Nutraceuticals are considered dietary foods for use by human beings to supplement the diet by increasing the total dietary intake. As on date, there are no standards for nutraceuticals in India so each time a new product is introduced, the Food Business Operator has to prove that the product is safe for human consumption. Ingredients in the product should not be prohibited under the Food Safety & Standards Act, 2006. Since nutraceuticals are not standardized so such products have to go through the Product Approval Process and get either a ‘No Objection Certificate (NOC)’ or be referred to FSSAI’s scientific panel so that the product can comply with Section 22 of the Food Safety and Standards Act (FSSA), 2006.
As per Section 22 of the Food Safety and Standards Act, 2006 (FSSA), “no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic food, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food without prior Central Government authorization.
“Foods for special dietary uses or functional foods or nutraceuticals or health supplements” are explained as foods which are specially processed or formulated for a particular dietary requirement that may exist because of a particular physical or physiological condition or specific disease and disorder. It must be presented as being for such a purpose. The composition of these foodstuffs must be significantly different from the composition of ordinary foods of comparable nature, if such ordinary foods exist.
These foods may contain one or more of the following ingredients, namely
- Plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
- Minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits).
- Substances from animal origin
- A dietary substance for use by human beings to supplement the diet by increasing the total dietary intake
A product that is labelled as a “Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods” which is not represented as conventional food may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and these are meant for oral use only Such products do not include
- ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made there under
- does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act
- does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made there under and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945
Nutraceuticals: Food or Medicine
The word nutraceutical is derived from two words ‘nutrition’ and ‘pharmaceuticals’. However, there is still a lot of confusion about the product being a food or medicine. Nutraceutical companies are of the view that nutraceuticals provide both health and medical benefits. They are seen as products that help to narrow the gap between food and medicine. Some of the products contain, for example, antioxidants, flavonoids like in tea and wine. On the other side of the debate, nutraceuticals are products
- that are isolated or purified from food but are sold as medicinal products and so are not really food
- have some physiological benefits but they also provide certain protection against chronic diseases
Nutraceuticals, however, do not have to go through the same testing process as pharmaceutical drugs even though they claim to prevent the diseases. Nutraceuticals are being seen as playing a major role in preventing and treating lifestyle diseases. Some of the products
- lower high cholesterol levels
- maintain the heart and arteries
- prevent cancer
Nutraceuticals fill up the nutritional gap
The quality of life has gone up but sedentary lifestyle, coupled with long working hours and unhealthy eating habits have given rise to a number of health related issues. Besides this the rise in medical costs has brought in awareness about preventive medicine. Nutraceuticals are now being seen by the consumer as a wellness product that can give them
- the necessary nutrients they may be missing in their daily diet.
- that will keep them healthy with the daily required dose of nutrients like vitamins, calcium or magnesium
- will prevent cardiovascular and other lifestyle diseases
The older generation views nutraceuticals as a
- disease management option that will allow them to go through old age with limited diseases
- build immunity and enhance overall health.
A general market trend
Nutraceuticals are popular among middle and higher income segments who have disposable incomes. However, the lower income groups are still dependent on the traditional methods of food intake as the cost of nutraceuticals are cost prohibitive. According to a report the consumption of nutraceuticals is likely to increase appreciatively in the coming years. It is predicted that ‘pharma’ is likely to be replaced by the ‘nutra’ industry even though presently nutraceuticals are being manufactured by pharmaceutical companies presently. It is likely that in the future nutraceuticals become a separate industry.
FSSAI is in the process of finalizing a regulation to deal with Nutraceutical products which may be introduced anytime.