FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products
Recently, the U.S. Food and Drug Administration released a white paper
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 regularly.
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 the next steps
in a regulatory process to address asbestos contamination in talc-containing
cosmetic products. The scientific opinions outlined 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 concerning 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.
The recent 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 before 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 imports. Despite limited authority 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.