FDA Proposes Rule for Standardized Asbestos Testing in Talc-Containing Cosmetic Products

The US Food and Drug Administration has announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products.1

Announced on December 26, 2024, the proposed rule would help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. According to a release from the FDA, the proposal is part of the agency’s work to fulfill the requirements of section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).1

“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,” Linda Katz, MD, MPH, director of the FDA's Office of Cosmetics and Colors, said in a press release.1 “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.”

A naturally occurring mineral with many uses in cosmetics and other personal care products, talc deposits are found in the same rock types as asbestos, a known carcinogen, and may be inseparable in the mining process. Composed of magnesium, silicon, oxygen, and hydrogen, talc may be used to absorb moisture, prevent caking, make facial makeup opaque, or improve the feel of a product.1,2

Due to the potential for contamination of talc with asbestos, the FDA cites the importance of testing for the presence of asbestos in talc-containing cosmetic products.1

The proposed rule would require manufacturers of talc-containing cosmetic products to test for asbestos using an analytical approach that includes both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED) to detect and identify the presence of asbestos. Alternatively, manufacturers may rely on a certificate of analysis from the talc supplier. Of note, the proposed rule contains provisions requiring manufacturers to keep records to demonstrate compliance with the rule.1

If finalized, cosmetic products would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if a manufacturer fails to operate in compliance with either the testing or recordkeeping requirements of the rule. The proposed rule also states that if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, that cosmetic product is adulterated under the FD&C Act; and that if asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under the FD&C Act.1

In the agency’s press release announcing the proposed rule, the FDA encouraged public comment, with the comment period ending 90 days after the date of publication in the Federal Register. After the comment period closes, the FDA will review and consider comments as it develops the final rule.1

References

1. US Food and Drug Administration. FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. December 26, 2024. Accessed December 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc
2. US Food and Drug Administration. Talc. Cosmetic Products and Ingredients. April 5, 2024. Accessed December 26, 2024. https://www.fda.gov/cosmetics/cosmetic-ingredients/talc