21 U.S.C. § 364c — Registration and product listing

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 for an abbre- viated 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 cos- metic product listing, or ensure that such sub- mission 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 abbre- viated process for the renewal of any cosmetic product listing under this subsection with re- spect 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 Regula- tions (or any successor regulations), or by the common or usual name of the ingre- dient; 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 prod- ucts with identical formulations, or formu- lations that differ only with respect to col- ors, fragrances or flavors, or quantity of con- tents. (5) Updates to content A responsible person that is required to sub- mit a cosmetic product listing shall submit 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 the cosmetic product or other responsible per- son, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Sec- retary 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 ac- tions required for reinstatement of registra- tion 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 pre- sented, 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 infor- mal hearing under paragraph (3), the Sec- retary determines that the suspension of reg- istration remains necessary, the Secretary shall require the registrant to submit a cor- rective 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 ac- tion plan or such other time period as deter- mined 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 sus- pended under this section, no person shall in- troduce or deliver for introduction into com- merce 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 va- cate an order of suspension shall not be dele- gated to any officer or employee other than the Commissioner. (June 25, 1938, ch. 675, § 607, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5851.) 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. § 364d. Safety substantiation (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 require- ments of section 361(a) of this title. A respon- sible person for a coal-tar hair dye shall main- tain records related to the safety of such prod- uct. (c) Definitions For purposes of this section: (1) Adequate substantiation of safety The term ‘‘adequate substantiation of safe- ty’’ means tests or studies, research, analyses,