A US Food and Drug Administration (FDA) compliance company is sounding the alarm over high non-compliance rates with new FDA cosmetics regulations. Registrar Corp’s assessment indicates that 48% of cosmetics companies importing to the top 25 US retailers are not FDA compliant and could risk removal from stores.
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Registrar Corp, which helps clients navigate FDA regulations, has released an assessment of companies selling imported cosmetics and whether these cosmetic products meet the new standards under the Modernization of Cosmetics Regulation Act (MoCRA). Their assessment indicates major US retailers are selling approximately 135,000 non-compliant products.
“MoCRA is a relatively new regulation aimed at protecting customers from unsafe cosmetics,” says David Lennarz, Registrar Corp president. “Our analysis indicates that retailers are struggling to ensure the cosmetics products on their shelves are FDA compliant.”
Passed in 2022 and enacted in December 2023, MoCRA expands the FDA’s regulation of cosmetic products and aims to increase safety and transparency in the cosmetic and personal care industry.
The law introduced new requirements for cosmetic producers, such as registering manufacturing facilities with the FDA, providing a list of products and reporting any serious or negative effects customers have to the products within 15 days.
While the purpose of MoCRA is to regulate cosmetic producers, retailers who sell these products are not directly responsible for compliance. However, customers do expect products sold in retailer locations to be FDA compliant, says Registrar Corp.
Registrar Corps’ FDA compliance assessment looked at products sold at major grocery stores, pharmacy chains, department stores and general merchandise chains in the US. Of these retailers, pharmacy chains had the highest supplier compliance rate of 54%, while general merchandise chains had the lowest at only 32%, Registrar Corp finds.
“These new regulations are designed to protect consumers from unsafe cosmetics,” says Lennarz. “As the holiday season starts, consumers will be buying millions of cosmetics gifts and should have confidence that the products on retailer shelves are FDA-compliant. Companies lagging to adopt the new regulations is a disservice to the customer trusting the safety of the product.”
FDA compliance extensions
Since going into effect, the FDA has given cosmetic companies multiple extensions to reach compliance with certain requirements, but those extension deadlines are about to expire. Companies have until December 29, 2024, to register manufacturing facilities, comply with product listing requirements and confirm safety substantiation. The FDA will also start enforcing the reporting requirement for serious adverse events on this date.
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