The U.S. Food and Drug Administration (FDA), on the 07/08/2023, issued a draft guidance for the cosmetic product facility registrations and product listings procedures, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This draft guidance document explains, among other things: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.
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA. The draft guidance also contains information about a new electronic registration and listing submission portal as well as certain exemptions to the registration and listing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.
As described in the draft guidance, a new information is that the FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.
If your firm does not have an FEI number assigned by the FDA, it is possible to send a request to feiportal@fda.hhs.gov.
Stakeholders should plan to register and list well in advance of the December 29, 2023.
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.
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Source:
Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
