Sat, Dec 07, 2019 - Page 9 News List

FDA bowed to industry for decades as alarms were sounded over talc

For some, even a tiny amount of asbestos can cause cancer

By Lisa Girion and Chad Terhune  /  Reuters

Illustration: Tania Chou

At an invitation-only gathering late last year, US regulators and their guests huddled at a hotel near Washington, DC, to discuss the best way to detect cancer-causing asbestos in talc powders and cosmetics.

The “Asbestos in Talc Symposium,” sponsored by the Food and Drug Administration (FDA), 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.

Key sessions were led by witnesses for Johnson & Johnson (J&J) in lawsuits alleging the company failed to warn customers that its baby powder was tainted with cancer-causing asbestos, the records show. Others who sought invitations were turned away, including a physician who had testified against J&J in trials that resulted in billions of dollars in damage awards against the company.

History was repeating itself.

Over the past 50 years, the 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.

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.

The agency said it lacks the authority to require manufacturers to test for asbestos in talc or report any results. It has seldom 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 regulator commissioned tests that found asbestos in 11 talc-based cosmetics, including Johnson’s Baby Powder. J&J recalled 33,000 bottles.

Raja Krishnamoorthi, Illinois representative who chairs a US House of Representatives subcommittee investigating talc safety, said it was time for regulators to stop relying on manufacturers’ safety assurances.

“When something as serious as cancer or carcinogens are at issue, self-regulation doesn’t make a lot of sense,” Krishnamoorthi said.

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.

“We are dependent on manufacturers to take steps to ensure the safety of their products,” the FDA said after announcing a voluntary recall of tainted cosmetics in March.

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.”

The agency said it now recognizes, as the WHO 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 regulator has stood by its recent tests of Johnson’s Baby Powder, despite pushback from the company.

J&J, the world’s largest producer of talc powders, said in a statement that it recalled the 33,000 bottles of Baby Powder out of an “abundance of caution.”

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