U.S. FDA Proposes Mandatory Asbestos Testing for Talc-Containing Cosmetics

On December 26, 2024, the U.S. Food and Drug Administration (FDA) announced a proposed rule mandating the testing of talc-containing cosmetic products for asbestos contamination. This initiative aligns with the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and is open for public consultation until March 27, 2025.

Talc, widely used in cosmetics for moisture absorption and texture enhancement, can be contaminated with asbestos, a known carcinogen. Currently, there are no specific requirements for asbestos testing in talc-containing cosmetics.

The proposed rule outlines two primary testing methods: Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED). Manufacturers of talc-containing cosmetics would be required to test representative samples from each batch or lot of their talc-containing cosmetic products or the talc ingredients used.

Furthermore, manufacturers may rely on a certificate of analysis from the talc suppliers if they can verify the reliability of the supplier’s documentation. Non-compliance with the new testing or recordkeeping provisions could result in products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).