Special Report: Powder Keg - FDA bowed to industry for decades as alarms were sounded over talc

- 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.

Again and again since at least the 1970s, the agency 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. “When something as serious as cancer or carcinogens are at issue,” Krishnamoorthi said, “self-regulation doesn’t make a lot of sense.”

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 company told Reuters that it “has long cooperated and supported the FDA in its mission to protect the public health,” and that any suggestion it has unduly influenced the agency to reduce regulation or standards is “just false.”

That same year, J&J, other talc companies and their trade group, the Cosmetic Toiletry and Fragrance Association, persuaded FDA officials that manufacturers could monitor the safety of their own products, according to records J&J and the group produced in litigation. Asbestos is a loose term for a group of six minerals that readily separate into needles or fibers. Easily inhaled, they are known to cause lung, ovarian and other types of cancer. While most people exposed never get cancer, for some even small amounts are enough to trigger the disease. Just how small has not been established.

That 1974 letter from J&J to the FDA said that, hypothetically, even if babies were exposed to talc powder with as much as 1% asbestos, it would be a far lower concentration than allowed at the time for industrial workers. Both of the paper’s authors had worked for J&J, one as an asbestos testing contractor and the other as its longtime talc supply manager. The authors argued that some testing methods were apt to misidentify microscopic lookalike rock splinters as asbestos. The industry’s test, the paper said, was designed to avoid this confusion.

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 2006, the World Health Organization’s International Agency for Research on Cancer classified use of talc powder in the perineum area - the pelvic region between the legs - as “possibly carcinogenic.” Two years later, Illinois medical scientist Epstein filed a second petition to the FDA seeking a cancer warning label on talc products.

Three days later, Wille told colleagues in an email, “We have every confidence that the FDA will dismiss this petition once they have reviewed our submission.” The lab had no experience testing for asbestos in talc. Its prior work focused on building materials such as vinyl flooring, according to the deposition testimony of AMA lab director Andreas Saldivar.

Then the FDA weighed in on the issue. In April 2014, 20 years after Epstein first contacted the agency, the FDA rejected both of his petitions for warning labels. Its announcement said the science wasn’t strong enough to support a cancer warning, echoing the assessment J&J and its industry partners had presented to the agency in 2009.

The company now faces more than 16,000 lawsuits alleging that its powders caused ovarian cancer and mesothelioma, an incurable cancer. The vast majority are awaiting trial. In court, there have been mixed verdicts, mistrials and some appellate rulings in J&J’s favor. J&J said that apart from recommending experts, it did not advise the FDA on the symposium. Ekuta, who has left J&J, declined to comment.In a statement to Reuters, the FDA downplayed its role in the symposium, saying the event was “hosted” by the Joint Institute for Food Safety and Applied Nutrition , a research group co-founded by the FDA. “No formal or regulatory recommendations were expected or made,” the agency said.

It’s not just talc.

So they knew, interesting ...

Talc and what else?

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Special Report: Powder Keg - FDA bowed to industry for decades as alarms were sounded over talcThe “Asbestos in Talc Symposium,” sponsored by the Food and Drug Administration, was dominated by industry hands: Most of the 21 non-government participants had done work for talc companies, such as testing and serving as expert witnesses and consultants, symposium documents and other records show.
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