FDA Withdraws Asbestos Testing Proposal for Talc Cosmetics
On November 28, 2025, in response to adverse comments, FDA published a notice announcing its withdrawal a December 2024 proposed rule that would have required manufacturers of talc-containing cosmetic products to test for asbestos.
The rulemaking is required by section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directs FDA to “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.” FDA’s notice makes clear that the agency plans to issue a new proposed rule in the future.
FDA cites “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” as good cause for the withdrawal.
The concern underlying the rulemaking stems from the geological relationship between asbestos and talc. According to FDA, asbestos is found in the same rock types that host talc deposits, which sometimes results in the presence of asbestos in talc cosmetics.
Although the testing requirements will not take effect, the Federal Food, Drug, and Cosmetic Act (FFDCA) continues to prohibit the sale of adulterated cosmetics, including those that contain “any poisonous or deleterious substance which may render [the product] injurious to users.” FDA has previously taken action in this area: testing in 2019 led to recalls of talc cosmetics potentially containing asbestos, while testing in 2023 did not detect asbestos in any of fifty sampled products.
December 2024 Proposal
The December 2024 proposed rule would have required manufacturers to test talc-containing cosmetic products—or the talc ingredient before use—and maintain records demonstrating compliance. Manufacturers would have needed to test a representative sample of each batch or lot using both:
- Polarized Light Microscopy (PLM) (with dispersion staining).
- Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).
Noncompliance would have rendered a cosmetic adulterated. A talc cosmetic product would also have been deemed adulterated if any asbestos was present—even if only a single fiber was detected.
Issues Raised by Commenters
In the withdrawal notice, FDA notes several provisions of the proposed rule that were contested by commenters, including:
- The proposed definition of “asbestos,” which differed from definitions used by OSHA, the Mine Safety and Health Administration (MSHA), and EPA.
- Whether FDA has statutory authority to add a specific adulteration provision relating to talc testing or to deem any detectable asbestos as adulterating a cosmetic.
- FDA’s inclusion of cosmetic products that are also drugs within the scope of the rule.
In addition, commenters raised concerns about the proposed test methods, although FDA did not address these in the withdrawal notice. For example, the United States Pharmacopeia (USP) questioned whether TEM was superior to other test methods, arguing that it might yield more false positives. USP also asserted that a single-fiber threshold for positive samples diverges from generally accepted TEM fiber counting procedures and would pose challenges for reproducibility.
More information on talc and asbestos can be found on FDA’s website.
