FDA Halts Voluntary Cosmetic Registrations Amidst Overhauls      

On March 27, 2023, the U.S. Food & Drug Administration (FDA) announced that it will no longer be accepting submissions to its Voluntary Cosmetic Registration Program (VCRP). Starting in 1972, VCRP has been the only type of submission that is available for cosmetic-only products at the federal level. However, since it has been voluntary, the vast majority of manufacturers and products are not registered or listed in the FDA’s databases. All of that is about to change.

With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), congress has directed the FDA to develop a program for the submission of both cosmetic facility registrations and product listings. Until the FDA has readied its submission process, we can only assume that the procedure will be similar to that currently applicable to OTC drug products, where manufacturers are required to register their facilities and list their products, as well as comply with good manufacturing practices—which, in the case of cosmetics, are to be determined by the FDA through the rulemaking process. In addition, MoCRA has mandated additions to the labeling regulations (particularly for allergens) and testing requirements. Needless to say, a lot of changes are on the way in the cosmetics industry, and it is important for companies to stay abreast of new regulatory requirements as they are announced.

For more information on how you or your company can achieve compliance with FDA regulations, reach us anytime at contact@giannamore-law.com.