FDA’s 2024 proposal (89 FR 105490) would have required manufacturers to test either talc ingredients or finished talc-containing cosmetic products for asbestos before use and maintain records demonstrating compliance. Under the proposal, any asbestos detected—at any level—would have rendered the product adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule would have applied broadly, including cosmetic products that are also regulated as drugs under chapter V of the FD&C Act.
The agency received 49 public comments, many of which raised concerns about how the rule’s scope could affect not only cosmetics but also consumer goods that contain talc. Several commenters argued that FDA’s proposed definition of asbestos—including chrysotile, crocidolite, and asbestiform amphiboles such as tremolite and actinolite—did not align with established definitions used by OSHA, MSHA, or EPA. Without harmonization, commenters warned, compliance requirements could create unnecessary confusion across regulatory frameworks.
Other stakeholders questioned FDA’s statutory authority to establish a talc-specific adulteration provision or to deem any detectable asbestos—regardless of threshold—automatically adulterating. FDA acknowledged these concerns in the withdrawal notice, noting the “highly scientific and technical issues” raised, alongside legal considerations under the Administrative Procedure Act.
The agency stated that “good cause exists to withdraw the proposed rule at this time,” referencing the Make America Healthy Again (MAHA) priorities around safe ingredients and the need to reassess how standardized testing requirements can best reduce asbestos exposure risks.
The withdrawal does not change MoCRA’s underlying mandate: FDA must establish standardized asbestos detection methods for talc-containing cosmetics. Talc naturally co-occurs with asbestos in certain geologic formations, and global mining variability has long posed a contamination risk. According to the World Health Organization (WHO), asbestos fibers can appear in talc deposits due to natural mineral intergrowth, making rigorous testing essential for exposure prevention.
Independent investigations have periodically found asbestos in cosmetic products marketed to children and teens, underscoring gaps in voluntary testing. In 2020, the U.S. House Subcommittee on Economic and Consumer Policy identified asbestos in multiple talc-based cosmetics during congressional testing. Environmental Working Group has continued to document instances of asbestos contamination in the U.S. market through 2023.
FDA confirmed that it will issue a revised proposed rule to satisfy MoCRA’s section 3505 obligations. Until then, manufacturers face a transitional period in which regulatory expectations are shifting, but public and investor pressure to ensure asbestos-free cosmetic supply chains remains strong.
