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21 U.S.C. § 364d — Safety substantiation
Federal law — U.S. Code and appendices · legal_authorities
**(a) Substantiation of safety** A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
**(b) Coal-tar hair dye** Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim). A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
**(c) Definitions** For purposes of this section:
(1) **Adequate substantiation of safety** — The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
(2) **Safe** — The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.
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Source file: Laws/federal/codes/united-states-code/title-21/section-364d-safety-substantiation--1027e14b08.md
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Source location: Title 21, Chapter 9, § 364d; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Substantiation of safety** A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
**(b) Coal-tar hair dye** Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim). A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
**(c) Definitions** For purposes of this section:
(1) **Adequate substantiation of safety** — The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
(2) **Safe** — The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.
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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
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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
Page 486
TITLE 21—FOOD AND DRUGS
§ 364d
1 So in original. Probably should be preceded by ‘‘subsection’’.
any updates to such cosmetic product listing
annually.
(6) Submission
A responsible person may submit product
listing information as part of a facility reg-
istration or separately.
(d) Facility registration and product listing num-
bers
At the time of the initial registration of any
facility under subsection (a)(1) or initial listing
of any cosmetic product under (c)(1),1 the Sec-
retary shall assign a facility registration num-
ber to the facility and a product listing number
to each cosmetic product. The Secretary shall
not make such product listing number publicly
available.
(e) Confidentiality
In response to a request under section 552 of
title 5, information described in subsection
(b)(2)(D) or (c)(4)(A)(i) that is derived from a reg-
istration or listing under this section shall be
withheld under section 552(b)(3) of title 5.
(f) Suspensions
(1) Suspension of registration of a facility
The Secretary may suspend the registration
of a facility if the Secretary determines that
a cosmetic product manufactured or processed
by a registered facility and distributed in the
United States has a reasonable probability of
causing serious adverse health consequences
or death to humans and the Secretary has a
reasonable belief that other products manufac-
tured or processed by the facility may be simi-
larly affected because of a failure that cannot
be isolated to a product or products, or is suf-
ficiently pervasive to raise concerns about
other products manufactured in the facility.
(2) Notice of suspension
Before suspending a facility registration
under this section, the Secretary shall pro-
vide—
(A) notice to the facility registrant of
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