Maharashtra show-cause notice to J&J India

The drugs regulator has asked the company to immediately stop roll out of advertisement

Maharashtra’s Food & Drug Administration (FDA) has served a show-cause notice to Johnson & Johnson (J&J) India for releasing advertisements in a section of press and media justifying how the company’s baby products were safe.

The FDA, however, has asked the company to immediately stop the roll-out of ads that it claimed were “misleading”, specially when the Maharashtra government  on June 20 had upheld FDA’s action to cancel  its licence to manufacture cosmetics from its facility in Mulund, north-east Mumbai. FDA Commissioner Mahesh Zagde told Business Standard, “We are implementing the law for the safety of citizens.”

However, a J&J India spokesperson said, "We have not received an order from FDA and therefore cannot comment. We fully respect the regulatory process and wish to clarify that our intention with regard to the advertisement was to reassure consumers of our confidence in the safety of our product.”

FDA had taken action against J&J in March this year, based on 15 batches comprising 160,000 retail containers of baby powder produced in 2007, shelf life of which had ended in July 2010. FDA expressed serious concerns over the Ethylene Oxide used during sterilisation that aimed to bring down microbial load in the same batch of baby powder produced in 2007. FDA had taken serious objection against J&J's decision to sterilise those batches again by Ethylene Oxide without the submission of standard operating process.  

J&J, in its advertisement, Your trust is in safe hands, said that Ethylene Oxide treatment was internationally recognised as a safe method and is commonly followed for various categories of products, including food. The additional process was in fact followed to ensure complete safety of its products on babies by eliminating any harmful micro-organisms on account of re-processing required on these batches.