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J&J to FDA: there really is no asbestos in Baby Powder

Rejects findings that product contained 'sub-trace' levels of asbestos

J&J

Johnson & Johnson has rejected the findings of FDA testing that suggested asbestos was present in ‘sub-trace’ amounts in a talc product, which sparked a recall.

The company says it has commissioned more than 150 tests by two independent laboratories on the same bottle of Johnson’s Baby Powder that resulted in the FDA announcement, as well as other samples from the same manufacturing lost, and has found zero asbestos.

Tests were also done on three lots manufactured before and after the recall, but were also negative, says J&J. All the analyses were conducted using three separate techniques – transmission electron microscopy (TEM), powder X-ray diffraction (XRD) and polarised light microscopy (PLM).

The recall of the lot (#22318RB) will however stay in effect as it is ‘not feasible’ to halt it, according to J&J.

In a statement, J&J also claims that the testing protocol used by the FDA’s contracted lab – AMA Analytical Services (AMA) – ‘deviated from standard practice’ and ‘did not execute a full asbestos confirmation as required by their lab’s test method’.

Baby PowderThe FDA hasn’t commented officially on the announcement, or J&J’s assertion that ‘test sample contamination and/or analyst error’ was likely the cause of the positive asbestos result.

The company has previous said that its independent tests revealed ‘sub-trace’ levels of asbestos in some samples that on investigation were linked to a portable air conditioner in use during sample preparation.

A spokesperson for the FDA said that the agency stood by the results, adding that there is no standardised test for detecting and quantifying asbestos fibres and different protocols can yield divergent data.

Asbestos fibres may also not be dispersed uniformly through a sample, according to the spokesperson, who added that the FDA’s action “warranted the actions the agency took to protect consumers”. It was the first time that the US regulator reported finding asbestos in Johnson’s Baby Powder.

Shares in J&J nudged upwards after its announcement, reflecting the fact that the company is facing more than 16,000 lawsuits which allege that its talc products contain asbestos that caused some users to develop cancer.

It’s just one of a serious of potential product liabilities looming over J&J at the moment, along with allegations of helping to drive the US opioid epidemic, as well as claims relating to damages that plaintiffs say stem from the company’s hip replacement and vaginal mesh products, and antipsychotic drug Risperdal (risperidone).

Bloomberg has previously suggested that the total bill for J&J’s still pending litigation could eventually reach $15bn.

Article by
Phil Taylor

5th December 2019

From: Regulatory

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