In addition to FDA's authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, FDA deems all other products meeting the definition of tobacco product under section 201(rr) of the Federal Food, Drug, and Cosmetic Act, except accessories of such other tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act.
Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco are subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. FDA has deemed all other tobacco products, except accessories of such other tobacco products, subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
For the purposes of this part:
Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored tobacco product; or
(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.
Component or part means any software or assembly of materials intended or reasonably expected:
(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or
(2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.
Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.
Tobacco product. As stated in section 201(rr) of the Federal Food, Drug, and Cosmetic Act in relevant part, a tobacco product:
(1) Means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product); and
(2) Does not mean an article that is a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act.
If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be subject to regulation as a drug, device, or combination product.
(a) The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms;
(b) The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
(a) FDA will refuse to accept for review, as soon as practicable, a premarket tobacco product application, modified risk tobacco product application, substantial equivalence application, or exemption request or subsequent abbreviated report for the following reasons, if applicable:
(1) The submission does not pertain to a tobacco product as defined in 21 U.S.C. 321(rr).
(2) The submission is not in English or does not contain complete English translations of any information submitted within.
(3) If submitted in an electronic format, the submission is in a format that FDA cannot process, read, review, and archive.
(4) The submission does not contain contact information, including the applicant's name and address.
(5) The submission is from a foreign applicant and does not identify an authorized U.S. agent, including the agent's name and address, for the submission.
(6) The submission does not contain a required FDA form(s).
(7) The submission does not contain the following product-identifying information: The manufacturer of the tobacco product; the product name, including the brand and subbrand; the product category and subcategory; package type and package quantity; and characterizing flavor.
(8) The type of submission is not specified.
(9) The submission does not contain a signature of a responsible official, authorized to represent the applicant, who either resides in or has a place of business in the United States.
(10) For premarket tobacco applications, modified risk tobacco product applications, substantial equivalence applications, and exemption requests only: The submission does not include a valid claim of categorical exclusion in accordance with part 25 of this chapter, or an environmental assessment.
(b) If FDA finds that none of the reasons in paragraph (a) of this section exists for refusing to accept a premarket submission, FDA may accept the submission for processing and further review. FDA will send to the submitter an acknowledgement letter stating the submission has been accepted for processing and further review and will provide the premarket submission tracking number.
(c) If FDA finds that any of the reasons in paragraph (a) of this section exist for refusing to accept the submission, FDA will notify the submitter in writing of the reason(s) and that the submission has not been accepted, unless insufficient contact information was provided.
(a) General requirements. Under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e(j)(3)), FDA may exempt from the requirements relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if FDA determines that:
(1) Such modification would be a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act (a legally marketed tobacco product);
(2) A report under section 905(j)(1) intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and
(3) An exemption is otherwise appropriate.
(b) Request for an exemption under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act. A request for an exemption from the requirement of demonstrating substantial equivalence may be made only by the manufacturer of a legally marketed tobacco product for a minor modification to that tobacco product. To request an exemption, the manufacturer must submit the request and all information supporting the request in an electronic format that FDA can process, review, and archive. If the manufacturer is unable to submit an exemption request in an electronic format, the manufacturer may submit a written request to the Center for Tobacco Products explaining in detail why the manufacturer cannot submit the request in an electronic format and requesting an alternative format. Such request must include an explanation of why an alternative format is necessary. All submissions, including requests to submit the information in an alternative format, requests for exemptions, and all supporting information must be legible and in the English language. An exemption request must contain:
(1) The manufacturer's address and contact information;
(2) Identification of the tobacco product(s);
(3) A detailed explanation of the purpose of the modification;
(4) A detailed description of the modification, including a statement as to whether the modification involves adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive;
(5) A detailed explanation of why the modification is a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act;
(6) A detailed explanation of why a report under section 905(j)(1) of the Federal Food, Drug, and Cosmetic Act intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health;
(7) A certification (i.e., a signed statement by a responsible official of the manufacturer) summarizing the supporting evidence and providing the rationale for the official's determination that the modification does not increase the tobacco product's appeal to or use by minors, toxicity, addictiveness, or abuse liability;
(8) Other information justifying an exemption; and
(9) An environmental assessment under part 25 of this chapter prepared in accordance with the requirements of § 25.40 of this chapter.
(c) Exemption determination. FDA will review the information submitted and determine whether to grant or deny an exemption request based on whether the criteria in section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act are met. FDA may request additional information if necessary to make a determination. FDA will consider the exemption request withdrawn if the information is not provided within the requested timeframe.
(d) Rescission of an exemption. FDA may rescind an exemption if it finds that the exemption is not appropriate for the protection of public health. In general, FDA will rescind an exemption only after notice and opportunity for a hearing under part 16 of this chapter is provided. However, FDA may rescind an exemption prior to notice and opportunity for a hearing under part 16 of this chapter if the continuance of the exemption presents a serious risk to public health. In that case, FDA will provide the manufacturer an opportunity for a hearing as soon as possible after the rescission.
