Today, FDA announced updated guidance regarding its MoCRA rollout.
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, FDA 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.
FDA has advised that it will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and encourages companies to meet that deadline if they are able to do so.
FDA’s announcement comes in response to industry concerns about the need for additional time, for example, to gather information required for facility registration and product listing, including obtaining facility registration numbers to associate with cosmetic product listings, obtaining access to the electronic submissions database, and entering and submitting accurate registration and listing information.
FDA has not advised whether it intends to delay enforcement of professional product labeling requirements, which, under MoCRA, come into effect on December 29, 2023. Likewise, FDA has not advised whether delayed enforcement changes the December 29, 2023 effective date for companies to maintain records of adverse events, report serious adverse events to FDA, or maintain adequate safety substantiation records.