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Federal Agency Team to Recommend Standard Asbestos Testing in Talc to FDA

The Food and Drug Administration (FDA) recently announced that it will host a public forum discussing the methods used to test for asbestos fibers in talc-based products, as well as the terminology and criteria that can be used to measure the carcinogen in consumer products. During that forum, the FDA will discuss preliminary recommendations from the Interagency Working Group on Asbestos in Consumer Products (IWGAC)—an interagency working group formed in 2018 to support the development of standardized testing methods for asbestos and other harmful particles.

The purpose of the IWGAC is to address the terminology and definitions of asbestos, recommend improvements for measuring asbestos in talc-based products, and recommend testing standards to test these products. The FDA forum comes two-years after the agency first began investigating reports of asbestos in talcum powder products, during which time it tested 50 such products and confirmed the presence of asbestos in some. One of those examinations in October 2019 revealed the presence of asbestos fibers in a lot of Johnson & Johnson’s Baby Powder, which caused the company to voluntarily recall 33,000 bottles of the iconic product.

Specifically, the IWGAC recommends adopting the term elongate mineral particles (EMP) to be “any mineral particle with a minimum aspect ratio of 3:1,” as to resolve ambiguity and disagreement of asbestos vs non-asbestos identification. Testing laboratories report all EMP having a length of over 500 nm and that testing methods specify reportable EMP identified as certain types of asbestos.

If adopted, the standardized testing methods would represent the most significant refinement and standardization of asbestos-testing methods in talc since they were developed in the 1970s, which tend to rely on optical microscopy methods such as x-ray diffraction or infrared spectroscopy. Additionally, the FDA has acknowledged that different laboratories testing the same talc product with identical methods may still resolve on different conclusions than one another, due to a lack of uniformity.

Over the past two years, Johnson & Johnson has been hit with an estimated 17,000 talcum powder asbestos cancer lawsuits brought by plaintiffs who claim they developed serious forms of cancer, including mesothelioma, from years of using the company’s talc-based products. Much of the litigation has centered around testing methods, and exactly what Johnson & Johnson knew what and when.

Asbestos is a naturally occurring mineral, once used in a variety of commercial and industrial products until federal regulations effectively banned the use of the product because of its link to causing mesothelioma and other health conditions. Both talc and asbestos can be found in deposits side by side with one another, which can lead to cross contamination if talc companies do not take precautions.

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