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J&J allowed to produce baby powder as FDA order quashed
The Bombay high court on Wednesday set aside a Food and Drug Administration (FDA) order that halted the production and sale of Johnson & Johnson baby talcum powder after a batch was found to be of substandard quality, ruling that the decision was arbitrary.
The Bombay high court on Wednesday set aside a Food and Drug Administration (FDA) order that halted the production and sale of Johnson & Johnson baby talcum powder after a batch was found to be of substandard quality, ruling that the decision was arbitrary.
The high court relied on the reports from government and private testing laboratories to conclude that FDA’s September 2022 decision was based on only one batch of the product, and did not merit a decision as harsh as ordering a complete halt in manufacturing at Johnson & Johnson (J&J) Private Limited’s Mulund unit.
“It is necessary to have a watchdog like FDA but it must do its job properly, which is to guard -- a purpose not achieved by delaying the testing of samples and protracting proceedings for months. It is also not necessary for FDA to always adopt a one-size-fits-all approach. A manufacturer, who is a repeat offender, may receive a different treatment compared to a manufacturer whose product has occasional lapse,” a bench of justice G S Patel and justice S G Dige said.
The court asked FDA to conduct regular checks and permitted J&J to manufacture and sell the powder.
FDA, on September 15, 2022, issued a stop-work notice to the company on the grounds that samples of the powder collected in Pune and Nashik had higher than permitted pH (potential of hydrogen) levels. The samples were taken in 2018 but the tests were conducted in 2019. The results were conveyed to the company in August 2022. Soon after, the company recalled the substandard product from the market and destroyed it.
The bench was hearing the petition filed by J&J challenging the FDA order and the subsequent rejection of its appeal by the minister concerned.
Advocate Ravi Kadam, appearing for the company, argued that though 11 to 12 samples were tested, only two of them -- belonging to the 2018 batch -- were found to be of substandard quality.
The action was needlessly delayed by four years, the HC ruled on Wednesday. “It’s too late to fall back on the example of a single batch sample taken in 2018, not tested till 2019, and was acted on only in 2022, to justify the extreme action of stopping production of all batches. We don’t believe impugned orders can be sustained,” it added.
The order further said the regulator must have a more granular approach for different products and batches, rather than cancelling a licence altogether, and there was nothing to show that FDA consistently adopted such stringent standards with J&J or other manufacturers.
The bench also said that the test was a simple one, and could be conducted in a few minutes. “We find the state’s argument astonishing that the pH test takes two weeks. Even if it had 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 also from the perspective of the consumer.”
Johnson & Johnson quote needed.
