Maharashtra FDA Cancels Johnson & Johnson's Baby Powder Manufacturing Licence Over Quality Issues

The firm, however, did not accept the report of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory.

By Anushka Vats
Sat, 17 Sep 2022 09:37 PM IST
Minute Read
Maharashtra FDA Cancels Johnson & Johnson's Baby Powder Manufacturing Licence Over Quality Issues
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THE FOOD and Drugs Administration (FDA) of Maharashtra has cancelled the baby powder manufacturing licence of Johnson & Johnson Pvt Ltd "in the interest of public health at large."

The state government agency on Friday issued a release and said that the company's product, Johnson's Baby Powder, may affect the skin of newborn babies. Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said, as reported by news agency PTI.

According to the release, the action was taken after Kolkata-based Central Drugs Laboratory's conclusive report that concludes "the sample does not conform to IS 5339:2004 with respect to the test for pH."

Notably, FDA had drawn samples of Johnson's Baby Powder from Pune and Nashik for quality check purposes. The government analyst had said that the sample are not of the "standard quality" as they do not comply with IS 5339:2004 specification for skin powder for infants in the test pH.

Following that FDA issued a show-cause notice to Johnson and Johnson under the Drugs Cosmetics Act 1940 and Rules, besides issuing instructions to the company to recall the stock of the said product from the market, said the release.

The firm, however, did not accept the report of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory, it added.

Earlier, Johnson & Johnson had said that it will stop the sale of its talc-based baby powder globally in 2023. "As part of a worldwide portfolio assessment, we have made the commercial decision to transition to an all cornstarch-based baby powder portfolio," it had said, adding that cornstarch-based baby powder is already sold in countries around the world, as reported by the news agency Reuters.

The company faces about 38,000 lawsuits from consumers and their survivors claiming its talc products caused cancer due to contamination with asbestos, a known carcinogen.

However, J&J denies the allegations claiming that decades of scientific testing and regulatory approvals have shown its talc to be safe and asbestos-free. The company reiterated the same when it announced the discontinuation of the baby talc powder.

Meanwhile, a 2018 investigation by the news agency Reuters found that J&J knew for decades that asbestos, a carcinogen, was present in its talc products. Internal company records, trial testimony, and other evidence showed that from at least 1971 to the early 2000s, J&J's raw talc and finished powders sometimes tested positive for small amounts of asbestos.

(With agency inputs)

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