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21 U.S.C. § 362 — Misbranded cosmetics
Federal law — U.S. Code and appendices · legal_authorities
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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e&num=0&edition=prelim): 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e&num=0&edition=prelim). 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 th
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Stable record: federal_law:legal_authorities:record_usc_b4f1a4689b9631ceb7809d84
Source file: Laws/federal/codes/united-states-code/title-21/section-362-misbranded-cosmetics--a73e8377e2.md
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Source location: Title 21, Chapter 9, § 362; chapter-009-federal-food-drug-and-cosmetic-act.md
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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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e&num=0&edition=prelim): 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim)).
**(f)** If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse.
(2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
(3) **Facility**
(A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(vii
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364
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Federal law — U.S. Code and appendices · legal_authorities
For the purpose of this Act—
(1) The term “Commission” means the Consumer Product Safety Commission.
(2) The term “household substance” means any substance which is customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household and which is—
(A) a hazardous substance as that term is defined in [section 1261(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1261/f&num=0&edition=prelim);
(B) a food, drug, or cosmetic as those terms are defined in [section 321 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim); or
(C) a substance intended for use as fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house.
(3) The term “package” means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage by individuals in or about the household, and, for purposes of [section 1473(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1473/a/2&num=0&edition=prelim), also means any outer container or wrapping used in the retail display of any such substance to consumers. Such term does not include—
(A) any shipping container or wrapping used solely for the transportation of any household substance in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof, or
(B) any shipping container or outer wrapping used by retailers to ship or deliver any household substance to consumers unless it is the only such container or wrapping.
(4) The term “special packaging” means packaging that is designed or
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 1471
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General requirement** Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
**(b) Fragrance allergens** The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
**(c) Cosmetic products for professional use**
(1) **Definition of professional** — For purposes of this subsection, the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
(2) **Professional use labeling** — A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—
(A) contains a clear and prominent statement that the product shall be administered or used only by license
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364e
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Unsafe color additives** A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—
(1)
(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.
While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim) if such article is a food, or within the meaning of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim) if such article is a cosmetic other than a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379e
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under [section 361 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim) or misbranded under [section 362 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section362&num=0&edition=prelim) and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.
**(b) Hearing** The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.
**(c) Order resolution** After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—
(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;
(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or
(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364g
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Federal law — U.S. Code and appendices · legal_authorities
Page 481
TITLE 21—FOOD AND DRUGS
§ 362
1 So in original. Probably should be ‘‘of’’.
have become contaminated with filth, or where-
by 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 cos-
metic product, including each ingredient in the
cosmetic product, does not have adequate sub-
stantiation for 1 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 Notes
AMENDMENTS
2022—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 o
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 362
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