(a) This part sets out the restrictions under the Federal Food, Drug, and Cosmetic Act on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products. Section 1140.16(d) sets out restrictions on the distribution of free samples for cigarettes, smokeless tobacco, and other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).
(b) The failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes, smokeless tobacco, covered tobacco products, or other tobacco products renders the product misbranded under the Federal Food, Drug, and Cosmetic Act.
(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
The purpose of this part is to establish restrictions on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products in order to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use.
For the purposes of this part:
Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored product; or
(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.
Cigarette. (1) Means a product that:
(i) Is a tobacco product and
(ii) Meets the definition of the term “cigarette” in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and
(2) Includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.
Cigarette tobacco means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter also apply to cigarette tobacco.
Component or part means any software or assembly of materials intended or reasonably expected:
(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or
(2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.
Covered tobacco product means any tobacco product deemed to be subject to the Federal Food, Drug, and Cosmetic Act under § 1100.2 of this chapter, but excludes any component or part that is not made or derived from tobacco.
Distributor means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this part.
Importer means any person who imports any tobacco product that is intended for sale or distribution to consumers in the United States.
Manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product.
Nicotine means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex of nicotine.
Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane) in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.
Point of sale means any location at which a consumer can purchase or otherwise obtain tobacco products for personal consumption.
Retailer means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays are permitted under this part.
Roll-your-own tobacco means any tobacco product that, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.
Smokeless tobacco means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.
Tobacco product. As stated in section 201(rr) of the Federal Food, Drug, and Cosmetic Act in relevant part, a tobacco product:
(1) Means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product) and
(2) Does not mean an article that is a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act.
Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the cigarettes, smokeless tobacco, or covered tobacco products it manufactures, labels, advertises, packages, distributes, imports, sells, or otherwise holds for sale comply with all applicable requirements under this part.
In addition to the other responsibilities under this part, each manufacturer shall remove from each point of sale all self-service displays, advertising, labeling, and other items that the manufacturer owns that do not comply with the requirements under this part.
(a) In addition to the other requirements under this part, each cigarette and smokeless tobacco retailer is responsible for ensuring that all sales of cigarettes or smokeless tobacco to any person comply with the following requirements:
(1) No retailer may sell cigarettes or smokeless tobacco to any person younger than 18 years of age;
(2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this section and in § 1140.16(c)(2)(i), each retailer must verify by means of photographic identification containing the bearer's date of birth that no person purchasing the product is younger than 18 years of age;
(ii) No such verification is required for any person over the age of 26;
(3) Except as otherwise provided in § 1140.16(c)(2)(ii), a retailer may sell cigarettes or smokeless tobacco only in a direct, face-to-face exchange without the assistance of any electronic or mechanical device (such as a vending machine);
(4) No retailer may break or otherwise open any cigarette or smokeless tobacco package to sell or distribute individual cigarettes or a number of unpackaged cigarettes that is smaller than the quantity in the minimum cigarette package size defined in § 1140.16(b), or any quantity of cigarette tobacco or smokeless tobacco that is smaller than the smallest package distributed by the manufacturer for individual consumer use; and
(5) Each retailer must ensure that all self-service displays, advertising, labeling, and other items, that are located in the retailer's establishment and that do not comply with the requirements of this part, are removed or are brought into compliance with the requirements under this part.
(b) Notwithstanding the requirements in paragraph (a) of this section and in addition to the other requirements under this part, each retailer of covered tobacco products is responsible for ensuring that all sales of such covered tobacco products to any person comply with the following requirements:
(1) No retailer may sell covered tobacco products to any person younger than 18 years of age;
(2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this section and in § 1140.16(c)(2)(i), each retailer must verify by means of photographic identification containing the bearer's date of birth that no person purchasing the product is younger than 18 years of age;
(ii) No such verification is required for any person over the age of 26; and
(3) A retailer may not sell covered tobacco products with the assistance of any electronic or mechanical device (such as a vending machine), except in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
(a) Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that were sold in the United States on January 1, 1995.
(b) Minimum cigarette package size. Except as otherwise provided under this section, no manufacturer, distributor, or retailer may sell or cause to be sold, or distribute or cause to be distributed, any cigarette package that contains fewer than 20 cigarettes.
(c) Vending machines, self-service displays, mail-order sales, and other “impersonal” modes of sale. (1) Except as otherwise provided under this section, a retailer may sell cigarettes and smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer. Examples of methods of sale that are not permitted include vending machines and self-service displays.
(2) Exceptions. The following methods of sale are permitted:
(i) Mail-order sales, excluding mail-order redemption of coupons and distribution of free samples through the mail; and
(ii) Vending machines (including vending machines that sell packaged, single cigarettes) and self-service displays that are located in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
(d)(1) Except as provided in paragraph (d)(2) of this section, no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).
