In the past 50 years, the U.S. Food and Drug Administration (FDA) has relied upon – and often deferred to – industry even as outside experts and consumers repeatedly raised serious health concerns about talc powders and cosmetics, a Reuters investigation found. Again and again, since at least the 1970s, the FDA has downplayed the risk of asbestos contamination and declined to issue warnings or impose safety standards, according to documents produced in court proceedings and in response to public records requests.
The FDA said it lacks the authority to require manufacturers to test for asbestos in talc or report any results. And the agency seldom has ordered its own tests – until recently.
Amid heightened scrutiny in Congress, a criminal investigation of J&J and costly jury verdicts against the company, the FDA commissioned tests that found asbestos in 11 talc-based cosmetics, including Johnson’s Baby Powder. Subsequently, J&J recalled 33,000 bottles.
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. “When something as serious as cancer or carcinogens are at issue,” Rep. Krishnamoorthi said, “self-regulation doesn’t make a lot of sense.”
In written responses to questions from Reuters, the FDA said its resources and authority to regulate the cosmetic industry are limited. The agency said it has no power to ensure the safety of cosmetics before they are put on store shelves, nor to force companies to pull them off when potential hazards are discovered.
The agency said it now recognizes, as the World Health Organization and other public health agencies did years ago, that there is no known safe level of asbestos. FDA officials said their current policy is to act swiftly – and if necessary encourage recalls – even when small amounts are discovered.
The FDA now is under increasing pressure to ensure talc powders and cosmetics are free from asbestos. The agency’s testing of talc-based cosmetics this year followed jury verdicts totaling more than $5 billion against J&J in cancer lawsuits, as well as a Dec. 14 Reuters report showing that J&J knew its raw talc and powders sometimes tested positive for asbestos from the 1970s into the early 2000s and did not report those findings to the FDA.
The FDA began looking into talc safety in 1971 after researchers at Mount Sinai Medical Center in New York found what appeared to be asbestos in unnamed brands of talc powder. Two years later, FDA records show that the agency found asbestos in a sample of Shower to Shower, a J&J powder at the time that was made with the same talc as Johnson’s Baby Powder. The FDA never publicly announced the finding.
Talc safety concerns resurfaced in 1983 when a graduate student, Philippe Douillet, preparing for a toxicology class, came across information in geology journals he considered disturbing: Talc deposits are commonly laced with asbestos, a similar mineral. Douillet petitioned the FDA to require an asbestos warning on talc powders. When the FDA began evaluating Douillet’s petition, the FDA agency records show it looked to J&J for key information. In the end, the FDA decided there was no need for an asbestos warning on talc powders. In a July 1986 letter to Douillet, acting associate FDA commissioner J.W. Swanson wrote that the quality of cosmetic talc had improved “and that even when asbestos was present, the levels were so low that no health hazard existed.”
Eight years later, the FDA received a new request for a warning label on talc powders, raising the possibility that talc, by itself, was a hazard worthy of a warning label. This request came from Dr. Samuel Epstein, a University of Illinois environmental medicine professor who chaired the Cancer Prevention Coalition, an advocacy group. In a brief July 1995 letter, FDA Acting Cosmetics Chief John Bailey told Epstein’s coalition that the agency had taken no action because it had other priorities. In 2002, having taken no action on the petition, Bailey moved to the cosmetic trade group now known as Personal Care Products Council. He is now lobbying for the industry.
Now a consultant, Bailey serves as a litigation expert witness for 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.
Together, J&J, its talc supplier and the Personal Care Products Council arranged for a pair of scientists to assess the published studies that linked talc and ovarian cancer, according to emails and other records produced in litigation. In 2009, the scientists concluded that the evidence was too weak to consider talc as a cause.
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. The lab had no experience testing for asbestos in talc and its techniques were very limited. Its prior work focused on building materials such as vinyl flooring, according to the deposition testimony of AMA lab director Andreas Saldivar. It found no asbestos in any of the 34 samples.
These issues are likely to be aired at the public hearing the FDA said it is planning for 2020. The gathering could signal how the agency intends to navigate between industry and consumer interests in coming years. Rep. Krishnamoorthi, the congressman heading the House investigation into talc safety, said the agency needs to bring consumers and their advocates into the discussion. “In light of the public interest around this particular issue,” he said, “we need to find out what’s going on.”
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This story appears in the January 2020 issue of The Jere Beasley Report. For more like this, visit the Report online and subscribe.