The U.S. Food and Drug Administration (FDA) has proposed requiring standardized testing methods for cosmetics containing talc to detect and identify potential asbestos contaminants. The FDA has also proposed corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in some cosmetics and is a known human carcinogen. If this proposed rule is finalized, it will help protect users of talc-containing cosmetics from harmful asbestos exposure, as these products may be contaminated.

The FDA issued this proposed rule under the Cosmetic Regulatory Modernization Act of 2022 (MoCRA), which mandates the enactment of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. If finalized, this proposed rule will help protect users of talc-containing cosmetics from harmful asbestos exposure, as these products may be contaminated with asbestos.

Summary of key provisions of the proposed rules

The proposed rule describes testing methods that, if finalized, manufacturers of talc-containing cosmetics will be required to use to detect and identify asbestos in these products. The proposed rule would require manufacturers to use polarized light microscopy (PLM) (dispersive staining) and transmission electron microscopy (TEM)/energy-dispersive spectroscopy (EDS)/selected area electron diffraction (SAED) to test representative samples of each batch or lot of talc-containing cosmetics for asbestos.

The proposed rule also includes provisions allowing manufacturers the flexibility to test each batch or lot of talc cosmetic ingredients, or to rely on analytical certificates for each batch or lot from qualified talc suppliers before using talc in the manufacture of talc-containing cosmetics, provided that the analytical methods used to test the talc include PLM and TEM/EDS/SAED. The FDA has learned from discussions and meetings with industry representatives that testing talc before adding it to cosmetics is industry practice to avoid the manufacture and sale of talc cosmetics containing asbestos. We specifically invite comments on existing industry practices and the practicality of this approach.

In addition, the proposed rule includes a clause requiring manufacturers to retain records to demonstrate compliance with the rule.

Finally, the proposed rule includes enforcement provisions. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a manufacturer's failure to comply with testing and record-keeping requirements can result in product adulteration. Furthermore, because no safe level of asbestos below which adverse health effects are established, the FDA has determined that any amount of asbestos in talc-containing cosmetics could potentially harm the user. Therefore, the proposed rule would stipulate that if asbestos is present in a talc-containing cosmetic or in the talc used in a cosmetic, the cosmetic is considered adulterated under the FD&C Act. Similarly, if asbestos is present in the talc used in a cosmetic, the talc is considered adulterated under the FD&C Act.

If finalized, the proposed rule would require the use of standardized testing methods to test cosmetics containing talc to detect and identify asbestos, which may be present as a talc contaminant. Benefits include the potential public health benefits of reduced asbestos exposure for consumers. If the proposed rule reduces exposure, health benefits would include a reduction in diseases such as mesothelioma, lung cancer, laryngeal cancer, and ovarian cancer.