Bombay HC quashes FDA order against Johnson & Johnson, permits company to sell baby powder

A bottle of Johnson & Johnson baby powder is seen in a photo illustration

A bottle of Johnson & Johnson baby powder is seen in a photo illustration
| Photo Credit: Reuters

In a big relief to Johnson & Johnson company, the Bombay High Court on Wednesday quashed and set aside the order by Maharashtra Food and Drug Administration (FDA) that restrained the company to produce and sell its baby powder.

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A division bench of Justice Patel and Justice S.G. Dhige allowed the sale of the product by noting, “There were altogether 11-12 results. Of these 2 are non-compliant. All others are within range. Is it either reasonable or proportionate on such a result that the product should be shut down in perpetuity, and manufacturer of all other batches also. Would we want reasonableness or proportionality to take such action that law permits on conforming batches?”

The court set aside the order by FDA and said, “The particular action is needlessly delayed by two years. It’s too late to fall back on example of single batch to justify extreme action of stopping all production of all batches of baby powder. We don’t believe impugned orders can be sustained.”

“Public purpose, welfare and consumer protection is at the heart of the law. There is a harsh delay. We find them to be unreasonable and for that reason arbitrary. It is necessary to have watchdog like FDA but it must do its proper job which is to guard, purpose which is not achieved by delaying testing of samples drawn and protracting proceedings for months and years,” the court added.

The court went on to say, “It is also not necessary for FDA to always adopt a one-size-fits-all approach. A manufacturer, which is repeated offender may receive different treatment compared to manufacturer whose product has occasional lapse. We understand testing process may take a few days but consider pH test in this case. We find it astonishing argument by state that it takes two weeks. Even if it has to be done in sterile lab conditions, it would not even take minutes.”

The court was hearing a petition filed by the company challenging the order by the State government cancelling the manufacturing license of its baby powder in Mumbai.

On September 15, the Joint Commissioner and Licensing Authority, FDA, Maharashtra issued an order cancelling the company’s license, effective from December 15, 2022. In December 2018, the FDA during a random inspector took samples of the baby powder and found it to be “not of standard quality.” The State had then revoked the licence citing public interest and in September 2022, cancelled it and directed the company to recall the stock of the powder from the market.

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