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21 U.S.C. § 364e — Labeling
Federal law — U.S. Code and appendices · legal_authorities
**(a) General requirement** Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
**(b) Fragrance allergens** The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
**(c) Cosmetic products for professional use**
(1) **Definition of professional** — For purposes of this subsection, the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
(2) **Professional use labeling** — A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—
(A) contains a clear and prominent statement that the product shall be administered or used only by license
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Source location: Title 21, Chapter 9, § 364e; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) General requirement** Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
**(b) Fragrance allergens** The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
**(c) Cosmetic products for professional use**
(1) **Definition of professional** — For purposes of this subsection, the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
(2) **Professional use labeling** — A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—
(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and
(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and [section 1453(a) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1453/a&num=0&edition=prelim).
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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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
A cosmetic shall be deemed to be misbranded—
**(a)** If its labeling is false or misleading in any particular.
**(b)** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) the information required under [section 364e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e&num=0&edition=prelim): Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
**(c)** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
**(d)** If its container is so made, formed, or filled as to be misleading.
**(e)** If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under [section 379e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e&num=0&edition=prelim). This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of [section 361(a) of th
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 362
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Federal law — U.S. Code and appendices · legal_authorities
Page 487
TITLE 21—FOOD AND DRUGS
§ 364f
or other evidence or information that is con-
sidered, 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 cos-
metic 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 cos-
metic product is safe, the Secretary may con-
sider, as appropriate and available, the cumu-
lative or other relevant exposure to the cos-
metic product, including any ingredient there-
of.
(June 25, 1938, ch. 675, § 608, as added Pub. L.
117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136
Stat. 5854.)
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.
TALC-CONTAINING COSMETICS
Pub. L. 117–328, div. FF, title III, § 3505, Dec. 29, 2022,
136 Stat. 5859, provided that:
‘‘The Secretary of Health and Human Services—
‘‘(1) not later th
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 364e
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