FDA Kept Silent for Decades Despite Evidence of Talc Contamination

Johnson & Johnson currently faces a legal nightmare, with more than 16,000 lawsuits filed against it. All of these lawsuits claim that the company’s baby powder contains trace amounts of asbestos. This deadly mineral has been linked to ovarian cancer and mesothelioma.

As a result of these lawsuits, talcum powder cancer has become a hot-button issue. Other companies — and even U.S. government agencies — have come under criticism for how they have handled the talc crisis.

According to a Reuters special report, the Food and Drug Administration (FDA) knew for years that there were health concerns about the talc in powders and cosmetics, but did nothing about it.

The rash of recent lawsuits against J&J forced the FDA to step up and finally acknowledge the problem — although critics say the agency is still bowing to industry pressure.

FDA Talc Symposium Draws Controversy

The FDA sponsored the “Asbestos in Talc Symposium” in November 2018, but many of the participants had worked for talcum powder companies at some point. Some had even served as expert witnesses and consultants for the talc companies through the years.

The event was by invitation only, and Dr. David Egilman never got one.

Egilman, a professor of family medicine at Brown University, testified in a trial that yielded a $4.69 billion verdict for women that claimed J&J’s talcum powder caused them to develop ovarian cancer.

Egilman hoped to offer his expertise as a physician and researcher on what doctors should look for under the microscope. He expressed concerns about which mineral fibers cause cancer, as geologists and industry consultants who were guiding the symposium might know little about the issues.

Determining which fibers are toxic to human health is often a key topic in J&J lawsuits related to talcum powder cancer.

FDA cosmetics chief Dr. Linda Katz informed Egilman in an email that the meeting was “not intended to discuss health-related issues or concerns.”

She added that no consensus was expected to be reached — yet three participants, who had formerly served as defense witnesses for J&J, drafted documents they called “consensus” or “concurrence” reports.

Two of the reports discouraged counting fibers that may possibly be asbestos in tests, which is directly against what most U.S. and European public health officials recommend to do.

A Long History of Deferring to the Industry

Reuters asserts that the FDA has allowed the talc industry to set their own safety rules for their products over the last 50 years.

“When something as serious as cancer or carcinogens are at issue, self-regulation doesn’t make a lot of sense,” said Raja Krishnamoorthi, an Illinois congressman who chairs a U.S. House subcommittee investigating talcum powder risks.

Further, Reuters uncovered many controversial FDA actions when digging through the agency’s history.

Here is a timeline of important FDA decisions:

  • 1973: The FDA finds asbestos in a sample of J&J’s Shower to Shower powder, but never announces the finding.
  • 1973: J&J, along with other talc companies and the Cosmetic Toiletry and Fragrance Association (CTFA), convinces the FDA that they could monitor the safety of their own products. The FDA ends plans to test talc samples and the CTFA publishes its own test for the companies to use.
  • 1986: A graduate student who learned talc deposits are often laced with asbestos petitions the FDA to require a warning on talc powders. Using information from J&J, the FDA determines this warning is not needed.
  • 1994: The FDA receives a request from Dr. Samuel Epstein, a University of Illinois environmental medicine professor, to put a warning label on talc powders. Epstein’s research showed talc itself could lead to ovarian cancer. The FDA denies the petition.
  • 2006: The World Health Organization’s International Agency for Research on Cancer said using talc in the pelvic region was “possibly carcinogenic.” Dr. Epstein files a second petition to the FDA. Despite protests from J&J, the FDA finally performs its own tests. While no asbestos was found, the lab that tested the sample had no prior experience testing for asbestos in talc.

In 2019, Krishnamoorthi called for the FDA to bring consumers and their advocates into the discussion rather than relying on the industry.

“In light of the public interest around this particular issue, we need to find out what’s going on,” he said.

FDA Finally Takes Action

In October 2019, the FDA finally tested samples of J&J baby powder that the federal regulator purchased online. Their testing revealed trace amounts of asbestos in the talc.

J&J responded to the findings by voluntarily recalling 33,000 bottles that came from the same shipment that the FDA tested.

Meanwhile, J&J began its own investigation of the tainted talc and claimed it had no asbestos. The FDA stood by its findings.

Furthermore, the FDA plans to hold a public hearing sometime in 2020. The event should reveal how the agency, which has long relied on the talc industry for expertise, will address consumer concerns over this issue.

Author:Talcum Powder Cancer Guide Editorial Team
Talcum Powder Cancer Guide Editorial Team

Talcum Powder Cancer Guide helps people understand the risks of talcum powder, what was thought to be a harmless product. The site was inspired by a group of medical experts and lawyers who were concerned about the dangers of talcum powder after lawsuits linked it to cancer. Talcum Powder Cancer Guide’s editorial team uses up-to-date studies and reports to help readers make informed health and legal choices.

Last modified: March 5, 2020

View 2 References
  1. Girion, L. and C. Terhune. (2019, Dec. 3). FDA bowed to industry for decades as alarms were sounding over talc. Retrieved from: https://www.reuters.com/investigates/special-report/usa-health-fda-talc/ 

     

  2. Steenhuysen, J. and L. Girion. (2019, Oct. 18). J&J recalls 33,000 bottles of baby powder as FDA finds asbestos in sample. Retrieved from: https://www.reuters.com/article/us-johnson-johnson-talc/jj-recalls-33000-bottles-of-baby-powder-as-fda-finds-asbestos-in-sample-idUSKBN1WX1L3