vegetative in origin, not considered yard trash, and derived from commercial, institutional, or agricultural operations without coming in contact with animal products, byproducts or manure or with an end user (consumer). Pre-consumer vegetative waste includes material generated by farms, packing houses, canning operations, wholesale distribution centers and grocery stores; products that have been removed from their packaging (such as out-of-date juice, vegetables, condiments, and bread); and associated packaging that is vegetative in origin (such as paper or corn-starch based products). Pre-consumer vegetative waste does not include table waste, packaging that has come in contact with materials (such as meat) that are not vegetative in origin, or any waste generated by restaurants.

Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro). Produce does not include food grains meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are primarily grown and processed for use as meal, flour, baked goods, cereals and oils rather than for direct consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed).

Production batch of sprouts means all sprouts that are started at the same time in a single growing unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other), whether or not the sprouts are grown from a single lot of seed (including, for example, when multiple types of seeds are grown in a single growing unit).

Qualified end-user, with respect to a food, means the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227) that is located:

(1) In the same State or the same Indian reservation as the farm that produced the food; or

(2) Not more than 275 miles from such farm.

Raw agricultural commodity (RAC) means “raw agricultural commodity” as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.

Sanitize means to adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

Sewage sludge biosolids means the solid or semi-solid residue generated during the treatment of domestic sewage in a treatment works within the meaning of the definition of “sewage sludge” in 40 CFR 503.9(w).

Small business means a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in this section.

Soil amendment means any chemical, biological, or physical material (such as elemental fertilizers, stabilized compost, manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea and yard trimmings) intentionally added to the soil to improve the chemical or physical condition of soil in relation to plant growth or to improve the capacity of the soil to hold water. The term soil amendment also includes growth media that serve as the entire substrate during the growth of covered produce (such as mushrooms and some sprouts).

Spent sprout irrigation water means water that has been used in the growing of sprouts.

Stabilized compost means a stabilized (i.e., finished) biological soil amendment produced through a controlled composting process.

Static composting means a process to produce stabilized compost in which air is introduced into biological material (in a pile (or row) that may or may not be covered with insulating material, or in an enclosed vessel) by a mechanism that does not include turning. Examples of structural features for introducing air include embedded perforated pipes and a constructed permanent base that includes aeration slots. Examples of mechanisms for introducing air include passive diffusion and mechanical means (such as blowers that suction air from the composting material or blow air into the composting material using positive pressure).

Surface water means all water open to the atmosphere (rivers, lakes, reservoirs, streams, impoundments, seas, estuaries, etc.) and all springs, wells, or other collectors that are directly influenced by surface water.

Table waste means any post-consumer food waste, irrespective of whether the source material is animal or vegetative in origin, derived from individuals, institutions, restaurants, retail operations, or other sources where the food has been served to a consumer.

Turned composting means a process to produce stabilized compost in which air is introduced into biological material (in a pile, row, or enclosed vessel) by turning on a regular basis. Turning is the process of mechanically mixing biological material that is undergoing a composting process with the specific intention of moving the outer, cooler sections of the material being composted to the inner, hotter sections.

Very small business means a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250,000.

Visitor means any person (other than personnel) who enters your covered farm with your permission.

Water distribution system means a system to carry water from its primary source to its point of use, including pipes, sprinklers, irrigation canals, pumps, valves, storage tanks, reservoirs, meters, and fittings.

We means the U.S. Food and Drug Administration (FDA).

Yard trimmings means purely vegetative matter resulting from landscaping maintenance or land clearing operations, including materials such as tree and shrub trimmings, grass clippings, palm fronds, trees, tree stumps, untreated lumber, untreated wooden pallets, and associated rocks and soils.

You, for purposes of this part, means the owner, operator, or agent in charge of a covered farm that is subject to some or all of the requirements of this part.

(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with an average annual monetary value of produce (as “produce” is defined in § 112.3) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as the baseline year for calculating the adjustment, is a “covered farm” subject to this part. Covered farms subject to this part must comply with all applicable requirements of this part when conducting a covered activity on covered produce.

