At the end of December 2024, the Food and Drug Administration (FDA) released a proposal to introduce standardised testing methods for talc-containing cosmetic products in the US. The testing would detect and identify asbestos that may be present as a contaminant in talc.
On 8 January 2025, the proposed rule was notified to the World Trade Organization (WTO).
What is asbestos and how to test it?
Asbestos is a potential contaminant in talc and is carcinogen to humans. Talc is used in certain cosmetics. In the United States, FDA does not currently require any specific method or approach to test for asbestos in talc-containing cosmetic products. However, the FDA is proposing that manufacturers test talc-containing cosmetic products for potential asbestos contamination using both Polarised Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED).
According to the proposal, manufacturers would have to test samples from each batch or lot, either of the talc-containing cosmetic product itself or the talc used in its manufacture. Alternatively, they could rely on a certificate of analysis provided by the supplier. In this scenario, manufacturers must perform verification testing on what is stated in the certificate and ensure that the analytical methods include both PLM and TEM/EDS/SAED.
Noncompliance with testing or recordkeeping requirements as well as any presence of asbestos would classify talc-containing cosmetics as adulterated under the FD&C Act.
Comment the FDA proposal
It is possible to submit comments on the proposed rules within 90 days after publication of the Notice of Availability in the Federal Register (from 27 December 2024). You may submit electronic comments to Regulations.gov.
Do you have questions on compliance of cosmetics in the United States? Send an email to COSlaw@obelis.net or contact us here.
References:
FDA (2024). FDA Issues Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. Retrieved on 7 January 2025.
Federal Register (2024). Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. Retrieved on 7 January 2025.
WTO (2025). Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products. Retrieved on 10 January 2025.
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