New Brunswick-based Johnson & Johnson Consumer Inc. reaffirmed on Wednesday that its Johnson’s Baby Powder is safe and free of asbestos after a comprehensive investigation into the FDA’s earlier reported finding of sub-trace levels of asbestos (no greater than 0.00002 percent) in samples from a single bottle of Johnson’s Baby Powder.
In a statement, the company said that tests conducted by two third-party labs show asbestos was not present in the single bottle that FDA’s contracted lab, AMA Analytical Services Inc. (AMA), tested, nor was it present in retained samples of the finished lot from which the bottle was produced. Additionally, the company’s investigation revealed that the testing protocol at AMA deviated from standard practice and that AMA did not execute a full asbestos confirmation as required by their lab’s test method.
J&J’s investigation concluded that the most probable root causes for the FDA’s reported results were either test sample contamination and/or analyst error at the AMA lab.
“Our talc is safe and asbestos free, and these 150-plus tests, and the tests we routinely do to ensure the quality and safety of our talc-based products, are consistent with the results from renowned independent research labs over the past 40 years,” the company stated.
Over the course of the investigation, J&J said that a total of 155 tests were conducted by two different third-party labs using four different testing methods on samples from the same bottle tested by AMA, the recalled lot of Johnson’s Baby Powder, as well as three lots manufactured before the recalled lot and three lots manufactured after the recalled lot.
“All results confirm there is no asbestos in our talc,” the company said. “The results of 63 of these tests were released on Oct. 29, and the company today released the results of the 92 subsequent tests. Other than test sample contamination and/or analyst error at the AMA lab, there is no viable explanation for AMA’s positive results in two out of three samples it tested, as compared to 32 third-party tests on samples from the same bottle finding no asbestos.”
The company ruled out the mine and manufacturing supply chain as root causes for AMA’s sub-trace asbestos findings. In its investigation, J&J also confirmed that the milling and mixing of Johnson’s Baby Powder results in a uniform product, ensuring that its testing would reveal asbestos if it was present in the product.
The company said its investigation into AMA’s test results is now concluded and that it shared its findings with the FDA.
Despite the conclusions of the investigation and the tests showing no asbestos in the bottle or lot, the company said that the previously announced recall of Lot No. 22318RB of Johnson’s Baby Powder, stays in effect. The recall was made out of an abundance of caution and before an investigation could be conducted, and, once initiated, it is not feasible to halt the recall.