Understanding FDA Cosmetic Registration and Cosmetic Registration MoCRA Compliance

In recent years, the cosmetics industry in the United States has seen a significant shift in regulatory oversight, especially with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). For companies involved in manufacturing, packing, or distributing cosmetics in the U.S., understanding and complying with FDA Cosmetic Registration and Cosmetic Registration MoCRA requirements is now essential.

What is FDA Cosmetic Registration?

FDA Cosmetic Registration refers to the voluntary process through which cosmetic companies submit information about their facilities and products to the U.S. Food and Drug Administration (FDA). While traditionally optional, registration helps the FDA monitor product safety and trace cosmetic products in the event of a health-related concern.

Under MoCRA, the previously voluntary FDA Cosmetic Registration becomes mandatory for certain businesses. This change is designed to improve the safety and transparency of cosmetic products sold in the U.S. Companies are now expected to register their facilities and list their products with the FDA in accordance with the new regulations.

Key Requirements of Cosmetic Registration MoCRA

Enacted in December 2022, Cosmetic Registration MoCRA represents the first major update to U.S. cosmetic laws since 1938. It requires:

1. Facility Registration: All domestic and foreign facilities that manufacture or process cosmetic products for U.S. distribution must register with the FDA. Each facility must renew its registration biennially.
   
   


2. Product Listing: Each marketed cosmetic product, along with its ingredients, must be listed with the FDA. Changes in formulation or labeling must be updated within 60 days.
   
   


3. Safety Substantiation: Companies must ensure their products are safe for use. They are required to maintain adequate safety documentation.
   
   


4. Adverse Event Reporting: Businesses must report serious adverse events to the FDA within 15 business days of receiving the report.
   
   


5. Labeling Requirements: Products must be properly labeled with specific ingredient disclosures and contact information for consumer complaints.
   
   

These updates under Cosmetic Registration MoCRA create a robust safety net and align the U.S. with international cosmetic safety standards.

Benefits of Compliance

Complying with FDA Cosmetic Registration and Cosmetic Registration MoCRA offers several benefits:

• Market Access: Registered facilities and listed products can legally be sold in the U.S., avoiding penalties or product recalls.
  
  


• Consumer Trust: Regulatory compliance enhances brand credibility and consumer confidence.
  
  


• Safety and Transparency: Better documentation and reporting systems increase accountability and improve product safety.
  
  


• Global Competitiveness: Aligning with FDA and MoCRA guidelines helps companies expand into global markets that value regulatory compliance.
  
  

Conclusion

With the enforcement of FDA Cosmetic Registration and the requirements under Cosmetic Registration MoCRA, cosmetic companies must adapt to a more structured and regulated environment. While the compliance process might seem complex, it ultimately benefits both consumers and businesses by ensuring safer products, transparent practices, and a more trustworthy cosmetics market. Companies are encouraged to take proactive steps toward registration and compliance to avoid disruptions and thrive in a competitive regulatory landscape.