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The U.S. Food and Drug Administration (FDA), on the 07/08/2023, issued a draft guidance for the cosmetic product facility registrations and product listings procedures, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Key Requirements for FDA Cosmetic Product Registration
This draft guidance document explains, among other things:
- The statutory requirement to submit cosmetic product facility registrations and product listings;
- Definitions;
- Who is responsible for making the submissions;
- What information to include in the submissions;
- How to make the submissions; and
- When to make the submissions.
How to Submit Your Registration and Listing
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA. The draft guidance also contains information about a new electronic registration and listing submission portal as well as certain exemptions to the registration and listing requirements. FDA intends to make the new electronic submission portal available in October 2023.
FDA Establishment Identifier (FEI Number)
As part of this process, the FDA intends to use the FDA Establishment Identifier (FEI also known as FEI number) as the official registration number for cosmetic facilities. Companies must obtain an FEI number before submitting their registrations.
This step is critical to complete the FDA cosmetic product registration process successfully.
In addition, FDA is soliciting applications from members of the cosmetic product industry interested in participating in a voluntary pilot program to conduct User Acceptance Testing (UAT) to help evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing. To learn more about MoCRA, please visit our MoCRA website.
Need Help With MoCRA Registration?
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References:
Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
