The pharmaceutical giant disputed the US regulator’s findings that the carcinogen was found in its baby powder.
Johnson & Johnson (J&J) has said that 15 new tests found no asbestos in a bottle of baby powder that the United States Food and Drug Administration says tested positive for trace amounts of asbestos, a finding the agency stands by.
The tests are the latest effort by J&J to prove the safety of its widely-used consumer product after a test by the FDA prompted J&J to undertake a nationwide recall of one lot of its Johnson’s Baby Powder.
FDA officials, in an interview with Reuters news agency, said the agency continues to support the company’s voluntary recall.
“They would say the product is free of asbestos based on their testing, and we would say the opposite for that sample,” said Steve Musser, deputy director for scientific operations in the FDA’s Center for Food Safety and Nutrition.
On October 18, J&J recalled about 33,000 bottles of baby powder in the US after the FDA found traces of asbestos in samples taken from a bottle purchased online.
“Rigorous and third-party testing confirms there is no asbestos in Johnson’s Baby Powder. We stand by the safety of our product,” J&J said in a statement. The company did not immediately respond to a request for additional comment on the FDA standing by its test result.
J&J also ran 48 more tests on samples from the lot that was inspected by the FDA, and said it found nothing.
The different test outcomes could have resulted from the fact that contaminants are not uniformly dispersed throughout talc and there is no standard test for asbestos in the powder, FDA officials said.
The agency also said that because of the small sample size used in the tests, it was possible for results to vary. The FDA said that one sub-sample came back negative, and two came back positive.
“Different samples may provide different results,” it said
The voluntary recall was limited to one lot of Johnson’s Baby Powder produced and shipped in the US in 2018, the company said at the time.
That move marked the first time the company recalled its iconic baby powder for possible asbestos contamination, and the first time US regulators have announced a finding of asbestos in the product. Asbestos is a known carcinogen that has been linked to deadly mesothelioma.
J&J will not reverse the recall of those 22-ounce (650ml) containers, but its baby powder remains available to consumers in stores, a company spokesman told Reuters.
The recall had been the latest blow to the more than 130-year-old US healthcare conglomerate that is facing thousands of lawsuits over a variety of products, including baby powder, opioids, medical devices and the antipsychotic Risperdal.
J&J faces more than 15,000 lawsuits from consumers claiming its talc products, including Johnson’s Baby Powder, caused their cancer.
SOURCE: Reuters news agency