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

Federal law — U.S. Code and appendices · legal_authorities

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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim). **(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](https://uscode.house.gov/view.xhtml?r

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Source location: Title 21, Chapter 9, § 361; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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21 U.S.C. § 364 — Definitions

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

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Federal law — U.S. Code and appendices · legal_authorities

18 U.S.C. § 1905 — Disclosure of confidential information generally

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.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics

**(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

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21 U.S.C. § 364b — Good manufacturing practice

**(a) In general** The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with [section 361 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim). Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph 11 So in original. Probably should be “this subsection”. during an inspection conducted under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim). **(b) Considerations** In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary. **(

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 331 — Prohibited acts

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. *

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 364g — Mandatory recall authority

**(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

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Federal law — U.S. Code and appendices · legal_authorities

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

Page 480 TITLE 21—FOOD AND DRUGS § 360fff–7 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle, with respect to a drug that was the subject of an appli- cation extinguished under paragraph (1).’’ § 360fff–7. Report (a) In general (1) In general Not later than 18 months after November 26, 2014, and on the dates that are 2 and 4 years thereafter, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives describing actions taken under this part. (2) Contents The reports under this subsection shall in- clude— (A) a review of the progress made in issuing GRASE determinations for pending requests, including the number of pending requests— (i) reviewed and the decision times for each request, measured from the date of the original request for an eligibility de- termination submitted by the sponsor; (ii) resulting in a determination that the nonprescription sunscreen active ingre- dient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded; (iii) resulting in a determination that the nonprescription sunscreen active in- gredient or combination of nonprescrip- tion sunscreen active ingredients is not GRASE and is misbranded and the reasons for such determinations; and (iv) for which a determination has not been made, and an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor; (B) a review of the progress made in issuing GRASE determinations

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