U.S. Code
»
Title 21
» Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VI— COSMETICS
21 U.S.C. § 361
Adulterated cosmetics
A cosmetic shall be deemed to be adulterated—(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 364b of this title.(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for 11 So in original. Probably should be “of”. safety, as defined in section 364d(c) of this title.(June 25, 1938, ch. 675, § 601, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, § 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(x), Aug. 13, 1993, 107 Stat. 778; Pub. L. 117–328, div. FF, title III, § 3503(a)(2), Dec. 29, 2022, 136 Stat. 5858.)Editorial NotesAmendments2022—Subsecs. (f), (g). Pub. L. 117–328 added subsecs. (f) and (g).
1993—Subsec. (a). Pub. L. 103–80 substituted “usual, except that this” for “usual: Provided, That this”.
1992—Par. (e). Pub. L. 102–571 substituted “379e(a)” for “376(a)”.
1960—Par. (e). Pub. L. 86–618 substituted “and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376(a) of this title” for “and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 364 of this title”.
Statutory Notes and Related SubsidiariesEffective 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 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. (e) effective Jan. 1, 1940, 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.
Effective DateSection effective twelve months after June 25, 1938, except par. (a), which, with certain exceptions, became effective on June 25, 1938, see section 1002(a) of act June 25, 1938, set out as a 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.
Notes of Decisions
Gardner v. Toilet Goods Assn., Inc., 387 U.S. 167 (1967).
· cites it 4× “A third regulation challenged by these respondents concerns the statutory exemption for hair dyes that conform to a statutory requirement set out in § 601 (e), 21 U. S. C. § 361 (e). That requirement provides that hair dyes are totally exempt from coverage of the statute if they…”
Gonzalez v. L'oreal USA, Inc., 489 F. Supp. 2d 181 (N.D.N.Y. 2007).
· cites it 4× “Plaintiffs seek to challenge the constitutionality of 21 U.S.C. § 361 . Plntfs’ Mem. of Law (Dkt.”
Clairol, Inc. v. Boston Disc. Ctr. of Berkley, Inc., 608 F.2d 1114 (6th Cir. 1979).
· cites it 2× “The foregoing statement also appears on the bottle label as required by the Federal Food Drug and Cosmetic Act § 601(a), 21 U.S.C. § 361 (a) (1976). 4 The salon product, *1117 on the other hand, being sold for use of professional beauticians and beauty schools only, is not…”
Byrd v. United States, 154 F.2d 62 (5th Cir. 1946).
· cites it 6× “I agree to the judgment, but think it a more direct and satisfactory thing to say simply that the Statute, 21 U.S.C.A. § 361 (e), positively declares that a cosmetic is adulterated if it is not a hair dye and bears or contains a coal tar color other than one from a batch that…”
Tripoli Co., Inc. v. Wella Corp., 425 F.2d 932 (3rd Cir. 1970).
“21 U.S.C. § 361 (a) (1964). Some Wella products are sold with an instruction sheet containing an instruction: HYPERSENSITIVITY AND THE PATCH TEST It is a well-known fact that some individuals are allergic to certain foods, drugs or cosmetics including hair coloring.”
Toilet Goods Ass'n v. Gardner, 278 F. Supp. 786 (S.D.N.Y. 1968).
· cites it 3× “1054 (1938), as amended, 21 U.S.C. § 361 (a) and (e) (1964). Subsection (a) was first enacted in 1938 and was not changed by the 1960 Amendments.”
Zotos Int'l, Inc. v. Kennedy, 460 F. Supp. 268 (D.D.C. 1978).
“Whatever the Association’s motive for cooperating with the agency, its explicit suggestion was that the filings would help the FDA enforce the ban against “adulterated” cosmetics imposed by section 601 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 361 et seq. In April…”
Flemming v. Florida Citrus Exch., 358 U.S. 153 (1959).
“1054 , 1055, 21 U. S. C. §§ 361 (e), 364. It is clear from these provisions that Congress contemplated that a color might be harmless in respect of drugs or cosmetics but not of foods.”
The Ltd., Inc. v. Cigna Ins. Co., 228 F. Supp. 2d 574 (E.D. Pa. 2002).
“” 21 U.S.C. § 361 (d). In the instant case, the Court finds that the term “adulteration” in the Policy’s definition of “accidental contamination” is susceptible of more than one meaning.”
Gelb v. Fed. Trade Comm'n, 144 F.2d 580 (2d Cir. 1944).
· cites it 2× “Moreover, ambiguity lurks in permission to advertise a product as "harmless" if used in accordance with instructions contained in the package, while the label on the bottle warns (as legally it must under the Federal Food, Drug, and Cosmetic Act as amended in 1938, 21 U.S.C.A. §…”
Toilet Goods Ass'n v. Gardner, 387 U.S. 158 (1967).
“A cosmetic containing such an “unsafe” additive is deemed to be adulterated, §601 (e), 21 U. S. C. §361 (e), and is prohibited from interstate commerce.”
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