Today, the U.S. Food and Drug Administration (FDA) has announced a proposed rule to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This initiative aims to protect consumers from potential asbestos exposure, a known carcinogen, in products that use talc—a mineral commonly incorporated into cosmetics for its moisture-absorbing and textural properties.
The proposed rule, part of the agency’s efforts under section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), mandates manufacturers to employ precise analytical methods. These include Polarized Light Microscopy (PLM) with dispersion staining and Transmission Electron Microscopy (TEM) with Energy Dispersive Spectroscopy (EDS) and Selected Area Electron Diffraction (SAED). Alternatively, manufacturers may rely on a certificate of analysis from their talc supplier.
The FDA emphasized the importance of these methods to ensure consumer safety, as talc deposits are often found near asbestos, increasing the risk of contamination during mining. “We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products,” said Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors.
The proposed rule includes provisions requiring manufacturers to maintain compliance records. Non-compliance or the presence of asbestos in talc-containing products would render them adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA is seeking public feedback on the proposal, with the comment period open for 90 days following its publication in the Federal Register. Afterward, the FDA will review and incorporate public input to finalize the rule, reinforcing its commitment to consumer safety in cosmetic products.
