The company said it decision to discontinue is part of a broader portfolio assessment related to COVID-19 prioritisation, and has nothing to do with safety of the product.
Johnson & Johnson (J&J) on May 21 said its decision to permanently discontinue its talc based baby powder is specific to US and Canada. For the rest of the world, including India it is "business as usual".
The company said its decision to discontinue is part of a broader portfolio assessment related to COVID-19 prioritisation, and has nothing to do with safety of the product. However company added that its cornstarch-based Johnson's Baby Powder will remain available in North America.
"We remain steadfastly confident in the safety of talc-based Johnson’s Baby Powder. Decades of independent scientific studies by medical experts around the world support the safety of our product," the company said in a statement.
J&J faces more than 16,000 lawsuits with consumers claiming the company’s talc products contained asbestos, a known carcinogen.
The company said these cases were largely filed due to litigation advertising, where lawyers in US advertise in mass media seeking out former baby powder users who developed cancer. If they win the lawsuit, the plaintiff will get compensation while the lawyers get a cut. If the case is lost, there is nothing to lose. The company said these lawyers use misinformation about safety of its products.
As sales of talc-based baby powder dwindles, lawsuits pile up in North America, analysts say J&J may have chosen to bite the bullet.
Status of India
India is a key market for J&J and the demand for its talc-based baby powder is high. While the company doesn't provide specific details related to sales and market share of its baby powder, J&J has a dominant share in India's Rs 4000 crore baby care market. The company not only manufactures baby powder in India but also exports it to neighbouring countries. Unlike North America where it sell cornstarch based baby powder, in India it only sells the talc-based powder.
In India too, the company had its share of troubles. In December 2018, Indian drug regulator - the Central Drugs Standard Control Organization (CDSCO) - barred the company from using raw materials until they were proven asbestos-free . The regulatory action came following an investigation by Reuters that indicated the company may have known for decades about the presence of asbestos in its product.
However, within two months, J&J resumed production at its factories in Mulund, Mumbai and Baddi s the government sanctioned testing couldn't detect any traces of asbestos in the samples collected, and affirmed the product as of standard quality.
The primary raw material in baby powder is talc. Talc naturally occuring mineral that is highly stable, chemically inert and odorless.
In India, J&J sources talc from its exclusive mines in Golcha, Rajasthan. The spokesperson of the company told that Golcha mine is geologically tested and is asbestos free. The spokesperson also claimed that the company has protocols to test the batches, before they are released into the market.
Many other Indian manufacturers who doesn't have dedicated mines import talc from China.
Need for better surveillance
Some public health experts have been raising concerns about safety of talc based products. They fear about possibility of asbestos contamination, lack of rigorous and high-quality testing by manufacturers and poor monitoring and surveillance by regulatory authorities.
Both talc and asbestos are naturally occurring silicate minerals that may be found in close proximity in the earth. Asbestos is a known carcinogen.
"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," said USFDA on its website.
There is general agreement among US federal agencies and the World Health Organization (WHO) that there is no known safe level of asbestos exposure. USFDA keeps a close watch and tests samples of talc-based powders and cosmetics in the market
Last year, J&J recalled around 33,000 bottles of baby powder in the US after USFDA said they found trace amounts of asbestos. The company said it retested the baby powder product and found no signs of asbestos that prompted recall.
DK Srinivas, Retired Dean, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, had raised questions over the government clean chit.
"Measurement of asbestos in the air or in any product for human consumption can be extremely challenging. First, even very small doses of the fibrous mineral in the talc can be dangerous over prolonged and sustained use. Second, detecting such small doses can be difficult. Third, both fibre diameter and length are directly related to the toxic effects of asbestos. Therefore, certifying a product “free of asbestos” and “safe” requires rigorous and high-quality testing," Srinivas said in a letter published by Indian Journal of Medical Ethics.
The Indian Toxicological Research Institute (CSIR-IITR), Lucknow, part of the Council of Scientific & Industrial Research (CSIR) lab in its 2005-06 annual report mentioned about a study, where it had picked five branded samples of talcum powder in the market and analysed.All were found to be contaminated with asbestos fibres. Asbestos fibre contamination in these powders ranged from 10.3 - 15.4 percent. The report urged regular monitoring and surveillance on all the cosmetic and pharmaceutical powders being marketed for asbestos contamination.