The FDA Announces Additional Submission Tools Are Now Available for Cosmetic Product Listing and Facility Registration

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the registration of cosmetic product facilities and the listing of cosmetic products. On January 8, 2024, the FDA announced the availability of SPL Xforms, an authorization tool for Structured Product Labeling (SPL).

One of the options for creating an SPL file including facility registration and listing details for cosmetic products is to use Xforms. The FDA is also accepting registrations for cosmetic product facilities and listing products for the following electronic submission options.

1. Cosmetics Direct, an electronic submission portal and authorization tool for FDA Structured Product Labeling (SPL)
2. SPL-formatted submissions

Additionally, the FDA stated today that Forms FDA 5066 and 5067 are now available as an extra submission option for submitting information to the FDA about cosmetic product listings and facility registrations. For more information please refer to the link: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/form-fda-5066-registration-cosmetic-product-facility

Completed paper forms can be mailed to the FDA. However, to improve the agency's efficiency and timeliness in data submission and management, the FDA highly encourages electronic submissions.

To give the industry enough time to submit the necessary facility registration and product listing information, the FDA announced on November 8, 2023, that it would be delaying the enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the FD&C Act as amended by MoCRA for six months.

For a further six months following the statutory deadline of December 29, 2023, or until July 1, 2024, the FDA does not plan to enforce the requirements related to cosmetic product facility registration and cosmetic product listing. This will give the regulated industry more time to come into compliance.

Furthermore, until July 1, 2024, the FDA does not plan to enforce the registration requirements for owners or operators of facilities that first engaged in the manufacturing or processing of cosmetic products after December 29, 2022, or the listing requirements for cosmetic products that were first marketed after that date.

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