The FDA has proposed a rule requiring manufacturers of talc-containing cosmetic products to use standardized testing methods to detect asbestos contamination, according to a notice in the Federal Register.

Asbestos exposure is linked to serious health risks, including lung and ovarian cancers, with no established "safe level" for exposure. Detecting and mitigating asbestos in talc products could reduce disease burden, particularly in at-risk populations.

The proposed regulation outlines specific methodologies for detecting asbestos, such as polarized light microscopy and transmission electron microscopy, which provide detailed analysis through electron beam imaging. Manufacturers would be required to test a sample from each batch and maintain comprehensive records to ensure compliance.

Failure to meet these requirements could result in products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act, triggering potential enforcement actions.

Johnson & Johnson faces lawsuits from over 62,000 claimants alleging that asbestos-contaminated talc in its products caused cancers. The company has denied these claims and continues to assert the safety of its products while pursuing a $10 billion settlement in bankruptcy.

The FDA is soliciting comments on the proposed rule from health care professionals, industry stakeholders, and the public over the next 90 days. Physicians may consider providing insights into the potential health implications of asbestos exposure.