(b) A farm is not a covered farm if it satisfies the requirements in § 112.5 and we have not withdrawn the farm's exemption in accordance with the requirements of subpart R of this part.

(a) A farm is eligible for a qualified exemption and associated modified requirements in a calendar year if:

(1) During the previous 3-year period preceding the applicable calendar year, the average annual monetary value of the food (as defined in § 112.3) the farm sold directly to qualified end-users (as defined in § 112.3) during such period exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and

(2) The average annual monetary value of all food (as defined in § 112.3) the farm sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

(b) For the purpose of determining whether the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.

(a) If your farm is eligible for a qualified exemption in accordance with § 112.5, you are subject to the requirements of:

(1) This subpart (General Provisions);

(2) Subpart O of this part (Records);

(3) Subpart Q of this part (Compliance and Enforcement); and

(4) Subpart R of this part (Withdrawal of Qualified Exemption).

(b) In addition, you are subject to the following modified requirements:

(1) When a food packaging label is required on food that would otherwise be covered produce under the Federal Food, Drug, and Cosmetic Act or its implementing regulations, you must include prominently and conspicuously on the food packaging label the name and the complete business address of the farm where the produce was grown.

(2) When a food packaging label is not required on food that would otherwise be covered produce under the Federal Food, Drug, and Cosmetic Act, you must prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business, or, in the case of Internet sales, in an electronic notice.

(3) The complete business address that you must include in accordance with the requirements of paragraph (b)(1) or (2) of this section must include the street address or post office box, city, state, and zip code for domestic farms, and comparable full address information for foreign farms.

If your farm is eligible for a qualified exemption in accordance with § 112.5:

(a) You must establish and keep records required under this provision in accordance with the requirements of subpart O of this part, except that the requirement in § 112.161(a)(4) for a signature or initial of the person performing the activity is not required for sales receipts kept in the normal course of business. Such receipts must be dated as required under § 112.161(a)(4).

(b) You must establish and keep adequate records necessary to demonstrate that your farm satisfies the criteria for a qualified exemption that are described in § 112.5, including a written record reflecting that you have performed an annual review and verification of your farm's continued eligibility for the qualified exemption.

You must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act on account of such hazards.

(a) You may establish alternatives to certain specific requirements of subpart E of this part, as specified in § 112.49, provided that you satisfy the requirements of paragraphs (b) and (c) of this section.

(b) You may establish and use an alternative to any of the requirements specified in paragraph (a) of this section, provided you have adequate scientific data or information to support a conclusion that the alternative would provide the same level of public health protection as the applicable requirement established in this part, and would not increase the likelihood that your covered produce will be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act, in light of your covered produce, practices, and conditions.

(c) Scientific data and information used to support an alternative to a requirement specified in paragraph (a) of this section may be developed by you, available in the scientific literature, or available to you through a third party. You must establish and maintain documentation of the scientific data and information on which you rely in accordance with the requirements of subpart O of this part. You are not required to notify or seek prior approval from FDA regarding your decision to establish or use an alternative under this section.

All of the following requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces:

(a) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as appropriate to the person's duties, upon hiring, and periodically thereafter, at least once annually.

(b) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must have a combination of education, training, and experience necessary to perform the person's assigned duties in a manner that ensures compliance with this part.

(c) Training must be conducted in a manner that is easily understood by personnel being trained.

(d) Training must be repeated as necessary and appropriate in light of observations or information indicating that personnel are not meeting standards established by FDA in subparts C through O of this part.

(a) At a minimum, all personnel who handle (contact) covered produce during covered activities or supervise the conduct of such activities must receive training that includes all of the following:

(1) Principles of food hygiene and food safety;

(2) The importance of health and personal hygiene for all personnel and visitors, including recognizing symptoms of a health condition that is reasonably likely to result in contamination of covered produce or food contact surfaces with microorganisms of public health significance; and

(3) The standards established by FDA in subparts C through O of this part that are applicable to the employee's job responsibilities.

