It’s ‘supplementary’ Watson: FSSAI cracks the whip

Late last month, the Food Safety and Standards Authority of India (FSSAI) came out with draft guidelines on nutraceuticals, health supplements and other categories of novel and medicinal foods. Coming about nine years after the FSS Act (2006) defined nutraceuticals as a food and not drug, the rules have made a rather late appearance. But it certainly did not go unnoticed by food and drug companies, despite the FSSAI being in the eye of a noodle storm over Maggi.

The proposed rules “will open up the sector for several companies waiting in the wings, who want to be on the right side of the law, but did not know how to go about it,” says regulatory expert DBA Narayana. In addition to already-recognizable food and health supplements like vitamin or protein products in the market, the long-pending nutraceutical guidelines pave the way for functional foods that supplement a dietary or medicinal purpose. So beverages that supplement the diet of a person, undergoing chemotherapy; with a kidney ailment or for just plain weight management, will fall in this category.

Consumers may already encounter a plethora of food products in the market promising weight-loss, boosting brain-power and making tall claims. . But this too will be nailed by the proposed rules. The draft clarifies on claims (they need substantiation) and product labels. And it mandates that such products sport labels stating they are “not for medicinal use.”

Despite teething problems with the rules, the neighbourhood grocery store is expected to see a spike in products such as probiotic foods (with living organisms to improve digestion) or fortified foods – salt with iodine, juice with vitamin A, biscuits, chocolates etc. “The rules also include ayurveda, siddha and unani ingredients, so food products can use their preventive and protective features,” says Narayana. About 400 odd ingredients with known safety profiles have been listed facilitating an easier pathway for approvals, he adds.

But there are rough edges to smoothen and product approvals have always been a sticky point between the food industry and the regulator. Old and established products in the market are called in for fresh approvals, resulting in unnecessary delays, allege industry representatives.

In fact, some industry representatives question the present draft’s logic in mandating final product approvals, even when all ingredients in the product are from the FSSAI’s approved list.

Product approvals do not make a product safe, says an industry-expert. For that, the FSSAI needs to lift samples from the market and test it regularly. Maggi was an approved product and yet the authority found it unsafe, he points out. With some rules still open to interpretation, industry hopes to sort them out before it is finalized.

RK Sanghavi, heading the Indian Drug Manufacturers’ Association - IDMA’s nutraceuticals subcommittee, says that the rules will help if they are in the spirit of the FSS Act that envisions an easy pathway to the market.

Operating in the prescription-driven segment of traditional products, Charak Pharma’s Managing Director Pulin Shroff explains the nutraceuticals phenomenon. “The market for fortified packaged foods is on the rise, as unlike earlier plain fresh milk is not good enough. People want fortified milk.” As people live longer, the accent is on wellness, not just tackling illness, he adds.

Nutraceuticals are largely sold over the counter. But consultancy firm RNCOS Founder Shushmul Maheshwari explains why claims and labels are important. Consumers need to know for how long they can take a product and should it be under supervision etc. Many unknown protein products are informally promoted at gyms to unsuspecting iron-pumping health enthusiasts, he says, adding that good marketing does not mean a good product.

So are we replacing fresh fruits and vegetables and becoming a pill popping nation? IDMA’s Sanghavi counters that consumers have to take huge quantities of a fresh food to get the right amount of vitamin or protein they require. That’s where a health supplement comes in. And so does the market.

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