Bombay High Court Quashes Orders Cancelling Johnson & Johnson's License For Baby Powder Production, Says FDA Action 'Arbitrary'

Johnson and Johnson will now be able to manufacture and sell its baby powder. 

A division bench of Justice Gautam Patel and Justice SG Dhige said FDA's action was unreasonably delayed and therefore arbitrary. "An administrator cannot use a hammer to kill an ant," said the court.

The court said it is not reasonable that the moment one sample from the batch is found not of standard quality, the license is cancelled. "It's an extreme approach. [There is] nothing to show FDA has adopted such a stringent standard with other J&J products or manufacturers," the bench said.

Observing that a watchdog like FDA is necessary, the court however said it cannot protract proceedings for weeks and months. 

"But a watchdog must do its job properly which is to guard and protect. 

Public purpose, welfare and consumer protection is at the heart of the law. There is a harsh delay. It is unreasonable not only from the point of view of the manufacturer but even for consumers," it added.

Meanwhile the court said the batch which was tested should be re-called and destroyed as 2 of the 11 samples tested were found to be of a higher pH level.

The probe was started against Johnson and Johnson in November - December 2018, after a random check by the FDA on J&J's powder in Pune and Nashik. The October 2018 batch sample was re-tested 11 months later wherein the pH levels were found to be slightly higher. The company was informed about this in January 2020 and sought re-testing. However, a show cause notice was issued only in February 2021 and a personal hearing was given in July 2022.

The apex drug regulating body of Maharashtra cancelled Johnson and Johnson’s licence on September 15, 2022. The company was later also told to recall their stocks. The company subsequently approached the HC.

“You are supposedly the torch bearers and champions of public health …Is this your sense of urgency?” Justice Patel had asked while hearing the petition.

On November 16, 2022 a coordinate bench ordered fresh testing of powder at two government and one private lab. The FDA laboratory at Bandra-Kurla Complex and Central Drug Testing Laboratory, Western Zone found the sample to be within the permissible limit of 5-8 pH level, the court noted. However, Intratech Laboratory, the private laboratory, opined the pH reading was unstable.

The pH Report of Intertek PTL found JBP samples at 7.58, 9.19, 6.37 and 7.59; The pH report of CDTL lab is 5.88, 7.80, 7.89 and 6.32; the pH report of FDA lab is 7.19, 8.52, 5.98 and 7.20. Intertek found that the pH reading was not stable even after five minutes.

The pH reading is ideally meant to be between 5-8.

Citation: 2023 LiveLaw (Bom) 19