'Withdraw baby powder from the market': Maharashtra FDA tells J&J

The Maharashtra Food & Drugs Administration (FDA) has asked pharma giant Johnson and Johnson (J&J) to recall from the market the baby powder produced at its plant in Mulund, Mumbai.

“The instruction has been issued to the company and they have to abide by it. The company should withdraw the product which has been produced from a particular site in Maharashtra,” a top official told Moneycontrol.

The FDA issued the notice of recall after cancelling the  manufacturing licence of Johnson’s Baby Powder.

The official said the FDA issued a show-cause notice to the firm under the Drugs & Cosmetics Act, 1940, as to why its product manufacturing licence should not be suspended or cancelled.

The FDA had collected samples of Johnson’s Baby Powder at Pune and Nashik for a quality check.

Also read: Johnson & Johnson won’t take controversial baby powder off shelves in India

“The samples were declared Not of Standard Quality by the government analyst as the pH test failed to comply with IS 5339:2004 (second revision, amendment no. 3) specifications for skin powder for infants,” said the Maharashtra FDA press note.

The pH values were higher than specified.

According to the official, J&J rejected the government analyst’s reports and challenged it in court, requesting that the samples be sent to the Central Drugs Laboratory (CDL), Kolkata.

“The Director, CDL Kolkata, confirmed the government analyst’s assessment and issued a report concluding that the sample does not conform to the standards laid down in India with respect to pH test,” the officer added.

“Use of the product may affect the health of the skin of the new-born babies. Hence, in the interest of the public health at large, the FDA has cancelled the manufacturing licence of Johnson’s Baby Powder vide order dated 15/09/2022,” said the press note from the FDA, Maharashtra.

Asked if J&J could go to other state drug authorities and get their product tested to overturn the cancellation as India does not have unified testing protocols, the officer said `‘it would not be easy.’’

“We have a nod from CDL, Kolkata, a nodal authority, which has found issues with the product,” he added.

Moneycontrol has reached out to Johnson and Johnson for a comment  on the matter, however, a response is still awaited.

It is important to note that the notice cancelling J&J’s licence to manufacture the product is for failing the pH test.  It does not mention anything about the use of asbestos in the product, which many have complained about.

Moneycontrol had reported in August that J&J is discontinuing its talc-based baby powder in the face of lawsuits claiming that it contains asbestos, a carcinogen. However the company has no plan to take the product off Indian shelves.

A J&J executive confirmed this. “There is no recall. We continue to stand by the safety of the product. We will continue to manufacture it till quarter one of next year. After that, we will stop manufacturing,” the executive said.