21 U.S.C. § 387c — Misbranded tobacco products

Page 671 TITLE 21—FOOD AND DRUGS § 387c (2) The document titled ‘‘Nicotine in Ciga- rettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Deliv- ery Devices Under the Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 41453–41787 (Au- gust 11, 1995)). (3) The preamble to the final rule in the doc- ument titled ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents’’ (61 Fed. Reg. 44396–44615 (August 28, 1996)). (4) The document titled ‘‘Nicotine in Ciga- rettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination’’ (61 Fed. Reg. 44619–45318 (August 28, 1996)). (Pub. L. 111–31, div. A, title I, § 102, June 22, 2009, 123 Stat. 1830.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. Chapter 9 [IX] of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see section 301 of this title and Tables. This division, referred to in subsec. (a)(2)(A), (5), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as the Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. The date of enactment of the Family Smoking Pre- vention and Tobacco Control Act, referred to in subsec. (a)(2)(G), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009. Section 103(q), referred to in subsec. (a)(6), is section 103(q) of Pub. L. 111–31, which enacted provisions set out as notes under sections 333 and 387c of this title. CODIFICATION Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act and not as part of the Federal Food, Drug, and Cosmetic Act which com- prises this chapter. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION For provision deeming reference to ‘‘180 days’’ in sub- sec. (a)(1) to be ‘‘270 days’’, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387b. Adulterated tobacco products A tobacco product shall be deemed to be adul- terated if— (1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poi- sonous or added deleterious substance that may render the product injurious to health; (2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; (3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; (4) the manufacturer or importer of the to- bacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee; (5) it is, or purports to be or is represented as, a tobacco product which is subject to a to- bacco product standard established under sec- tion 387g of this title unless such tobacco prod- uct is in all respects in conformity with such standard; (6)(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or (B) it is in violation of an order under sec- tion 387j(c)(1)(A) of this title; (7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or (8) it is in violation of section 387k of this title. (June 25, 1938, ch. 675, § 902, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1787.) Editorial Notes PRIOR PROVISIONS A prior section 902 of act June 25, 1938, was renum- bered section 1002. Subsec. (a) of section 1002 is set out as a note under section 301 of this title. Subsecs. (b) and (c) of section 1002 are classified to section 392 of this title. Subsec. (d) of section 1002 is set out as a note under section 392 of this title. § 387c. Misbranded tobacco products (a) In general A tobacco product shall be deemed to be mis- branded— (1) if its labeling is false or misleading in any particular; (2) if in package form unless it bears a label containing— (A) the name and place of business of the tobacco product manufacturer, packer, or distributor; (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; (C) an accurate statement of the percent- age of the tobacco used in the product that is domestically grown tobacco and the per- centage that is foreign grown tobacco; and (D) the statement required under section 387t(a) of this title, except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary; (3) if any word, statement, or other informa- tion required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such Page 672 TITLE 21—FOOD AND DRUGS § 387c conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary indi- vidual under customary conditions of purchase and use; (4) if it has an established name, unless its label bears, to the exclusion of any other non- proprietary name, its established name promi- nently printed in type as required by the Sec- retary by regulation; (5) if the Secretary has issued regulations re- quiring that its labeling bear adequate direc- tions for use, or adequate warnings against use by children, that are necessary for the protec- tion of users unless its labeling conforms in all respects to such regulations; (6) if it was manufactured, prepared, propa- gated, compounded, or processed in an estab- lishment not duly registered under section 387e(b), 387e(c), 387e(d), or 387e(h) of this title, if it was not included in a list required by sec- tion 387e(i) of this title, if a notice or other in- formation respecting it was not provided as re- quired by such section or section 387e(j) of this title, or if it does not bear such symbols from the uniform system for identification of to- bacco products prescribed under section 387e(e) of this title as the Secretary by regulation re- quires; (7) if, in the case of any tobacco product dis- tributed or offered for sale in any State— (A) its advertising is false or misleading in any particular; or (B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regula- tions prescribed under section 387f(d) of this title; (8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other de- scriptive printed matter issued or caused to be issued by the manufacturer, packer, or dis- tributor with respect to that tobacco prod- uct— (A) a true statement of the tobacco prod- uct’s established name as described in para- graph (4), printed prominently; and (B) a brief statement of— (i) the uses of the tobacco product and relevant warnings, precautions, side ef- fects, and contraindications; and (ii) in the case of specific tobacco prod- ucts made subject to a finding by the Sec- retary after notice and opportunity for comment that such action is appropriate to protect the public health, a full descrip- tion of the components of such tobacco product or the formula showing quan- titatively each ingredient of such tobacco product to the extent required in regula- tions which shall be issued by the Sec- retary after an opportunity for a hearing; (9) if it is a tobacco product subject to a to- bacco product standard established under