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. Company spokespersons have confirmed the licence cancellation order to both the news papers.
“The FDA raised concerns about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA,” the spokesperson has been quoted as saying in The New Indian Express report. Read the reports here and here.
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.”