Bombay High Court sets aside FDA order, allows Johnson and Johnson to sell baby powder

A division bench of Justice G S Patel and Justice S G Dige passed an order in a plea filed by the company challenging the FDA order.

The company also undertook to destroy the batch of products which was tested by private Intertech labs and the samples were found non-compliant with the regulations. The court asked the company to ensure all its official distributors recall products from the said batch so that it does not reach the market.

The state FDA, on September 15, 2022, cancelled the licence and later instructed the company to recall the product from the market.

During a random inspection in December 2018, the FDA had taken samples of J&J’s talc-based baby powder from Pune and Nashik for quality check. The sample manufactured at the Mulund plant was declared “not of standard quality” in 2019.

The company told the court there were altogether 11 to 12 test results undertaken so far regarding the product in question and only two of them have been found non-compliant of the standards and all others were well within the range.

“The particular action is needlessly delayed by two years. It’s too late to fall back on the example of a single batch sample taken in 2018, not tested till 2019 and acted only in 2022, to justify extreme action of stopping all production of all batches of baby powder. We don’t believe impugned orders can be sustained,” the bench held.

“Public purpose, welfare and consumer protection are at the heart of the law. There is a harsh delay. We find them to be unreasonable and for that reason arbitrary,” the high court held.

It also said that while quality and safety standards are ‘undoubtedly important’ for cosmetics, all of such products which are used for eyes, skin cannot have same standards and “more granular approach” can be taken by the regulator regarding a particular batch of the said product based on the facts, instead of cancelling manufacturing license altogether.

The bench also noted the FDA’s action was “harsh” as there was nothing on record to show that FDA had consistently adopted stringent standards with the petitioner or other manufacturers.

“It is necessary to have a watchdog like FDA but it must do its proper job which is to guard, a purpose which is not achieved by delaying testing of samples drawn and protracting proceedings for months and years. It is also not necessary for FDA to always adopt a one-size-fits-all approach. A manufacturer, which is a repeated offender may receive different treatment compared to manufacturer whose product has occasional lapse,” the bench questioned FDA action

“We find the state’s argument astonishing that the pH test takes two weeks. Even if it has to be done in sterile lab conditions, it would not even take minutes. It is unreasonable not only from the point of view of the manufacturer but it is unreasonable from the perspective of the consumer…If there is a substandard product being put in market, everyone as consumers has the statutory right to be protected by FDA. It is therefore for FDA to act with utmost care and exercise its powers,” it noted

The bench said that the law provides for seizure and causing destruction of a particular batch, therefore, shutting down all manufacturing after one sample from particular batch was found not as per standards was ‘not reasonable.”

“Indeed we rather believe that this kind of approach would result in considerable degree of commercial chaos and wastefulness . It is hard to imagine how any manufacturer of any cosmetic would properly function,” the bench noted.