Cosmetic Facility Registration – FDA Draft Guidance

On August 7, 2023, the FDA issued Registration and Listing of Cosmetic Product Facilities and Products: Guidance For Industry as a draft guidance distibuted for comment purposes. It describes the Modernization of Cosmetic Regulations Act (MoCRA) requirements for facility registration and product listings, and the exemptions under MoCRA for certain small businesses. It is open for comment until September 7th.

This guidance, when finalized, will provide details to cosmetic manufacturers on how and when to submit registration of their cosmetic facilities and products to the FDA, as required under MoCRA.

Small businesses, defined as businesses with less than $1 million in annual cosmetic revenue,¹ are exempt from facility and product registration, EXCEPT if the businesses produces any of the following:

• Cosmetic products that regularly come into contact with mucous membrane of the eye under conditions of use that are customary or usual;
• Cosmetic products that are injected;
• Cosmetic products that are intended for internal use; or
• Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

FDA terminated the Voluntary Cosmetic Registration Program (VCRP) as of March 27, 2023. A new system to replace the VCRP is being developed which will handle the increased number of facility and product registrations, now that both are required by MoCRA. The new submission portal is planned to be available in October 2023.

All companies manufacturing cosmetic products must complete their initial facility registration and register all cosmetic products currently for sale by December 29, 2023. [This deadline has been extended.]

1. Revenue is calculated as an average over the last 3 years. ↩︎