Nutraceutical, Functional Foods and the Market Perspective

The role of dietary active compounds in human nutrition is one of the most important areas of investigation with the findings having wide‐ranging implications for consumers, health care providers, regulators, food producers, processors and distributors. Thus, the concept of ‘adequate nutrition’ is beginning to be replaced by ‘optimal nutrition’ with consumer belief increasing at an unprecedented pace.

In the past few years, many bioactive constituents of food have been commercialized in the form of pharmaceutical products (pills, capsules, solutions, gels, liquors, powders, granulates, etc.) that incorporate food extracts or phytochemical‐enriched extracts to which a beneficial physiological function has been directly or indirectly attributed. This range of products cannot be truly classified as “food” or “pharmaceutical”, and a new hybrid term between nutrients and pharmaceuticals, ‘nutraceuticals’, has been coined to designate them.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk or yoghurts containing probiotics for intestinal health. Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.”

In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.

There is a slight difference between the functional foods and nutraceuticals. When food is being cooked or prepared using “scientific intelligence” with or without knowledge of how or why it is being used, the food is called “functional food”. Thus, functional food provides the body with the required amount of vitamins, fats, proteins, carbohydrates, etc. needed for its healthy survival. When functional food aids in the prevention and/or treatment of disease(s) and/or disorder(s) other than anemia, it is called nutraceutical.

Nutraceuticals are foods or food ingredients that provide medical or health benefits. This emerging class of products blurs the line between food and drugs. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. Within European Union (EU) law the legal categorization of a nutraceutical is, in general, made on the basis of its accepted effects on the body.

Thus, if the substance contributes only to the maintenance of healthy tissues and organs it may be considered to be a food ingredient. If, however, it can be shown to have a modifying effect on one or more of the body’s physiological processes, it is likely to be considered to be a medicinal substance. Within European Medicines law a nutraceutical can be defined as a medicine for two reasons:

1) It can used for the prevention, treatment or cure of a condition or disease or

2) It can be administered with a view to restoring, correcting or modifying physiological functions in human beings.

CLASSIFICATION OF NUTRACEUTICALS:

Regarding the promise of nutraceuticals, they should be considered in two ways:

Potential nutraceuticals

Established nutraceuticals

A potential nutraceutical is one that holds a promise of a particular health or medical benefit; such a potential nutraceutical only becomes an established one after there are sufficient clinical data to demonstrate such a benefit. It is disappointing to note that the overwhelming majority of nutraceutical products are in the ’potential’ category, waiting to become established.

NEUTRACEUTICAL- Market Perspective:

Nutraceuticals in India are not conceptualized in terms of segments, regulations, manufacturing, marketing, exports and imports. For the first time in the Indian regulatory system, the Food Safety and Standards Act, 2006 (FSSA) has formally created a special third category — “Foods for Special Dietary Uses/Functional Foods/Nutraceuticals/Health Supplements” in addition to the first two — “conventional foods” and “drugs”. These products are not recognized as a standalone category, instead the FSSA includes them as a special category of products

that fall under the general umbrella of foods, that shall have specific regulatory requirements under the forthcoming regulations. The previous food laws of India do not formally recognize and define nutraceuticals. While the FSSA has taken the first step in recognizing nutraceuticals and classifying them under foods, the rules and regulations are yet to be framed. The formulation of rules and regulations for nutraceuticals is a mammoth task and is anticipated to begin shortly. It is noteworthy that most countries do not formally define or directly regulate nutraceuticals; the regulation of health claims represents the indirect system for these food products.

THE FUTURE OF NUTRACEUTICALS:

Increasing awareness levels about fitness and health, spurred by media coverage are prompting the majority of people to lead healthier lifestyles, exercise more, and eat healthy. The expanding nutraceutical market indicates that end users are seeking minimally processed food with extra nutritional benefits and organoleptic value. This development, in turn, is propelling expansion in the nutraceutical markets globally. The emerging nutraceuticals industry seems destined to occupy the landscape in the new millennium. Its tremendous growth has implications for the food, pharmaceutical, healthcare, and agricultural industries. Many scientists believe that enzymes represent another exciting frontier in nutraceuticals. “Enzymes have been underemployed… they’re going to be a hot area in the future.” Fermentation technology using microbes to create new food products also represents potential. Global trends to healthy products cannot be reversed. Companies taking the lead by investing strategically in science, product development, marketing and consumer education will not go unrewarded.