Cosmetic Industry Faces Significant Non-Compliance Under New FDA Regulations

HAMPTON, Va., Nov. 12, 2024 /PRNewswire/ -- An analysis from Registrar Corp, the world's largest FDA compliance company with 32,000 clients in 190 countries, reveals that 48% of companies selling imported cosmetics at America's top 25 retailers are non-compliant with the U.S. Food and Drug Administration's (FDA) new cosmetics regulations.

New FDA cosmetics regulations now in place to safeguard consumers
Concerned about the safety of cosmetics products, the U.S. Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) in 2022. The new regulation requires the FDA to more rigorously regulate cosmetics products such as makeup, fragrance, skincare, creams, shampoCos, conditioners, and more. 

In 2023, the FDA received over 5,000 health-related complaints from consumers using cosmetic products. These include severe allergic reactions, skin burns, and permanent disfigurement. Industry experts believe the actual number of health-related incidents is much higher, and simply not reported to the FDA.

"These new regulations are designed to protect consumers from unsafe cosmetics," says David Lennarz, President of Registrar Corp. "As the holiday season starts, consumers will be buying millions of cosmetics gifts and should have confidence that the products on retailer shelves are in fact FDA-compliant. Companies lagging to adopt the new regulations is a disservice to the customer trusting the safety of the product."

48% of cosmetics companies importing to top 25 retailers are not FDA compliant
Registrar Corp analyzed companies selling imported cosmetics to U.S. top 25 retailers including grocery stores, pharmacy chains, department stores, and general merchandise chains.

Key findings: 

• While progress has been made, of the top 25 retailers selling cosmetics, 48% of imported cosmetics companies are not FDA MoCRA compliant. This represents approximately 135,000 products 
• Pharmacy chains had the highest supplier compliance rate at 54%
• Grocery chains had 41% supplier compliance rate 
• Department chains with 38% supplier compliance rate
• General merchandise chains had the lowest supplier compliance rate at only 32% 

"MoCRA is a relatively new regulation aimed at protecting customers from unsafe cosmetics," says Lennarz. "Our analysis indicates that retailers are struggling to ensure the cosmetics product on their shelves are in fact FDA compliant." 

While retailers are not directly responsible for complying with the MoCRA regulations, their customers expect products on retailer shelves to be safe and compliant with FDA regulations. Some of the top 25 retailers have notified their cosmetic suppliers that they fully expect them to comply.

"In the past six months, we have helped more than a thousand cosmetics companies become MoCRA compliant," says Raj Shah, CEO of Registrar Corp. "As FDA enforcement now ramps up, we expect that retailers will press on the cosmetics brands to get compliant, or risk being removed from their shelves." 

About Registrar Corp
Registrar Corp is the world's largest FDA compliance company with over 32,000 clients in 190 countries. Our software, services, and training help cosmetics, food, drug and medical device clients comply with complex FDA regulations and keep people healthy and safe. 

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SOURCE Registrar Corp