Industry Update: Modernization of Cosmetics Regulation Act (MoCRA)

Industry Update: Modernization of Cosmetics Regulation Act (MoCRA)

The Modernization of Cosmetics Regulation Act (MoCRA) was recently passed as part of the Consolidated Appropriations Act of 2023. The act represents a major change for the cosmetics industry, greatly expanding FDA’s regulatory oversight.

MoCRA defines “Responsible Person” and “Facility”
A “Responsible Person” is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product. A “facility” is defined as “any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

Good Manufacturing Practice (GMP)
One of the most notable sections of the act is SEC. 606, which establishes good manufacturing practices for facilities that produce cosmetic products. Prior to the passing of MoCRA, the FDA provided only suggestions for Cosmetic GMPs. Under the new regulation, the Secretary must publish finalized GMP rules no later than three years from the date of enactment. This means we can expect to see cosmetic GMP regulations by December 29, 2025. There is an exception from GMP compliance for small businesses if their average gross annual sales for the previous 3-year period are below $1,000,000 and they do not make certain products, like eye-area cosmetics.

Facility Registration and Product Listing
Per section 607 of the Act, cosmetic facilities will soon be required to register with the FDA and list their cosmetic products and respective ingredients. Responsible persons must register their products or ensure that their manufacturer is registered. Existing facilities must register no later than December 29, 2023. New facilities must register within 60 days after beginning to manufacture cosmetics, or 60 days after the deadline for existing facilities. If a responsible person is using a contact manufacturing facility, only one registration is required between the two. Registrations must be renewed every two years.

Cosmetic Safety Substantiation
Section 608 requires responsible persons to ensure that their cosmetic products have adequate safety substantiation and records. Adequate safety substantiation must be conducted and verified by experts who are trained and qualified.

Adverse Event Reporting
“Responsible Persons” must maintain records of adverse events and report serious adverse events to FDA within 15 days.

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