New Delhi: India’s top drug regulator has asked Johnson and Johnson (J&J) Pvt. Ltd to reveal the composition of its talcum powder, two people aware of the matter said. The company’s US parent was ordered to pay $4.7 billion to 22 women who claimed asbestos in its talc had caused them ovarian cancer.
In an email dated 19 July, the Central Drugs Standard Control Organisation (CDSCO) wrote to J&J to share the composition of its powder sold in India and the US, the people cited above said on condition of anonymity.
On 12 July, a Missouri court had ordered the pharmaceutical giant to pay compensation and damages in the asbestos case.
Johnson and Johnson insists its talc is safe and pure, and plans to appeal the verdict.
“Some people may dust powder after shower and never think much of it. But recent court cases have brought a spotlight on the possible link between women’s regular use of talcum powder on their genitals and an increased risk of developing ovarian cancer. The lawyers in US alleged the company knew its talc was contaminated with asbestos. We want to be sure that the product marketed in India is safe and that’s why have written to them," the first of the two people cited above said on condition of anonymity.
In March 2016, the Maharashtra Food and Drug Administration and the West Zone unit of CDSCO had inspected Johnson and Johnson’s manufacturing plant at Mulund in Mumbai, collected samples of baby powder and analysed them at a drug control laboratory in Maharashtra.
“While the powder was found to be safe then and no action was taken against the company, the recent cases have alerted the regulatory bodies once again," the second person cited above said.
Talcum powder is made from talc, a clay mineral composed of silicon, magnesium and oxygen.
Johnson and Johnson says the talcum powder passes “five-level safety assurance process" and, hence, is completely safe and free from asbestos.
“At the Johnson and Johnson family of consumer companies, each product formulation must pass our five-level safety assurance process," a company spokesperson said.
“All Johnson and Johnson products meet and many even exceed global regulatory standards. The safety of cosmetic talc is based on a long history of safe use and decades of research and clinical evidence by independent researchers and scientific review boards across the world. Over the past 50 years, multiple independent, non-litigation-driven scientific evaluations that have been conducted by government bodies, including the US Food and Drug Administration (FDA) have found the talc in Johnson and Johnson baby powder to be free from asbestos. Health authorities have reviewed the data and talc is accepted for use in countries around the world, including India. The baby powder contains only US Pharmacopeia (USP) grade talc, which meets the highest quality, purity and compliance standards. The company’s sources for talc are routinely evaluated using a sophisticated battery of tests designed to ensure compliance with all global standards," Johnson and Johnson said in a statement, adding that their powder does not cause ovarian cancer or mesothelioma.
“Our position remains unchanged. We will continue to defend the safety of baby powder. The baby powder does not contain asbestos or cause mesothelioma or ovarian cancer," the spokesperson said.
The company is battling some 9,000 legal cases involving its signature baby powder.
“To date, all verdicts with regard to this matter going against Johnson and Johnson that have been appealed, have been reversed," the company spokesperson further said.
According to market research firm Euromonitor, the talcum powder category is shrinking in India, with a decline in compound annual growth rate by 5.7%.
Anil Talreja, partner, Deloitte India, said the dip in growth is not based on one particular incident, and its awareness among consumers that could have resulted in the shrinking of the segment.
“It’s a chemical product and people are aware about what they use. It’s not that soap doesn’t have chemicals but then one cannot do without soaps," Talreja said.