FDA Proposes New Rule for Standardized Asbestos Testing in Talc-Containing Cosmetics

The U.S. Food and Drug Administration (FDA) has introduced a proposed rule to establish standardized testing methods for detecting asbestos in talc-containing cosmetic products. This move aligns with requirements outlined in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and aims to enhance consumer safety by minimizing asbestos-related health risks. Asbestos, a known carcinogen, can contaminate talc, a common ingredient in many cosmetic products.

Under the proposed rule, manufacturers would be required to employ both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to detect asbestos in talc-containing products. This requirement would apply to either representative samples of finished cosmetic products or the talc ingredients used in production. Manufacturers may also rely on certificates of analysis from talc suppliers, provided the reliability of these certificates is verified through consistent testing.

The proposed rule builds upon recommendations from an Interagency Working Group on Asbestos in Consumer Products (IWGACP), which began examining the issue in 2018. Scientific findings from the group were shared during a 2020 public meeting and later formalized in a peer-reviewed White Paper released in 2022.

The rule includes provisions deeming products adulterated if manufacturers fail to comply with testing or recordkeeping requirements. Cosmetic products or talc found to contain asbestos would also be classified as adulterated under the Federal Food, Drug, and Cosmetic Act. If implemented, the rule is expected to reduce asbestos-related illnesses and limit product recalls, ultimately benefiting both consumers and manufacturers.

The FDA has opened a 90-day public comment period on the proposed rule. Comments can be submitted electronically via Regulations.gov or in writing, referencing docket number FDA-2023-N-4225.

Article by multiple RFHC contributors.

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