21 U.S.C. § 364h | Small businesses

(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.

(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.

June 25, 1938, ch. 675, § 612 Pub. L. 117–328, div. FF, title III, § 3502Dec. 29, 2022136 Stat. 5857(, as added , , .)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

section 3502 of Pub. L. 117–328 section 331(j) of this title section 1905 of title 18 section 552(b)(4) of title 5 section 3503(c)(2) of Pub. L. 117–328 section 364 of this titleNothing in , which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under or or that is subject to withholding under , see , set out as a note under .