The Maharashtra Food and Drug Administration has cancelled Johnson and Johnson's (J&J) licence for manufacturing cosmetics, following complaints of carcinogenic substances residue in its talcum powder for infants.
The complaint relates to 15 batches of talcum powder, comprising 160,000 containers, manufactured in 2007, by the company at its facility in Mulund, a Mumbai suburb. The J&J baby powder has a three-year shelf-life.
“We have not suspended the licence, we have cancelled it. The company cannot manufacture the Johnson baby powder at this stage,'' confirmed K.B. Shende, Joint Commissioner (Drug), Maharashtra FDA.
Speaking to Business Line, Shende told that “The company has been using ethylene oxide in its skin powder for infants. The sterilisation process using the chemical is completely wrong, for it remains as a residue. With usage, the talcum powder could turn carcinogenic and cause irreparable damage''.
Following complaints, the Maharashtra FDA carried out a series of investigations and laboratory tests on some containers and found “unacceptable levels of ethylene oxide, which is a main trigger for cancer. We found ethylene oxide residue, which was used to bring down the microbial load in the powder”,' said Shende.
A J&J official said the FDA raised concerns about ethylene oxide treatment, which is not part of the manufacturing process as submitted to the FDA. The shelf-life of the concerned batch ended July 2010.
J&J has up to June to plead its case before the State Government. “We have followed the due process of law. The company can now take up the matter with the State Government, if it wants to continue to manufacture the baby powder at its plant,” said Shende.