J&J RECALLS FOR THE FIRST TIME EVER BABY POWDER AFTER ABESTOS TEST PROVES POSITIVE
Washington, DCFor the first time ever, Johnson & Johnson recalled its baby powder (specifically single lot #22318RB, comprising 33,000 bottles) after the FDA announced trace levels of asbestos were found—purchased from an online retailer. J&J said it is working with the FDA to determine whether the product tested is authentic, counterfeit, or whether cross-contamination of the sample caused a false positive. And it also shows how the FDA lacks the ability to test consumer talc products.
FDA NON-TESTING OF CONSUMER PRODUCTS
Also indicating its failure to regulate cosmetics, the FDA in March found asbestos in talc-based makeup products sold by retailers Claire's and Justice. Three Claire’s products and one from Justice tested positive for asbestos. Justice recalled eight makeup products in 2017, including the one that tested positive for asbestos, according to the FDA.
In a statement issued March 5, 2019, the agency said it “routinely monitors the market for cosmetic products that may pose a public health risk. This is how the FDA, in 2017, first became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.” The word “monitors” does not mean testing or regulating.
The law governing the FDA’s oversight of cosmetic products has not been updated since 1938 – when it was first enacted. The current law does not require cosmetics to be reviewed and approved by the FDA prior to being sold to American consumers. Nor does it require the FDA to test products—that is left to a third party and the agency reviews reports of adverse events, studies and research, etc. Claire’s and Justice cosmetics were tested in 2017 by third-party laboratories: two years later the FDA announced to the public results of the tests.
J&J’s baby powder is in the cosmetics category, and cosmetic products don’t even need to be registered with the FDA. The agency continues: “We’re also committed to continuing our efforts specifically around talc and asbestos. In 2010, we surveyed 34 cosmetic products from four major talc suppliers and found no traces of asbestos contamination using the most sensitive techniques available…the FDA will continue to have products tested and take regulatory and enforcement action as needed. “Surveyed” does not mean tested. On October 18, 2019 the agency warned consumers not to use certain cosmetic products that tested positive for asbestos.
THIRD PARTY ASBESTOS TESTING
Among its reports, AMA Analytical Services Inc. certified that asbestos was detected in J&J baby powder – specifically, it detected trace levels of “chrysotile asbestos” no greater than 0.00002%. Technical director Andreas Saldivar signed the certificate of analysis. Reuters reported that Andreas Saldivar has served as a litigation expert on several occasions for J&J since 2017 in its defense against plaintiffs’ claims that asbestos in talc caused their cancers. How could he be motivated to tamper with or conspire against J&J?
J&J announced on October 29 that labs it hired found no asbestos in samples from the bottle tested by the U.S. Food and Drug Administration or from the same production lot.
This statement from the FDA is particularly concerning, and some consumers might say worrisome: FDA contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct a laboratory talc survey for one year, ending September 2010. It found nine talc suppliers from a 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and by searching online. Seven suppliers complied and sent samples of their talc. Conclusion: “While FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination.”
Also worrisome for J&J baby powder users is that Johnson & Johnson CEO Alex Gorsky said, “we unequivocally believe that our talc and our baby powder does not contain asbestos,” 13 days before the Food and Drug Administration (FDA) said it found trace levels in a bottle of the product, reported Reuters. Johnson & Johnson has been aware of possible asbestos contamination in talc for at least 50 years but did not warn consumers. Why change your story now? Unless you’re worried that over 100,000 asbestos talc complaints could cost up to $20 billion.
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