J&J refutes FDA findings on asbestos in talc

Johnson & Johnson has rejected an assertion by the FDA that asbestos had been found in one of its Baby Powder talc products, saying independent testing has found otherwise.

The company claims it has carried out 15 new tests on the same bottle analysed by the US regulator’s scientists and found no asbestos. Moreover, another 48 tests from other bottles from the same lot (#22318RB) were voluntarily recalled after the FDA’s announcement has also come out negative for the cancer-causing substance.

J&J says the testing was conducted by two third-party laboratories using three separate techniques – transmission electron microscopy (TEM), powder X-ray diffraction (XRD) and polarised light microscopy (PLM) – and “confirms there is no asbestos in Johnson’s Baby Powder.”

The FDA’s announcement was the first time that the US regulator had reported finding asbestos in the product, and J&J’s recall was the first for the iconic product for potential asbestos contamination.

It was a massive development, because J&J is facing multiple lawsuits from plaintiffs claiming they developed cancer after using its talc products, and shares in the company rose 3% hours after it issued its statement on the independent testing.

The company is also fighting other product liability lawsuits related to opioid drugs, vaginal mesh and orthopaedic products, and its schizophrenia drug Risperdal (risperidone). J&J has just been handed an $8 billion damages judgment in a case brought by a man who claims the company failed to warn him Risperdal could cause breast growth.

So why the disparity with the FDA’s asbestos findings? J&J points to differing results that came from the independent tests when the laboratories carried out their analysis in a second “auxiliary” lab room.

That resulted in positive results for asbestos in three out of five samples, which on further investigation was linked to a portable air conditioner in use during sample preparation.

“This finding underscores the importance of investigating any positive test result [as] even when careful safeguards are followed, asbestos contamination may be introduced during sample division, storage, preparation and analysis,” insists J&J.

In its natural, mined form, talc contains asbestos, but J&J has long argued that all of its talc products used in homes in the US have been asbestos-free since the 1970s – and insists it has demonstrated that repeatedly in testing.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.