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  1. CFSAN Constituent Updates

FDA Releases Data from the Agency’s Year-Long Sampling Assignment to Test Talc-Containing Cosmetic Products for the Presence of Asbestos

Constituent Update

March 9, 2020

The U.S. Food and Drug Administration (FDA) has released a final report in six parts from the agency’s year-long sampling assignment of testing talc-containing cosmetic products for the presence of asbestos, performed by AMA Analytical Services, Inc. (AMA).

In September 2018, AMA was awarded a one-year contract to test talc-containing cosmetics for the presence of asbestos fibers. AMA was selected because of its expertise and knowledge in asbestos testing, as well as having conducted a previous successful survey for the FDA. For this assignment, a contract was established with AMA to test talc-containing powder cosmetic products, which were selected and purchased by the FDA and were provided to AMA as blinded samples. The results showed that 43 samples were negative while 9 were positive.

The products were selected based on various factors including: type of talc-containing powder cosmetic product, price range (i.e., low end to high end products), popular products on social media and in advertisements, children’s products, as well as certain products that had been reported by third parties to be contaminated with asbestos. As such, the occurrence of positive samples in the 2019 testing should not be interpreted as reflecting the overall frequency of positive samples in the marketplace.    

In the case of the positive samples, when the FDA received those test results from AMA, the agency immediately notified the public about the results, and worked closely with the affected companies on their subsequent recalls.

For testing purposes, AMA used Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) to detect and quantify mineral particles suspected of being a form of asbestos. TEM is currently the most sensitive testing method for the detection and quantification of asbestos minerals.

The FDA is planning to continue its talc sampling assignment throughout 2020, with 50 samples selected for blinded testing by AMA. Those final results will be released when available in early 2021. If the FDA finds positive samples, the agency will once again inform the public of the results, and will work closely with the companies involved to remove affected products from the market.

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