FDA gives J&J March 31 deadline for explanation

Maharashtra's Food and Drugs Administration (FDA) has set a deadline of March 31 for pharmaceutical major Johnson & Johnson to respond to its demand for an explanation as to what it can do to correct the defective labelling of its products.

The FDA will meet with central government officials attached to the Bureau of Indian Standards (BIS) on March 30 to discuss the larger issue of misrepresentative advertising by pharmaceutical companies.

A senior FDA official said: "We have issued a notice to the company following a complaint received by our department. It was found during investigations that while the company (J&J) advertised its oil product as a baby oil that was good for maintaining a smooth texture for infants, it contained parafin oil which contains no such properties."

"We feel that describing the product as a 'baby oil' also is 'defective labelling' and have asked J&J to reply how this may be corrected. There is no quality issue regarding adulteration. In many products there are cases of some persons experiencing side effects. This does not mean it is a case of adulteration," the FDA official added.

The official said that the FDA had also initiated a general study of many products that advertise themselves as coconut oil but in reality contain little or no coconut oil.

"Our point is that products that advertise themselves are being made of pure coconut are misleading people. In reality these hair oil products,, when tested by us, were found to contain 98 per cent of parafin oil and two per cent of incense. It is a general cosmetics issue that we are looking into, and not at one or two companies," he clarified.