Cigarettes and smokeless tobacco (21 CFR 1140.1-1140.34)

753 Food and Drug Administration, HHS § 1140.3 (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 de termination. FDA will consider the ex emption request withdrawn if the in formation is not provided within the requested timeframe.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 op portunity 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 oppor tunity for a hearing as soon as possible after the rescission. Subpart B [Reserved] PART 1140—CIGARETTES AND SMOKELESS TOBACCO Subpart A—General Provisions Sec. 1140.1 Scope. 1140.2 Purpose. 1140.3 Definitions. Subpart B—Prohibition of Sale and Distribu tion to Persons Younger Than 18 Years of Age 1140.10 General responsibilities of manufac turers, distributors, and retailers. 1140.12 Additional responsibilities of manu facturers. 1140.14 Additional responsibilities of retail ers. 1140.16 Conditions of manufacture, sale, and distribution. Subpart C [Reserved] Subpart D—Labeling and Advertising 1140.30 Scope of permissible forms of label ing and advertising. 1140.32 Format and content requirements for labeling and advertising. 1140.34 Sale and distribution of nontobacco items and services, gifts, and sponsorship of events. AUTHORITY: 21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111–31, 123 Stat. 1776. SOURCE: 75 FR 13230, Mar. 19, 2010, unless otherwise noted. Subpart A—General Provisions § 1140.1 Scope. (a) This part sets out the restrictions under the Federal Food, Drug, and Cos metic Act (the act) on the sale, dis tribution, and use of cigarettes and smokeless tobacco that contain nico tine. (b) The failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes and smokeless tobacco renders the product misbranded under the act. (c) References in this part to regu latory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. § 1140.2 Purpose. The purpose of this part is to estab lish restrictions on the sale, distribu tion, and use of cigarettes and smoke less tobacco in order to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences asso ciated with tobacco use. § 1140.3 Definitions. (a) 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 Fed eral Cigarette Labeling and Adver tising 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 to bacco. VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00763 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 754 21 CFR Ch. I (4–1–16 Edition) § 1140.10 (b) Cigarette tobacco means any prod uct 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 shall also apply to cigarette tobacco. (c) Distributor means any person who furthers the distribution of cigarettes or smokeless tobacco, whether domes tic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal con sumption. Common carriers are not considered distributors for the pur poses of this part. (d) Manufacturer means any person, including any repacker and/or re labeler, who manufactures, fabricates, assembles, processes, or labels a fin ished cigarette or smokeless tobacco product. (e) Nicotine means the chemical sub stance named 3-(1-Methyl-2 pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex of nico tine. (f) Package means a pack, box, car ton, or container of any kind in which cigarettes or smokeless tobacco are of fered for sale, sold, or otherwise dis tributed to consumers. (g) Point of sale means any location at which a consumer can purchase or otherwise obtain cigarettes or smoke less tobacco for personal consumption. (h) Retailer means any person who sells cigarettes or smokeless tobacco to individuals for personal consump tion, or who operates a facility where vending machines or self-service dis plays are permitted under this part. (i) Smokeless tobacco means any to bacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. Subpart B—Prohibition of Sale and Distribution to Persons Young er Than 18 Years of Age § 1140.10 General responsibilities of manufacturers, distributors, and re tailers. Each manufacturer, distributor, and retailer is responsible for ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, pack ages, distributes, sells, or otherwise holds for sale comply with all applica ble requirements under this part. § 1140.12 Additional responsibilities of manufacturers. In addition to the other responsibil ities under this part, each manufac turer shall remove from each point of sale all self-service displays, adver tising, labeling, and other items that the manufacturer owns that do not comply with the requirements under this part. § 1140.14 Additional responsibilities of retailers. In addition to the other requirements under this part, each retailer is respon sible for ensuring that all sales of ciga rettes or smokeless tobacco to any per son comply with the following require ments: (a) No retailer may sell cigarettes or smokeless tobacco to any person younger than 18 years of age; (b)(1) Except as otherwise provided in § 1140.16(c)(2)(i) and in paragraph (b)(2) of this section, each retailer shall verify by means of photographic identi fication containing the bearer’s date of birth that no person purchasing the product is younger than 18 years of age; (2) No such verification is required for any person over the age of 26; (c) 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 me chanical device (such as a vending ma chine); (d) No retailer may break or other wise 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 cig arette package size defined in § 1140.16(b), or any quantity of cigarette tobacco or smokeless tobacco that is smaller than the smallest package dis tributed by the manufacturer for indi vidual consumer use; and (e) Each retailer shall ensure that all self-service displays, advertising, label ing, and other items, that are located in the retailer’s establishment and that VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00764 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 755 Food and Drug Administration, HHS § 1140.16 do not comply with the requirements of this part, are removed or are brought into compliance with the re quirements under this part. § 1140.16 Conditions of manufacture, sale, and distribution. (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 Janu ary 1, 1995. (b) Minimum cigarette package size. Ex cept 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 dis plays, mail-order sales, and other ‘‘imper sonal’’ modes of sale. (1) Except as oth erwise provided under this section, a retailer may sell cigarettes and smoke less 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 dis