Email exchanges concerning the presence of asbestos in Johnson & Johnson's talc powder products demonstrate how the company kept warning labels off their products for such an extended period of time. J&J “tested” baby powder only for larger sized asbestos fibers so a lot of the shorter (and still deadly) fibers were not reported in the tests. The FDA finally tested in 2019 and their results in 2020 showed small asbestos fibers which J&J said must have come from already being in a lab. However, the FDA has refuted Johnson & Johnson's assertions.
However, the FDA told Chemical Watch that it believes the results of its original tests are of concern and warranted the actions the agency took to protect consumers.
"We are aware of the company’s assertions and the FDA stands by its findings," it said.
The FDA did acknowledge there is no industry-wide standard to detect and count asbestos fibers. Therefore, different testing methods among labs can yield varying results.
"Given the powdered nature of the product, contaminant fibers likely are not uniformly dispersed throughout talc, meaning different samples may provide different results," added the FDA.
The issue concerning a warning label for the talc products is a bit tougher for Johnson & Johnson to explain.
Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer.
The emails — unsealed in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning — show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powder’s health risks.
They also show the researchers changed the final version of their report at the companies’ behest.
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product. The emails among executives of J&J and Rio Tinto Minerals, its supplier at the time, provide a behind-the-scenes glimpse of dealings between companies and their industry group that successfully fended off a cancer warning on talc-based powders for nearly 40 years.
One could legitimately ask why the FDA relied on a report that was conducted by a group that had a financial stake in the outcome and partnered with Johnson & Johnson. Perhaps that is the most troubling aspect of this latest revelation.
“This is just another example of industry not being transparent about where the science is coming from,” said Peter Doshi, a University of Maryland professor who specializes in the drug-approval process. “Consumers rely on the FDA to make independent decisions on the benefits and harms of products they use every day. Submitting ghost-written materials subverts that process.”
Doshi's argument is well-founded and should put the spotlight on the FDA for allowing Johnson & Johnson to avoid warning labels on one of their most popular products for four decades.
Now, almost 39,000 users and their families are suing J&J, most claiming their ovarian cancers and those of loved ones were linked to asbestos, the potent carcinogen in the products pulled from U.S. and Canadian shelves in May 2020.