The Bombay High Court on Wednesday quashed a Maharashtra government ban on a Johnson & Johnson (J&J) plant and allowed J&J to make and sale its baby powder.
The case is related to three orders of the Maharashtra government which banned the manufacturing, sale, and distribution of baby powder from J&J's Mulund plant close to Mumbai. It was found that powder samples had higher pH levels than specified.
The High Court also criticised the Maharashtra Food and Drug Administration (FDA) for delayed tests and said the Maharashtra government's action to ban manufacturing at the plant was an extreme action.
Here we explain what's the case, what the court said, and what are the other controversies with Johnson & Johnson's powder.
What's the case about?
Johnson & Johnson (J&J) makes baby powder at its plant in Maharashtra Mulund.
Samples of powder made at the plant showed higher pH level than specified.
The case concerns three Maharashtra government orders:
- On September 15, 2022, the licence was cancelled
- On September 20, 2022, the manufacturing and sale of baby powder was stopped
- On October 15, 2022, the minister issued the order to uphold the above two orders
The Bombay High Court has ruled against these orders.
The pH level shows how acidic or basic a product is.
The pH level of the powder was found to be 9.285, which is higher than the permitted range of 5.5 to 8.
What did Bombay High Court say?
The Bombay High Court passed its order on a petition filed by Johnson & Johnson agaist the three government orders listed above.
The HC terming the government orders as “stringent, unreasonable and unfair”.
A division bench of Justices Gautam Patel and S G Dige also came down heavily on Maharashtra Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company’s baby powder seized in December 2018.
The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products. It said such an approach would result in considerable amount of "commercial chaos and wastefulness".
The HC in its order on Wednesday noted the fresh tests conducted showed all batches of the baby power product were compliant with the norms prescribed.
The HC in its order said, "The Executive cannot use a hammer to kill an ant. Is it always inevitable that when there is a single case of deviation or non-compliance (to prescribed norms) by a product the only option left with the regulatory authority is to cancel or revoke the license of the manufacturing company? This seems to us as an extreme approach. There seems to be an unfairness and unreasonableness in the executive action. There is also nothing to show that the FDA has adopted such a stringent approach for any other product of the petitioner company or any other company."
Noting that the government orders cannot sustain, the HC quashed them and permitted the company to manufacture, distribute and sell its baby powder products.
The High Court criticised Maharashtra FDA
The court also came down heavily on the FDA for the delay in carrying out tests on a sample of the company’s baby powder seized in December 2018.
A test on the sample was done in December 2019, as per the company.
The bench said such delay is “unreasonable, unacceptable and arbitrary” and contrary to the provisions of law.
“Since 2018, when the sample was taken for test, the company has been manufacturing and selling its product till 2022 when its license was revoked. It is necessary to have a watchdog like the FDA but a watchdog must do its job of guarding. This is not achieved when there is delay in testing samples,” it said.
The HC said a “more granular approach” would be available to the FDA under the provisions of law.
“It does not seem reasonable to us to accept that the moment a product is found to be deviant or non-conforming to the prescribed standards, then the only possible consequence is to shut down all manufacturing,” the court said.
Such an approach by the FDA would result in considerable amount of commercial chaos and wastefulness, it said.
The orders of suspension and revoking of license were passed by the joint commissioner and licensing authority of the state FDA based on a report of the Central Drug Laboratory in Kolkata, which found the powder contained higher pH level than prescribed.
In December 2022, the high court had in an interim order permitted the company to manufacture its product but not distribute or sell it.
The HC had then ordered for fresh samples to be collected from the company’s factory in suburban Mulund and sent to three labs – two government and one private facility – for testing.
The bench in its order on Wednesday noted that the fresh tests conducted showed that all batches of the baby power product were compliant with the norms prescribed.
“The prescribed pH level is 5.5 to 8 and as per reports submitted by the government following fresh tests conducted, the products were compliant with the prescribed levels,” it said.
The company had in its plea said 14 random batches of February, March and September 2022 were tested by an independent public testing laboratory and all were found to be well within the prescribed pH value.
Other controversies over Johnson & Johnson baby power
This is not the first time Johnson & Johnson (J&J) baby powder has been under controversies.
Earlier, a section of people have linked J&J talc-based baby powder to cancer. However, the company has denied it and no conclusive connection has been drawn so far.
Amid 40,000 cases over talc-based powder, the J&J in August announced that it would stop selling talc-based powder and would instead switch to corn starch-based powder.
The idea behind talc-based powder's link with cancer is that talc at times can be contaminated with asbestos, a toxic which can cause cancer.
Outlook earlier explained, "However, if and when contaminated with asbestos, talc can be cancerous. Concerns arise as talc and asbestos are often found close to each other inside the Earth and there is a risk of asbestos getting mixed with talc during the mining process."
The US FDA notes, "There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently."
Talc has several applications in cosmetics, such as in baby powder, foundation, and blush. Its properties include absorbing moisture, preventing caking, and making facial makeup opaque.
Reuters earlier reported that J&J was once aware of its talc-based powder containing asbestos but did not alert FDA or the public.
"J&J didn’t tell the FDA that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc – in one case at levels reported as 'rather high'," reported Reuters in 2018.
It further reported, "From at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public."
Despite rejecting claims, J&J has paid billions to settle cases over its powder, according to Fortune.
Fortune reports that J&J has so far paid $3.5 billions in the cases.
"A 2018 jury verdict out of state court in St. Louis ultimately forced J&J to pay $2.5 billion to 20 women who targeted its baby powder for their ovarian cancer," reports Fortune, adding that J&J further spent $1 billion in legal fees over last five years.
(With PTI inputs)