U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VI— COSMETICS

21 U.S.C. § 362

Misbranded cosmetics

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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.(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.)Editorial NotesAmendments

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 SubsidiariesEffective Date of 2022 Amendment

Amendment 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 Amendment

Amendment 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 Amendment

Amendment 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; Postponement

Par. (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; Confidentiality

Nothing 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 DocumentsTransfer 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.

Notes of Decisions
Cited in 22 cases (4 in the last 5 years), 1969–2023 · leading case: Critcher v. L'Oreal USA, Inc., 959 F.3d 31 (2d Cir. 2020).
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Critcher v. L'Oreal USA, Inc., 959 F.3d 31 (2d Cir. 2020). · cites it 8× “13 21 U.S.C. § 362 (a). 14 Id. § 362(b). 15 Id.”
Ebner v. Fresh, Inc., 838 F.3d 958 (9th Cir. 2016). “” 21 U.S.C. § 362 (a). In other words, both the federal FDCA and California’s Sherman Law prohibit the false or misleading labeling of a cosmetic.”
Skye Astiana v. the Hain Celestial Grp., 783 F.3d 753 (9th Cir. 2015). “” 21 U.S.C. § 362 (a). The more specific preemption language prohibits any state or local government from “establishing] or continuing] in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical…”
Goldemberg v. Johnson & Johnson Consum. Companies, Inc., 8 F. Supp. 3d 467 (S.D.N.Y. 2014). “Plaintiff argues that GBL § 349 does not add any new requirements because the FDCA seeks to prohibit misbranding, 21 U.S.C. § 362 (a) (cosmetic deemed misbranded if “labeling is false or misleading in any particular”); of.”
In re Kind LLC \Healthy & All Nat.\" Litig.", 209 F. Supp. 3d 689 (S.D.N.Y. 2016). “’ See 21 U.S.C. § 362 .”). This factor therefore weighs in favor of staying this case under the primary jurisdiction doctrine.”
Langan v. Johnson & Johnson Consum. Companies, 95 F. Supp. 3d 284 (D. Conn. 2015). · cites it 2× “” See 21 U.S.C. § 362 (a) (prohibiting such labeling in cosmetics); 21 U.”
Zazu Designs, a P'ship v. L'oreal, S.A., 979 F.2d 499 (7th Cir. 1992). “See 21 U.S.C. § 362 (b); 15 U.S.C. §§ 1452 , 1453(a); 21 C.”
Astiana v. Hain Celestial Grp., Inc., 905 F. Supp. 2d 1013 (N.D. Cal. 2012). · cites it 2× “” 21 U.S.C. § 362 . Plaintiffs argue that this court need not wait for any specific guidance from the FDA regarding this prohibition, pointing out that courts routinely “decide whether conduct is misleading.”
Gonzalez v. L'oreal USA, Inc., 489 F. Supp. 2d 181 (N.D.N.Y. 2007). · cites it 2× “Claims asserted under 21 U.S.C. § 362 Plaintiffs’ pleadings allege that Defendant violated labeling requirements laid out in the Food, Drug and Cosmetics Act (“FDCA”), in particular 21 U.”
Angela Ebner v. Fresh, Inc., 818 F.3d 799 (9th Cir. 2016). “” 21 U.S.C. § 362 (a). In'other words, both the federal FDCA and California’s Sherman Law prohibit the false or misleading labeling of a cosmetic.”
United States v. Roux Labs., Inc., 456 F. Supp. 973 (M.D. Fla. 1978). · cites it 2× “Consequently, the Court agrees with Judge Schlesinger, and therefore holds, that two separate inspections, pursuant to valid administrative search warrants, issued more than two years apart, “cannot be considered” harassment.”
Dessert Beauty, Inc. v. Fox, 617 F. Supp. 2d 185 (S.D.N.Y. 2007). “In addition, the definition of a misbranded cosmetic is provided in 21 U.S.C. § 362 . There are also more specific federal labeling regulations that have been promulgated with respect to cosmetics.”
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