Today, 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. These opinions of scientific experts are intended to inform the FDA’s consideration of testing methods for talc and talc-containing cosmetics.
“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.”
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. For example, the method voluntarily adopted by the cosmetics industry in 1976, Cosmetic, Toiletry, and Fragrance Association (CTFA) J4–1, 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.
The white paper’s scientific opinions include 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; 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 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. Should the FDA decide to develop recommendations with respect to standards or testing methods for asbestos in talc, it would issue draft guidance for public comment. Likewise, the FDA would propose any related regulations through a public notice and comment process.
The IWGACP was formed by the FDA and consists of subject matter experts from U.S. federal agencies. In February 2020, the FDA hosted a public meeting to solicit information on asbestos testing methods. The IWGACP considered the comments and information received at the public meeting and from the docket, to inform the development of its scientific opinions.
Today’s release of the white paper concludes the efforts of the IWGACP. The FDA will consider the scientific opinions presented in the white paper, including having it peer-reviewed, as part of its overall efforts to help ensure the safety of talc-containing cosmetic products. Under the Federal Food, Drug, and Cosmetic Act – the law governing the FDA’s oversight of cosmetic products – cosmetic products do not have to undergo FDA review or approval prior to being sold to American consumers. This statutory framework has also not been modernized to take into account an enormous growth in the domestic industry and in foreign imports. Despite limited authorities over cosmetics, the FDA continues to engage in efforts like the IWGACP, monitors for potential safety problems with cosmetic products on the market, and remains committed to taking action when needed to help keep consumers safe from contaminated cosmetic products.