sec- tion 387g of this title, unless it bears such la- beling as may be prescribed in such tobacco product standard; or (10) if there was a failure or refusal— (A) to comply with any requirement pre- scribed under section 387d or 387h of this title; or (B) to furnish any material or information required under section 387i of this title. (b) Prior approval of label statements The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such state- ments do not violate the misbranding provisions of subsection (a) and that such statements com- ply with other provisions of the Family Smok- ing Prevention and Tobacco Control Act (includ- ing the amendments made by such Act). No reg- ulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in section 387k of this title. No advertisement of a tobacco prod- uct published after June 22, 2009, shall, with re- spect to the language of label statements as pre- scribed under section 1333 of title 15 and section 4402 of title 15 or the regulations issued under such sections, be subject to the provisions of sections 52 through 55 of title 15. (June 25, 1938, ch. 675, § 903, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1788; amended Pub. L. 116–94, div. N, title I, § 603(d)(3), Dec. 20, 2019, 133 Stat. 3124.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classi- fication of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. PRIOR PROVISIONS A prior section 903 of act June 25, 1938, was renum- bered section 1003 and is classified to section 393 of this title. Another prior section 903 of act June 25, 1938, was re- numbered section 1004 and is classified to section 394 of this title. AMENDMENTS 2019—Subsec. (a)(7)(B). Pub. L. 116–94 inserted ‘‘sec- tion 387f(d)(5) of this title or of’’ after ‘‘violation of’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 111–31, div. A, title I, § 103(q)(5), (6), June 22, 2009, 123 Stat. 1840, provided that: ‘‘(5) PACKAGE LABEL REQUIREMENTS.—The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)] (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009]. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333[(d)]), as amended by sec- tion 201 of this division. The package label require- ments of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the Page 673 TITLE 21—FOOD AND DRUGS § 387d date of manufacture, provided that, in any case, begin- ning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a)(2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387t(a)]. ‘‘(6) ADVERTISING REQUIREMENTS.—The advertising re- quirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (as amend- ed by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009].’’ § 387d. Submission of health information to the Secretary (a) Requirement Each tobacco product manufacturer or im- porter, or agents thereof, shall submit to the Secretary the following information: (1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including to- bacco, substances, compounds, and additives that are, as of such date, added by the manu- facturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand. (2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accord- ance with regulations promulgated by the Sec- retary in accordance with section 1333(e) of title 15. (3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as ap- plicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promul- gated under section 387o of this title in report- ing information under this paragraph, where applicable. (4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behav- ioral, or physiologic effects of current or fu- ture tobacco products, their constituents (in- cluding smoke constituents), ingredients, components, and additives. (b) Data submission At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the fol- lowing: (1) Any or all documents (including under- lying scientific information) relating to re- search activities, and research findings, con- ducted, supported, or possessed by the manu- facturer (or agents thereof) on the health, tox- icological, behavioral, or physiologic effects of tobacco products and their constituents (in- cluding smoke constituents), ingredients, components, and additives. (2) Any or all documents (including under- lying scientific information) relating to re- search activities, and research findings, con- ducted, supported, or possessed by the manu- facturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the em- ployment of technology available or known to the manufacturer. (3) Any or all documents (including under- lying scientific or financial information) re- lating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors. An importer of a tobacco product not manufac- tured in the United States shall supply the in- formation required of a tobacco product manu- facturer under this subsection. (c) Time for submission (1) In general At least 90 days prior to the delivery for in- troduction into interstate commerce of a to- bacco product not on the market on June 22, 2009, the manufacturer of such product shall provide the information required under sub- section (a). (2) Disclosure of additive If at any time a tobacco product manufac- turer adds to its tobacco products a new to- bacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing. (3) Disclosure of other actions If at any time a tobacco product manufac- turer eliminates or decreases an existing addi- tive, or adds or increases an additive that has by regulation been designated by the Sec- retary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such ac- tion so advise the Secretary in writing. (d) Data list (1) In general Not later than 3 years after June 22, 2009, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under sub- section (e). (2) Consumer research The Secretary shall conduct periodic con- sumer research to ensure that the list pub- lished under paragraph (1) is not misleading to lay persons. Not later than 5 years after June 22, 2009, the Secretary shall submit to the ap- propriate committees of Congress a report on the results of such research, together with rec- ommendations on whether such publication should be continued or modified. (e) Data collection Not later than 24 months after June 22, 2009, the Secretary shall establish, and periodically revise as appropriate, a list of harmful and po- tentially harmful constituents, including smoke constituents, to health in each tobacco product