Moneycontrol PRO
Open App
you are here: HomeNewsOpinion

 J&J’s move to exit talc globally need not raise any fresh concerns

India's drug regulator could be pulled up for several lapses, but in the J&J talc case, it has ticked the boxes

August 30, 2022 / 08:39 AM IST
(Representative Image)

(Representative Image)

Earlier this month, the United States-headquartered multinational Johnson & Johnson (J&J) announced that it would discontinue its talc-based baby powder products globally in 2023. The company will drop talc — a mineral that is mined — from its baby powder while making available an alternative that is based on corn starch.

J&J has been sued for billions of dollars by consumers in the US alleging that its baby talc caused cancer, and that it hid the risk posed by traces of asbestos, a known carcinogen, in the talc. It is also being reportedly investigated by the US Department of Justice. Asbestos may be present in the mines from which talc is sourced, and may lurk in the end product unless the mines are chosen carefully, and the talc ore is adequately purified. Not all talc contains asbestos, according to the US Food & Drug Administration (US FDA). J&J claims that its talc is asbestos-free.

In 2020, J&J announced it would stop distributing its baby talc in the US, and Canada owing to declining consumer demand from changing habits, “and fuelled by misinformation around the safety of the product and a constant barrage of litigation advertising.” The corn starch-based powder continues to be available.

At the time of the 2020 announcement, baby powder reportedly made up less than one percent of the company’s US consumer health revenue, and had seen a 60 percent decline since 2017. A top J&J executive said at the time that only 25 percent of its baby powder customers in the US and Canada still used the talc, and the rest used the corn starch-based product. However, as the reverse was true in some other markets, talc would continue to be made available there. That included India.

In India, as of 2021, Johnson’s Baby Powder still holds the leading position in the baby powder market, according to Euromonitor. It operates with the blessings of the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO), after CDSCO reportedly commissioned third party-testing that found the talc to be asbestos-free. In theory, the Indian unit could have continued to distribute baby talc in India — the regulator does not object, and there has been no wholesale abandonment by customers as in Western markets. However, a decision by its parent to move out of talc globally, rules that out.

Close

The Indian unit’s intention to continue sales till stocks run out has raised some eyebrows. However, it is in line with how J&J moved out of talc in the US and Canada in 2020 with on-market inventory continuing to be sold as the product was not ordered off those markets by authorities.

J&J’s intent to exit from talc globally comes against the backdrop of a decision last year to separate the consumer healthcare unit from pharmaceuticals and medical devices into a publicly-listed company. Taken together with an earlier move to offload all liabilities emerging from talc to a separate company that has declared bankruptcy, it may be viewed as an attempt to cap liabilities and allow the new company to start with something resembling a clean slate.

Ergo, to all appearances, J&J’s exit from talc is a business decision. It is not J&J’s commentary on the talc’s safety, and nor is it an admission of guilt. Even where J&J has settled talc lawsuits in the US, it has maintained that its talc is safe. Importantly, no regulator has forced its hand, nor banned the product.

In 2019, the company voluntarily recalled a batch in its home market after US FDA testing of two samples of J&J talc showed one to be asbestos positive. (The US FDA cannot order a recall of cosmetics, but can request one if a product found harmful is not voluntarily recalled). The tests were part of a larger US FDA survey of cosmetic products for asbestos which it has begun to conduct periodically. In this case too, the company refuted the US FDA’s findings based on third-party testing of the same sample that found it asbestos-free. (The US FDA stood by its findings).

The latest announcement has renewed criticism of the CDSCO for allowing the talc to stay on post-2020, and now, to be phased out gradually. It is true that Indian drug regulators at the state and central level — who also oversee medical devices and cosmetics including talc — have not covered themselves in glory for the last several years. When it comes to medicines, from waiving local clinical trials on new drugs without just cause to condoning irrational drug combinations and allowing drugs banned elsewhere to stay on here, much has been laid at their door.

As a result, experts and observers have questioned its effectiveness in protecting patients/consumers, and reform has been called for. The decision to allow J&J to continue marketing talc could, understandably, be seen as all of a piece with these other actions. But in this case, CDSCO has ticked the boxes. It has allowed the talc-based product to stay on after testing samples. That, and the actions of the world’s regulators, must serve as its defence for now.

Gauri Kamath is an independent journalist. Twitter: @Apothecurry. Views are personal, and do not represent the stand of this publication.
Gauri Kamath is an independent journalist. Twitter: @Apothecurry. Views are personal, and do not represent the stand of this publication.
first published: Aug 30, 2022 08:36 am
Sections
ISO 27001 - BSI Assurance Mark