PRIA, Government Policy, Made Personal

Summary

A tobacco product is misbranded if its label is false or misleading or if a packaged product does not show required information. Required items include the name and place of business of the maker, packer, or distributor; how much is in the package; the percent of tobacco that is domestic versus foreign; and the statement called for in section 387t(a). The Secretary may allow small-package exceptions and reasonable variations. A product is also misbranded if required label words are not easy to see and read, if an established nonproprietary name is missing or not used alone, if required directions or child warnings are missing, if the product was made in an unregistered or unlisted establishment or lacks required ID symbols, if advertising is false or it is sold in violation of section 387f(d), if ads don’t include the established name and brief uses/warnings (or, for some products, a full ingredient list), if it lacks labeling required by a standard under section 387g, or if rules or information duties under sections 387d, 387h, or 387i were ignored. The Secretary may require that label statements be approved ahead of time by regulation to make sure they follow these rules and the Family Smoking Prevention and Tobacco Control Act. Regulations cannot require prior approval of ads except for modified risk tobacco products under section 387k. Advertisements published after June 22, 2009 are not subject to sections 52 through 55 of title 15 for the language of label statements.

Title 21, §387c

Food and Drugs, Source: USLM XML via OLRC

(a)In general

A tobacco product shall be deemed to be misbranded—

(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 percentage of the tobacco used in the product that is domestically grown tobacco and the percentage 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 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;

(4)if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;

(5)if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;

(6)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;

(7)if, in the case of any tobacco product distributed 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 regulations 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 descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—

(A)a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and

(B)a brief statement of—

(i)the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and

(ii)in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;

(9)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

(10)if there was a failure or refusal—

(A)to comply with any requirement prescribed 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 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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 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 Provisions

A 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.

Amendments

2019—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].”

§387c Misbranded Tobacco Products

Summary

Title 21, §387c

Notes & Related Subsidiaries

Editorial Notes

References in Text

Short Title

Prior Provisions

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Regulations

Effective Date

Effective Date

Citations & Metadata