FDA NOTICE TO JOHNSON & JOHNSON

Johnson & Johnson, the multinational healthcare and consumer products major, has come under the scanner of the Maharashtra Food & Drug Administration.

The FDA, the apex body for food and drug products, recently served a notice on Johnson & Johnson for its baby oil product, Johnson's Baby Oil.

“There is nothing specific for babies in their oil. It's a clear case of mis-branding,” A Ramakrishnan, the FDA commissioner, when contacted.

The FDA has given 15 days' time to the company to take corrective steps failing which it may initiate a legal action.

“There have been no clinical trials to brand the product a special baby product. The company has no permission from the Drug Controller General of India (DCGI) for the same. In this situation the product fails to qualify as a baby product,” Mr Ramakrishnan said. The FDA has informed the DCGI about the action. At a later stage the DCGI may inform other states about the action taken against the company.

Officials at Johnson & Johnson India confirmed that the company had received a communication from the FDA.

“We are examining the notification. We need to look into the details to formulate our defence,” said Anil Upadhyay, corporate legal counsel at Johnson & Johnson India.

Johnson's Baby Oil is a leading product in the baby care segment of its business. The baby care market is estimated to worth over Rs 200 crore. Johnson & Johnson dominates the market, with a share of almost 75%.

Promotional material on Johnson & Johnson's website states that Johnson's baby oil is made of mineral oil, that remains clear at all temperatures and is free from bacteria. It also contains Vitamin D.

According to industry sources, the product does not come under the purview of the DCGI because it is not classified as a medicinal preparation., but as a toilet preparation. It is likely that Johnson & Johnson may take this line of defence to counter the FDA.