U.S. FDA Registration & Labeling Compliance Assistance

FDA Cosmetic Facility Registration and Product Listing- MoCRA 

Cosmetic Facility Registration: Under the newly approved Modernization of Cosmetics Regulation Act of 2022 - MoCRA, most cosmetic facilities, including contract manufacturers engaged in manufacturing cosmetic products marketed in the U.S., must register with the FDA. Registered facilities must promptly update any changes to their registration and renew their registration biennially. All facilities outside the U.S. must designate a U.S. Agent with the FDA.

Cosmetic Product Listing: The MoCRA further requires the cosmetic manufacturers, packers, and distributors whose name is on the product label to submit a cosmetic product listing to the FDA. Among other things, the cosmetic product listing must include a list of ingredients, including color additives, fragrances, and flavors, manufacturer facility name and location, responsible party, and a product label. Cosmetic product listings must be updated annually. Flexible listing option will enable a unified submission for multiple cosmetic products that share identical formulations or exhibit variances limited to packing size, color .additives, fragrances, or flavors 

Cosmetic Labeling Requirement: All cosmetic product labels are subject to the FDA cosmetic labeling regulationsThat means the FDA law prohibits false or misleading claims and inaccurate information on a cosmetic label. The differences between a cosmetic claim, either direct or implied, and a drug claim can be very subtle, and failure to recognize the distinction can result in enforcement actions by the FDA. The MoCRA introduces additional labeling requirements, including adverse events contact, declaration of allergens, and a statement for use by an industry professional. 

MoCRA Exemptions: Small businesses whose average gross annual U.S. sales for the past three years is less than 1,000,000 USD are exempt from some MoCRA requirements such as GMP, facility registration, and product listing (optional registration will still be available for such small businesses). Certain cosmetic products, such as items that come in contact with the eye or cosmetics for internal use, injectables, and long-lasting cosmetics, are not eligible for the exemption and must comply with MoCRA regardless of their sales volume.

Registration timeline:

1. Assessment of Responsible Party………......( 1-2 days)
2. Cosmetic Facility Registration .................. (2-3 days)
3. Cosmetic Product Listing.......................... (3-5 days)
4. Cosmetic Label Compliance Review .......... (5-7 days)

Other MoCRA Requirements: Most of the MoCRA requirements, including facility registration and product listing, will become effective before the end of 2023. Below is a synopsis of the main MoCRA requirements:

• Mandatory FDA registration for cosmetics facilities
• Mandatory product Listings for products marketed in the U.S.
• Compliance with additional FDA cosmetic labeling requirements 
• Compliance with FDA-issued Good Manufacturing Practices -GMP
• Record keeping, recalls, adverse event, and safety substantiation records

Compliance with MoCRA requirements can be challenging, time-consuming, and often requires expert knowledge. FDA Listing Inc. simplifies the process of complying with the MoCRA regulations, helping your firm to meet the FDA requirements in the following ways. Please email or call us if you need assistance.

• Assistance in registering cosmetic facilities with the FDA.
• Assistance with cosmetic product listings and proper data submission.
• Serving as U.S. Agents for cosmetic facilities located outside the U.S.
• Expert Label review to comply with the FDA cosmetic labeling requirements