Major Overhaul in FDA Cosmetics Registration Rules for 2024
The U.S. Food and Drug Administration (FDA) has issued updated guidance on cosmetic product facility registration and product listing requirements. This marks a significant development in the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance, finalized on December 11, 2024, includes three new frequently asked questions covering responsibilities of U.S. agents, facility identification numbers, and product listings for free samples and gifts.
This update represents the most substantial change to federal cosmetics law since 1938, requiring manufacturers to register their facilities and list products with the FDA. Companies must now maintain records supporting safety substantiation and report serious adverse events within 15 business days. The new regulations also mandate that cosmetic product labels include domestic contact information for reporting adverse events starting December 29, 2024.
“Because MoCRA requires certain companies to register their facilities and list their products with FDA, FDA is creating a new system to handle the large number of submissions that will result,” says Linda Katz, director of the office of cosmetics and colors at FDA.
The agency has also proposed new testing methods for detecting asbestos in talc-containing cosmetics, with a comment period ending March 27, 2025.