plays. (2) Exceptions. The following methods of sale are permitted: (i) Mail-order sales, excluding mail order redemption of coupons and dis tribution of free samples through the mail; and (ii) Vending machines (including vending machines that sell packaged, single cigarettes) and self-service dis plays that are located in facilities where the retailer ensures that no per son younger than 18 years of age is present, or permitted to enter, at any time. (d)(1) Except as provided in para graph (d)(2) of this section, no manu facturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smoke less tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cos metic Act). (2)(i) Paragraph (d)(1) of this section does not prohibit a manufacturer, dis tributor, or retailer from distributing or causing to be distributed free sam ples 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 oth erwise 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 re stricted area that: (A) Requires each person present to provide to a law enforcement officer (whether on or off duty) or to a secu rity guard licensed by a governmental entity government-issued identifica tion showing a photograph and at least the minimum age established by appli cable law for the purchase of smokeless tobacco; (B) Does not sell, serve, or distribute alcohol; (C) Is not located adjacent to or im mediately across from (in any direc tion) a space that is used primarily for youth-oriented marketing, pro motional, or other activities; (D) Is a temporary structure con structed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smoke less 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 en trances 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 see ing into the qualified adult-only facil ity, unless they make unreasonable ef forts to do so; and (F) Does not display on its exterior: (1) Any tobacco product advertising; (2) A brand name other than in con junction with words for an area or en closure to identify an adult-only facil ity; or VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00765 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 756 21 CFR Ch. I (4–1–16 Edition) § 1140.30 (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 smoke less tobacco. If such package of smoke less tobacco contains individual por tions of smokeless tobacco, the indi vidual portions of smokeless tobacco shall not exceed eight individual por tions, and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any manufac turer, distributor, or retailer who dis tributes 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, dis tributor, or retailer may distribute or cause to be distributed any free sam ples of smokeless tobacco: (i) To a sports team or entertainment group; or (ii) At any football, basketball, base ball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be cov ered by paragraph (d)(3) of this section. (4) The Secretary shall implement a program to ensure compliance with paragraph (d) of this section and sub mit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and To bacco 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, dis tributor, or retailer may sell or dis tribute, or cause to be sold or distrib uted, cigarettes or smokeless tobacco with labels, labeling, or advertising not in compliance with subpart D of this part, and other applicable require ments. Subpart C [Reserved] Subpart D—Labeling and Advertising § 1140.30 Scope of permissible forms of labeling and advertising. (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 con junction with any other word) or any other indicia of tobacco product identi fication, in newspapers; in magazines; in periodicals or other publications (whether periodic or limited distribu tion); on billboards, posters, and plac ards; 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 la beling may be seen by persons younger than 18 years of age. The manufac turer, distributor, or retailer shall send this notice to the Office of Compliance, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850–3229. (b) [Reserved] (c) This subpart D does not apply to cigarette or smokeless tobacco pack age labels. § 1140.32 Format and content require ments for labeling and advertising. (a) Except as provided in paragraph (b) of this section, each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00766 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 757 Food and Drug Administration, HHS Pt. 1141 or causing to be disseminated, any la beling or advertising for cigarettes or smokeless tobacco shall use only black text on a white background. This sec tion does not apply to advertising: (1) In any facility where vending ma chines and self- service displays are permitted under this part, provided that the advertising is not visible from outside the facility and that it is af fixed to a wall or fixture in the facility; or (2) Appearing in any publication (whether periodic or limited distribu tion) that the manufacturer, dis tributor, 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 evi dence; and (ii) That is read by fewer than 2 mil lion persons younger than 18 years of age as measured by competent and reli able 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 ef fects. (2) Video formats shall be limited to static black text only on a white back ground. Any audio with the video shall be limited to words only with no music or sound effects. § 1140.34 Sale and distribution of non tobacco items and services, gifts, and sponsorship of events. (a) No manufacturer and no dis tributor of imported cigarettes or smokeless tobacco may market, li cense, 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 iden tical 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 of fered any gift or item (other than ciga rettes or smokeless tobacco) to any person purchasing cigarettes or smoke less 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, artis tic, 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 iden tical 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 ath letic, musical, artistic, or other social or cultural event, or team or entry, in the name of the corporation which manufactures the tobacco product, pro vided 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 prod uct identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. PART 1141—CIGARETTE PACKAGE AND ADVERTISING WARNINGS Subpart A—General Provisions Sec. 1141.1 Scope. 1141.3 Definitions. Subpart B—Cigarette Package and Advertising Warnings 1141.10 Required warnings. 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