FDA cancels J&J licence to make baby powder in Mumbai

Later, a show-cause notice was served to the firm under Drugs and Cosmetics Act-1940 and Rules. But the firm challenged the result and demanded a retest, which was then referred to the government-run Central Drugs Laboratory, Kolkata.

“As the second test result that came recently re-established our findings that samples didn’t meet the standard quality parameters, there was no need to again send them show-cause notice. So, we directly cancelled their licence,” said an official from the FDA.

As per a FDA release, the product may affect the health of the skin of the babies. “For the safety of the public, we have cancelled the licence and instructed them to recall the stock,” said an official from the FDA, who didn’t wish to be identified.

In January 2020, the All Food and Drug Licence Holders’ Foundation wrote to the FDA-Maharashtra, pointing out the delay in initiating action against J&J.

“Generally, when the pH of baby powder is above average, it indicates a mistake in the manufacturing process and an impurity in an admixture element or ingredient during the manufacturing process. If the pH level in baby powder is above average, it can affect the skin of babies. Therefore, I request you to take this matter very seriously and conduct a fair investigation,” read the letter.

Meanwhile, there was no response from J&J when a message was sent for a comment.

Explained | Facing heat across the world

J&J’s talc-based baby power is already mired in controversies across the globe over its quality. On August 11, the company announced that it will discontinue the sale of its baby powder globally in 2023, after facing a flood of lawsuits, amid complaints of ovarian cancer due to the alleged contamination of asbestos, a known carcinogen.