(2)(i) Paragraph (d)(1) of this section does not prohibit a manufacturer, distributor, or retailer from distributing or causing to be distributed free samples of smokeless tobacco in a qualified adult-only facility.
(ii) Paragraph (d)(2) of this section does not affect the authority of a State or local government to prohibit or otherwise restrict the distribution of free samples of smokeless tobacco.
(iii) For purposes of paragraph (d) of this section, the term “qualified adult-only facility” means a facility or restricted area that:
(A) Requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco;
(B) Does not sell, serve, or distribute alcohol;
(C) Is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;
(D) Is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco in accordance with this paragraph (d)(2) of this section;
(E) Is enclosed by a barrier that:
(1) Is constructed of, or covered with, an opaque material (except for entrances and exits);
(2) Extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and
(3) Prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and
(F) Does not display on its exterior:
(1) Any tobacco product advertising;
(2) A brand name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or
(3) Any combination of words that would imply to a reasonable observer that the manufacturer, distributor, or retailer has a sponsorship that would violate § 1140.34(c).
(iv) Distribution of samples of smokeless tobacco under paragraph (d)(2) of this section permitted to be taken out of the qualified adult-only facility shall be limited to one package per adult consumer containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If such package of smokeless tobacco contains individual portions of smokeless tobacco, the individual portions of smokeless tobacco shall not exceed eight individual portions, and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, distributor, or retailer who distributes or causes to be distributed free samples also shall take reasonable steps to ensure that the amounts in this paragraph (d)(2)(iv) are limited to one such package per adult consumer per day.
(3) Notwithstanding paragraph (d)(2) of this section, no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of smokeless tobacco:
(i) To a sports team or entertainment group; or
(ii) At any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be covered by paragraph (d)(3) of this section.
(4) The Secretary shall implement a program to ensure compliance with paragraph (d) of this section and submit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.
(5) Nothing in paragraph (d) of this section shall be construed to authorize any person to distribute or cause to be distributed any sample of a tobacco product to any individual who has not attained the minimum age established by applicable law for the purchase of such product.
(e) Restrictions on labels, labeling, and advertising. No manufacturer, distributor, or retailer may sell or distribute, or cause to be sold or distributed, cigarettes or smokeless tobacco with labels, labeling, or advertising not in compliance with subpart D of this part, and other applicable requirements.
(a)(1) A manufacturer, distributor, or retailer may, in accordance with this subpart D, disseminate or cause to be disseminated advertising or labeling which bears a cigarette or smokeless tobacco brand name (alone or in conjunction with any other word) or any other indicia of tobacco product identification, in newspapers; in magazines; in periodicals or other publications (whether periodic or limited distribution); on billboards, posters, and placards; in nonpoint-of-sale promotional material (including direct mail); in point-of-sale promotional material; and in audio or video formats delivered at a point-of-sale.
(2) A manufacturer, distributor, or retailer intending to disseminate, or to cause to be disseminated, advertising or labeling for cigarettes or smokeless tobacco in a medium that is not listed in paragraph (a)(1) of this section, shall notify the agency 30 days prior to the use of such medium. The notice shall describe the medium and discuss the extent to which the advertising or labeling may be seen by persons younger than 18 years of age. The manufacturer, distributor, or retailer shall send this notice to the Office of Compliance and Enforcement, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993.
(b) [Reserved]
(c) This subpart D does not apply to cigarette or smokeless tobacco package labels.
(a) Except as provided in paragraph (b) of this section, each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating or causing to be disseminated, any labeling or advertising for cigarettes or smokeless tobacco shall use only black text on a white background. This section does not apply to advertising:
(1) In any facility where vending machines and self- service displays are permitted under this part, provided that the advertising is not visible from outside the facility and that it is affixed to a wall or fixture in the facility; or
(2) Appearing in any publication (whether periodic or limited distribution) that the manufacturer, distributor, or retailer demonstrates is an adult publication. For the purposes of this section, an adult publication is a newspaper, magazine, periodical, or other publication:
(i) Whose readers younger than 18 years of age constitute 15 percent or less of the total readership as measured by competent and reliable survey evidence; and
(ii) That is read by fewer than 2 million persons younger than 18 years of age as measured by competent and reliable survey evidence.
(b) Labeling and advertising in an audio or video format shall be limited as follows:
(1) Audio format shall be limited to words only with no music or sound effects.
(2) Video formats shall be limited to static black text only on a white background. Any audio with the video shall be limited to words only with no music or sound effects.
(a) No manufacturer and no distributor of imported cigarettes or smokeless tobacco may market, license, distribute, sell, or cause to be marketed, licensed, distributed, or sold any item (other than cigarettes or smokeless tobacco or roll-your-own paper) or service, which bears the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco.
(b) No manufacturer, distributor, or retailer may offer or cause to be offered any gift or item (other than cigarettes or smokeless tobacco) to any person purchasing cigarettes or smokeless tobacco in consideration of the purchase thereof, or to any person in consideration of furnishing evidence, such as credits, proofs-of-purchase, or coupons, of such a purchase.
