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- Title 21. Food and Drugs
- Chapter 9. Federal Food, Drug, and Cosmetic Act
- Subchapter VI. Cosmetics
21 U.S.C. § 364h Small Businesses
Library | United States Statutes |
Edition | 2023 Edition |
Currency | Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023) |
(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, adjusted 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 manufacturers and processors of cosmetics
The exemptions under subsection (a) shall not apply to any responsible person or facility engaged 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.
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