FDA Withdraws Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

On Nov. 28, 2025, The Food and Drug Administration (FDA) announced the withdrawal of the proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” which published in the Federal Register of December 27, 2024.

FDA issued the proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products” as part of its implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

The proposed rule, if finalized, would require manufacturers of talc-containing cosmetic products to test their talc-containing cosmetic products or the talc cosmetic ingredient prior to using the talc to manufacture a talc-containing cosmetic for asbestos, and to keep records to demonstrate compliance with the rule. Failure to comply with the rule’s testing or recordkeeping obligations would result in FDA deeming a cosmetic product to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as would the presence of any asbestos in a talc-containing cosmetic product, talc used in a cosmetic product, or talc intended for use in a cosmetic. FDA received 49 comments on the proposed rule.

FDA proposed that the rule would apply to all manufacturers of talc-containing cosmetic products, including cosmetic products that are subject to the requirements of chapter V of the FD&C Act (Drugs and Devices). Therefore, the proposed rule, if finalized, would apply to cosmetic products that are also drugs. FDA received comments that suggested the proposed rule would have unintended consequences for many consumer products containing talc, including but not limited to talc-containing cosmetic products.

FDA proposed to define “asbestos” to include “amosite, chrysotile, crocidolite; asbestiform tremolite, actinolite, anthophyllite, winchite, and richterite; and other asbestiform amphibole minerals.” FDA received comments that requested consistency with the established definitions or approaches used by other Federal agencies, including the Department of Labor (Occupational Safety and Health Administration and Mine Safety and Health Administration) and Environmental Protection Agency, to avoid unnecessary confusion.

MoCRA requires FDA to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The proposed rule was issued pursuant to MoCRA and sections 601 and 701 of the FD&C Act. FDA received comments regarding the Agency’s statutory authority under law to add a specific adulteration provision relating to talc testing and regarding its authority to consider a cosmetic containing any amount of asbestos to be adulterated.

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Source: U.S. Federal Register
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