(c) No manufacturer, distributor, or retailer may sponsor or cause to be sponsored any athletic, musical, artistic, or other social or cultural event, or any entry or team in any event, in the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. Nothing in this paragraph prevents a manufacturer, distributor, or retailer from sponsoring or causing to be sponsored any athletic, musical, artistic, or other social or cultural event, or team or entry, in the name of the corporation which manufactures the tobacco product, provided that both the corporate name and the corporation were registered and in use in the United States prior to January 1, 1995, and that the corporate name does not include any brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco.
(a) This part sets forth the requirements for the display of health warnings on cigarette packages and in advertisements for cigarettes. FDA may require additional statements to be displayed on packages and in advertisements under the Federal Food, Drug, and Cosmetic Act or other authorities.
(b) The requirements of this part do not apply to manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or distribution within the United States.
(c) A cigarette retailer shall not be considered in violation of this part as it applies to the display of health warnings on a cigarette package if the package:
(1) Contains a health warning;
(2) Is supplied to the retailer by a license- or permit-holding tobacco product manufacturer, importer, or distributor; and
(3) Is not altered by the retailer in a way that is material to the requirements of section 4(a) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(a)) or this part, including by obscuring the warning, by reducing its size, by severing it in whole or in part, or by otherwise changing it in a material way.
(d) A cigarette retailer shall not be considered in violation of this part as it applies to the display of health warnings in an advertisement for cigarettes if the advertisement is not created by or on behalf of the retailer and the retailer is not otherwise responsible for the inclusion of the required warnings. This paragraph shall not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a health warning or that contains a warning that has been altered by the retailer in a way that is material to the requirements of section 4(b) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(b)), this part, or section 4(c) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(c)), including by obscuring the warning, by reducing its size, by severing it in whole or in part, or by otherwise changing it in a material way.
For the purposes of this part,
Cigarette means:
(1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco; and
(2) Any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (1) of this definition.
Commerce means:
(1) Commerce between any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof;
(2) Commerce between points in any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any place outside thereof; or
(3) Commerce wholly within the District of Columbia, Guam, the U.S. Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman Reef, or Johnston Island.
Distributor means any person who furthers the distribution of cigarettes at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this part.
Front panel and rear panel mean the two largest sides or surfaces of the package.
Importer means any person who imports any cigarette that is intended for sale or distribution to consumers in the United States.
Manufacturer means any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette product.
Package means a pack, box, carton, or container of any kind in which cigarettes are offered for sale, sold, or otherwise distributed to consumers.
Person means an individual, partnership, corporation, or any other business or legal entity.
Required warning means the combination of one of the textual warning statements and its accompanying color graphic, which are set forth in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12.
Retailer means any person who sells cigarettes to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of cigarettes are permitted.
United States, when used in a geographical sense, includes the several States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, and Johnston Island. The term “State” includes any political division of any State.
(a) Packages. (1) It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes the package of which fails to bear, in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part, one of the required warnings on the front and the rear panels.
(2) The required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings.”
(3) The required warning shall appear directly on the package and shall be clearly visible underneath the cellophane or other clear wrapping.
(4) The required warning shall be located in the upper portion of the front and rear panels of the package and shall comprise at least the top 50 percent of these panels; Provided, however, that on cigarette cartons, the required warning shall be located on the left side of the front and rear panels of the carton and shall comprise at least the left 50 percent of these panels.
(5) The required warning shall be positioned such that the text of the required warning and the other information on that panel of the package have the same orientation.
(b) Advertisements. (1) It shall be unlawful for any manufacturer, importer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless its advertising bears, in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part, one of the required warnings.
(2) The text in each required warning shall be in the English language, except that:
(i) In the case of an advertisement that appears in a non-English publication, the text in the required warning shall appear in the predominant language of the publication whether or not the advertisement is in English; and
(ii) In the case of an advertisement that appears in an English language publication but that is not in English, the text in the required warning shall appear in the same language as that principally used in the advertisement.
(3) For English-language and Spanish-language warnings, each required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings.”
(4) For foreign-language warnings, except for Spanish-language warnings, each required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings,” including the insertion of a true and accurate translation of the textual warning. The inserted textual warning must comply with the requirements of section 4(b)(2) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(b)(2)).
(5) The required warning shall occupy at least 20 percent of the area of each advertisement, and shall be placed in accordance with the requirements in the Federal Cigarette Labeling and Advertising Act.
(c) Irremovable or permanent warnings. The required warnings shall be indelibly printed on or permanently affixed to the package or advertisement. Such warnings, for example, must not be printed or placed on a label affixed to a clear outer wrapper that is likely to be removed to access the product within the package.
