FDA hopes to put lid on `baby oils' issue soon

Parents are confused, doctors divided and corporates are standing their ground as more "baby" oils are being called into question by the Maharashtra Food and Drug Administration (FDA).

However, the FDA hopes to put a lid on the "baby" oil issue in about a fortnight, Commissioner Mr A. Ramakrishnan, told Business Line.

This, even as the FDA issued notices to two more companies, Himalaya Drug Company and Emami, over the composition of their baby oils.

Since mid-March, baby oils from four companies have been put under the scanner, including products from Johnson and Johnson and Wipro.

The FDA's contention is that the baby oils contain liquid paraffin as a base, which is unfit for babies.

The FDA Commissioner said that investigations are in an advanced stage and scientific opinions are being sought. A final directive on the issue would be given in 15 days.

An official with the Drug Controllers' office said that the Centre would wait for the Maharashtra FDA's investigations to be completed before taking any action, if required.

Confirming the receipt of the notice, a spokesperson for Himalaya said that the company conducts controlled clinical trials in children before the products are launched in the market.

"Himalaya Baby Oil was launched only after it passed extensive dermal toxicity and safety trials in infants and children and the product was proved to be absolutely safe on baby skin," said a note issued by the company.

Emami is a recent entrant in the estimated Rs 200-crore baby products market; its product is called Sona Chandi Healthy and Fair Baby Massage Oil. Emami has not received the FDA notice.

An industry representative familiar with the developments said that besides being clinically tested, the ingredients used in the baby oil are listed on the pack.

However, Dr R.K. Anand, Head of the Paediatrics Department at Mumbai's Jaslok Hospital, said that he has often treated babies with rashes caused by baby-specific oils and soaps.

"There is no need for such products as they can cause a rash. Liquid paraffin needs to be handled carefully and sometimes the quality of paraffin is not good. Companies sub-contract the manufacturing of these products and quality could suffer."

Dr Anand is the author of Guide to Child-care, in which he advises against the use of "baby" products available in the market.

But Dr Raju Shah, President of the Indian Academy of Paediatricians, said that paraffin oil is used in baby products globally.

Vaseline, which is pure paraffin, is used on infants and no contra-indications have been found. "Allergic reactions could be because of an individual skin type."

With opinions being divided as they are, parents may end up reverting to grandmother's suggestion of using coconut or mustard oil for their baby's massage!