FDA Looks at Stricter Testing for Asbestos in Talc
January 18, 2022
The U.S. Food and Drug Administration recently moved a step closer to a much-needed, stricter standardization of testing for the presence of toxic asbestos fibers in talc-containing cosmetic products.
On Jan. 13, the FDA released its 124-page consensus document written by the Interagency Working Group on Asbestos in Consumer Products. It outlined a scientific assessment on testing that should better protect the public.
Eight U.S. federal agencies, selected by the FDA, were represented in the Interagency Working Group, which began the project in 2018.
The burgeoning issue of small amounts of dangerous asbestos in talc products stems from the rise of cancers – including malignant mesothelioma – that have been linked in recent years to various consumer products containing talc.
Talc and asbestos, two naturally occurring minerals, often are found in close proximity near the Earth’s surface. Asbestos is no longer mined within the U.S., but talc remains a commonly used and valuable resource.
Over the past several years, traces of asbestos have been found in children’s toys, crayons and makeup products.
Tighter Cosmetics Regulations Coming
Under current law, cosmetic products and their ingredients do not require FDA approval or testing.
Companies producing the products do their own safety testing – with no standardization – and are not required to share the data with the FDA.
All of that could be changing. These latest recommendations reject long-held positions within the industry and are designed to end the discrepancies in analysis.
Congressional legislation, fueled by FDA recommendations, is expected to be debated soon and possibly alter the future production of talc-based products.
“We have become aware that methods employed by some industry members to test for asbestos in talc-containing products may not always detect the presence of asbestos,” said Susan Mayne, director of the FDA 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.”
More Comprehensive Talc Testing Advised
The latest consensus provided a more comprehensive testing regimen than is currently being conducted within private industry. It could be a sign of things to come.
- Both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) should be used to test every sample. Most testing sites today use either PLM or TEM, but not both.
- X-Ray Diffraction (XRD) and Scanning Electron Microscopy (SEM) also should be utilized in certain circumstances.
- Particles similar to asbestos, and asbestos fibers of a smaller dimension, must be reported.
- Analytical reports and documentation of all findings must be provided.
- Policies and procedures should be established to ensure testing laboratories are qualified, with reviews on a regular basis.
Studies Highlight Discrepancy in Testing Methods
Findings in this consensus document will be used to support potential regulatory changes, although the FDA will be required to move through a slow, public process that includes a peer review and additional input from interested parties.
The agency has been conducting its own testing of talc products over the last three years, which has accentuated the discrepancy in various testing methods.
In one study involving cosmetics in 2020, the TEM method of testing revealed asbestos contamination in nine of the 52 tested products. The PLM method detected traces of asbestos in only two of the same 52 products.
The FDA announced in 2019 that its testing discovered traces of asbestos in a container of Johnson’s Baby Powder, leading to a 33,000-bottle recall of the product.
Johnson & Johnson insisted that its testing of the same sample showed no signs of asbestos. The company continues to insist its product is safe, but it has discontinued selling talc-based baby powder in the United States and Canada.
In October 2021, the FDA’s latest round of extensive testing of talc in cosmetics revealed no signs of asbestos contamination in 50 different products. Both PLM and TEM testing methods were used.