12/11/24: FDA Updates Guidance on Registration and Listing of Cosmetic Product Facilities and Products

FDA Updates Guidance on Registration and Listing of Cosmetic Product Facilities and Products

On December 11, 2024, the U.S. Food and Drug Administration (FDA) issued updated guidance for the cosmetic industry titled "Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products". This updated guidance, which provides clarification and additional information on the registration and listing process for cosmetic products, includes important new FAQs, some of which are open for public comment.

What’s New in the Guidance?

The updated guidance finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19), which addresses various aspects of the registration and listing process under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). In addition, three new FAQs have been added (Q20-22) to provide further clarification on key issues. These new FAQs focus on:

1. Responsibilities of a U.S. Agent

  • This FAQ clarifies the role of a U.S. Agent in the registration process and how their responsibilities align with compliance requirements for non-U.S. manufacturers.

2. FEI Numbers for Multiple Facilities

  • This question explains when a single FDA Establishment Identifier (FEI) number can be associated with multiple buildings involved in manufacturing or processing cosmetic products.

3. Product Listings for Free Samples/Gifts

  • This FAQ addresses how free samples or gifts should be listed and whether they require registration.

These new FAQs are currently marked as "for comment purposes only" and provide the public with an opportunity to offer feedback before they are finalized. The comment period will end on January 13, 2025.

Background on the Guidance

The FDA’s initial final guidance on cosmetic product facility registrations and product listings was issued in December 2023. This guidance was a critical step in implementing MoCRA, which introduced significant changes to how the FDA manages the registration and listing of cosmetic products. The guidance helps stakeholders understand the requirements for submitting their facility and product information, including:

  • Who is responsible for making the registration and listing submissions.
  • What information needs to be included in the submissions.
  • How and when to submit the information.
  • Exemptions to the registration and listing requirements.

This updated guidance helps ensure that businesses comply with MoCRA’s requirements and provides a clear path for registering and listing cosmetic products with the FDA. It also emphasizes the use of the Cosmetics Direct portal for electronic submissions.

Comment Period for New FAQs

The FDA encourages industry stakeholders to review the new FAQs (Q20-22) and submit their comments during the open comment period. This feedback will help refine the guidance and ensure that it reflects the concerns and needs of the industry. The comment period closes on January 13, 2025, and comments can be submitted electronically or in writing according to the instructions in the Federal Register Notice.

How to Prepare

As the cosmetic industry continues to adapt to MoCRA’s requirements, companies should review the updated guidance and the new FAQs carefully. This will help ensure compliance and avoid delays in registration and listing. Additionally, companies can prepare by using the Cosmetics Direct portal for electronic submissions, as it streamlines the process and provides a more efficient method for submitting facility and product details.

For more details on the guidance, exemptions, and submission process, refer to the full FDA guidance document and resources in the "Additional Information" section.

Conclusion

The FDA’s updated guidance provides critical clarification on the registration and listing process for cosmetic product facilities and products. With the introduction of new FAQs and the opportunity to submit comments, the FDA is ensuring that stakeholders have the information and opportunity to participate in shaping the final guidance. Cosmetics businesses are encouraged to review the new FAQs, submit their comments, and ensure they are in full compliance with MoCRA requirements as the enforcement deadlines approach.

 

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