The US Food and Drug Administration (FDA) has proposed a new rule for standardised asbestos testing in cosmetics products containing talc ingredients.
The agency is seeking to establish and require standardised testing methods to detect and identify asbestos. If finalised, this rule will help protect consumers using talc-containing cosmetic products from harmful asbestos exposure.
FDA said that the proposal supports its efforts to meet section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
According to the health agency, talc is a natural mineral used in cosmetics for moisture absorption, preventing the appearance of caking, enhancing facial makeup opacity, and improving the texture of products.
Asbestos, a carcinogen, can be found in the same rock formations as talc and may contaminate talc during the mining process. Due to the risk of asbestos contamination, the FDA emphasised the importance of testing talc-containing cosmetics for its presence.
FDA Office of Cosmetics and Colors director Linda Katz said: “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.
“We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products.”
The proposed rule would mandate that manufacturers of talc-containing cosmetics products to test for asbestos using Polarised Light Microscopy (PLM) with dispersion staining and Transmission Electron Microscopy (TEM) with Energy Dispersive Spectroscopy (EDS) or Selected Area Electron Diffraction (SAED).
Alternatively, manufacturers can use a certificate of analysis from their talc supplier. The rule will also require manufacturers to maintain records to prove compliance.
If finalised, the proposed rule would deem cosmetic products adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if manufacturers fail to comply with testing or recordkeeping requirements.
Additionally, the FDA stated that any cosmetic product found to contain asbestos would be considered adulterated.
The FDA is inviting public comments on the proposed rule, with the comment period ending 90 days after publication in the Federal Register. The agency will review the comments before finalising the rule.
