§364h — Title 21 Food and Drugs | U.S. Code

Summary

Treats people or businesses who are responsible for cosmetics, and owners or operators of cosmetic facilities, as small businesses and lets them skip certain other federal cosmetic rules if their average gross annual U.S. sales of cosmetic products for the prior 3-year period are less than $1,000,000 (adjusted for inflation) and they do not manufacture or process certain kinds of products. The exemption does not apply to anyone who makes or processes any of four types of cosmetics: products that regularly touch the eye’s mucous membrane in normal use, products that are injected, products for internal use, or products meant to change appearance for more than 24 hours when the consumer does not normally remove them.

Title 21, §364h

Food and Drugs — Source: USLM XML via OLRC

(a)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)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.

(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.

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.

§364h Small businesses

Summary

Title 21, §364h

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata