1 / 3FILE PHOTO: U.S. Rep. Krishnamoorthi questions Ambassador Sondland in WashingtonBy Lisa Girion and Chad Terhune
The agency said it lacks the authority to require manufacturers to test for asbestos in talc or report any results. And it seldom has ordered its own tests - until recently. Story continuesIn 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 regulator has stood by its recent tests of Johnson’s Baby Powder, despite pushback from the company. 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 totalling 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 agency.
The FDA dropped plans to impose testing and purity standards for talc powders and cosmetics. The trade group published its own test, which was voluntary for companies to use. The written standard for that test acknowledges that it cannot detect most types of asbestos at low levels, nor one common type - chrysotile - at all.
Philippe Douillet immediately thought of the talc powder his sister used on her baby, he recalled in an interview with Reuters. He urged her to stop using it. Then he petitioned the FDA to require an asbestos warning on talc powders. J&J told Reuters in a statement that “at no point has Johnson & Johnson taken the position that it would consider talc containing 1% asbestos appropriate for sale to consumers.”
Other U.S. and European public health authorities have come to regard such splinters as presumptive toxins because of their similarity to asbestos. Bailey told Reuters in a statement that he issued this “interim” response because the petition lacked scientific support. J&J went to work to defeat it. In a May 2008 email to colleagues, J&J executive Kathleen K. Wille wrote: “Our response could be a potential source of data and information on which the FDA can base their response.”
J&J told Reuters in a statement that the company had been confident because it believed the agency would be swayed by science, which it said supported J&J’s position that talc does not cause ovarian cancer. The FDA has said Saldivar’s lab used “the most sensitive techniques available” but cautioned that the results were limited to the 34 talc powders and cosmetics tested.
In court, such arguments have not always proved convincing. In early 2016, a Missouri jury concluded J&J’s powders caused a woman’s ovarian cancer death and awarded her survivors $72 million. An appellate court later set that verdict aside, ruling that the woman had filed her suit in the wrong state.
Last year, in response to renewed asbestos concerns, FDA cosmetics chief Linda Katz began organizing the November 2018 symposium and a public hearing on talc testing, now planned for next year. In fact, records show, the FDA initiated and paid for the meeting, set the agenda and chose the participants.
The guest list showed that more than half of the 54 participants were employed by or recently retired from FDA and other agencies. Of the 21 non-government participants, 17 had either worked for talc companies, done lab testing or served as expert witnesses for the industry, Reuters found. Five of the participants affiliated with talc companies also have served as expert witnesses for plaintiffs. Most of the non-government participants were experts in geology or minerals testing.
Katz took a different view. In an email forwarded to Egilman, she said: “This meeting is not intended to discuss health-related issues or concerns.” She met with Egilman later.