The FDA has spotted ethylene oxide, a carcinogen and irritant, in 15 batches of baby talcum powder produced in 2007 and had shelf life until 2010.

The Maharashtra Food and Drug Administration has cancelled licence to manufacture cosmetics at Johnson & Johnson's Mulund plant after it found a few batches of its baby talcum powder which had expiry dates until 2010 contained cancer causing substance.

According to a report in the Pune Mirror, the order is effective 24 June.

The FDA has spotted ethylene oxide, a carcinogen and irritant, in 15 batches of baby talcum powder produced in 2007 and had shelf life until 2010. So the products in question are not available in the market now. According to the Pune Mirror report, the 15 batches consisted of 1,60,000 containers.

According to a report in The New Indian Express, ethylene oxide was used to bring down microbial load in the powder by sterilisation. The FDA has expressed concern about the presence of the matter and also said the procedure "used to make the powder is not healthy and exposes consumers to the risk of developing cancer".

"While ethylene oxide can be used for sterilisation, the company did not bother to carry out a test after the process to check the amount of residue in the product," FDA joint commissioner KB Shende was quoted as saying in the Pune Mirror report.

"...It was found that there was ethylene oxide residue in the talcum powder, which is primarily used on infants. In light of this, we have suspended the licence," Shende told the New Indian Express.

Read the reports here and here.

Company spokespersons have confirmed the licence cancellation order to both the news papers.

"We confirm receiving the Order from the Maharashtra FDA which pertains to the manufacturing of cosmetic products only. We continue to manufacture non-cosmetic products at the same site.

The matter in question as cited by the FDA order relates to a limited number of batches produced in 2007, shelf life of which ended in July 2010. The FDA raised concern about following Ethylene Oxide treatment, which was not included as part of the manufacturing process submitted to the FDA. This method is widely used for Medical Devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effect reported concerning any of the batches in question.

We stay committed to manufacturing products that meet the high safety and quality standards followed by all our global manufacturing sites and meeting all local regulatory standards. We are working diligently with the agency to resolve this issue," the company spokesperson said in an emailed response to Firstpost.

This is not the first time that the multinational company has been pulled up by the FDA. According to an Economic Times report, the FDA in 2005 had said that J&Js baby oil was a clear case of "misbranding" as there had been "no "clinical trials to brand the product a special baby product."