(b) Persons who conduct harvest activities for covered produce must also receive training that includes all of the following:

(1) Recognizing covered produce that must not be harvested, including covered produce that may be contaminated with known or reasonably foreseeable hazards;

(2) Inspecting harvest containers and equipment to ensure that they are functioning properly, clean, and maintained so as not to become a source of contamination of covered produce with known or reasonably foreseeable hazards; and

(3) Correcting problems with harvest containers or equipment, or reporting such problems to the supervisor (or other responsible party), as appropriate to the person's job responsibilities.

(c) At least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration.

You must assign or identify personnel to supervise (or otherwise be responsible for) your operations to ensure compliance with the requirements of this part.

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part.

(b) You must establish and keep records of training that document required training of personnel, including the date of training, topics covered, and the persons(s) trained.

(a) You must take measures to prevent contamination of covered produce and food contact surfaces with microorganisms of public health significance from any person with an applicable health condition (such as communicable illnesses that present a public health risk in the context of normal work duties, infection, open lesion, vomiting, or diarrhea).

(b) The measures you must take to satisfy the requirements of paragraph (a) of this section must include all of the following measures:

(1) Excluding any person from working in any operations that may result in contamination of covered produce or food contact surfaces with microorganisms of public health significance when the person (by medical examination, the person's acknowledgement, or observation) is shown to have, or appears to have, an applicable health condition, until the person's health condition no longer presents a risk to public health; and

(2) Instructing personnel to notify their supervisor(s) (or a responsible party) if they have, or if there is a reasonable possibility that they have an applicable health condition.

(a) Personnel who work in an operation in which covered produce or food contact surfaces are at risk of contamination with known or reasonably foreseeable hazards must use hygienic practices while on duty to the extent necessary to protect against such contamination.

(b) The hygienic practices that personnel use to satisfy the requirements of paragraph (a) of this section when handling (contacting) covered produce or food contact surfaces during a covered activity must include all of the following practices:

(1) Maintaining adequate personal cleanliness to protect against contamination of covered produce and food contact surfaces;

(2) Avoiding contact with animals other than working animals, and taking appropriate steps to minimize the likelihood of contamination of covered produce when in direct contact with working animals;

(3) Washing hands thoroughly, including scrubbing with soap (or other effective surfactant) and running water that satisfies the requirements of § 112.44(a) (as applicable) for water used to wash hands, and drying hands thoroughly using single-service towels, sanitary towel service, electric hand dryers, or other adequate hand drying devices:

(i) Before starting work;

(ii) Before putting on gloves;

(iii) After using the toilet;

(iv) Upon return to the work station after any break or other absence from the work station;

(v) As soon as practical after touching animals (including livestock and working animals), or any waste of animal origin; and

(vi) At any other time when the hands may have become contaminated in a manner that is reasonably likely to lead to contamination of covered produce with known or reasonably foreseeable hazards;

(4) If you choose to use gloves in handling covered produce or food contact surfaces, maintaining gloves in an intact and sanitary condition and replacing such gloves when no longer able to do so;

(5) Removing or covering hand jewelry that cannot be adequately cleaned and sanitized during periods in which covered produce is manipulated by hand; and

(6) Not eating, chewing gum, or using tobacco products in an area used for a covered activity (however, drinking beverages is permitted in designated areas).

(a) You must make visitors aware of policies and procedures to protect covered produce and food contact surfaces from contamination by people and take all steps reasonably necessary to ensure that visitors comply with such policies and procedures.

(b) You must make toilet and hand-washing facilities accessible to visitors.

All agricultural water must be safe and of adequate sanitary quality for its intended use.

(a) At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces in light of your covered produce, practices, and conditions, including consideration of the following:

(1) The nature of each agricultural water source (for example, ground water or surface water);

(2) The extent of your control over each agricultural water source;

(3) The degree of protection of each agricultural water source;

(4) Use of adjacent and nearby land; and

(5) The likelihood of introduction of known or reasonably foreseeable hazards to agricultural water by another user of agricultural water before the water reaches your covered farm.

(b) You must adequately maintain all agricultural water distribution systems to the extent they are under your control as necessary and appropriate to prevent the water distribution system from being a source of contamination to covered produce, food contact surfaces, areas used for a covered activity, or water sources, including by regularly inspecting and adequately storing all equipment used in the system.

