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21 U.S.C. § 364c — Registration and product listing
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
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Stable record: federal_law:legal_authorities:record_usc_37a5f9deba4457fbf09fb098
Source file: Laws/federal/codes/united-states-code/title-21/section-364c-registration-and-product-listing--065eeb3be8.md
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Source location: Title 21, Chapter 9, § 364c; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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 a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).
**(b) Format; contents of registration**
(1) **In general** — Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.
(2) **Contents** — The registration under subsection (a) shall contain—
(A) the facility’s name, physical address, email address, and telephone number;
(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;
(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);
(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and
(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
**(c) Cosmetic product listing**
(1) **In general** — For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.
(2) **Cosmetic product listing** — The responsible person of a cosmetic product that is marketed on December 29, 2022, shall submit to the Secretary a cosmetic product listing not later than 1 year after December 29, 2022, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).
(3) **Abbreviated renewal** — The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.
(4) **Contents of listing**
(A) *In general* — Each such cosmetic product listing shall include—
(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;
(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
(iii) the applicable cosmetic category or categories for the cosmetic product;
(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and
(v) the product listing number, if any previously assigned by the Secretary under subsection (d).
(B) *Flexible listings* — A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
(5) **Updates to content** — A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
(6) **Submission** — A responsible person may submit product listing information as part of a facility registration or separately.
**(d) Facility registration and product listing numbers** At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),11 So in original. Probably should be preceded by “subsection”. the Secretary shall assign a facility registration number 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim), information described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration or listing under this section shall be withheld under [section 552(b)(3) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/3&num=0&edition=prelim).
**(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 manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently 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 provide—
(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and
(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.
(3) **Hearing on suspension** — The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.
(4) **Post-hearing corrective action plan** — If, after providing opportunity for an informal hearing under paragraph (3), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant.
(5) **Vacating of order; reinstatement** — Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility.
(6) **Effect of suspension** — If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility.
(7) **No delegation** — The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.
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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.
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)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
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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
Page 485
TITLE 21—FOOD AND DRUGS
§ 364c
§ 364c. Registration and product listing
(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 cos-
metic product for distribution in the United
States shall register each facility with the
Secretary not later than 1 year after Decem-
ber 29, 2022.
(B) New facilities
Every person that owns or operates a facil-
ity 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 Sec-
retary such facility within 60 days of first
engaging in such activity or 60 days after
the deadline for registration under subpara-
graph (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 cos-
metic products on behalf of a responsible per-
son, the Secretary shall require only a single
registration for such facility even if such facil-
ity is manufacturing or processing its own
cosmetic products or cosmetic products on be-
half 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 f
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 364c
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.