FDA Delays Enforcement of Cosmetic Facility Registration and Product Listing Requirements

On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing.

As we reported previously, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States, one of which was a requirement for annual cosmetic product facility registration and product listing. Additionally, we reported in September that the FDA published drafts of the Cosmetics Direct electronic submission portal and paper forms for use in the registration and listing process.

Under MoCRA, owners or operators of facilities engaged in the manufacturing or processing of a cosmetic product on December 29, 2022, are required to register each facility no later than December 29, 2023. Owners or operators of facilities that first engage in manufacturing or processing a cosmetic product after December 29, 2022, are required to register such facilities within 60 days of first engaging in such activity or by February 27, 2024, whichever is later.

Now, however, the FDA has announced its intent to delay enforcement of the registration and listing provisions until July 1, 2024, to provide industry additional time to comply with these requirements. The FDA issued guidance to provide further information on this delay, noting that the agency anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023. While the FDA will delay enforcement of the December 29 statutory deadline, the agency nonetheless encourages companies to meet this deadline if they are able to do so.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA or need guidance on complying with these new requirements, please contact ArentFox Schiff’s FDA Practice Group.


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