New FDA Guidelines for Cosmetic Product Facility Registrations and Listings
The FDA has recently updated its guidance for cosmetic product facility registrations and product listings, as part of the Modernization of Cosmetics Regulation Act (MoCRA), which was published on December 11, 2024. This updated guidance finalizes frequently asked questions and introduces three new Q&As, which address the responsibilities of U.S. agents, facility registration requirements, and product listings for free samples.
The new guidance is designed to assist cosmetic companies with the requirements for facility registration and product listing submissions. It provides details on who is responsible for making submissions, what information should be included, and when these submissions should be made. This represents a significant step in the FDA’s implementation of MoCRA, marking the first major update to federal cosmetics law since 1938.
Furthermore, the FDA issued a proposed rule on December 27, 2024, which requires standardized testing methods for detecting asbestos in talc-containing cosmetic products. Under this rule, manufacturers would be required to test each batch using both Polarized Light Microscopy and Transmission Electron Microscopy methods. The comment period for this proposed rule will end on March 27, 2025.
Source: FDA.gov