MoCRA Update: Enforcement of facility registration and product listing pushed back until July 2024

As previously reported, the submission of information about existing facilities who are marketing cosmetic products in the US, and listing of their cosmetic products according to MoCRA will be required from 29th December 2023. The FDA is about to set up an electronic portal (“Cosmetics Direct”) for this purpose. However, as of November 8, only the start page is available. The launch was originally announced for October 2023. On November 1, 2023, FDA announced that further information on the launch of the electronic submission portal and paper submission forms will be provided “in the coming weeks“.

On November 8, 2023, FDA published the “Final Guidance Document” and further announced that FDA “does not intend to enforce the requirements related to 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 will be however “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.

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