Talcum powder cannot be manufactured in Maharashtra by Johnson & Johnson

On Thursday, the FDA in Maharashtra revoked Johnson & Johnson's license to manufacture and sell baby powder in the state due to safety concerns. On Friday, the FDA ordered the company to recall its stock immediately.

This year, the pharma giant announced that it would replace talc-based baby powder with corn starch globally in 2023. It has been discontinued in the US and Canada since two years ago, but it is still widely available in India.

Licence cancellation after year-and-a-half dispute

As a result of the FDA's cancellation of Johnson & Johnson's license for its Mulund plant for making baby talcum powder, the company has been at odds with the FDA for the past one-and-a-half years. Samples were collected from Pune and Nashik in November 2019. The tests revealed that they were "not of standard quality". Samples from batches that expired in 2020 and 2021 were included in these samples. A report by an analyst indicated pH levels (9.285) were higher than permissible (5.5-8). While FDA's action is significant, the huge gap in time between calling out a harmful product and its recall has raised questions.

According to FDA officials, they have issued a showcause notice asking why the firm's manufacturing licence should not be suspended or revoked. It was challenged in court by the company. According to the Central Drugs Laboratory in Kolkata, the sample failed the pH test according to IS5339: 2004.

On September 15, the FDA ordered the product to be recalled and to cease manufacturing. The FDA announced it had revoked the manufacturing licence for Johnson's Baby Powder made by M/s Johnson's & Johnson Pvt Ltd, Mulund, in the interests of "public health." The company has one plant in the state.

A senior FDA official said Johnson's baby powder is popular, particularly with parents who use it for newborns. "The use of a product with higher pH could affect the skin of young babies and ultimately their health," he said. A senior paediatrician said drug regulators in India should have stopped the use of Johnson baby powder as soon as it was linked to cancer abroad. J&J faces lawsuits from women who allege its talcum powder contained asbestos which caused them to develop ovarian cancer.

Abhay Pandey of All Food and Drug Licence Holders Foundation said they had written to the FDA in January 2020 to initiate action based on the reports, but FDA took its time. "Lakhs of children would have used it over the past two years," he said.