On December 11, 2024, the U.S. Food and Drug Administration (FDA) released updated guidance for the registration and listing of cosmetic product facilities and products. This guidance finalizes previously issued FAQs and introduces three new questions (Q20-22) that are currently open for public comment until January 13, 2025.
The new FAQs address:
- Responsibilities of U.S. Agents: Clarifying their roles in the registration process.
- Multiple Facilities Under One FEI Number: Discussing how one Facility Establishment Identifier (FEI) number can apply to multiple buildings involved in manufacturing or processing.
- Product Listings for Free Samples/Gifts: Outlining how to handle product listings for items distributed as free samples.
This guidance is part of the FDA’s efforts to comply with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). It provides essential information on who is responsible for submissions, what information is required, and the procedures for submitting registrations and listings.
While the guidance offers recommendations, it does not create legally enforceable obligations. Stakeholders are encouraged to submit comments on the new FAQs to ensure their input is considered before the finalization of these sections.
For more details, you can access the full guidance document here.
 released updated guidance for the registration and listing of cosmetic product facilities and products. This guidance finalizes previously issued FAQs and introduces three new questions (Q20-22) that are currently open for public comment until January 13, 2025.){kind=link}