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Johnson & Johnson says tests find no asbestos in baby talc

PT Jyothi Datta Mumbai | Updated on November 05, 2019

J&J said that 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by the US regulator found no asbestos. File Photo   -  Reuters

Contradicts USFDA findings on tests conducted on the same talc bottle; consumers await regulatory all-clear

Late last week, Johnson and Johnson (J&J) said it had conducted over 60 new tests on the same bottle of baby powder previously tested by the United States Food and Drug Administration (USFDA), but found no asbestos.

This round of testing had followed a voluntary recall of the product by J&J, after the USFDA had found that a sample from one lot of the product contained chrysotile fibres, a type of asbestos. “Consumers who have Johnson’s Baby Powder lot #22318RB should stop using it immediately and contact Johnson & Johnson for a refund. The FDA stands by the quality of its testing and results and is not aware of any adverse events relating to exposure to the lot of affected products,” the USFDA had said.

Read more: Johnson & Johnson to recall single lot of baby powder in US as FDA finds traces of asbestos

Against this backdrop, J&J’s latest test findings may bring it some cheer, as the multinational remains locked in litigation in the US over possible links between its talcum powder and ovarian cancer. However, the test findings may not quite clear the air of confusion that continues to linger over baby talc and other such talcs that crowd the marketplace.

In the US, the loop will need to be closed with the USFDA, which had raised the red flag on the baby talc. And in India, say regulatory experts, the Drug Controller General of India needs to send out a clear advisory on whether talc products are safe to use.

Regulators’ nod needed

In it’s latest clarification, J&J said that 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by the US regulator found no asbestos. An additional 48 new laboratory tests of samples from the single lot of Johnson’s Baby Powder that the company had voluntarily recalled (Lot #22318RB) also confirm that the product does not contain asbestos. “These tests were conducted by two third-party laboratories as part of the Company’s ongoing testing and investigation,” the company said.

But former Maharashtra FDA Commissioner Mahesh Zagade, who had hauled up baby talc years ago for another harmful ingredient, pointed out that consumers cannot take the company’s word for it and would need an “all clear” from a regulatory authority.

Besides, it’s not just about a single brand of talcum powder being under scrutiny, he said, adding that the DCGI needed to send out an advisory on other similar talcum products in the market as well.

What the FDA says

The USFDA has explained the powder-asbestos link and the reason to worry: “During talc mining, if talc mining sites are not selected carefully and steps are not taken to purify the talc ore sufficiently, the talc may be contaminated with asbestos. Asbestos is a known carcinogen.” The FDA has been testing talc-containing cosmetic products for asbestos. “Not all talc contains asbestos and the majority of product samples tested by the FDA did not contain asbestos,” it clarified.

Related news: Baby talc and the asbestos concern

J&J further pointed out that its tests also demonstrated that positive results were possible due to lab contamination. The contracted labs conducted a number of tests of the recalled lot of Johnson’s Baby Powder utilising Transmission Electron Microscopy (TEM), Powder X-Ray Diffraction (XRD) and Polarised Light Microscopy (PLM) testing, J&J said.

But one of the laboratories deviated from their normal protocol by using an auxiliary room (not the standard separation room). “In that auxiliary room, five samples were prepared, and three initially tested positive for asbestos. Upon this finding, the laboratory undertook an investigation and determined that a portable air conditioner in use during sample preparation in the auxiliary room was contaminated with asbestos. No asbestos was detected in any of the samples when prepared in the standard room,” J&J said.

As evidence is placed on either side of the safety argument involving baby talc, consumers will be looking for clarity from the regulators before they use it on their babies or themselves.

Published on November 05, 2019

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