FDA Delays Requirements for Cosmetic Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) issued a guidance on the delay of enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

The MoCRA provided new authorities to FDA including:

• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
• Product Listing: A responsible person (i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Background

In March this year, the FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) as a result of the facility registration and product listing authorities mandated by MoCRA.

In August, the agency issued a draft guidance on cosmetic product facility registrations and product listings, as mandated by MoCRA. The draft guidance, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.

The FDA announced in September an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms. The authority strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. The FDA expects that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.

Finally, in October, the agency has published a structured product labeling (SPL) implementation guide with validation procedures for cosmetic product facility registrations and product listings (updated in November 2023).

Delayed Enforcement

The cosmetic industry has expressed concerns that they need additional time, for example to gather the relevant information required for facility registration and product listing, including obtaining facility registration numbers to associate with cosmetic product listings, obtain access to the electronic submissions database, and enter and submit accurate registration and listing information.

Thus, the FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. In addition, the agency does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.

For more information please see FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.