The Hindu Business Line : Maharashtra FDA questions claims of nutraceuticals

IF it is a food supplement, then why does it have dosages? What food is taken in dosages, questions Mr Ramesh Kumar, Commissioner of the Maharashtra Food and Drug Administration (FDA).

Companies making therapeutic or curative claims on nutraceutical products will not be allowed to sell in Maharashtra from July, unless they have a drug licence. Industry representatives are to meet Ministry of Consumer Protection and FDA authorities in this regard on Tuesday.

The FDA directive was triggered some months ago, when Ranbaxy was asked to get a drug license for its Revital, a nutritional supplement for mental and physical health. The FDA's contention was that drug companies were circumventing the rules and evading excise by selling their drugs as food supplements. Ranbaxy officials were not available for comment.

But nutraceuticals, food supplements and dietary supplements have always walked the thin line between food and drug. The Centre continues to lack clarity on whether to bring nutraceuticals as part of the constantly-under-review Drugs and Cosmetics Act or put it under the purview of the proposed Integrated Food Bill.

The dilemma over nutraceuticals is not a new one. It had started some years ago when the Centre brought in the system of indicating vegetarian and non-vegetarian products through green and brown dots on the packaging.

Nutraceutical products take a food-licence and are sold over the counter, but their capsules are made of animal gelatin, points out an industry representative. Some companies unilaterally decided to carry the non-vegetarian brown dot, even though the Centre was not clear.

The FDA Commissioner points out, that nutraceutical products contain vitamins and minerals in dosage levels similar to drugs. A pharma industry representative said that nutraceutical regulations are in the process of evolving in other global markets too.

Several domestic and multinational companies are believed to harbour plans for this segment. They are waiting for regulatory clarity before truly launching their basket of products.

Manufacturers of ayurvedic products are also wary of frivolous claims being made on nutraceutical products that may use ayurvedic knowledge. They fear that manufacturers may not put nutraceutical products through the rigours of the ayurvedic science and yet reap benefits from tagging onto the ayurvedic label.

Ayurveda manufacturers have demanded that nutraceutical, dietary and food supplements be allowed to make therapeutic claims, only if they substantiate it through tests. Otherwise, they should stick to broad health statements, as opposed to making claims of curing the illness. This is the practice in global markets, where nutraceuticals is an estimated $ 1-billion market.

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