On November 8, 2023, the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the facility registration and product listing requirements set forth in in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for an additional six months (until July 1, 2024) to allow cosmetics companies enough time to submit facility registration and product listing information.
Absent exemption, MoCRA requires that:
- owners and operators of U.S. and foreign-based facilities that manufacture and process cosmetics distributed in the U.S. register their facilities with the FDA, and
- manufacturers, packers, and distributors of cosmetics in the U.S. submit listings of their cosmetics products (and ingredients) to the agency.
In August, the FDA issued draft guidance, which provides recommendations and instructions to assist with facility registration and product listing compliance. In September, FDA announced its newly developed draft electronic submission portal—Cosmetics Direct. The comment period closed on October 18, and FDA is now in the process of obtaining approval from the Office of Management and Budget. Screenshots released by the FDA for commenting on Cosmetics Direct, provide helpful, step-by-step guidance for how to submit required information to the FDA through the new system.
For further information, please contact:
Rachel Raphael, Partner, Crowell & Moring
rraphael@crowell.com
