21 U.S.C. § 362 — Misbranded cosmetics

submitted 88 years ago by ch. 675 to r/title-21-FOOD-AND-DRUGS · 290 words · no verdicts yet

in plain englishAI-generated · not legal advice

A cosmetic is "misbranded" if its labeling is false or misleading. Packaged cosmetics need a label with the maker's name, address, and accurate contents. Labels must be clear and containers must not mislead buyers. Color additives need proper packaging under the rules, except those made only for hair dyes.

A cosmetic counts as "misbranded" — improperly labeled — if any of the following is true.

(a) Its labeling is false or misleading in any way.

(b) It comes in a package but lacks a proper label. That label must show the maker's or distributor's name and address. It must also give an accurate statement of the contents' weight or amount, and the information required by section 364e. The Secretary may allow reasonable variations and exempt small packages by regulation.

(c) Required information on the label is not displayed clearly enough. It must stand out compared to other words or designs so an ordinary buyer would likely read and understand it under normal buying conditions.

(d) Its container is made, shaped, or filled in a way that misleads buyers.

(e) It is a color additive whose packaging and labeling do not follow the required regulations for that additive. This rule does not apply to color additive packages meant only for use in hair dyes.

(f) Its packaging or labeling violates regulations issued under sections 1472 or 1473 of title 15.

facts

- Citation: 21 U.S.C. § 362, titled "Misbranded cosmetics," originally enacted June 25, 1938 (ch. 675, § 602, 52 Stat. 1054). - Length: The statute comprises approximately 290 words, outlining six specific misbranding conditions (a)–(f). - Amendments: The section has been amended five times, most recently by Pub. L. 117–328 (Dec. 29, 2022). - Source Credit: The source credit includes six distinct legislative references spanning from 1938 to 2022. - Regulatory Cross-References: The statute cross-references other provisions, including sections 364e, 379e, and 361(a) of Title 21, and sections 1472/1473 of Title 15.

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

A cosmetic shall be deemed to be misbranded—

(a)

If its labeling is false or misleading in any particular.

(b)

If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) the information required under section 364e of this title: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c)

If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, 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.

(d)

If its container is so made, formed, or filled as to be misleading.

(e)

If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 379e of this title. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 361(a) of this title).

(f)

If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.

Source credit: (June 25, 1938, ch. 675, § 602, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, § 6(f), formerly § 7(f), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 102–571, title I, § 107(12), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 117–328, div. FF, title III, § 3503(a)(3), Dec. 29, 2022, 136 Stat. 5858.)

history & why it existsrecord from the source credit

1938Enacted · Act of June 25, 1938, ch. 675 · 52 Stat. 1054
1960Amended · Pub. L. 86-618 · 74 Stat. 398
1970Amended · Pub. L. 91-601 · 84 Stat. 1673
1992Amended · Pub. L. 102-571 · 106 Stat. 4499
2022Amended · Pub. L. 117-328 · 136 Stat. 5858

The record. The source credit shows this section originated in the Federal Food, Drug, and Cosmetic Act, enacted June 25, 1938 (ch. 675, § 602, 52 Stat. 1054). It has since been amended several times: by Pub. L. 86–618 (1960), Pub. L. 91–601 (1970, later renumbered by Pub. L. 97–35 in 1981), Pub. L. 102–571 (1992), and most recently Pub. L. 117–328 (2022). This amendment history indicates that Congress and subsequent legislatures have periodically revisited the cosmetics-misbranding provisions, adjusting labeling and packaging requirements over more than eight decades. Historical context. The Federal Food, Drug, and Cosmetic Act of 1938 is generally understood to have been enacted in response to widespread public concern over unsafe and deceptively labeled food, drug, and cosmetic products, replacing the weaker Pure Food and Drug Act of 1906. The Act's commonly cited purpose was to strengthen federal authority to prevent adulteration and misbranding across these product categories, including establishing baseline labeling standards for cosmetics to protect consumers from false or misleading claims. The record does not establish the specific legislative intent behind each individual amendment listed in the source credit, such as the 1960, 1970, 1992, or 2022 changes. Without access to the committee reports or debates associated with those particular enactments, this note cannot responsibly characterize why Congress made those specific changes to the misbranding provisions beyond noting that they occurred.

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