J&J in talks with FDA over baby oil label changes

Johnson & Johnson, the multinational healthcare and consumer products company, is in dialogue with the Food and Drug Administration (FDA) over making changes on the label of its flagship brand Johnson's Baby Oil.

The FDA, Maharashtra had in March served a notice on the company asking it to provide substantial clinical evidence to prove that its Johnson's Baby Oil brand is safe for use by children, as claimed in the product's label.

A senior official from the Food and Drug Administration (FDA), Maharashtra, said the company has responded to the notice, and has also stated that it will look into the issue of carrying a statutory warning on the product label in compliance with the regulator's directive.

A Johnson & Johnson spokesperson said dialogue with the regulatory authorities is currently on.

"The company has time up to August 1 to finalise any revision in the labels. The timing for implementing the change will be determined after the revision of the text is finalised," the spokesperson said.

The regulator had also pulled up the company for not putting up a statutory warning on the label on the safe use of the product.

The FDA had also warned the company of legal action if it failed to take corrective steps.

But the matter related to substantial clinical evidence to back the baby oil claim has been referred to the Drug Controller General of India (DCGI) and a probe on the matter is awaited.

The company, in a communique to Business Standard, said there are no concerns on safety of the products and consumers can continue to use all Johnson & Johnson baby products including baby oil.

Johnson's Baby Oil is the brand leader in the baby care market in India, which estimated to be worth over Rs 200 crore.