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Johnson & Johnson won’t take controversial baby powder off shelves in India

While experts questioned the company’s decision not to immediately withdraw the product that’s said to contain cancer-causing asbestos, the Indian drug regulator is silent.

August 22, 2022 / 02:12 PM IST
Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015.  REUTERS/Lucas Jackson  - RTS4S6Q

Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015. REUTERS/Lucas Jackson - RTS4S6Q

Johnson and Johnson, the US company that is discontinuing its talc-based baby powder globally in the face of lawsuits claiming it contains a cancer-causing substance, has no plan to take the product off the market in India.

“We will work with retailers to keep the product on the shelves until our supply of talc-based powder runs out,” a J&J spokesperson told Moneycontrol.

An executive of J&J further confirmed to Moneycontrol that there are no plans to withdraw the talc-based powder. J&J faces tens of thousands of lawsuits on charges that its talcum powder was contaminated with cancer-causing asbestos.

“There is no recall. We continue to stand by the safety of the product. We will continue to manufacture it till quarter one of next year. After that, we will stop manufacturing,” the executive said.

Asked whether J&J’s decision in India was an outcome of regulatory action, the executive said, “It’s a global decision.”

Close

Questions sent to the Drug Controller General of India regarding J&J’s decision remained unanswered.

Last year, the National Commission of Protection for Child Rights (NCPCR) had summoned the DCGI and the Central Drugs Standard Control Organisation (CDSCO) over the lack of uniformity in testing methods for detecting the presence of formaldehyde and asbestos (both identified as substances that promote formation of cancer in humans) in J&J’s baby shampoo and talcum powder.

Product recall

Experts questioned J&J for not withdrawing the product from the market and asked why they should be sold to Indians if talc-based powder is not in demand and faces litigation. The company ended sales of the product in the US more than two years ago.

“In India, the company is late in implementing the strategy that it has adopted in the western part of the world. If a product is being discontinued for manufacturing, why should it be sold and why not recall it?” an official asked.

In India, as per CDSCO guidelines, any batch of products not meeting quality standards has to be recalled – either voluntarily or statutorily.

In an affidavit, the CDSCO said the issue of testing methods for formaldehyde and asbestos in baby care products was under the jurisdiction of the Bureau of Indian Standards.

“Under the Drugs and Cosmetics Rules, 1945, as per rule 150 A, it has been mentioned in Schedule S that cosmetics in finished form shall conform to the Bureau of Indian Standards specifications laid down from time to time,” CDSCO said in the affidavit, which Moneycontrol reviewed.

Transition phase

J&J said August 11 that it will stop making talc-based baby powder globally in 2023 and will transition to an all cornstarch-based baby powder portfolio. The company, which reported global sales of $94 billion in 2021, moved to cornstarch-based baby powder in the US, Canada, and the UK two years ago and it is slowly implementing this in other parts of the world including India.

“Corn starch-based Johnson’s baby powder is already sold in countries around the world. We’re excited to be able to offer corn starch-based Johnson’s baby powder to more consumers around the world,” the spokesperson said.

An executive said consumer demand for talc has reduced.

“The Johnson & Johnson baby powder will remain, but it will not be a talc-based product, rather it will be a corn starch-based product,” the executive said.

The J&J spokesperson said the company evaluates and optimises its portfolio to best position the business for long-term growth.

“This transition will help simplify our product offerings, deliver sustainable innovation, and meet the needs of our consumers, customers and evolving global trends,” the spokesperson said.

Talcum-based baby powder is made from talc, the softest known mineral formed by magnesium, silicon, and oxygen. Corn starch is made from a food ingredient. It contains larger particles and so has been considered to be a safer form of baby powder than talc.

Some talc contains asbestos because many talc mines are located in areas where asbestos occurs naturally. Studies have linked asbestos to lung and ovarian cancer.

The company has been the target of lawsuits that claim the prolonged use of its talcum powder can cause ovarian cancer in some women.

NCPCR chairperson Priyank Kanoongo welcomed the company’s decision to switch from talc to corn starch.

“Children in India have similar rights to those in the US. It is a good move but there are apprehensions against the baby shampoo also. The company should work on that as well,” Kanoongo said.

The baby product market in India is worth over $15 billion as of 2022 and is dominated by J&J, according to the All-India Organization of Chemists and Druggists (AIOCD).

“When you talk about the baby talcum product market in India, Johnson & Johnson still has the lion’s share in this portfolio. It has about 60 to 70 percent of market share in the country today,” said Rajiv Singhal, general secretary of the AIOCD.

Asked about overall sales of baby talc powder and the impact of this transition in India, the J&J executive said, “We don’t share sales numbers.”

J&J has been at the centre of controversies related to its products in recent years. The Maharashtra drug regulator cancelled the company’s licence in 2013 after it found that the plant manufacturing powder was using ethylene oxide, a chemical that can cause cancer.

In 2018, the Indian drug regulator asked J&J to pay compensation to patients for selling faulty hip implants. In February 2019, samples of Johnson’s baby shampoo tested positive for the presence of formaldehyde. However, later the Gujarat regulator gave the green signal for the product.

J&J said last year it was voluntarily recalling all lots of five sunscreen products after some samples were found to contain low levels of benzene, a chemical that can cause cancer with repeated exposure.
Ayushman Kumar Covers health and pharma for MoneyControl.
first published: Aug 22, 2022 02:12 pm
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