The US Food and Drug Administration (FDA) has issued updated guidance titled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. The update offers clarifications for manufacturers and suppliers in the cosmetics industry, ensuring compliance with regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This latest update finalizes previously released frequently asked questions (FAQs) in Appendix B (Q1–Q19) and introduces three new draft FAQs (Q20–Q22) for public review and comment. These latest additions address critical areas of interest for industry stakeholders.
Key updates to the Guidance
The three draft FAQs, which are currently marked “for comment purposes only,” focus on:
- Responsibilities of a U.S. Agent: This provides clarity on the agent’s role, particularly for foreign companies navigating U.S. regulatory requirements.
- Situations involving multiple buildings under one FEI number: This FAQ explains scenarios in which a single Facility Establishment Identifier (FEI) may be linked to several buildings that manufacture or process cosmetic products.
- Requirements for free samples and promotional gifts: The guidance outlines how these products should be listed to ensure compliance.
These updates aim to address practical questions from industry participants and foster smoother compliance with FDA regulations.
Background on the Guidance
The FDA initially issued its final guidance on cosmetic product facility registration and product listing in December 2023, fulfilling key requirements of MoCRA. The initial guidance detailed submission processes, including who is responsible for filing, what information to include, and applicable exemptions.
The FDA aims to provide the resources and clarity needed to navigate these mandatory requirements efficiently. For example, the agency noted that its Cosmetics Direct platform offers a centralized submission tool and further guidance on exemptions.
In its original release, the FDA emphasized the importance of industry input, requesting comments on the first set of FAQs (Q1–Q19). This collaborative approach continues with the introduction of the new draft FAQs.
Comment period and industry participation
The FDA is inviting public comments on the three draft FAQs through January 13, 2025, allowing stakeholders to shape the final guidance. “To ensure that the agency considers your comments on the three new FAQ (Q20–Q22)…submit either electronic or written comments on these FAQ,” the FDA stated.
By actively participating in this process, industry members can help address ambiguities and ensure the guidance reflects real-world operational challenges. For example, manufacturers with complex facility arrangements or promotional strategies will likely find the draft FAQs particularly relevant.
Accessing additional resources
The FDA has made a wealth of resources available to assist with compliance. These include detailed guidance documents, a Federal Register notice, and the Cosmetics Direct platform for registration and listing submissions.
The agency also encourages stakeholders to review related updates from December 2023 to understand their regulatory obligations comprehensively.
This updated guidance underscores the FDA’s ongoing commitment to transparency and collaboration. As the cosmetics industry evolves, these measures aim to build a regulatory framework supporting innovation and consumer safety.
For further information, visit the FDA’s webpage on Registration & Listing of Cosmetic Product Facilities and Products.
