The Hindu Business Line : This one's for the consumers!

Do brands live up to their promises? After cracking the whip on companies selling baby oil, the Maharashtra FDA has trained its guns on other consumer products.

IT was a consumer's complaint on allergy caused by the oil used to massage her baby that put the spotlight on baby oils. And the Maharashtra Food and Drug Administration (FDA) subsequently got into the act. It sent out a slew of notices to companies manufacturing baby oils in the country, starting with Johnson & Johnson (J&J), the oldest player in the segment.

The FDA's more than a month-long campaign, ostensibly to power the consumer's choice with more information on a product, covered baby oils from Wipro, Himalaya, Emami and Dabur.

With regard to J&J, Wipro and Himalaya's baby oil, the regulatory authority's contention was that the product was based on paraffin, supposedly unfit for babies. Hence using the `baby' label for a product that was similar to the adult product was, in fact, misbranding, the FDA felt. With Emami and Dabur, the FDA wanted the companies to list all ingredients in the baby oil.

As most branded baby oils in the market were put on the FDA's watch-list, parents naturally got unnerved about the safety of products that they unquestioningly associated with their babies.

A. Ramakrishnan, Commissioner, FDA

"Consumers are not getting their due," says an emphatic A. Ramakrishnan, Commissioner, FDA, the man who spearheaded this campaign. "Products are made for the consumer, but the consumers' voice is never heard," he observes.

Baby oils are just the beginning and the FDA chief has now trained his guns on other products "that sell dreams." And the specific segments that will be confronted include cosmetics, proprietary ayurvedic medicines and nutraceuticals. "Companies make promises about their products with insufficient scientific backing. They play on the emotions of consumers and confuse traditions with marketing," he alleges.

Drawing an analogy between baby oils and the infant formula controversy, he says: "Infant formula became popular on the strength of aggressive marketing. So much so that the Centre had to intervene, as it found that breast-feeding was on the wane. The Government had to make it mandatory for infant formula products to underwrite their products saying that mother's milk is the best."

Branded baby oils don't offer anything very different, and, in fact, through marketing it overshadows healthy, traditional, inexpensive options such as natural oils, he says.

J&J products sold in global markets, he points out, take care to list all ingredients, the contra-indications and other necessary information. The point he makes is that if the baby oil selling in India contained mineral oil, then it should say so in as many words.

J&J on its part stood by the safety of its product. The company said that Johnson's Baby Oil contained a "superior grade" of mineral oil that is obtained after distillation and purification of liquid paraffin. Paraffin has a wide base of applications and is used in various therapeutic and cosmetic products, from petroleum jelly to lip balms and laxatives, it added.

Further, a note from the company said: J&J's specifications for products and formulations have been accepted by the FDA in India for more than 40 years and globally for more than 100 years.

Going beyond baby oils, the FDA chief points out that there are baby soaps that claim to make the baby's skin soft and clear. "Unless a baby is unwell, is there anything that comes close to being soft and clear than a baby's skin?" he asks incredulously.

J&J in its response to the FDA on baby oils has said that the company meets Indian standards. "J&J meets the Bureau of Indian Standards (BIS) specifications where they exist in India - as in the case of Johnson's baby powder and Johnson's baby soap. Where there are no BIS standards — as in the case of baby oils, baby creams and baby lotions - J&J adheres to its own stringent global standards. These standards have established the safety and efficacy of these products over a period of time," the company had said in its initial reactions to the FDA's action.

But for analysts who tracked the controversy over soft drinks containing pesticides, it was that familiar sense of déjà vu. Cola companies too had claimed to meet Indian standards on pesticides, when the Indian norms had no standards for pesticides then.

Meanwhile, Wipro and Himalaya also stood by the safety of their products. Wipro's spokesperson said that while the company used liquid paraffin oil, it did declare this information on the label of its baby oil. A Himalaya spokesperson said that the company conducted controlled clinical trials among children before launching its products 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 babies' skin," said a note issued then by the company.

