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21 U.S.C. § 364j — Preemption

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

21 U.S.C. § 364j — Preemption

**(a) In general** No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this subchapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. **(b) Limitation** Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product. **(c) Savings** Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law. **(d) Rule of construction** Nothing in this section shall be construed to amend, expand, or limit the provisions under [section 379s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379s&num=0&edition=prelim).

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Source file: Laws/federal/codes/united-states-code/title-21/section-364j-preemption--0f0cc87047.md
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Source location: Title 21, Chapter 9, § 364j; 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. § 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. § 379s — Preemption for labeling or packaging of cosmetics

**(a) In general** Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 ([15 U.S.C. 1471](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1471&num=0&edition=prelim) et seq.), or the Fair Packaging and Labeling Act ([15 U.S.C. 1451](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1451&num=0&edition=prelim) et seq.). **(b) Exemption** Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that— (1) protects an important public interest that would otherwise be unprotected; (2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and (3) would not unduly burden interstate commerce. **(c) Scope** For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.

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

21 U.S.C. § 364j — Preemption

Page 489 TITLE 21—FOOD AND DRUGS § 364j Statutory Notes and Related Subsidiaries CONSTRUCTION; CONFIDENTIALITY Nothing in section 3502 of Pub. L. 117–328, which en- acted this section, to be construed to authorize the dis- closure of information that is prohibited from disclo- sure 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. § 364h. Small businesses (a) In general Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, ad- justed for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title. (b) Requirements applicable to all manufactur- ers and processors of cosmetics The exemptions under subsection (a) shall not apply to any responsible person or facility en- gaged in the manufacturing or processing of any of the following products: (1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual. (2) Cosmetic products that are injected. (3) Cosmetic products that are intended for internal use. (4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual. (June 25, 1938, ch. 675, § 612, as added Pub. L. 117–328,

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