Although Maharashtra FDA asked Johnson & Johnson and other companies for removing the word 'baby' from several of its products meant for infants, sources in the FDA claim that the notification and the subsequent action against the company could have been done years ago, as J&J have been marketing the products in question since decades.
According to sources, Maharashtra FDA had known the usage of the word "baby" on the label was wrong for the past few decades. There have been attempts to raise the issue. "However, due to "unknown reasons," the past FDA inspectors did not allow the matter to come out of closet," said a senior official in the state FDA. Similar would have been the case with other state FDAs also, since none of them have raised an objection to the usage of 'baby' on the company's brands.
According to state FDA commissioner A Ramakrishnan, the usage of the word baby was misleading as chemicals used in the products were in no way different from those used in other cosmetic products.
Ramakrishnan said the use of liquid paraffin in baby oil violates section 17 C (c) of the Drugs and Cosmetic Act (1940) amounting to misbranding and misleading labelling.
Maharashtra FDA has also sent directions to all the other state FDAs and a letter to Drug Controller General of India on the issue.
He said at least six products, including baby shampoo and baby oil came under FDA scanner following complaints. The liquid paraffin or mineral oil used in products like baby oil could be carcinogenic and could cause harm to babies, he said.
The FDA has given 15 days time to J&J and other companies to file reply.
In the meanwhile, a corporate spokesperson in J&J said that the company would be filing reply to Mah FDA in the stipulated time frame.
In a detailed media release, the company has stated that its baby care products in India, including baby oil, meet stringent global quality standards of J&J worldwide. It said that the products made in India are manufactured and sold under the license and approval from the FDA.
"J&J's baby oil uses a pure grade of mineral oil. This oil meets J&J's worldwide specifications and has been clinically proven to be mild, gentle and safe for use on a baby's sensitive skin.
J&J scrupulously follows all regulatory guidelines in force in India and adheres to a global standard of ethics in every country where it does business. J&J India has always abided by these norms in India", said the company in its release.