“Cigarette Required Warnings” Edition 1.0 (June 2011), consisting of electronic files, U.S. Food and Drug Administration, referred to at § 1141.3, § 1141.10(a) and (b), and § 1141.16(a), is 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. To enforce any edition other than that specified in this section, FDA must publish notice of change in the
(a) A cigarette shall be deemed to be misbranded under section 903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part. A cigarette shall be deemed to be misbranded under section 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act if its advertising does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part.
(b) A cigarette advertisement or package will be deemed to include a brief statement of relevant warnings for the purposes of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act if it bears one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part. A cigarette distributed or offered for sale in any State shall be deemed to be misbranded under section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the manufacturer, packer, or distributor includes in all advertisements and packages issued or caused to be issued by the manufacturer, packer, or distributor with respect to the cigarette one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part.
(a) The required warning shall include a reference to a smoking cessation assistance resource in accordance with, and as specified in, “Cigarette Required Warnings” (incorporated by reference at § 1141.12).
(b) In meeting the smoking cessation needs of an individual caller, the smoking cessation assistance resource required to be referenced by paragraph (a) of this section must, as appropriate:
(1) Provide factual information about the harms to health associated with cigarette smoking and the health benefits of quitting smoking;
(2) Provide factual information about what smokers can expect when trying to quit;
(3) Provide practical advice (problem solving/skills training) about how to deal with common issues faced by smokers trying to quit;
(4) Provide evidence-based advice about how to formulate a plan to quit smoking;
(5) Provide evidence-based information about effective relapse prevention strategies;
(6) Provide factual information on smoking cessation treatments, including FDA-approved cessation medications; and
(7) Provide information, advice, and support that is evidence-based, unbiased (including with respect to products, services, persons, and other entities), and relevant to tobacco cessation.
(c) The smoking cessation resource must:
(1) Other than as described in this section, not advertise or promote any particular product or service;
(2) Except to meet the particularized needs of an individual caller as determined in the context of individual counseling, not selectively present information about a subset of FDA-approved cessation products or product categories while failing to mention other FDA-approved cessation products or product categories;
(3) Not provide or otherwise encourage the use of any drug or other medical product that FDA has not approved for tobacco cessation;
(4) Not encourage the use of any non-evidence-based smoking cessation practices;
(5) Ensure that staff providing smoking cessation information, advice, and support are trained specifically to help smokers quit by delivering unbiased and evidence-based information, advice, and support; and
(6) Maintain appropriate controls to ensure the criteria described in paragraphs (b) and (c) of this section are met.
(d) If the Secretary of the Department of Health and Human Services (Secretary) determines that a part of the smoking cessation assistance resource referenced by paragraph (a) of this section does not meet the criteria described in paragraphs (b) and (c) of this section, the Secretary shall take appropriate steps to address the noncompliance.
For purposes of this part:
Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored tobacco product; or
(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product
Cigar means a tobacco product that:
(1) Is not a cigarette and
(2) Is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco.
Cigarette tobacco means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter also apply to cigarette tobacco.
Component or part means any software or assembly of materials intended or reasonably expected:
(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or
(2) to be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.
Covered tobacco product means any tobacco product deemed to be subject to the Federal Food, Drug, and Cosmetic Act pursuant to § 1100.2 of this chapter, but excludes any component or part that is not made or derived from tobacco.
Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.
Point of sale means any location at which a consumer can purchase or otherwise obtain tobacco products for personal consumption.
Principal display panels means the panels of a package that are most likely to be displayed, presented, shown, or examined by the consumer.
Required warning statement means a textual warning statement required to be on packaging and in advertisements for cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products.
Retailer means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays are permitted under this part.
Roll-your-own tobacco means any tobacco product that, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.
Tobacco product. As stated in section 201(rr) of the Federal Food, Drug, and Cosmetic Act in relevant part, a tobacco product:
(1) Means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product) and
(2) Does not mean an article that is a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act.
(a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States such product unless the tobacco product package bears the following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
(2) The required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows:
(i) Be located in a conspicuous and prominent place on the two principal display panels of the package and the warning area must comprise at least 30 percent of each of the principal display panels;
(ii) Be printed in at least 12-point font size and ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section; and
(v) Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panel have the same orientation.
(3) A retailer of any tobacco product covered by paragraphs (a)(1) and (2) of this section will not be in violation of this section for packaging that:
(i) Contains a health warning;
(ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and
(iii) Is not altered by the retailer in a way that is material to the requirements of this section.
(b) Advertisements. (1) For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement specified in paragraph (a)(1) of this section.
(2) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Internet Web pages, and electronic mail correspondence), the required warning statement must appear in the upper portion of the area of the advertisement within the trim area as follows:
(i) Occupy at least 20 percent of the area of the advertisement;
(ii) Appear in at least 12-point font size and ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;
(iii) Appear in conspicuous and legible Helvetica bold or Arial bold type (or other similar sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other material on the advertisement;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section;
(v) Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation; and
(vi) Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 millimeters (mm) or more than 4 mm.
(3) This paragraph (b) applies to a retailer only if that retailer is responsible for or directs the health warning required under the paragraph. However, this paragraph does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a health warning or contains a health warning that has been altered by the retailer in a way that is material to the requirements of this section.
