§364c Registration and Product Listing

Summary

Owners or operators of places that make or process cosmetics must register each facility with the Secretary. If a facility was making or processing cosmetics on December 29, 2022, it must register within 1 year after that date. If a facility first starts after December 29, 2022, it must register within 60 days of starting or within 60 days after the December 29, 2022 deadline, whichever is later. Registrations must be renewed every two years. If a facility makes products for others (a contract manufacturer), only one registration is needed for that location. Any required changes to registration information must be sent to the Secretary within 60 days. The Secretary must offer a shorter renewal option when no changes were made. Registration must include basic facility contact details, U.S. agent information for foreign sites, any facility number previously given, the brand names made there, and the product categories plus the responsible person for those products. The person responsible for each cosmetic product must file a product listing with the Secretary. Products sold on December 29, 2022 must be listed within 1 year after that date. Products first sold after December 29, 2022 must be listed within 120 days of first sale. Listings must be updated once a year and a shorter renewal is allowed if nothing changed. Each listing must show the facility registration numbers where the product is made, the responsible person’s name and contact, the product name as on the label, the product categories, an ingredient list with required ingredient names, and any product listing number the Secretary assigned. The Secretary will assign facility and product numbers; product numbers will not be made public. Brand names and facility numbers from registrations or listings are protected from certain public disclosure requests. The Secretary may suspend a facility’s registration if products pose a reasonable probability of serious harm or death and the problem may affect other products; the facility will get notice and 5 business days to respond, an informal hearing within 5 business days, and, if needed, must submit a corrective plan that the Secretary will review within 14 business days. If suspended, products from that facility cannot be sold in the United States. Only the Commissioner may issue or lift such a suspension.