The FDA has issued a guidance document finalizing the frequently asked questions and answers on this topic along with some new FAQs that you can comment on before the additional FAQs are finalized. The 3 new FAQs address:
- The Responsibilities of a U.S. Agent
- Situations when one FEI number may be associated with multiple buildings that manufacture or process cosmetic products
- Product listings for free samples/gifts
The comment period closes on January 13th, 2025, and you can view a summary plus the instructions for submitting comments here.
Back in December 2023, The FDA issued initial guidance for cosmetic facility registrations and product listings as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA.) We issued a progress update in July of this year where the product submissions portal, Cosmetics Direct, had been enhanced, and now this communication provides the next update on the topic. The guidance available here can assist you with determining who is responsible for the cosmetic product facility registration and product listing submissions to the FDA, the information to include, how and when to submit, and what the exemptions are.
