MoCRA Update – Delayed Enforcement

This morning (November 8, 2023) the FDA issued a statement that they are delaying enforcement of cosmetic facility and product registration requirements until July 1, 2024.

As part of the Modernization of Cosmetic Regulations Act of 2022, cosmetic facilities and products must be registered with the FDA. Over the past year, FDA has been moving forward to update their system to make that possible. In March, FDA terminated the Voluntary Cosmetic Registration Program (VCRP). The in August, they issued a draft guidance on how the registration process would work.

MoCRA states that registrations must be in place, and facilities and products all registered, within 1 year (by December 29, 2023). According to FDA’s statement today, and the Compliance Policy they issued, the registration portal will be available in early December 2023 and they “encourage companies to meet that deadline if they are able to do so.” However, they do not intend to enforce the requirments until July 1, 2024.

To Whom Does Registration Apply?

Registration applies to cosmetic facilities and persons responsible for cosmetic products.¹

Small businesses, defined as businesses with less than $1 million annual cosmetic revenue,² are exempt from facility and product registration, EXCEPT if the businesses produces any of the following:

• Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual;
• Cosmetic products that are injected;
• Cosmetic products that are intended for internal use; or
• Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

If you need help figuring out what aspects of MoCRA apply to you, check out the MoCRA Quiz on the Handcrafted Soap and Cosmetic Guild site.

1. The responsible person is the person whose name is on the label ↩︎
2. Revenue is calculated as an average over the last 3 years. ↩︎