FDA Downplayed Asbestos Concerns for Talc in Baby Powder

For decades, the Food and Drug Administration downplayed concerns over cancer-causing asbestos found in talc contained in baby powder and cosmetics. A Reuters investigation found that over the past 50 years, the agency has repeatedly ignored concerns from experts and consumers while leaving testing for asbestos to the companies themselves.

Reuters reports that the FDA downplayed risks, failed to issue warnings, and did not impose proper safety standards, according to documents produced in court proceedings. The agency said it did not have the authority to require manufacturers of powders and cosmetics to test for asbestos. The agency rarely conducted independent tests until recent pushback led to changes.

FDA Acts, Finds Talc Containing Asbestos

Following increased scrutiny in Congress and from the public, the FDA commissioned testing and found asbestos in 11 talc-based cosmetics, including Johnson & Johnson Baby Powder. J&J recalled 33,000 bottles following the testing. The company was already facing lawsuits alleging they failed to warn customers about asbestos in its products.

The FDA’s findings revealed what many feared. So why did it take so long for the agency to act? FDA officials responded to questions from Reuters, stating that the agency does not have the authority to require manufacturers to test for asbestos or report results. The FDA also does not have the authority to force companies to pull products off of shelves or ensure the safety of cosmetics.

No Known Safe Levels of Asbestos in Talc

FDA officials said they now recognize that there is no known safe level of asbestos for products. This recognition was made by the World Health Organization and other public health agencies years ago. The agency said it uses the best available information to make decisions, and that the new tests improved “understanding of how and why asbestos fibers are hazardous.”

Following the tests, the FDA has moved to increase the regulation of talc-based products. FDA officials said the agency’s current policy is to act quickly and to encourage recalls if necessary when small amounts of asbestos are discovered. The agency announced a voluntary recall of the tainted products in March. Agency officials said they stand by recent tests despite pushback from Johnson & Johnson.

The FDA now faces increased pressure to regulate talc powders and cosmetics to ensure they are free from asbestos. This year’s testing by the agency followed jury verdicts against J&J that exceeded $5 billion in cancer lawsuits. A December 2018 Reuters report found that J&J was aware of its raw talc and powders occasionally tested positive for asbestos and did not report the findings to the FDA.

Company Push Back, Legal Battles Continue

Johnson & Johnson disputed Reuters’ 2018 report as “one-sided, false and inflammatory.” J&J officials told Reuters the company has cooperated and supported the FDA’s mission to protect public health, and suggestions that the company pushed for reduced standards of regulation are “just false.” Officials said the company was under investigation by the U.S. Justice Department and Securities Exchange Commission.

Following the FDA testing that found asbestos in J&J Baby Powder, the company issued a statement that is was recalling the 33,000 bottles as an “abundance of caution.” J&J announced 11 days later that tests conducted by labs the company hired found no asbestos in the talc in baby powder. J&J written responses to Reuters said the company systematically tests the talc and has consistently found the product to be pure and safe.

Regulatory Standards in Flux

Last year, FDA cosmetic chief Dr. Linda Katz began organizing a symposium and public hearing on talc testing following renewed asbestos concerns. The symposium, set to take place at some point in 2020, will likely address contention over which particular mineral powders cause cancer. The meeting might also set precedence for how the FDA plans to navigate industry and consumer concerns in the future.

The symposium follows 2018’s “Asbestos in Talc Symposium” that the FDA sponsored. The 2018 event set formal recommendations on talc testing, but Reuters investigations raised concerns over industry influence for the procedures. Reuters reviewed reports of the session that discouraged counting fibers that “may or may not be asbestos” as hazardous, an issue of courtroom contention nationwide. This contradicts other U.S. and European public health official positions that consider mineral fibers that even look like asbestos to toxic.

Dr. David Egilman, a clinical professor of family medicine at Brown University, issued concerns over the lack of medical professionals present at the 2018 symposium; most non-government participants had backgrounds in mineral testing or geology. Egilman told Reuters that if the FDA was guided by geologists and industry consultants, it could be overlooking which mineral fibers cause cancer. Egilman offered his expertise as a physician and researcher, but an FDA official said his expertise was not required.

Push for Public Assurance

Raja Krishnamoorthi, an Illinois congressman, is chair of a U.S. House subcommittee that is investigating talc safety. Krishnamoorthi told Reuters that the FDA and other regulators need to stop depending on manufacturers for safety assurance. He said the agency needs to bring consumers and advocates into the discussion moving forward.

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