The U.S. Food and Drug Administration released a white paper developed by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) that contains scientific opinions for the testing of talc-containing cosmetics and talc intended for use in cosmetics for the possible presence of asbestos, a known human carcinogen with well-documented health risks.
Identify & Report Presence of Asbestos
The white paper, “Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics),” outlines the scientific opinions of the IWGACP related to the detection and identification of asbestos fibers in talc-containing cosmetic products. These opinions are important given the long-recognized shortcomings of other methods in use in their ability to detect asbestos.
The method voluntarily adopted by the cosmetics industry in 1976, Cosmetic, Toiletry, and Fragrance Association, relies on Polarized Light Microscopy (PLM) if amphibole minerals are first detected by X-ray diffraction. However, recent testing of cosmetics using Transmission Electron Microscopy (TEM) has revealed the presence of asbestos fibers in samples that had negative findings for the same products using PLM.
It includes the following related advice: utilizing both PLM and TEM to identify and report the presence of asbestos, reporting all asbestos and other similar particles greater than or equal to 0.5 µm in length with a length to width aspect ratio greater than or equal to 3-to-1.
Efforts to Help Ensure Safety of Cosmetics
Providing analytical reports with adequate documentation of findings, and establishing policies and procedures covering training, quality assurance, and quality control, to accompany testing methods, to ensure laboratories are qualified and their qualifications are reviewed on a regular basis.
The FDA, in its efforts to protect public health, has ongoing sampling and testing to assess for the presence of asbestos in talc-containing cosmetics. The FDA’s previous and current talc-containing cosmetics sampling assignments have used PLM and TEM to detect asbestos.
“The FDA has been sampling and testing talc-containing cosmetics for asbestos as part of our overall efforts to help ensure the safety of cosmetics in the U.S. marketplace. We have become aware that methods employed by some industry members to test for asbestos in talc-containing cosmetic products may not always detect the presence of asbestos,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “That’s why an interagency working group sought to take a state-of-the-science look at available methods.”
FDA Plans to Peer-review the White Paper
The FDA plans to have the white paper peer-reviewed as part of its consideration of these scientific opinions when formulating next steps in a regulatory process to address asbestos contamination in talc-containing cosmetic products. The scientific opinions set forth in the white paper could potentially be used to support regulatory policy developments on a definition of particles of interest and standardized testing methods for asbestos and other mineral particles that could potentially affect talc-containing cosmetic product safety.
In February 2020, the FDA hosted a public meeting to solicit information on asbestos testing methods. The IWGACP was formed by the FDA and consists of subject matter experts from U.S. federal agencies. The IWGACP considered the comments and information received at the public meeting and from the docket, to inform the development of its scientific opinions.
Special Chem, 20 January 2022