India’s Drug Regulator to Detect J&J Talc

India’s drug regulator is going to conduct a test for the Johnson & Johnson’s Baby Powder for traces of asbestos.

The move by the Central Drugs Standard Control Organization (CDSCO) comes after a report said that Johnson and Johnson’s knew for decades about the presence of cancer-causing asbestos in the product.

The central drug licensing inspectors are said to draw samples of raw material used for Johnson and Johnson’s Baby Powder as well as the finished product from retail stores across the country and start its probe. “The inspectors will visit J&J’s manufacturing facility, draw samples for further investigation,” a senior government official told the paper. “They will be tested at the central drug laboratory,” another official told the paper.

Investigation found that while most tests in past decades found no asbestos in J&J talc and talc products, tests on Baby Powder conducted by scientists at Mount Sinai Medical Center in 1971 and Rutgers University in 1991, as well as by labs for plaintiffs in cancer lawsuits, found small amounts of asbestos.

In 1972, a University of Minnesota scientist found what he called incontrovertible asbestos in a sample of Shower to Shower. Other tests by J&J’s own contract labs and others periodically found small amounts of asbestos in talc from mines that supplied the mineral for Baby Powder and other cosmetic products into the early 2000s.

The company did not report to the FDA three tests by three different labs from 1972 to 1975 that found asbestos in the company’s talc.

In response to the report, J&J said that its Baby Powder is safe and asbestos-free. It said that “any suggestion that Johnson & Johnson knew or hid information about the safety of talc is false.”

The company said the Reuters’ report “ignores thousands of tests by J&J, regulators, leading independent labs, and academic institutions have repeatedly shown that our talc does not contain asbestos”.

‘The article ignores that Johnson and Johnson has cooperated fully and openly with the US Food and Drug Administration and other global regulators, providing them with all the information they requested over decades. We have also made our cosmetic talc mines and processed talc available to regulators for testing. Regulators have tested both, and they have always found our talc to be asbestos-free,” the company spokesperson said.

This is, however, not the first time that the product has come under the scanner. In July, the drug regulator had asked Johnson and Johnson to reveal the composition of its talcum powder following a report that the US parent was ordered to pay $4.7 billion to 22 women who claimed asbestos in its talc had caused them ovarian cancer.

On July 12, a Missouri court had ordered the pharmaceutical giant to pay compensation and damages in the asbestos case.

Back home in 2013, the Maharashtra Food and Drug Administration cancelled the licence of Johnson and Johnson’s facility at Mulund in Mumbai after it found that 1.6 lakh packets of baby talcum powder were sterilized at another plant using ethylene oxide — a chemical that is widely believed to cause cancer.

“It was found that J&J deviated from their normal practice of sterilising its Baby Powder. In our investigations, we found that J&J sent batches of its talcum powder to another plant in Thane to sterilize the powder. The powder was sterilized with ethylene oxide, which is carcinogenic. The facility where they sent the powder was not licensed to treat powder. The company was charged for multiple violations and their  licence was cancelled, facility shut for three months after which they went to the court and got the relief,” Mahesh Zagade, former FDA commissioner, Maharashtra said.

While Johnson and Johnson has dominated the talc powder market for more than 100 years, the products contributed less than 0.5 percent of the company’s $76.5 billion in revenue last year.