December 12, 2024
The U.S. Food and Drug Administration (FDA) has released updated guidance for the cosmetics industry, focusing on the registration and listing of cosmetic product facilities and products. The latest document, titled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, introduces key updates to the Frequently Asked Questions (FAQ) section in Appendix B, including new questions for public comment.
Registration and Listing Key Updates
The updated guidance finalizes responses to the original 19 FAQs in Appendix B while introducing three new questions, labeled as Q20-22, which remain open for public feedback. These new FAQs address critical areas:
Responsibilities of a U.S. Agent (Q20):
A U.S. Agent acts as a communication liaison between the FDA and foreign establishments.
Responsibilities include assisting with FDA communications, responding to inquiries about imported products, helping schedule inspections, and receiving FDA documents on behalf of the foreign establishment when direct contact is not possible.
The FDA emphasizes that it does not endorse or recommend specific U.S. agents.
FEI Numbers for Multiple Buildings (Q21):
Multiple buildings within three miles of each other can share one Facility Establishment Identifier (FEI) number if they are part of the same establishment, under unified local management, and capable of being inspected in a single visit.
Cosmetic facility registration requires the physical address in the registration to match the address listed in the FEI Search Portal.
Note: FEI registration and cosmetic product facility registration are separate processes, and FEI registration must be completed first.
Product Listings for Free Samples or Gifts (Q22):
Cosmetic products, including free samples or promotional gifts, generally require a product listing submission under section 607(c) of the FD&C Act.
Exemptions apply to products provided at trade shows, incidental to other services, or for research and development purposes. However, free samples for consumer use must be listed unless exempted by other provisions.
The FDA aims to ensure these updates provide clearer instructions for stakeholders while aligning with the evolving regulatory landscape.
Background: Modernization of Cosmetics Regulation Act (MoCRA)
This update builds upon the final guidance issued in December 2023, following the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA introduced new requirements for cosmetic product facility registrations and product listings, making compliance a key focus for the cosmetics industry.
The guidance covers the following essential topics:
Who Should Register:Â Identifies responsible parties for facility registration and product listing submissions.
Required Information:Â Details the data needed for submissions, including exemptions.
Submission Timing:Â Specifies when registration and listing updates should occur.
For stakeholders, the guidance serves as a comprehensive resource to navigate these mandatory requirements effectively.
Public Comment Period
Stakeholders are encouraged to provide feedback on the three new FAQs (Q20-22) before they are finalized. Comments can be submitted electronically or in writing, as outlined in the Federal Register Notice: Guidance: Registration and Listing of Cosmetic Product Facilities and Products, by January 13, 2025. Feedback will play a crucial role in shaping the final version of these questions.
Next Steps for Compliance
Cosmetic manufacturers and facility operators should:
Review the updated guidance and FAQs to understand their obligations under MoCRA.
Ensure all facility registrations and product listings are current and accurate.
Designate a U.S. Agent if operating outside the United States.
Consider submitting comments to help refine the guidance..
Additional Resources
For further assistance, feel free to contact Provision Consulting Group. Our experts are here to help you navigate FDA requirements and maintain compliance with ease.
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