The Maharashtra Food and Drugs Administration (FDA) is yet to take a decision on the Johnson and Johnson’s willingness to display a safety warning and declare details of all the ingredients on the label instead of displaying only ‘key ingredients’ in its baby oil.
“Company has been given time till 1st of August to make the necessary changes on the label. They have written us a letter agreeing to display a safety warning and to display all the ingredients on the label. We are yet to respond to their letter and is in the process of analysing their suggestions,” M Ramesh Kumar, commissioner, FDA told Pharmabiz.
The Maharashtra FDA had sought J&J either to replace 'liquid paraffin' as ingredient in its products like baby oil or pull out descriptions like the word 'baby' from the packs, making them more general and less exclusive. 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, contended the FDA.
J&J’s Baby Oil is a leading product in the baby care segment, estimated to have a domestic market of over Rs 200 crore. J&J dominates the market, with a share of almost 75 per cent of the whole market.
Johnson and Johnson, along with Wipro, Emami etc. were given show cause notices by Maharashtra FDA during March 2005 on the same issue. Wipro has already agreed to the FDA demand to make necessary changes on the label and promote it as an emollient and not as baby oil.