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Code · U.S. Code · Title 21 - FOOD AND DRUGS · CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT · SUBCHAPTER VI— COSMETICS · § 364h

§ 364h. Small businesses

286 words·~1 min read·/usc/title-21/section-364h

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(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, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
Connections6 cite this · traces to 5
2 references not yet in our index
  • June 25, 1938, ch. 675, § 612
  • 136 Stat. 5857
Citation graph
cites case law
§ 364h
Small businesses
Fed. Reg.×2
U.S.C.×2
Pub. L.×1
Stat.×1
ActJune 25, 1938, ch. 675, § 612
Stat.136 Stat. 5857
Cites 7Cited by 6 across 4 sources
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