Title 21Food and DrugsRelease 119-73

§364j Preemption

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VI— - COSMETICS › § 364j

Last updated Apr 6, 2026|Official source

Summary

States may not make or keep any rule about cosmetics that is different from the federal rules under this subchapter for registration and product lists, good manufacturing practices, records, recalls, reporting bad reactions, or proof of safety. The Modernization of Cosmetics Regulation Act of 2022 does not cancel other state actions except as described above. States can ban or limit an ingredient and can keep ingredient-reporting rules that existed when the Act passed. Federal rules also do not change state damage claims or legal responsibility. Nothing here changes section 379s.

Full Legal Text

Title 21, §364j

Food and Drugs — Source: USLM XML via OLRC

(a)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)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)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)Nothing in this section shall be construed to amend, expand, or limit the provisions under section 379s of this title.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The

Amendments

to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, referred to in subsecs. (b) and (c), means the

Amendments

made by subtitle E (§§ 3501–3508) of title III of div. FF of Pub. L. 117–328, which enacted this section and sections 364 to 364i of this title and amended section 331, 361, 362, 374, and 381 of this title. The time of enactment of the Modernization of Cosmetics Regulation Act of 2022, referred to in subsec. (b), probably means the date of enactment of subtitle E (§§ 3501–3508) of title III of div. FF of Pub. L. 117–328, which was approved Dec. 29, 2022.

Statutory Notes and Related Subsidiaries

Construction

ConfidentialityNothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 364j

Title 21Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73