Update on U.S. Cosmetic Facility Registration and Product Listing – FDA to Delay Enforcement

Nov. 9 2023

On November 8, 2023, the United States Food and Drug Administration (FDA) released the Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing, indicating that the FDA intends to delay enforcement for six months “to help ensure that industry has sufficient time to submit facility registration and product listing information.”

The guidance further states that the “FDA anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.”
Discussion from the Guidance document states the following:

“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. 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.”

Link to Constituent Update:

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