(c) Self-certification. A tobacco product that would otherwise be required to bear the warning in paragraph (a)(1) of this section but does not contain nicotine is not required to bear the warning in paragraph (a)(1) of this section on packages or advertisements if the tobacco product manufacturer has submitted to FDA a confirmation statement certifying to be true and accurate that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion. Any product not required to bear the warning in paragraph (a)(1) of this section must include the statement “This product is made from tobacco.” on all packages and advertisements in accordance with the requirements of this part.
(d) Small packages. A tobacco product that would otherwise be required to bear the warning in paragraph (a)(1) of this section but is too small or otherwise unable to accommodate a label with sufficient space to bear such information is exempt from compliance with the requirement provided that the information and specifications required under paragraphs (a)(1) and (2) of this section appear on the carton or other outer container or wrapper if the carton, outer container, or wrapper has sufficient space to bear the information, or appear on a tag otherwise firmly and permanently affixed to the tobacco product package. In such cases, the carton, outer container, wrapper, or tag will serve as the location of the principal display panels.
(a) Packages. (1) It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigar product unless the product package bears one of the following required warning statements on the package label:
(i) WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
(ii) WARNING: Cigar smoking can cause lung cancer and heart disease.
(iii) WARNING: Cigars are not a safe alternative to cigarettes.
(iv) WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
(v)(A) WARNING: Cigar use while pregnant can harm you and your baby.; or
(B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.
(vi) WARNING: This product contains nicotine. Nicotine is an addictive chemical.
(2) Each required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows:
(i) Be located in a conspicuous and prominent place on the two principal display panels of the package and the warning area must comprise at least 30 percent of each of the principal display panels;
(ii) Appear in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other similar sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section; and
(v) Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on that principal display panel have the same orientation.
(3) No person may manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigar without a required warning statement, except for cigars that are sold individually and not in a product package. For cigars that are sold individually and not in a product package, the required warning statements must be posted at the retailer's point-of-sale in accordance with the following:
(i) All of the warnings in paragraph (a) of this section must be placed on a sign that is a minimum of 8.5 x 11 inches, posted on or within 3 inches of each cash register where payment may be made so that the sign(s) are unobstructed in their entirety and can be read easily by each consumer making a purchase;
(ii) The sign must be clear, legible, and conspicuous and be printed in black Helvetica bold or Arial bold type (or other similar sans serif fonts) against a solid white background in at least 17 point type with appropriate space between the warning statements;
(iii) Be printed in a manner that contrasts by typography, layout, or color, with all other printed material; and
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section.
(4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of this section will not be in violation of this section for packaging that:
(i) Contains a health warning;
(ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and
(iii) Is not altered by the retailer in a way that is material to the requirements of this section.
(b) Advertisements. (1) It is unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of cigars to advertise or cause to be advertised within the United States any cigar unless each advertisement bears one of the required warning statements specified in paragraph (a)(1) of this section.
(2) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Internet Web pages, and electronic mail correspondence), each required warning statement must appear in the upper portion of the area of the advertisement within the trim area as follows:
(i) Occupy at least 20 percent of the area of the advertisement;
(ii) Appear in at least 12-point font size that ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the text required;
(iii) Appear in conspicuous and legible Helvetica bold or Arial bold type (or other similar sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other material on the advertisement;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section;
(v) Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation; and
(vi) Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 mm or more than 4 mm.
(3) This paragraph (b) applies to a retailer only if that retailer is responsible for or directs the warning statements required under the paragraph. However, this paragraph does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a health warning or contains a health warning that has been altered by the retailer in a way that is material to the requirements of this section.
(c) Marketing requirements. (1) Except for cigars sold individually and not in a product package, the warning statements required for packages in paragraph (a)(1) of this section must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the cigar manufacturer, importer, distributor, or retailer to, and approved by, the Food and Drug Administration.
(2) The warning statements required for advertisements in paragraph (a)(1) of this section must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar in accordance with a plan submitted by the cigar manufacturer, importer, distributor, or retailer to, and approved by, the Food and Drug Administration.
(3) Each person required to randomly display and distribute or rotate warnings in accordance with an FDA-approved plan under this part shall submit a proposed warning plan to FDA no later than either 12 months after May 10, 2016, or 12 months before advertising or commercially marketing a product that is subject to such requirement, whichever is later.
The text in each warning statement required in § 1143.3 or § 1143.5 must be in the English language, except as follows:
(a) In the case of an advertisement that appears in a non-English medium, the text in the required warning statement must appear in the predominant language of the medium whether or not the advertisement is in English, and;
(b) In the case of an advertisement that appears in an English language medium but that is not in English, the text in the required warning statement must appear in the same language as that principally used in the advertisement.
The warning statements required by this section must be indelibly printed on or permanently affixed to the package or advertisement. These warnings, for example, must not be printed or placed on a product label affixed to a clear outer wrapper that is likely to be removed to access the product within the package.
