FDA Issues Final Guidance on Requirements for Cosmetic Facility Registration and Product Listing

The U.S. Food and Drug Administration’s (FDA) recently released final guidance, titled, “Registration and Listing of Cosmetic Product Facilities and Products,” provides information to be included with registration and listing submissions required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA also has launched a “Cosmetics Direct” electronic submissions portal to receive the cosmetic facility registration and product listing information.

By way of background, MoCRA (enacted in December of 2022) dramatically expanded the statutory obligation of cosmetic manufacturers and gave FDA greater authority over such products. The facility registration and cosmetic product listing provisions are among several new requirements that will come into effect over the next three years. While FDA stated in a November 8, 2023 Compliance Policy that it is not enforcing the facility registration or product listing requirements until July 1, 2024, now may be a good time to plan for compliance with the new provisions. FDA’s final guidance for cosmetic facility registration and cosmetic product listing provides further information delineating (1) what types of facilities must register and who bears the responsibility for registration as well as listing submissions, (2) the information to be included on registration forms and listing submissions, (3) how to submit, (4) when to submit, and (5) certain exemptions to the registration and listing requirements. (An announcement about the final guidance can be found here.)

In an announcement about the Cosmetics Direct electronic portal for companies to submit facility registration, product listing, and labeling information, FDA describes the portal as a Structured Product Labeling (SPL) authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing. A detailed User’s Guide to Cosmetics Direct is also available.

For more detailed information, see our publication on Keller and Heckman’s website, KHlaw.com, “FDA Issues Final Guidance Document on MoCRA Requirements for Cosmetic Facility Requirements for Cosmetic Product Listing, Also Opens Electronic Portal for Submissions,” which can be found here.