FDA suspends J&J Licence

The Maharashtra Food and Drug Administration (FDA) has suspended the licence for manufacturing cosmetics of Johnson and Johnson after residues of carcinogenic substances were found in baby talcum powder produced by it.

The licence has been suspended as the FDA expressed serious concern over the presence of ethylene oxide in a batch of baby powder produced in 2007. Ethylene oxide was used to bring down microbial load in the powder by sterilisation. Consumers need not worry as the shelf life of the batch ended in July 2010 and it would not be available for sale in the market.

The FDA has maintained that the procedure used to make the powder is not healthy and exposes consumers to the risk of developing cancer. Kamlesh B Shende, FDA joint commissioner (drugs), said: “There were unacceptable levels of ethylene oxide, which is a trigger for cancer. Ethylene oxide was being used to bring down microbial load in the powder by sterilisation. But 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.”

A spokesperson for Johnson and Johnson confirmed receiving the order from the FDA suspending its licence only for cosmetic products, adding that the action pertains to a limited number of batches produced in 2007, whose shelf-life ended in 2010.

“The FDA raised concerns about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA,” said the spokesperson.



Ethylene Oxide (ETO) is a known carcinogen i.e. a cancer-causing agent. A “leading scientist” in a premier Government of India laboratory has recommended that carcinogenic ETO should not be used for sterilization of Baby products. This indicates lethality of ETO for babies even in very small amounts. If FDA Mumbai has taken such “drastic step” against J&J, it indicates that the serious nature of this incidence & hints that the residual level of ETO must be very high in Baby Powder containers released into market by J&J and it can be termed as a crime against humanity. One WHO presentation on childhood cancer mentions that children have a longer life expectancy. Therefore they take longer to manifest a disease with a long latency period, and live longer with toxic damage. Therefore, the symptoms of cancer in babies can be exhibited anytime in next few years even if the exposure to ETO may have happened 5-6 years back by use of Baby Powder or other baby product with residual ETO.

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