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

(a) Submission of registration: (1)(A) Anyone who, as of December 29, 2022, owns or runs a facility that manufactures or processes cosmetics for U.S. distribution must register that facility within 1 year of that date. (B) Anyone who starts such manufacturing or processing after December 29, 2022, must register within 60 days of starting, or 60 days after the deadline in (A), whichever is later. (2) Registered facilities must renew their registration every two years. (3) If a facility makes products for a responsible person under contract, the Secretary only requires one registration for that facility, even if it makes products for itself or for more than one responsible person; that single registration can be filed by the facility or by any responsible person using it. (4) Anyone required to register must tell the Secretary within 60 days of any change to the required information described in (b)(2). (5) The Secretary must offer a shortened renewal process for facilities that have not had to update their information since their last registration or renewal. (b) Format; contents of registration: (1) The Secretary decides the time and manner for submitting registration information. (2) The registration must include: (A) the facility's name, physical address, email, and phone number; (B) for a foreign facility, the contact information for its U.S. agent, plus electronic contact if available; (C) any facility registration number the Secretary previously assigned under (d); (D) all brand names sold under products made or processed at the facility; and (E) the product category or categories made there, and the responsible person for each. (c) Cosmetic product listing: (1) For each cosmetic product, the responsible person must submit, or make sure someone submits, a product listing, in the time and manner the Secretary sets. (2) A product already on the market as of December 29, 2022, needs a listing within 1 year of that date; a newly marketed product needs a listing within 120 days of first being sold in interstate commerce. After that, updates happen annually, following (4) and (5). (3) The Secretary must offer a shortened renewal process for listings that have not changed since the last one filed. (4)(A) Each listing must include: (i) the registration number of every facility that makes or processes the product; (ii) the responsible person's name and contact number, and the product's name as it appears on the label; (iii) the applicable cosmetic category or categories; (iv) a full ingredient list, including fragrances, flavors, and colors, using names required under federal labeling rules, or common names; and (v) the product's listing number, if one was already assigned under (d). (B) A single listing submission can cover multiple products that have identical formulas, or that differ only in color, fragrance, flavor, or amount. (5) Anyone required to submit a listing must update it annually. (6) A responsible person can submit product listing information together with a facility registration, or separately. (d) Facility registration and product listing numbers: When a facility first registers, or a product is first listed, the Secretary assigns a facility registration number and a product listing number. The Secretary must not make the product listing number public. (e) Confidentiality: If someone requests it under the Freedom of Information Act, section 552 of title 5, the brand names from (b)(2)(D) and the ingredient list from (c)(4)(A)(i) must be withheld under section 552(b)(3) of title 5. (f) Suspensions: (1) The Secretary can suspend a facility's registration if the Secretary decides a product it makes has a reasonable chance of causing serious health harm or death, and reasonably believes other products from that same facility could be similarly affected, because the problem cannot be isolated to just one product, or is widespread enough to raise concern about the whole facility. (2) Before suspending, the Secretary must give the facility's registrant or responsible person notice explaining the reasons for the planned suspension, and 5 business days to propose a plan addressing those reasons. (3) The registrant gets an informal hearing, held within 5 business days of the suspension order or another time both sides agree to, to argue why the registration should not stay suspended and what would be needed to reinstate it. The Secretary must reinstate the registration if the evidence does not support continuing the suspension. (4) If, after that hearing, the Secretary still finds suspension necessary, the registrant must submit a corrective action plan showing how they will fix the problem. The Secretary must review that plan within 14 business days of submission, or another timeframe agreed with the registrant. (5) Once the Secretary decides there is no longer a good reason for the suspension, the Secretary must promptly lift it and reinstate the registration. (6) While a facility's registration is suspended, no one may bring cosmetic products from that facility into U.S. commerce. (7) The power to suspend or lift a suspension under this section can only be exercised by the Commissioner personally; it cannot be handed off to any other officer or employee.