Title 21 — Food and DrugsRelease 119-73
§362 Misbranded cosmetics
Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VI— - COSMETICS › § 362
Summary
A cosmetic is misbranded when its label is false or misleading. It is also misbranded if a package does not show the maker’s name and place of business, an accurate amount (weight, measure, or count), and the information required under section 364e. The Secretary may allow reasonable variations and exempt very small packages. A cosmetic is misbranded if required label information is not easy to see and read, if the container’s shape or fill is misleading, if a color additive’s packaging or labeling does not follow rules under section 379e (except color additives sold only for hair dyes), or if the packaging or labeling breaks regulations under title 15, sections 1472 or 1473.
Full Legal Text
Title 21, §362
Food and Drugs — Source: USLM XML via OLRC
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.
Legislative History
Notes & Related Subsidiaries
Editorial Notes
Amendments
2022—Subsec. (b)(3). Pub. L. 117–328 added par. (3) before proviso. 1992—Par. (e). Pub. L. 102–571 substituted “379e” for “376”. 1970—Par. (f). Pub. L. 91–601 added par. (f). 1960—Par. (e). Pub. L. 86–618 added par. (e).
Statutory Notes and Related Subsidiaries
Effective Date
of 2022 AmendmentAmendment by Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.
Effective Date
of 1970 AmendmentAmendment by Pub. L. 91–601 effective Dec. 30, 1970, and
Regulations
establishing special packaging standards effective no sooner than 180 days or later than one year from date
Regulations
are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an
Effective Date
note under section 1471 of Title 15, Commerce and Trade.
Effective Date
of 1960 AmendmentAmendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.
Effective Date
PostponementPar. (b) effective Jan. 1, 1940, and such subsection effective July 1, 1940, as provided by
Regulations
for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an
Effective Date
Postponement in Certain Cases note under section 301 of this title.
Construction
ConfidentialityNothing in amendment made by Pub. L. 117–328, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
Executive Documents
Transfer of Functions
For
Transfer of Functions
of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
Reference
Citations & Metadata
Citation
21 U.S.C. § 362
Title 21 — Food and Drugs
Last Updated
Apr 6, 2026
Release point: 119-73