- FDA has withdrawn a proposed rule that would have required cosmetics manufacturers to test for asbestos in their talc products. According to the Agency, the proposed rule may have unintended consequences beyond cosmetics containing talc.
- FDA introduced the proposed rule on December 27, 2024. It would have required “testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc.” The rule would have applied to all manufacturers of talc cosmetic products, including cosmetic products that are also drugs.
- According to FDA’s withdrawal, the Agency intends to “reconsider best means of addressing the issues covered by the proposed rule and broader principles to reduce exposure to asbestos.” FDA said it had received comments that requested aligning the proposed definition of asbestos with the definition used by other federal agencies; other comments pointed out testing issues, such as potential for the proposed method to yield false positives. In addition, because talc is used in healthcare products, including some drugs, manufacturers may be forced to find replacements or take products off the market “for reasons having nothing to do with product safety,” according to some comments.
- In addition to addressing the potential presence of asbestos in talc product through rulemaking, FDA also convened a scientific expert panel on talc in May 2025, as we previously blogged. Keller and Heckman will continue to monitor developments related to talc.