US FDA Proposes Rule on Testing for Asbestos in Talc Cosmetic Products

On November 26, 2024, the US Food and Drug Administration (FDA) proposed establishing and requiring standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This proposed rule, if finalized, would protect consumers by – to the extent it reduces exposure to asbestos – resulting in fewer asbestos-related illnesses. Manufacturers would also benefit from fewer recalls of talc-containing cosmetics. Comments on the proposed rule should be submitted within 90 days after publication of the Notice of Availability in the Federal Register.

Testing Methods

The proposed rule would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods that contain both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test talc-containing cosmetic products for potential asbestos contamination.

• Polarized Light Microscopy (PLM): Capable of analyzing larger sample quantities, it identifies the presence and type of asbestos fibers by observing the optical properties of the sample under polarized light, such as refractive index, birefringence, and color.
• Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED): Capable of detecting trace amounts of asbestos fibers, providing detailed information on particle morphology, composition, and crystal structure.

Implementation Requirements

The proposed rule requires manufacturers to test representative samples of each batch or lot of talc-containing cosmetic products or on representative samples of each batch or lot of the talc ingredient used in the manufacture of cosmetic products. Further, manufacturers of talc-containing cosmetic products may rely on a certificate of analysis from the talc supplier if they qualify the supplier by establishing and maintaining the reliability of the supplier’s certificate of analysis by performing verification testing.

The proposed rule also contains enforcement provisions. The FDA proposes that failure to operate in compliance with the testing or recordkeeping provisions of the rule would render the talc-containing cosmetic product adulterated under 601(c) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 361(c)]. In addition, the proposed rule states if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, that cosmetic product would be deemed adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)]; and if asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)].

Talc and Asbestos

The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Talc (CAS No.13376-74-4, 14807-96-6) used as abrasive, absorbent, anticaking, bulking, opacifying, skin protecting or slip modifier in cosmetics.

Talc has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021), the Inventory of Restricted Cosmetic Ingredients and the List of Allowed Colorants. Its scope of use and restrictions are (a) Powdery products intended to be used under 3 years of age and (b) Other products. (a) “Keep powder away from children’s nose and mouth” must be included on the labels.

Asbestos (CAS No.12001-28-4), a known human carcinogen, is a potential contaminant in talc, which has been included in the Inventory of Prohibited Cosmetic Ingredients in China. Therefore, it is crucial to test for the presence of asbestos in talc-containing cosmetics.

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Further Information

FDA News

IARC Reclassified Talc as Probably Carcinogenic to Humans