Title 21, Food and DrugsRelease 119-110
§364i Exemption for Certain Products and Facilities
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VI — COSMETICS › § 364i
Summary
Cosmetic products or facilities under subchapter V don't have to follow sections 364a–364g (including 364e(a)). If a facility also makes cosmetics not under subchapter V, those products must follow 364a–364g.
Full Legal Text
Title 21, §364i
Food and Drugs, Source: USLM XML via OLRC
(a)In general
Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of section 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.
(b)Exception
A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of section 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.
Legislative History
Notes & Related Subsidiaries
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. § 364i
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110