The U.S. Food and Drug Administration (FDA) has announced a delay in enforcing the registration requirements for production facilities and product notifications under MoCRA until July 1, 2024, to give the industry additional time for implementation. Owners or operators of production facilities that began manufacturing or processing after December 29, 2022, are exempt from the registration requirement until that date. Similarly, cosmetic products first marketed after December 29, 2022, are exempt from the listing requirement until July 1, 2024.

There are exceptions for certain small businesses and certain cosmetic products. Production facilities that manufacture products that come into contact with the mucous membrane of the eye or alter appearance for more than 24 hours are not exempt from the exception. Furthermore, exceptions do not apply to products and production facilities that are subject to the requirements for drugs and medical devices.

To facilitate compliance, the FDA has issued guidelines and draft guidance for the registration of production facilities and product notification. The agency encourages electronic submission through the newly developed Cosmetics Direct Portal and plans to make electronic submission forms available starting in early December 2023.


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