21 U.S.C. § 361 — Adulterated cosmetics

submitted 88 years ago by ch. 675 to r/title-21-FOOD-AND-DRUGS · 308 words · no verdicts yet

in plain englishAI-generated · not legal advice

A cosmetic is legally "adulterated" if it contains harmful substances, filth, or an unsafe color additive. It also counts if it was made or stored unsanitarily, or its container could harm users. Coal-tar hair dye gets a limited exception if it carries a required warning label.

A cosmetic counts as "adulterated" — meaning legally impure or mislabeled — under any of these conditions. (a) It contains a poisonous or harmful substance that could injure users under normal or labeled use. Coal-tar hair dye is excepted if its label carries a specific warning about skin-irritation testing and injury risk, and gives testing directions. This exception does not cover eyelash or eyebrow dye. (b) It contains any filthy, rotten, or decomposed material. (c) It was made, packed, or stored in unsanitary conditions that could contaminate it or make it harmful. (d) Its container is made partly or fully of a poisonous substance that could harm users. (e) It is not a hair dye and contains a color additive that is unsafe under section 379e(a). (f) It was made under conditions that don't meet the manufacturing rules in section 364b. (g) It is a cosmetic product that lacks adequate safety proof for each ingredient, as defined in section 364d(c).

facts

- Codified at 21 U.S.C. § 361, titled "Adulterated cosmetics," within the Federal Food, Drug, and Cosmetic Act framework. - Originally enacted June 25, 1938, ch. 675, § 601, 52 Stat. 1054. - Comprises 308 words and defines seven distinct grounds (a)–(g) for deeming a cosmetic adulterated. - Amended four times, most recently by Pub. L. 117–328, div. FF, title III, § 3503(a)(2), Dec. 29, 2022, 136 Stat. 5858. - Source credit lists five separate legislative enactments/amendments spanning 1938 to 2022.

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

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 1 safety, as defined in section 364d(c) of this title.

Source credit: (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.)

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
1992Amended · Pub. L. 102-571 · 106 Stat. 4499
1993Amended · Pub. L. 103-80 · 107 Stat. 778
2022Amended · Pub. L. 117-328 · 136 Stat. 5858

The record shows that this section was originally enacted as § 601 of the Act of June 25, 1938, ch. 675, 52 Stat. 1054 — the Federal Food, Drug, and Cosmetic Act. According to the source credit, the section has since been amended four times: by Pub. L. 86–618 (1960), Pub. L. 102–571 (1992), Pub. L. 103–80 (1993), and most recently Pub. L. 117–328 (2022), which added the substantiation-of-safety provision reflected in subsection (g). Historical context: The Federal Food, Drug, and Cosmetic Act of 1938 is generally understood to have been enacted in response to public health failures under the earlier 1906 Pure Food and Drug Act, most notably the 1937 "Elixir Sulfanilamide" poisoning deaths, which exposed gaps in federal authority over drugs and related consumer products. The 1938 Act broadened federal regulation to cover cosmetics for the first time, establishing adulteration standards meant to protect consumers from products that were poisonous, contaminated, or unsanitary. The specific inclusion of the coal-tar hair dye exception is commonly associated with industry concerns of that era regarding allergic reactions to hair dyes, though the record here does not document the particular legislative reasoning behind that provision. The later amendments, including the 2022 addition addressing safety substantiation, reflect ongoing congressional attention to cosmetic regulation, but the source credit does not itself explain the specific purposes behind those amendments.

all 0 arguments · sorted by: best

no arguments yet — make the first case