Dabur's Chief Executive Officer, Sunil Duggal, reiterated that the baby oils from Dabur contained pure vegetable oil. He pointed out that the company was listing the ingredients on the baby product in line with requirements of the Drugs and Cosmetics Act. However, he indicated that Dabur would be willing to list all ingredients in the baby oil as it was about something as sensitive as a baby's skin. While Dabur's Lal Tail had passed muster, it was Dabur's Baby Olive Oil that drew flak from the FDA.

While the FDA chief's spate of notices were viewed with some scepticism, R. K. Anand, Head of the Pediatrics Department at Mumbai's Jaslok Hospital, completely endorses the FDA's concerns on branded baby oils.

He has often treated babies with rashes caused by baby-specific oils and soaps, he says. "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." Anand is the author of Guide to Child-care, in which he advises against the use of baby products available in the market. His alternatives for baby massage is sesame (til) oil, coconut or mustard oil.

On the promises made by nutraceutical products, the FDA chief says that very few stability or efficacy tests are done on these products though they "promise the sky."

In the US, for instance, there are clear dos and don'ts on nutraceuticals or dietary supplements. In the absence of laws in the domestic market, an unholy nexus exists between the doctors, chemists and manufacturers to promote these products among unsuspecting consumers, he alleges.

The proposed Integrated Food Bill brings nutraceuticals under its scope. But it will be effective only if there is a machinery created to monitor the production and marketing of these products, he says. "Companies get into nutraceuticals as they can market the product as a food with insufficient studies. But why would food be taken in a particular dose on a doctor's advice? Companies know that by classifying a product as food they can skirt the Drug Price Control Order," he observes.

And while there may be companies making genuine nutraceutical products, he worries about the ripple effects or the me-toos that make their way into the market on flimsy promises and in the guise of nutraceuticals.

Proprietary ayurvedic products are another segment where companies make unsubstantiated claims, he points out. But industry representatives point out that the companies that the FDA has put on the mat have been given licences to operate from some State or the other.

To which the FDA Chief admits, "There are several States and licences can be obtained. But if the Centre wants help to monitor these areas, there are enough resources in the country who will offer themselves up for the job."

After baby oils, the FDA also issued notices to No Marks toilet soap and Reckitt & Benckiser on its popular disinfectant Harpic. The regulatory authority felt that the company needed a drug licence to manufacture the product.

In its notice to the manufacturer of No Marks toilet soap, Ozone Ayurvedic Company, the FDA asked the company to support its claims with documentation. "The company has been claiming in the advertisement that this is an all-cure dermatological soap with property to remove all types of blemishes on the skin such as acne, pimples, warts, toning of skin and so on," the FDA said.

Similary, the regulatory authority has also put herbal teas under the scanner. "These products do not contain tea as defined in the books. They are merely extracts or infusions — kashayams!" he exclaims, giving the Indian equivalent for the product.

But taking on products that do not match performance is all very well. Do the regulators follow through with their action and fix the problem too? Take the worms-in-Cadbury's-chocolate issue that shot into prominence during the previous FDA Commissioner's office. "They have taken corrective action. The company has changed the packaging of the product," says Ramakrishnan.

Recently, the FDA issued a directive that all perishable foods should have a helpline for consumers. Whether it is bread, biscuit or ice cream. "It will take time, as companies will have to change their packaging. But the first step has been taken," he says.

So, with the FDA expected to bring the curtains down on the baby oil issue soon, will Ramakrishnan call for products to have a more elaborate ingredient lists or would he ask them to incorporate cautionary labels on allergies? Like it was done with infant formula, will baby oils be asked to incorporate a statement that natural oils are best for the baby?

"There are several options before us and a committee has been set up, comprising the Drug Controller General of India, the FDA and other experts," he says, unwilling to divulge more. And given that even Chinese regulatory authorities had picked up the news and done their own checks on baby oils in their market, the FDA chief says, "The world is watching. But I will put the directive out on the Maharashtra Web site so that a consumer anywhere in the country will be able to read all the information and make a decision on whether or not she wants to use branded baby oils," he says.

At least this time, hopefully, the consumer will have the last word!

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