(c) You must adequately maintain all agricultural water sources to the extent they are under your control (such as wells). Such maintenance includes regularly inspecting each source to identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces; correcting any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections); and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination of covered produce to the extent practicable and appropriate under the circumstances.

(d) As necessary and appropriate, you must implement measures reasonably necessary to reduce the potential for contamination of covered produce with known or reasonably foreseeable hazards as a result of contact of covered produce with pooled water. For example, such measures may include using protective barriers or staking to keep covered produce from touching the ground or using an alternative irrigation method.

(a) When agricultural water is treated in accordance with § 112.45:

(1) Any method you use to treat agricultural water (such as with physical treatment, including using a pesticide device as defined by the U.S. Environmental Protection Agency (EPA); EPA-registered antimicrobial pesticide product; or other suitable method) must be effective to make the water safe and of adequate sanitary quality for its intended use and/or meet the relevant microbial quality criteria in § 112.44, as applicable.

(2) You must deliver any treatment of agricultural water in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

(b) You must monitor any treatment of agricultural water at a frequency adequate to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

(a) When you use agricultural water for any one or more of these following purposes, you must ensure there is no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purposes:

(1) Used as sprout irrigation water;

(2) Applied in any manner that directly contacts covered produce during or after harvest activities (for example, water that is applied to covered produce for washing or cooling activities, and water that is applied to harvested crops to prevent dehydration before cooling), including when used to make ice that directly contacts covered produce during or after harvest activities;

(3) Used to contact food contact surfaces, or to make ice that will contact food contact surfaces; and

(4) Used for washing hands during and after harvest activities.

(b) When you use agricultural water during growing activities for covered produce (other than sprouts) using a direct water application method, the following criteria apply (unless you establish and use alternative criteria in accordance with § 112.49):

(1) A geometric mean (GM) of your agricultural water samples of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water (GM is a measure of the central tendency of your water quality distribution); and

(2) A statistical threshold value (STV) of your agricultural water samples of 410 or less CFU of generic E. coli per 100 mL of water (STV is a measure of variability of your water quality distribution, derived as a model-based calculation approximating the 90th percentile using the lognormal distribution).

(a) If you have determined or have reason to believe that your agricultural water is not safe or of adequate sanitary quality for its intended use as required under § 112.41 and/or if your agricultural water does not meet the microbial quality criterion for the specified purposes as required under § 112.44(a), you must immediately discontinue that use(s), and before you may use the water source and/or distribution system again for the intended use(s), you must either:

(1) Re-inspect the entire affected agricultural water system to the extent it is under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces, make necessary changes, and take adequate measures to determine if your changes were effective and, as applicable, adequately ensure that your agricultural water meets the microbial quality criterion in § 112.44(a); or

(2) Treat the water in accordance with the requirements of § 112.43.

(b) If you have determined that your agricultural water does not meet the microbial quality criteria (or any alternative microbial quality criteria, if applicable) required under § 112.44(b), as soon as practicable and no later than the following year, you must discontinue that use, unless you either:

(1) Apply a time interval(s) (in days) and/or a (calculated) log reduction by:

(i) Applying a time interval between last irrigation and harvest using either:

(A) A microbial die-off rate of 0.5 log per day to achieve a (calculated) log reduction of your geometric mean (GM) and statistical threshold value (STV) to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable), but no greater than a maximum time interval of 4 consecutive days; or

(B) An alternative microbial die-off rate and any accompanying maximum time interval, in accordance with § 112.49; and/or

(ii) Applying a time interval between harvest and end of storage using an appropriate microbial die-off rate between harvest and end of storage, and/or applying a (calculated) log reduction using appropriate microbial removal rates during activities such as commercial washing, to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable), and any accompanying maximum time interval or log reduction, provided you have adequate supporting scientific data and information;

(2) Re-inspect the entire affected agricultural water system to the extent it is under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces, make necessary changes, and take adequate measures to determine if your changes were effective and adequately ensure that your agricultural water meets the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable); or

(3) Treat the water in accordance with the requirements of § 112.43.

