The Deadline for Registration and Listing of Cosmetic Product Facilities and Products is Approaching

On December 29, 2022, U.S. President Biden signed the "2022 Modernization of Cosmetics Regulation Act" (MoCRA). This act significantly amends the previous "Federal Food, Drug, and Cosmetic Act" (FD&C Act), mandating cosmetic businesses to register their facilities and submit product listings. Previously, the U.S. Food and Drug Administration (FDA) regulated cosmetics through the Voluntary Cosmetic Registration Program (VCRP). As of March 27, 2023, the FDA has ceased accepting submissions for the VCRP.

According to the regulations, the FDA was required to accept facility registrations and product listings by December 29, 2023. However, in November 2023, the FDA issued guidelines delaying the implementation of cosmetic facility registrations and product listings under MoCRA until July 1, 2024, to ensure the industry had sufficient time to submit the necessary information. Additionally, the FDA adjusted the requirements for registrations and product listings for facilities that first began manufacturing or processing cosmetic products after December 29, 2022, to be mandatorily enforced by July 1, 2024.

In December 2023, the FDA announced the launch of the electronic registration portal, Cosmetics Direct, for facility registrations and product listings, and issued final guidelines on registration and marketing requirements. Paper forms (Forms 6055 and 5067) are also available as alternative submission tools. Cosmetic businesses may also use the Structured Product Labeling (SPL) framework to submit content through Cosmetics Direct.

Thus, cosmetic exporters to the U.S. should complete their facility registrations and product listings by July 1, 2024 to avoid impacting their product launch timelines.

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Further Information

US FDA Cosmetic Product Facility Registration and Cosmetic Product Listing