US FDA Proposes Mandatory Testing of Talc-Containing Products

US FDA Proposes Mandatory Testing of Talc-Containing Products

The U.S. Food and Drug Administration (FDA) has announced a proposed rule to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This proposed rule, part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), aims to protect consumers from harmful exposure to asbestos, a known human carcinogen.

Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors, stated, “For many years, the FDA has been sampling and testing talc-containing cosmetics for asbestos and working with federal partners on efforts to reduce consumers’ risk of exposure to asbestos from contaminated talc-containing cosmetic products. We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products”

The proposed rule would require manufacturers to test samples of each batch of talc-containing cosmetic products using methods such as Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). If finalized, cosmetic products would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if a manufacturer fails to comply with the testing or recordkeeping requirements.

The FDA is seeking public comments on the proposed rule for 90 days after its publication in the Federal Register. This move is expected to lead to fewer asbestos-related illnesses, such as lung and ovarian cancers, by ensuring the safety of talc-containing cosmetic products.

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