FDA to Delay Cosmetics Registration, Listing Requirements Until July 2024
The FDA will delay cosmetics registration and listing requirements that had been set to take effect at the end of the year until July 1, 2024, the agency said in a guidance document issued Nov. 8. The delay comes in response to industry concerns that more time is needed to “gather the relevant information required for facility registration and product listing,” access the relevant databases and submit that information to FDA.
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In the guidance, the FDA said it is still working on finalizing a separate draft guidance that includes instructions for submissions, and is also developing an electronic submission portal called Cosmetics Direct to “streamline submission and receipt of facility registration and product listing information.” The agency said it will conduct a pilot program to test the portal, and that it anticipates the portal, along with other submission methods, will be available in early December 2023.
“FDA will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and we encourage companies to meet that deadline if they are able to do so,” it said. “However, FDA does not intend to enforce the requirements under section 607 of the FD&C Act 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,” the agency said.
The National Customs Brokers & Forwarders Association of America recently submitted comments to the FDA seeking more clarity on the requirements, including confirmation that the facility registration number will not be required on entry documentation and information on how the FDA will validate U.S. agents designated on registrations for foreign cosmetics facilities (see 2309050042).