The provisions of this part do not apply to a manufacturer or distributor of tobacco products that does not manufacture, package, or import tobacco products for sale or distribution within the United States.
(a) Except as stated in paragraph (b) of this section, this part will take effect 24 months after May 10, 2016. The effective date will be with respect to the date of manufacture, provided that, in any case, beginning 30 days after the effective date, a manufacturer may not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with this part.
(b) The requirement to submit a warning plan to FDA under § 1143.5(c)(3) will take effect 12 months after May 10, 2016.
This part establishes requirements related to tobacco product user fees under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s). The total amount of user fees may not exceed the amount specified for that fiscal year in section 919(b) of the Federal Food, Drug, and Cosmetic Act. All domestic manufacturers and importers of tobacco products are required to pay to FDA their percentage share of the total assessment for a fiscal year.
The following definitions are applicable to this part:
Class of tobacco products means each of the following types of tobacco products as defined in 26 U.S.C. 5702 and for which taxes are required to be paid for the removal of such into domestic commerce: Cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.
Domestic manufacturer means a person who is required to obtain a permit from the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury with respect to the production of tobacco products under title 27 of the Code of Federal Regulations.
Fiscal year quarter means a quarter in a fiscal year (the fiscal year is October 1 through September 30). The fiscal year quarters are October 1-December 31, January 1-March 31, April 1-June 30, and July 1-September 30.
Importer means a person who is required to obtain a permit from the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury with respect to the importation of tobacco products under title 27 of the Code of Federal Regulations.
Total assessment means the total amount of user fees (in dollars) authorized to be assessed and collected for a specific fiscal year under section 919 of the Federal Food, Drug, and Cosmetic Act.
Units of product means:
(1) The number of sticks for cigarettes, or
(2) The weight (measured in pounds) for snuff, chewing tobacco, and roll-your-own tobacco.
Units of product means:
(1) The number of sticks for cigarettes and cigars, or
(2) The weight (measured in pounds) for snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.
Yearly class allocation means the amount of user fees (in dollars) assessed for a class of tobacco products for a particular fiscal year.
(a) General. Each domestic manufacturer and importer of tobacco products that are part of a class of tobacco products must submit the information described in this section for such products each month, and the information must be received by FDA no later than the 20th day of each month. The information must be submitted using the form that FDA provides. The information must be submitted even if the domestic manufacturer or importer had no removals subject to tax during the prior month. FDA will use the information submitted under this section and any other available information, as FDA determines appropriate, to make tobacco product user fee assessments.
(b) Contents. Each domestic manufacturer and importer must submit the following:
(1) Identification information. (i) Its name and the mailing address of its principal place of business;
(ii) The name and a telephone number including area code of an office or individual that FDA may contact for further information;
(iii) The email address and postal address at which it wishes to receive notifications FDA sends under this part;
(iv) The Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit Number(s); and
(v) The Employer Identification Number(s) (EIN).
(2) Removal information. The units of product, by class, removed and not tax exempt for the prior month and the Federal excise tax it paid, by class, for such removal.
(i) This information must be reported for each TTB tobacco permit.
(ii) If the domestic manufacturer or importer did not remove any amount of tobacco product, it must report that no tobacco product was removed into domestic commerce.
(3) Certified copies. Certified copies of the returns and forms that relate to:
(i) The removal of tobacco products into domestic commerce (as defined by section 5702 of the Internal Revenue Code of 1986); and
(ii) The payment of the Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986.
(c) First report for cigars. Domestic manufacturers and importers of cigars must submit the information described in this section beginning no later than the 20th day of August, 2016. Domestic manufacturers and importers of cigars must submit the information described in this section for each of the prior months of fiscal year 2016 as their first monthly submission. The previous sentence only applies for the first report in fiscal year 2016.
(d) First report for pipe tobacco. Domestic manufacturers and importers of pipe tobacco must submit the information described in this section beginning no later than the 20th day of August, 2016.
For each fiscal year, FDA will allocate the total assessment among the classes of tobacco products.
(a) Calculation. FDA will calculate the percentage shares for each class as follows:
(1) Except for cigars, FDA will multiply the units of product removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for that class (class dollar figure).
(2) For cigars, FDA will:
(i) Multiply the units of small cigars removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for small cigars (small cigar subclass dollar figure).
(ii) Multiply the units of large cigars removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for large cigars (large cigar subclass dollar figure).
(iii) Add the small cigar subclass dollar figure and the large cigar subclass dollar figure (cigar class dollar figure).
(3) FDA will total the class dollar figures for all tobacco classes for the most recent full calendar year (total dollar figure).
(4) FDA will divide the class dollar figure by the total dollar figure to determine the percentage share for each class.
(5) FDA will calculate the allocation for each class of tobacco products by multiplying the percentage share for each class by the total assessment.
