Health food under government lens

PUNE: The ever-increasing craze for dietary supplements, especially among youths who yearn for a well-sculpted body with six or 10 pack abs, has compelled the Food Safety and Standards Authority of India (FSSAI) to come up with regulations on the food supplements and nutraceuticals (see box) industry.

The FSSAI intends to formulate guidelines for labelling, packaging, manufacturing and sale of such products.

Besides targeting popular vitamins or protein based products, the guidelines - which were long awaited - will look at regulating dietary or medicinal supplements that promise guaranteed prevention or treatment of diseases. The comprehensive guidelines are in the draft stage right now.

"Overload of information on the internet and aggressive marketing have increased the sale of supplements, which are often consumed without consulting doctors. This is not advisable, as prolonged use of too much protein or supplements can have adverse effects like damage to kidneys," says nutritionist Esther Sathiaraj.

Sathiaraj said that several people come to her wondering if they really need food supplements. "Guidelines framed by the government can play an important role in creating awareness and keeping a check on spurious or harmful products. They would also ensure that such food products are not sold as medicines," said Sathiaraj.

At present, India does not have any rules for approving or monitoring products under this segment. As a result, the food regulators find it difficult to segregate fake or products that are potentially harmful for health. "It is not possible for us to frame charges against any firm indulging in malpractices. Hence, there have been no registered cases in the nutraceuticals category," said Dilip Sangat, assistant commissioner, the Food and Drug Administration (FDA), Pune.

While India lacks any specific framework, the nutraceutical industry continues to grow steadily in tandem with the global market. Established pharmaceutical and even beauty product firms are venturing and investing heavily in the products - seeing the interest rise among the Indian consumer.

A recent report released by the Associated Chambers of Commerce & Industry of India (ASSOCHAM) and RNCOS market research firm, estimates this vast industry in India will cross US$ 6.1 billion by 2020 from the current level of US$ 2.8 billion, "growing at a compound annual growth rate (CAGR) of about 17%".

DS Rawat, secretary general, Assocham, said, "The Indian nutraceuticals market is at a nascent stage, but fast emerging and accounts for 1.5% of the global market. Its market share is indeed on the rise."

Sheetal Arora, managing director of pharma major Mankind, said, "Since innovation in pharma sector is slow, every company is moving towards nutraceuticals as it is a sector with a lot of scope as lifestyle diseases are also on the rise. In the last 18 months, 60% of our products have been from this segment. In the coming years too our focus will be majorly on nutraceuticals."

Once the guidelines are in place, the already existing products may be called in for approvals again, even though many from the industry claim that their product line is already approved by the FSSAI.

Prachi Mohapatra, senior manager, brand and communication - South Asia, Oriflame, says, "We already have all our products FSSAI-approved and follow all current regulations." Oriflame has recently launched a wellness division through which they sell weight management shakes and soups and omega 3 fish oil supplements.

What are nutraceuticals:

Can come in the form of granules, powder, tablet, capsule, liquid or gel, which contains a naturally occurring chemical compound which has a physiological benefit or provides protection against chronic disease

Examples: Sports drinks, fortified milk, protein powders and shakes, whey protein etc

Foods or health supplements

They are foods which are concentrated sources of one or more nutrients and are offered alone or in combination, but are not drugs as defined in the Drugs and Cosmetics Act, 1940

Examples: Multi-vitamins and multi-minerals, omega 3 fish oil, etc

Novel foods:

Foods that were not historically consumed by humans or contain ingredients obtained by new processes which result in significant changes in the composition or structure of the food products

Examples: Coconut water powder, noni juice etc

Guidelines snapshot:

No hormones or steroids or psychotropic ingredients shall be added to these foods

- Every package should carry the words - ' food or health supplement'. The term 'not for medicinal use' shall be prominently written

Amount of nutrients added shall be declared

The labels shall clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address

A food, which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, shall not be designated as "food supplements" or by any other equivalent term

The quantity of nutrients added shall not exceed the recommended daily allowance

Nutraceutical, which does not have a history of safe use in India, but such safety has been established in other countries, it may be manufactured or sold in India only after taking prior approval from the food authority

- Weight loss products should mention "For the weight control and management" and a statement that the product should not be used by pregnant, nursing and lactating women or by infants, children, adolescents and elderly, except when medically advised

Assocham recommends:

- All products, before reaching the market, should go through rigorous tests

- Small committees should be built at block levels to check counterfeit products in the market and immediately discard them

- The government should provide special incentives and subsidies to emerging companies

Voices:

"Guidelines for supplements and nutraceuticals will bring clarity to the industry stakeholders and they can invest with no fear of counterfeiting": D S Rawat, secretary general, Assocham

"Not everyone needs supplements. Many health problems can be sorted out by correcting diet. However, some may find the supplements useful.": Esther Sathiaraj, nutritionist