An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs who allege contaminated talc products caused their cancers.
The most significant recommendation from the panel of government experts is that mineral particles found in talc products small enough to be drawn into the lungs – even those the industry would not call asbestos – should be counted as potentially harmful.
Because both asbestos and look-alike minerals are suspected of causing “similar pathological outcomes, the distinction is irrelevant,” the expert panel said in a summary of its preliminary recommendations posted this week on the FDA’s website.
The panel also underscored the view of the World Health Organization and other public health authorities that there is no known safe level of asbestos exposure and called for talc powders and cosmetics to be tested with the most sensitive methods available.
The recommendations – which came from experts from eight government agencies, including the U.S. Geological Survey and National Institute for Occupational Safety and Health – are set to be considered Feb. 4 at the FDA campus in Silver Spring, Maryland. It will be the first FDA hearing focused on testing methods for asbestos in talc and cosmetics since 1971, according to the agency.
The panel’s assessment marks a sharp departure from that of previous advisers. In late 2018, at an FDA-sponsored meeting closed to the public, numerous experts with industry ties downplayed the potential hazard of talc contamination with asbestos lookalike minerals, according to a Reuters report in December. [LINK] The gathering and resulting reports drew criticism from other scientists, consumer advocates, a congressman and plaintiffs’ attorneys.
The agency declined to comment Friday on the substance of the new recommendations in advance of the meeting. In a statement, the FDA noted that its panel of government experts “worked independently and has not solicited recommendations from cosmetic manufacturers, industry groups or any other non-governmental groups.”
A spokesman for market leader Johnson & Johnson said the company looked “forward to a thorough review of the most effective and reliable ways to test for asbestos in cosmetic talc.”
In October, the FDA announced that it had found asbestos in a bottle of Johnson’s Baby Powder, prompting the recall of 33,000 bottles. The move marked the first time the company had recalled the iconic brand for possible asbestos contamination, as well as and the first time U.S. regulators had announced a finding of asbestos in the product.
After that, J&J hired outside labs to conduct a series of tests that it said found no asbestos in its talc.
J&J’s “test methods exceed industry standards, and just recently, 155 tests by third-party labs using state of the art methods, including those outlined by the FDA, show there is no asbestos in our talc,” said J&J spokesman Jake Sargent.
A spokeswoman for the Personal Care Products Council said the national cosmetics trade group had not had any interactions with the FDA about the upcoming meeting and declined to comment further.
The recommendations are an early step in U.S. regulators’ reconsideration of testing standards and safety parameters for the talc powders and cosmetics used by millions of people. Although talc and asbestos are similar minerals and are often found together in the ground, the FDA has never required manufacturers to test for the known carcinogen, allowing them to vet their products as they see fit.
FDA officials will consider the guidance in deciding whether to propose standardized testing methods and have not announced a timetable.
The panel’s recommendations could by themselves influence scientific practice and courtroom strategy, experts said.
Adam Zimmerman, a professor at Loyola Law School in Los Angeles, said the recommendations could be used in courtrooms to strengthen plaintiffs’ cases and were particularly valuable because they come from “experts looking out for public safety who don’t have any skin in the game.”
Mark Lanier, a plaintiffs’ lawyer for a group of women with ovarian cancer who won a $4.6 billion verdict against J&J, said he would use the recommendations in future trials. The FDA panel shot several of J&J’s defenses “out of the water,” he said.
Steven Compton, a director of a Duluth, Georgia-based lab that conducts tests for talc companies and has worked for plaintiffs, said the recommendations could provide guidance for scientists now operating in a vacuum, without recognized standards.
“It’s helpful for labs to understand what they should be counting — whether it’s for the courtroom or for a client in industry,” Compton said.
The FDA tests last year, which found asbestos in a number of widely sold cosmetics besides Johnson’s Baby Powder, renewed concerns among some members of Congress and consumer advocates about the risks of asbestos contamination in talc and the potential need for stricter safety standards to protect public health. Thousands of pending consumer lawsuits allege talc powders caused their ovarian cancer or mesothelioma, an incurable cancer of the lining of the lungs and other organs.
For decades, the cosmetic talc industry has largely been allowed to police itself, with little intervention from the FDA.
A 2018 Reuters report [link] showed that although J&J knew its raw talc and powders sometimes tested positive for asbestos from the 1970s into the early 2000s, the company did not report those findings to the FDA. The Dec. 3 Reuters report showed that, since the 1970s, the FDA downplayed health concerns about talc in powders and cosmetics and deferred again and again to manufacturers.
More recently, the agency has taken a tougher stance amid heightened scrutiny in Congress, a criminal investigation into J&J’s statements regarding the safety of its talc powders and jury verdicts against talc manufacturers.
