Johnson & Johnson Recalls Baby Powder Over Asbestos Worry

ImageJohnson & Johnson, which is facing thousands of lawsuits over its baby powder and other talc-based products, said it is initiating a recall in the United States “out of an abundance of caution.”
Johnson & Johnson, which is facing thousands of lawsuits over its baby powder and other talc-based products, said it is initiating a recall in the United States “out of an abundance of caution.”CreditCreditMike Segar/Reuters

Johnson & Johnson, which has spent years insisting that its baby powder is safe, recalled 33,000 bottles of the product on Friday after the Food and Drug Administration discovered evidence of asbestos, a known carcinogen, in one of the bottles.

The recall, the first time Johnson & Johnson has pulled baby powder from store shelves over asbestos concerns, could undercut its defense against a swarm of allegations that its talc-based products caused cancer. It comes as the company, which reaches into the lives of millions of people through brands such as Tylenol, Band-Aid and Rogaine and reported nearly $82 billion in sales last year, is entangled in numerous legal battles over the safety of its products.

The company has settled some claims — and is still fighting others — involving its role in the nationwide opioid crisis. On Thursday, Johnson & Johnson agreed to pay $117 million in a settlement over the deceptive marketing of transvaginal pelvic mesh implants, and a jury this month ordered it to pay $8 billion to a Maryland man who accused the company of playing down the risks associated with the antipsychotic drug Risperdal. In total, the company faces more than 100,000 lawsuits over its products.

More than 15,000 of those are from people who say baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer.

The decision to pull the baby powder, sourced from China and distributed last year, is a “whopper” for a company as dependent on consumer trust as Johnson & Johnson, said David Noll, a law professor at Rutgers University.

“I can’t imagine an attorney for Johnson & Johnson standing up in front of a jury now and saying with a straight face that the product is safe,” Mr. Noll said. He added that “if people come to associate the company’s signature product with deadly diseases, there will be huge spillover effects for its ability to market other products.”

The recall was prompted by the FD.A.’s discovery of trace levels of chrysotile asbestos in samples from a bottle of baby powder bought from an online retailer. The company said it was informed of the results on Thursday and recalled bottles from lot number 22318RB out of an “abundance of caution,” though the F.D.A. advised consumers with baby powder from the affected lot to “stop using it immediately.”

But Johnson & Johnson also repeated its longstanding defense against cancer claims, saying that “thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.” The company appeared to question the testing process, saying in a statement that it is working with the F.D.A. to “determine the integrity of the tested sample and the validity of the test results.”

Dr. Susan Nicholson, Johnson & Johnson’s vice president of women’s health, said during a short conference call with investors on Friday that the F.D.A.’s report showed “an extremely unusual finding” that was “inconsistent with our testing to date.”

In response, an agency spokeswoman, Gloria Sánchez-Contreras, said, “The F.D.A. stands by the quality of its testing and results.”

Analysts estimate the baby powder lawsuits could cost Johnson & Johnson $5 billion to $10 billion. The recall could lead to the company’s having to pay more in damages or to settle cases, said Erik Gordon, a University of Michigan business professor who studies corporate governance. Shares of the company closed down more than 6 percent on Friday.

Plaintiffs in the talc cases have accused Johnson & Johnson of failing to warn customers of the risks of asbestos contamination, despite being aware of concerns for decades. A New York Times investigation last year found internal memos and reports made public during litigation that document executives’ concerns about potential contamination that date back 50 years.

[Read our investigation into claims about asbestos in baby powder.]

Johnson & Johnson disclosed this year that it was being investigated by the Justice Department and the Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

Johnson & Johnson is awaiting a major decision that could tilt the talc litigation in its favor. As part of pretrial proceedings for thousands of talc lawsuits consolidated in New Jersey, a federal judge is mulling whether to block testimony from expert witnesses hired by plaintiffs, a move that could cause many talc cases to be dismissed or dropped.

[Thousands of people who trusted Johnson & Johnson’s baby powder for decades are suing the company after developing cancer. “The Weekly,” our new TV show, investigates their allegations.]

Baby powder represents a tiny fraction of Johnson & Johnson sales but an outsize threat to its reputation.

Johnson & Johnson’s name is “so synonymous with their line of baby products,” said Alla Valente, an analyst with Forrester. But recently, she said, the company has started a “damage control campaign” that casts it as bigger than its baby powder, focusing on its slate of other products.

“It’s about trust: If a mother could trust a Johnson & Johnson product for their children, then that product must be safe,” Ms. Valente said. “But now, the dam is finally breaking, where consumers are saying that enough is enough.”

Talc is a natural mineral, formed in underground deposits under the same geological conditions as asbestos. In mines, veins of asbestos can intermingle with talc, geologists say.

Johnson & Johnson officials emphasized on Friday that the level of asbestos detected was very low, just a fraction of 1 percent of the sample. United States health agencies, however, say there is no known safe level of exposure to asbestos.

While health risks increase with heavier and longer exposure to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

Several earlier F.D.A. tests, including one in the past year and another about a decade ago, did not detect any asbestos in samples of baby powder.

The F.D.A. does not require safety testing for personal-care products and cosmetics before they are marketed, and tests products only occasionally, usually after complaints by consumers or advocacy groups.

The agency considered — and soon abandoned — a plan to monitor talcum products for asbestos in the 1970s, when concern about asbestos in household products captured the public’s attention. The F.D.A. commissioned tests of Johnson & Johnson powders back then, and the company successfully challenged their validity.

This year, after consumer tests found asbestos in makeup kits for children sold at Claire’s, the F.D.A. followed up with its own tests. It detected the carcinogen in half of 20 products, including Claire’s eye shadow and compact powder, JoJo Siwa makeup sold at Claire’s, and bronzers, blush and other makeup made by Beauty Plus Global City Color Cosmetics and sold in retail outlets. The products were eventually recalled.

The agency plans to test 30 more products containing talcum powder, including those popular on social media and others marketed to children, Ms. Sánchez-Contreras said. The products are a tiny percentage of the thousands of personal-care products available for sale.


An earlier version of this article misspelled the surname of a spokesman for Johnson & Johnson. His name is Ernie Knewitz, not Knewizt.

Follow Tiffany Hsu and Roni Rabin on Twitter: @tiffkhsu and @RoniNYTimes.

A version of this article appears in print on , Section B, Page 1 of the New York edition with the headline: Baby Powder Is Recalled For Asbestos. Order Reprints | Today’s Paper | Subscribe