FDA MoCRA Registration & US Agent Done Right.

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.

Find out which requirements your company will need to meet. Registrar Corp’s industry experts created the MoCRA Wizard to help companies determine which requirements they must meet. Answer a few short questions and in less than two minutes, know exactly which you’ll need to comply with and how we can help.

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.

Wondering if you’re exempt? Find out if you’re exempt by answering a few questions using our MoCRA Wizard, developed by our industry experts to help you find out which, if any, requirements you must meet.

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.

In the Draft Guidance, FDA announced that Cosmetics Direct will be using the same electronic submission system as drugs, meaning all listings will need to be submitted through the Structure Product Labeling (SPL Format). The SPL will require to list all shades, fragrance and quantity variations.

Not sure where to start? Our industry professionals created a simple tool to help companies determine which requirements apply to them. Answer a few short questions and in less than two minutes, the MoCRA Wizard will show exactly which requirements you must meet to maintain FDA compliance.

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.

Learn more about adverse event requirements and how we can help you comply.

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.