On August 7, 2023, the U.S. Food and Drug Administration (FDA) offered the public a draft guidance titled “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.” This draft guidance, if adopted, will mandate facilities that manufacture and process cosmetics to register their establishments and submit listings of cosmetic products to the FDA. Notably, this initiative is set to formalize the FDA’s Voluntary Cosmetic Registration Program, according to a report by McGuireWoods LLP.
The core purpose of the intended regulatory action appears to be ensuring the safety of cosmetic products sold within the U.S. If this guidance becomes law, it will likely significantly alter how cosmetic companies approach product safety and compliance.
Under the current regulations, participation in the Voluntary Cosmetic Registration Program is optional for cosmetic companies. They have been deciding whether to register their products with the FDA on their own terms up to now. The draft guidance, however, posits a substantial shift in the FDA’s approach, heralding a transition to a mandatory regime.
The full impact of this proposed regulatory change on the cosmetic industry is yet to be understood entirely. It is recommended for all legal professionals with a stake in the cosmetics industry to stay attached to the latest developments in this regulatory space and adjust their compliance strategies accordingly.