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21 U.S.C. § 364h — Small businesses
Federal law — U.S. Code and appendices · legal_authorities
**(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.
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Source file: Laws/federal/codes/united-states-code/title-21/section-364h-small-businesses--a1ecee980b.md
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Source location: Title 21, Chapter 9, § 364h; chapter-009-federal-food-drug-and-cosmetic-act.md
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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.
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse.
(2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
(3) **Facility**
(A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(vii
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Serious adverse event reporting requirements** The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.
**(b) Submission of reports**
(1) **Serious adverse event report** — The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
(2) **New medical information** — The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.
(3) **Consolidation of reports** — The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.
**(c) Exemptions** The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health.
**(d) Contact information** The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with [section 364e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-pr
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364a
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Federal law — U.S. Code and appendices · legal_authorities
Page 489
TITLE 21—FOOD AND DRUGS
§ 364j
Statutory Notes and Related Subsidiaries
CONSTRUCTION; CONFIDENTIALITY
Nothing in section 3502 of Pub. L. 117–328, which en-
acted this section, to be construed to authorize the dis-
closure of information that is prohibited from disclo-
sure 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
(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, ad-
justed 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 manufactur-
ers and processors of cosmetics
The exemptions under subsection (a) shall not
apply to any responsible person or facility en-
gaged 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,
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