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21 U.S.C. § 364 — Definitions
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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Stable record: federal_law:legal_authorities:record_usc_2b5ff3db2562fba45ce73bb7
Source file: Laws/federal/codes/united-states-code/title-21/section-364-definitions--828e88d3ef.md
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Source location: Title 21, Chapter 9, § 364; chapter-009-federal-food-drug-and-cosmetic-act.md
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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.
(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:
(I) Labeling.
(II) Relabeling.
(III) Packaging.
(IV) Repackaging.
(V) Holding.
(VI) Distributing.
(C) *Clarification.—* — For the purposes of subparagraph (B)(viii), the terms “packaging” and “repackaging” do not include filling a product container with a cosmetic product.
(4) **Responsible person** — The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with [section 364e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e/a&num=0&edition=prelim) or [section 1453(a) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1453/a&num=0&edition=prelim).
(5) **Serious adverse event** — The term “serious adverse event” means an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity;
(v) a congenital anomaly or birth defect;
(vi) an infection; or
(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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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) Unsafe color additives** A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—
(1)
(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.
While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim) if such article is a food, or within the meaning of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim) if such article is a cosmetic other than a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379e
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
A cosmetic shall be deemed to be adulterated—
**(a)** If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.
**(b)** If it consists in whole or in part of any filthy, putrid, or decomposed substance.
**(c)** If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
**(d)** If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
**(e)** If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim).
**(f)** If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of [section 364b of this title](https://uscode.house.gov/view.xhtml?r
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 361
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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
**(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
**(a) In general** The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with [section 361 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim). Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph 11 So in original. Probably should be “this subsection”. during an inspection conducted under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(b) Considerations** In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.
**(
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Submission of registration**
(1) **Initial registration**
(A) *Existing facilities* — Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.
(B) *New facilities* — Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
(2) **Biennial renewal of registration** — A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.
(3) **Contract manufacturers** — If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
(4) **Updates to content** — A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).
(5) **Abbreviated renewal registrations** — The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364c
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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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364d
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