In December 2024, the U.S. Food and Drug Administration (FDA) has updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products.
This guidance assists enterprises in achieving compliance with MOCRA with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), streamlining the processes for cosmetic product facility registrations and product listings.
Key updates
The revised guidance finalises the 19 frequently asked questions (FAQ) included in Appendix B of the December 2023 version and introduces three new draft FAQ (Q20-22) marked “for comment purposes only.”
These new FAQ address:
- U.S. Agent responsibilities: Clarifying the role and obligations of U.S. agents under MoCRA.
- FEI numbers for multi-building facilities: Guidance on managing Facility Establishment Identifier (FEI) numbers for facilities with multiple manufacturing or processing buildings.
- Product listings for free samples: Specifics on how to handle registration for promotional cosmetic products.
Comment period open until 13 January 2025
Stakeholders are encouraged to submit feedback on the new draft FAQ before they are finalised. Comments can be submitted electronically or in writing, as outlined in the Federal Register Notice.
Guidance highlights
The guidance provides a comprehensive overview of the requirements, including:
- Who must register facilities and list products.
- What information needs to be included in submissions.
- How and when to submit required information.
- Exemptions to registration and listing requirements.
Do you have any questions on compliance of cosmetics in the EU, UK, or US? Contact us here or write an email to COSlaw@obelis.net.
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