A tobacco product shall be deemed to be misbranded-
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;
The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the Family Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation 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 product published after June 22, 2009, shall, with respect to the language of label statements as prescribed 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.
21 U.S.C. § 387c
EDITORIAL NOTES
REFERENCES IN TEXTThe Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111-31, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.
PRIOR PROVISIONSA prior section 903 of act June 25, 1938, was renumbered section 1003 and is classified to section 393 of this title.Another prior section 903 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.
AMENDMENTS2019-Subsec. (a)(7)(B). Pub. L. 116-94 inserted "section 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 section 201 of this division. The package label requirements 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 date of manufacture, provided that, in any case, beginning 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 requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (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]."