(a) There is no requirement to test any agricultural water that is subject to the requirements of § 112.44 when:

(1) You receive water from a Public Water System, as defined under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that furnishes water that meets the microbial requirements under those regulations or under the regulations of a State (as defined in 40 CFR 141.2) approved to administer the SDWA public water supply program, and you have Public Water System results or certificates of compliance that demonstrate that the water meets that requirement;

(2) You receive water from a public water supply that furnishes water that meets the microbial quality requirement described in § 112.44(a), and you have public water system results or certificates of compliance that demonstrate that the water meets that requirement; or

(3) You treat water in accordance with the requirements of § 112.43.

(b) Except as provided in paragraph (a) of this section, you must take the following steps for each source of water used for purposes that are subject to the requirements of § 112.44(b):

(1) Conduct an initial survey to develop a microbial water quality profile of the agricultural water source.

(i) The initial survey must be conducted:

(A) For an untreated surface water source, by taking a minimum total of 20 samples of agricultural water (or an alternative testing frequency that you establish and use, in accordance with § 112.49) over a minimum period of 2 years, but not greater than 4 years.

(B) For an untreated ground water source, by taking a minimum total of four samples of agricultural water during the growing season or over a period of 1 year.

(ii) The samples of agricultural water must be representative of your use of the water and must be collected as close in time as practicable to, but prior to, harvest. The microbial water quality profile initially consists of the geometric mean (GM) and the statistical threshold value (STV) of generic Escherichia coli (E. coli) (colony forming units (CFU) per 100 milliliter (mL)) calculated using this data set. You must determine the appropriate way(s) in which the water may be used based on your microbial water quality profile in accordance with § 112.45(b).

(iii) You must update the microbial water quality profile annually as required under paragraph (b)(2) of this section, and otherwise required under paragraph (b)(3) of this section.

(2) Conduct an annual survey to update the microbial water quality profile of your agricultural water.

(i) After the initial survey described in paragraph (b)(1)(i) of this section, you must test the water annually to update your existing microbial water quality profile to confirm that the way(s) in which the water is used continues to be appropriate. You must analyze:

(A) For an untreated surface water source, a minimum number of five samples per year (or an alternative testing frequency that you establish and use, in accordance with § 112.49).

(B) For an untreated ground water source, a minimum of one sample per year.

(ii) The samples of agricultural water must be representative of your use of the water and must be collected as close in time as practicable to, but prior to, harvest.

(iii) To update the microbial water quality profile, you must calculate revised GM and STV values using your current annual survey data, combined with your most recent initial or annual survey data from within the previous 4 years, to make up a rolling data set of:

(A) At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(iv) You must modify your water use, as appropriate, based on the revised GM and STV values in your updated microbial water quality profile in accordance with § 112.45(b).

(3) If you have determined or have reason to believe that your microbial water quality profile no longer represents the quality of your water (for example, if there are significant changes in adjacent land use that are reasonably likely to adversely affect the quality of your water source), you must develop a new microbial water quality profile reflective of the time period at which you believe your microbial water quality profile changed.

(i) To develop a new microbial water quality profile, you must calculate new GM and STV values using your current annual survey data (if taken after the time of the change), combined with new data, to make up a data set of:

(A) At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(ii) You must modify your water use based on the new GM and STV values in your new microbial water quality profile in accordance with § 112.45(b).

(c) If you use untreated ground water for the purposes that are subject to the requirements of § 112.44(a), you must initially test the microbial quality of each source of the untreated ground water at least four times during the growing season or over a period of 1 year, using a minimum total of four samples collected to be representative of the intended use(s). Based on these results, you must determine whether the water can be used for that purpose, in accordance with § 112.45(a). If your four initial sample results meet the microbial quality criteria of § 112.44(a), you may test once annually thereafter, using a minimum of one sample collected to be representative of the intended use(s). You must resume testing at least four times per growing season or year if any annual test fails to meet the microbial quality criteria in § 112.44(a).