On January 13, 2022, the US Food and Drug Administration (FDA) released a white paper outlining scientific opinions on the testing for asbestos contamination in talc-containing cosmetic products. The white paper was prepared by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) and was prepared with the goal of providing testing guidelines to support reliable detection and identification of asbestos particles (if present). The FDA routinely samples talc-containing products for the presence of asbestos. Due to the lack of a uniform standard for identifying and counting asbestos fibers, even when the most sensitive electron microscopy methods are employed, laboratories testing the same product may reach different conclusions about the presence of asbestos. This lack of uniformity and inconsistent analysis results is ultimately what led the FDA to establish the working group to create guidelines for testing for asbestos.
The IWGACP consisted of subject matter experts from eight different US federal agencies. The goal of the IWGACP was to create a consensus document focused on the development of standardized testing methods for asbestos and other similar particles in talc that could potentially affect cosmetic product safety.
The white paper follows the February 2020 public meeting on asbestos testing and recommends utilizing both polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods to identify and report the presence of asbestos as well as outlining recommendations for reporting, policies and procedures related to the testing. The white paper recommends for the reporting of all asbestos and similar particles greater than or equal to (>) 0.5 µm in length with a length to width aspect ratio (AR) > 3:1.
There will be an external peer review of the White Paper and Technical Appendices and the FDA will continue to analyze talc-containing cosmetic products for asbestos at random. Should there be any regulatory steps following the external review, these will go through a public process to allow interested parties to provide comments to the agency.
If you have any questions regarding the testing of talc-containing cosmetics or any other FDA or compliance matter, please feel free to contact Shannon Gainey at shannon@reach24h.com.
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