REUTERS: At an invitation-only gathering late last year, U.S. regulators and their guests huddled at a hotel near Washington, D.C., to discuss the best way to detect cancer-causing asbestos in talc powders and cosmetics.
Raja Krishnamoorthi, an Illinois congressman who chairs a U.S. House subcommittee investigating talc safety, told Reuters it was time for regulators to stop relying on manufacturers’ safety assurances. FDA officials declined to comment on the decisions of former employees over the years, saying only that the agency relies on the best information available and that studies “have improved our understanding of how and why asbestos fibers are hazardous.”
In written responses to Reuters, J&J said it systematically tests its talc and has always found its powders to be safe and pure. “Throughout the 1970s and '80s, the FDA and other regulatory bodies defended talc,” J&J's Chief Executive Alex Gorsky testified in an Oct. 3 deposition. “FDA agreed overall with the position that we had taken with the safety of our talc.”
J&J told Reuters the result was not final, citing findings in an FDA table issued in 1976. But that table, reviewed by Reuters, is ambiguous, listing no result for the type of asbestos found in 1973.Assured by J&J and other manufacturers that their talc was safe, the FDA eventually ended its inquiry without taking action because “the potential hazard did not warrant a recall,” Heinz J.
Chrysotile is the type of asbestos the FDA-commissioned test found in Baby Powder this year. It also was found in several tests conducted by labs for J&J on its talc from 1972 through 2003, according to records produced in litigation. J&J has said that some of the tests were on industrial talc and that others, on Baby Powder talc, reflected background contamination.
When the FDA began evaluating Douillet’s petition, it looked to J&J for key information, agency records show. The FDA’s June 1985 risk assessment relied upon a decade-old letter from the company for the agency’s estimate of the amount of dust babies were exposed to during diapering. What’s more, Swanson wrote, agency officials had come to question earlier reported findings of asbestos in talc powders. Those doubts, he wrote, were based in part on a paper published in the proceedings of a 1977 scientific conference.
Epstein’s 1994 petition didn’t concern asbestos. It raised the possibility that talc, by itself, was a hazard worthy of a warning label. His petition was based on research showing that talc, when used as an antiperspirant and deodorant in underwear, was associated with ovarian cancer. Now a consultant, Bailey serves as a litigation expert witness to J&J and other talc companies. In his statement to Reuters, Bailey said he had been hired at the council “as a scientist responsible for applying sound science to decision making.” He disputed Reuters’ finding that the FDA deferred to industry, saying the agency takes potential health concerns seriously and does its own evaluations.
At a May 2009 meeting, Bailey, Wille and other industry representatives briefed FDA officials on the assessment, according to a meeting memo produced in litigation by J&J’s talc supplier. Acting on that 2009 report, the FDA commissioned talc tests for the first time in 40 years, hiring Maryland-based AMA Analytical Services Inc, which analyzed 34 samples of talc powders and cosmetics, including Johnson’s Baby Powder. It found no asbestos in any of them.
Saldivar’s lab was recently rehired by the FDA. This time, it found the asbestos that led to the first recall of J&J’s iconic Baby Powder. Saldivar declined to comment.In the first verdict of its kind, a South Dakota jury found in October 2013 that J&J had a duty to warn women that research had linked its talc powder to ovarian cancer. No damages were awarded.
Since then, lawsuits have compelled J&J to produce internal documents that show the company knew its talc and powders had tested positive for asbestos on occasion for decades. Two of the experts Ekuta recommended, as well as a third J&J defense witness, led sessions at the closed-door “Asbestos in Talc Symposium” on Nov. 28, 2018. None of the sessions were led by medical experts who had questioned the safety of talc powders and cosmetics.