Food and Drug Administration (FDA) has recently cancelled Johnson & Johnson India’s Mulund plant license to produce cosmetic products. The orders given by the FDA will come into effect from June 24. According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilized by ethylene oxide, a known carcinogenic and irritant.
FDA joint commissioner KB Shende said that, “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.” The company can appeal to the State government before the order comes into effect, he added.
Shende added that the traces of ethylene oxide, if any, should have been measured “The products are used for new born babies. It is must for the company to follow all measures.” The 15 batches in question consisted of 1,60,000 containers. When contacted Johnson & Johnson, the company spokesperson confirmed the FDA action.
The spokesperson said “Nothing is more important to us than the safety of our products and health of the consumers. We continue to manufacture non-cosmetic products at the same site.” He added that the matter in question related 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,” he said adding that the company is now in the process of filing an appeal with the state government.
Ethylene oxide is a known carcinogen. The organic compound is known to be flammable, irritating, anaesthetic and carcinogenic at room temperature. The USFDA has recommended that companies should measure the residue of ethylene oxide after sterilisation of products and before releasing the products in the market.