As part of section 3505 of MoCRA, the FDA announced a proposed rule for standardized testing across talc-containing cosmetic products. The potential asbestos contamination of this ingredient was brought to public attention through class-action lawsuits against Johnson & Johnson for its baby powder product and a recall of Claire's makeup. When talc is mined, the asbestos that grows in the same rock is often inseparable; exposure to asbestos-containing talc has been linked to mesothelioma and lung cancers.
Under the FDA's new rule, manufacturers of talc-containing cosmetic products will need to test for asbestos using Polarized Light Microscopy (PLM) (with dispersion staining), Transmission Electron Microscopy (TEM) with Energy Dispersive Spectroscopy (EDS), and Selected Area Electron Diffraction. Alternatively, the manufacturer can receive a certificate of analysis directly from its talc supplier.
"For many years the FDA has been sampling and testing talc-containing cosmetics for asbestos as well as working with our federal partners on efforts to reduce consumers' risk of exposure to asbestos, a known human carcinogen, from contaminated talc-containing cosmetic products," states Linda Katz, M.D., M.P.H., Director of the FDA's Office of Cosmetics and Colors. "We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products. We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products."
Finalizing this rule would deem cosmetic products adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if the manufacturer fails to comply or asbestos is present in the talc used for the product. The FDA is encouraging public comment on this rule, open for 90 days after the date of publication in the Federal Register. After this period closes, the FDA will review and develop the final rule.