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

submitted 88 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 807 words · no verdicts yet

in plain englishAI-generated · not legal advice

A tobacco product is "misbranded" if its label or ads are false, or missing required information. Packages must list the maker, quantity, tobacco source percentages, and required health statements. The Secretary may require pre-approval of label wording but generally not of advertisements.

(a) A tobacco product is "misbranded" in any of ten situations. First, its labeling is false or misleading. Second, a packaged product needs a label with several things. It must show the manufacturer's, packer's, or distributor's name and business address. It must state the quantity of contents accurately. It must state the percentage of tobacco that is domestically grown versus foreign-grown. It must carry the health statement required under section 387t(a) of this title. Small packages may get exceptions to these rules. Third, any required word or information must be easy to read and understand under normal buying conditions. Fourth, if the product has an "established name," that name must appear prominently on the label instead of any other name. Fifth, if the Secretary requires warnings or directions for use, the label must fully follow those rules. Sixth, it is misbranded if made in an unregistered establishment, left off a required product list, or missing required identification symbols. Seventh, for products sold across states, misleading advertising or violations of certain marketing rules also count. Eighth, ads and other printed materials must include the product's established name and a brief statement of its uses, warnings, and, when required, its ingredients. Ninth, if a tobacco product standard applies under section 387g of this title, the product must carry the labeling that standard requires. Tenth, it is misbranded if the manufacturer fails to meet requirements under sections 387d, 387h, or 387i of this title. (b) The Secretary may require prior approval of label statements to prevent misbranding. Generally, the Secretary cannot require prior approval of advertisement content, except for modified risk tobacco products.

facts

- Codified at 21 U.S.C. § 387c, titled "Misbranded tobacco products," part of the Federal Food, Drug, and Cosmetic Act framework (originally ch. 675, § 903). - Enacted via Pub. L. 111–31, div. A, title I, § 101(b)(3), on June 22, 2009 (123 Stat. 1788), added to the June 25, 1938 chapter 675 statute. - Subsequently amended once by Pub. L. 116–94, div. N, title I, § 603(d)(3), enacted December 20, 2019 (133 Stat. 3124). - The section contains 807 words and reflects 2 amendments in its legislative history. - Structured into two subsections: (a) enumerating ten misbranding conditions, and (b) addressing prior approval of label statements.

the actual law source: uscode.house.gov ↗public domain

(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.

Source credit: (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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 111-31 · 123 Stat. 1788
2019Amended · Pub. L. 116-94 · 133 Stat. 3124

The source credit identifies this section as part of the Federal Food, Drug, and Cosmetic Act, originally enacted June 25, 1938 (ch. 675). Section 903 itself, however, was not part of that original enactment; it was added later by Public Law 111–31, division A, title I, § 101(b)(3), on June 22, 2009. The credit further records one subsequent amendment, made by Public Law 116–94, division N, title I, § 603(d)(3), enacted December 20, 2019. Beyond these citations, the record does not detail the substance of that amendment. Public Law 111–31 is commonly known as the Family Smoking Prevention and Tobacco Control Act of 2009. This Act is generally understood to have granted the Food and Drug Administration authority to regulate tobacco products, including their manufacture, marketing, and labeling, for the first time. The broader legislative purpose commonly cited for the Act was to address public health concerns associated with tobacco use, particularly among minors, by establishing a comprehensive federal regulatory framework analogous to that governing drugs and other consumer products. The specific inclusion of misbranding provisions modeled on established food and drug law concepts—such as false or misleading labeling, established names, and required disclosures—reflects this general regulatory purpose. However, the record does not establish the particular legislative reasoning behind the specific requirements enumerated in this section, and no further detail should be inferred beyond what is generally understood about the Act's overall aims.

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