21 U.S.C. § 361 Adulterated Cosmetics

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-22 with Court Rules updates (published on www.congress.gov on 12/01/2023)
• Year: 2023
• Citation: 21 U.S.C. § 361

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.

Cite as 21 U.S.C. § 361

Source: 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.

Notes from the Office of Law Revision Counsel

current through 5/22/2023

Amendment of Section

Pub. L. 117-328 div. FF, title III, §3503(a)(2), (b)(1), Dec. 29, 2022, 136 Stat. 5858, 5859, provided that, effective on the date that is 1 year after Dec. 29, 2022, this section is amended by adding at the end the following:

(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.