FDA MoCRA Compliance for Your Cosmetics Products

MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84 years and establishes many new requirements, such as:

• Facility Registration
• Product Listings
• Good Manufacturing Practices (GMPs)
• Safety Substantiation
• New labeling requirements
• Adverse Event Reporting
• Record Keeping

Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Most facilities will need to register and comply with GMPs issued by FDA.

The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the cosmetic label.

The “responsible person” will be responsible for:

• Cosmetic product listings
• Adverse event reporting and record keeping
• Safety substantiation
• Labeling updates
• Recalls
• Fragrance allergen disclosures

Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:

• Come into contact with eyes,
• Are injected,
• Are intended for internal use,
• Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.

For existing facilities, facility registration and product listings are due by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later. 

MoCRA allows for flexible listings where companies can submit a single listing for cosmetic products with identical formulations or formulations that only differ with respect to colors, fragrances or flavors, or quantity of contents.

By December 29, 2023, companies must provide electronic contact information in which a responsible person can receive adverse event reports.

Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.

Within 1 year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.

Within 2 years: Labels must include responsible person’s contact information for adverse reporting and must identify fragrance allergens determined by FDA.