Preemption

21 U.S.C. § 364j

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER VI—COSMETICS

Text

(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.

History

(June 25, 1938, ch. 675, §614, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Editorial Notes

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 sections 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; Confidentiality
Nothing 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.