(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.