US healthcare giant Johnson and Johnson (J&J) has come under the scanner of regulators in India once again after the company’s popular baby shampoo failed quality tests conducted by the Drugs Control Organization of Rajasthan.

According to people aware of the matter, the shampoo samples revealed presence of Formaldehyde, which is a known cancer causing chemical. The International Agency for Research on Cancer (IARC) classifies formaldehyde as a human carcinogen. According to a report published in Forbes magazine in 2011, the U.S. Department of Health and Human Services added formaldehyde to its list of known human carcinogens in June 2011. In 2014, in response to consumer pressure, J&J had claimed to have removed this potentially harmful chemical-formaldehyde.

The state’s drug regulatory body has labelled some samples of J&J’s baby shampoo as “not of standard quality" and said the product contains “harmful ingredients".

In a 5 March letter, the Drugs Control Organization asked state drug controllers across India to withdraw available stocks of J&J’s baby shampoo from the market to ensure that it is not used anymore. “The samples of cosmetics contains harmful ingredients," according to the report of samples tested between 16 and 28 February. Mint has reviewed a copy of the report.

The baby shampoo is manufactured at Johnson & Johnson Pvt. Ltd’s plant at Baddi in Himachal Pradesh.

“The samples failed the quality tests. The company will have to reply after which action will be taken as per the Drugs and Cosmetics Act," a senior official in the Drugs Control Organization in Rajasthan, said on condition on anonymity.

J&J offers a range of toiletries for toddlers that includes shampoo, baby lotion, baby soap and baby oil.

A spokesperson for the company said J&J’s products are “safe" and its assurance process is the most “rigorous in the world".

“We have contested the interim test results of the government analysis that were based on unknown and unspecified methods. The government did not disclose the test methods, details or any quantitative findings. This is concerning especially when there is no prescribed test method or requirement for testing formaldehyde in shampoo under the applicable standards," the spokesperson said.

The samples have been sent for re-testing, the spokesperson added.

On 21 December, India’s drug regulator initiated a wider probe into the entire range of baby care products of J&J after ordering it to halt production of its baby talcum powder amid allegations that it contains asbestos.

While the test report affirmed that the baby talc is of standard quality, its baby shampoo has now come under the regulatory lens after it failed quality standards. “These samples could have been picked during the same time," added the official.

In August, J&J said it removed an array of chemicals and re-engineered its baby care products to make them safer for children. “The portfolio of ingredients was reduced by more than 50%, and all baby products have been designed for gentle care with no parabens, phthalates, formaldehyde-releasing preservatives and sulfates. Even Johnson’s shampoo is no longer its signature golden hue, but instead a clear formula packaged in a translucent yellow bottle for a transparent look and feel," the company said in a statement then.

Ubiquitous in many Indian homes, Johnson’s baby products specially the powder has been in the news for all the wrong reasons. In 2018, the company’s US parent was ordered to pay $4.7 billion to 22 women, who claimed that asbestos in its talc caused them ovarian cancer.

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