(b) Reallocation. For any class of tobacco products that is not deemed by FDA to be subject to regulation under chapter IX of the Federal Food, Drug, and Cosmetic Act, the amount of user fees that would otherwise be assessed to such class of tobacco products will be reallocated to the classes of tobacco products that are subject to chapter IX of the Federal Food, Drug, and Cosmetic Act in the same manner and based on the same relative percentages otherwise determined under paragraph (a) of this section.
Each quarter, FDA will calculate the assessment owed by each domestic manufacturer or importer for that quarter.
(a) Calculation. (1) For each class of tobacco products except cigars, FDA will calculate the percentage share for each domestic manufacturer and importer by dividing the Federal excise taxes that it paid for the class for the prior quarter by the total excise taxes that all domestic manufacturers and importers paid for the class for that same quarter.
(2) For the cigar class, FDA will calculate the percentage share for each domestic manufacturer and importer by dividing the Federal excise taxes that it paid for the class for the prior fiscal year by the total excise taxes that all domestic manufacturers and importers paid for the class for the prior fiscal year.
(3) If the percentage share calculated for a domestic manufacturer or importer in this section, as applicable, is less than 0.0001 percent, the share is excluded from the assessment for that class of tobacco products.
(4) Within each class of tobacco products, the assessment owed by a domestic manufacturer or importer for the quarter is the yearly class allocation, determined as described in § 1150.7, divided by four, multiplied by the domestic manufacturer's or importer's percentage share, truncated to the fourth decimal place, for that class of tobacco products.
(b) Adjustments. Annually, FDA will make any necessary adjustments to individual domestic manufacturer or importer assessments if needed to account for any corrections (for example, to include domestic manufacturers or importers that were not included in a relevant assessment calculation).
(a) Notification. No later than 30 calendar days before the end of each fiscal year quarter, FDA will notify each domestic manufacturer and importer of the amount of the quarterly assessment imposed on the domestic manufacturer or importer.
(b) Content of notification. The notification under paragraph (a) of this section will include the following:
(1) The amount of the quarterly assessment imposed on the domestic manufacturer or importer and the date that payment of the assessment must be received by FDA;
(2) Class assessment information, including each class' initial percentage share, the reallocation amount (if any) and each class' percentage share after any such reallocation, and the quarterly assessment for each class;
(3) Domestic manufacturer or importer assessment information, including the domestic manufacturer's or importer's percentage share of each relevant class of tobacco products and invoice amount;
(4) Any adjustments FDA has made under § 1150.9(b);
(5) The manner in which assessments are to be remitted to FDA;
(6) Information about the accrual of interest if a payment is late; and
(7) Information regarding where to send a dispute and when it needs to be sent.
(a) Payment of an assessment must be received by FDA no later than the last day of each fiscal year quarter.
(b) Payments must be submitted to FDA in U.S. dollars and in the manner specified in the notification.
(c) Except as provided in paragraph (d) of this section, if an assessment is not received by the last day of the fiscal year quarter, FDA will begin assessing interest on the unpaid amount in accordance with 31 U.S.C. 3717.
(d) If FDA does not send the notification described in § 1150.11(a) 30 calendar days before the end of a quarter, no interest will be assessed by FDA under paragraph (c) of this section until 30 calendar days have elapsed from the date FDA sent notification of the amount owed.
(e) If a domestic manufacturer or importer disputes the amount of an assessment, it must still pay the assessment in accordance with paragraphs (a) and (b) of this section.
(a) A domestic tobacco manufacturer or importer may dispute an FDA assessment. The dispute must include the basis for the dispute, and the dispute must be:
(1) Submitted in writing;
(2) Received by FDA no later than 45 days after the date on the assessment notification;
(3) Legible and in English; and
(4) Sent to the address found on our Web site (http://www.fda.gov/tobaccoproducts).
(b) If FDA determines that there was an error related to the assessment and the assessment was too high, FDA will refund the amount assessed in error to the domestic manufacturer or importer.
(c) FDA will provide a dated, written response, and its response will provide information about how to submit a request for further Agency review.
(d) A request for further Agency review under § 10.75 of this chapter may be submitted. Such a request must be submitted in writing by the domestic manufacturer or importer and received by FDA within 30 days from the date on FDA's response. The request for further Agency review must be legible, in English, and submitted to the address found on our Web site (http://www.fda.gov/tobaccoproducts).
(a) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387b), a tobacco product is deemed adulterated if the domestic manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer by the later of the date the assessment is due, 30 days from the date FDA sent notification of the amount owed, or 30 days after final Agency action on a resolution of any dispute as to the amount of the fee.
(b) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act, a tobacco product is deemed adulterated if the domestic manufacturer or importer of the tobacco product fails to report the information required by § 1150.5 to calculate assessments under this part.
(c) The failure to report the information required by § 1150.5 to calculate assessments under this part is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act.
(d) Information submitted under § 1150.5 is subject to 18 U.S.C. 1001 and other appropriate civil and criminal statutes.