,The FDA's proposed rule (RIN 0910-AI82) aims to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Mandated by the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, the rule requires manufacturers to test representative samples from each batch or lot using both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) combined with Energy Dispersive Spectroscopy (EDS) and Selected Area Electron Diffraction (SAED). Alternatively, manufacturers may rely on certificates of analysis from qualified suppliers, provided they verify the reliability of these certificates. Failure to comply with testing or recordkeeping requirements would render the product adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA issued the proposed rule on December 27, 2024, with a comment period ending on March 27, 2025. The final rule is expected by March 2026.
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