FDA Cosmetic Registration

 Under the Modernization of Cosmetics Regulation Act (MoCRA), FDA Cosmetic Registration and product listing are mandatory for manufacturers and processors of cosmetic products marketed in the United States. Facilities must register with the FDA and renew their registration every two years. Additionally, each marketed cosmetic product must be listed with the FDA, including details of ingredients and any annual updates.  

At RAPS, we guide businesses through every step of the FDA cosmetic compliance process—from facility registration to product listing—ensuring full adherence to regulatory requirements. 

• Facility Registration with the FDA (biennial renewal required)
   
• Cosmetic Product Listing, including ingredients
   
• Annual Updates for any changes in product formulation or status

While MoCRA provides exemptions for certain small businesses from Good Manufacturing Practices (GMP), facility registration, and product listing requirements, these exemptions do not apply if a company manufactures:

• Products intended for use in or around the eyes (e.g., eyeliners, mascaras)
   
• Products intended for injection
   
• Products intended for internal use (e.g., oral care cosmetics)
   
• Products designed to alter appearance for more than 24 hours, where removal by the consumer is not part of typical use (e.g., long-lasting tattoos or certain skin applications)
   

Additionally, products or facilities regulated under drug or device requirements are not eligible for cosmetic exemptions.

At RAPS, our regulatory experts help you determine your exemption status and ensure your products meet all applicable FDA standards. Trust us to streamline your FDA Cosmetic Registration and ongoing compliance.

Partner with RAPS for Hassle-Free FDA Cosmetic Compliance

Navigating FDA cosmetic regulations can be complex—but with RAPS by your side, compliance becomes simple, efficient, and stress-free. Whether you're a small business seeking clarity on exemptions or a global brand needing full-scale registration and listing support, our expert team is here to help. Let RAPS be your trusted compliance partner in bringing safe, compliant, and successful cosmetic products to the U.S. market.