Source: https://www.law.cornell.edu/uscode/text/21/387c?qt-us_code_tabs=1
Timestamp: 2015-04-27 04:31:01
Document Index: 609399600

Matched Legal Cases: ['§ 387', '§ 387', '§ 387', '§ 903', '§ 101', '§ 103', 'art 1', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25', 'art 1141']

21 U.S. Code § 387c - Misbranded tobacco products | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter IX › § 387c 21 U.S. Code § 387c - Misbranded tobacco products
In general A tobacco product shall be deemed to be misbranded—
if in package form unless it bears a label containing—
the statement required under section 387t
if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such 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 individual under customary conditions of purchase and use;
if it was manufactured, prepared, propagated, compounded, or processed in an establishment 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 section 387e
(i) of this title, if a notice or other information respecting it was not provided as required 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 tobacco products prescribed under section 387e
(e) of this title as the Secretary by regulation requires;
if, in the case of any tobacco product distributed or offered for sale in any State—
it is sold or distributed in violation of regulations prescribed under section 387f
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 descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—
a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and
a brief statement of—
if it is a tobacco product subject to a tobacco product standard established under section 387g of this title, unless it bears such labeling as may be prescribed in such tobacco product standard; or
if there was a failure or refusal—
to comply with any requirement prescribed under section 387d or 387h of this title; or
to furnish any material or information required under section 387i of this title.
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 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.
(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.)
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) andsection 920(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387t
“(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].”
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR Part 1 - GENERAL ENFORCEMENT REGULATIONS21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 1141 - CIGARETTE PACKAGE AND ADVERTISING WARNINGS