FDA Proposes Mandatory Asbestos Testing for Talc-Containing Cosmetics

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In a recent move to protect consumers, the US Food and Drug Administration (FDA) announced a proposed rule mandating standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.¹ This proposal aims to safeguard public health by addressing the potential risks of asbestos contamination in products that often come into direct contact with the skin.

Talc is a widely used ingredient in cosmetics and personal care products, known for its moisture-absorbing, anti-caking, and smooth-texture-enhancing properties. However, talc is naturally occurring and often found in close proximity to asbestos deposits, which are known carcinogens.²

Due to the challenges in separating asbestos from talc during the mining process, there is an ongoing concern about asbestos contamination in talc-containing products.

Asbestos is a well-established risk factor for various health issues, including lung cancer, mesothelioma, and asbestosis.³ Due to these serious health concerns, the FDA has taken steps to ensure that consumers are protected from exposure to harmful levels of asbestos in talc-based cosmetics.

The proposed rule, a key part of the FDA’s efforts under the Modernization of Cosmetics Regulation Act of 2022,⁴ outlines new requirements for manufacturers of talc-containing cosmetics. These requirements include the use of polarized light microscopy with dispersion staining and transmission electron microscopy combined with energy dispersive spectroscopy and selected area electron diffraction for identifying asbestos particles in talc.

Alternatively, manufacturers may use certificates of analysis from their talc suppliers to demonstrate compliance. However, the FDA emphasizes that it is ultimately the responsibility of the manufacturers to ensure their products are free of asbestos contamination.

The rule also mandates that manufacturers keep comprehensive records to demonstrate their adherence to the testing and recordkeeping requirements.

If the rule is finalized, talc-containing cosmetic products found to be contaminated with asbestos would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), thereby rendering them unfit for sale.¹

According to Linda Katz, MD, MPH, director of the FDA's Office of Cosmetics and Colors, the agency has carefully examined scientific evidence and policy implications surrounding asbestos detection in talc.

"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," Katz said in a news 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."

If enacted, this rule would help close regulatory gaps in the cosmetics industry by requiring manufacturers to prove the safety of their products through standardized, reliable testing methods. Failure to comply with the proposed testing or recordkeeping guidelines would lead to products being classified as adulterated under the FD&C Act, subjecting them to regulatory action.

The FDA has opened a 90-day comment period for stakeholders, including manufacturers, health care professionals, and consumers, to provide feedback on the proposed rule. Once the comment period closes, the FDA will review and consider the input before moving forward with the finalization of the rule.

References

1. FDA proposes rule to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. News release. US FDA. December 26, 2024. Accessed January 3, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc
2. Talc. News release. US FDA. December 26, 2024. Accessed January 3, 2025. https://www.fda.gov/cosmetics/cosmetic-ingredients/talc
3. Asbestos. National Cancer Institute. Accessed January 3, 2025. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/asbestos#:~:text=Exposure%20to%20asbestos%20causes%20most,lung%2C%20larynx%2C%20and%20ovary
4. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). US FDA. Updated December 18, 2023. Accessed January 3, 2025. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra