INTRODUCTION:

The quality of life in terms of income, spending and lifestyle has improved with economic development. However, it has also thrown up a major challenge in the form of `lifestyle diseases'. The first victim of this lifestyle change has been food habits. Consumption of junk food has increased manifold, which has led to a number of diseases related to nutritional deficiencies. Nutraceuticals can play an important role in controlling them. No wonder more and more people are turning to nutraceuticals.

The term nutraceutical was coined from nutrition and pharmaceutical in 1989 by Stephen Defelice, founder and chairman of foundation for innovation in medicine, an American organization which encourages medical health.

According to him “a nutraceutical is any substance that is a food or a part of food and provides medical or health benefits, including the prevention and treatment of disease”. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered designer foods and herbal products. The concept of nutraceutical was stared from the survey in U.K., Germany and France and it concluded that diet is rated more highly by consumer then exercise or hereditary factor to achieving a good health^1-5. In the U.S. “nutraceutical" was commonly used, but no regulatory definition existed. Its meaning was modified by health ministry of Canada which defines nutraceutical as “a product isolated or purified from the food, generally sold in medicinal form not associated with food and demonstrated to have a physiological benefit .It also provides benefit against chronic disease” ^6.

Figure 1. Nutraceutical was coined from nutrition and pharmaceutical

In Britain, the Ministry of Agriculture, Fisheries and Food has developed a definition of a functional food as "a food that has a component incorporated into it to give it a specific medical or physiological benefit, other than purely nutritional benefit ⁷.

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 a nutraceutical. Examples of nutraceuticals include fortified dairy products (e.g. milk) and citrus fruits (e.g. orange juice) ⁸.

Health Canada defines nutraceutical as “a product prepared from foods, but sold in the form of pills, or powder (potions) or in other medicinal forms, not usually associated with foods”

The DSHEA (dietary supplement health and education act of 1994) formally defined "dietary supplement" using several criteria. A dietary supplement: ⁹

· Is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients- a vitamin, a mineral, a herb or other botanicals, amino acids or a dietary substance for use by man to supplement the diet by increasing the total daily intake or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

· Is intended for ingestion in pill, capsule, tablet or liquid form.

· Is not represented for use as a conventional food or as the sole item of a meal or diet.

· Is labeled as a "dietary supplement".

BENEFITS:

From the consumers' point of view, functional foods and nutraceuticals may offer many

benefits:

· May increase the health value of our diet.

· May help us live longer.

· May help us to avoid particular medical conditions.

· May have a psychological benefit from doing something for oneself.

· May be perceived to be more "natural" than traditional medicine and less likely to produce unpleasant side-effects.

· May be present food for populations with special needs (e.g. nutrient-dense foods for the elderly) ¹⁰.

· May be used to improve health, prevent chronic diseases, postpone the aging process (and in turn increase life expectancy), or just support functions and integrity of the body.

· They are considered to be healthy sources for prevention of life threatening diseases such as diabetes, renal and gastrointestinal disorders, as well as different infections¹¹

BRIDGING THE GAP BETWEEN FOOD AND MEDICINE:

Hippocrates highlighted around 2000year ago “Let food be your medicine and medicine be your food”⁵. Nutraceuticals are foods or food ingredients that provide medical or health benefits. This emerging class of products blurs the line between food and drugs ¹². They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two¹³.

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 ¹⁴.

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 ¹⁵.

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. The food products used as nutraceutical are categorized as¹⁶ Probiotic, Prebiotic, Dietary fiber, Omega 3 fatty acid and Antioxidant

· They are classified on basis of their

1) Natural sources

2) Pharmacological conditions

3) Chemical constitution of the products

· Most often they are grouped into:

1) Dietary supplements

2) Functional food

3) Medicinal food

4) Farmaceuticals

DIETARY SUPPLIMENTS:

A dietary supplement represents a product that contains nutrients derived from food products, and is often concentrated in liquid, capsule, powder or pill form. Although dietary supplements are regulated by the FDA as foods, their regulation differs from drugs and other foods.

FUNCTIONAL FOOD:

Functional food is a category which includes whole foods and fortified, enriched or enhanced dietary components that may reduce the risk of chronic disease and provide a health-benefit beyond the traditional nutrients it contains.

MEDICINAL FOOD:

Medical food is formulated to be consumed or administered internally, under the supervision of a qualified physician. Its intended use is a specific dietary management of a disease or condition for which distinctive nutritional requirements are established by the medical evaluation

FARMACEUTICALS:

Farmaceuticals are medically valuable components produced from modified agricultural crops or animals. The term is a combining of the words “farm” and “pharmaceuticals”. Proponents of this concept are convinced that using crops (and possibly even animals) as pharmaceutical factories is much more cost effective than conventional methods, with higher revenue for agricultural producers.¹¹

AREA COVERED BY NUTRACEUTICAL PRODUCTS:

All therapeutic areas such as anti-arthritic, pain killers, cold and cough, sleeping disorders, digestion and prevention of certain cancers, osteoporosis, blood pressure, cholesterol, depression and diabetes have been covered by nutraceuticals¹⁷.

NUTRACEUTICALS REVOLUTION

The nutraceuticals revolution began in the early 1980s, sparked off when the actual or potential clinical benefits of calcium, fiber and fish oil were supported by clinical studies published in distinguished medical journals, and when physicians began to educate their colleagues and consumers about these substances via the mass media.

Factors effecting Revolution:

· Physician - Increased physician acceptance of the medical benefits of nutritional products increased market demand of nutraceuticals.

· Media- The mass media have emerged as the primary sources of medical claims, mass media has now become the powerful and legitimate promotion agency of nutraceutical products ^18,
19.

RESEARCH AND DEVELOPMENT:

The greatest scientific need in nutraceuticals pertains to standardization of compounds and/or products, to carefully develop and execute clinical studies/trials to provide the basis for health claims for nutraceuticals that impact consumers as well as companies making strategic investments²⁰.

Powerful market forces are fueling the interest in nutraceuticals:

· Rapid advances in scientific knowledge supporting the vital role of diet in health and disease prevention.

· Skyrocketing health care costs.

· An aging population.

· Technical advances in the food industry that are allowing the development of health

promoting foods that can be marketed to health-conscious consumers at a premium.

· The changing regulatory environment.

Role of R and D in nutraceuticals:

· To test safety, purity and potency of products.

· To develop more effective and efficient means of producing ingredients for use in products.

· To develop testing methods for ensuring and verifying the consistency of the dosage of ingredients included in the company’s products.

· Develop the new products either by combining existing ingredients used in nutritional supplements or identifying new ingredients that can be used in nutritional supplements²¹.

MARKET TRENDS OF NUTRACEUTICALS:

The nutraceutical industry's three main segments include functional foods, dietary supplements, and herbal/natural products⁵. Nutrition Business Journal (NBJ) identified an $80 billion nutraceuticals market in 1995 by considering natural and organic foods ($6.2 billion), functional foods ($13.4 billion), certain lesser-evil foods with reduced or no unhealthy ingredients ($23 billion), dietary supplements ($8.9 billion), and selected market standard foods ($28.3 billion). NBJ has begun tracking nutraceuticals industry growth. Since 1995, the industry, as defined by NBJ, has grown by an average of 7.1 percent per year. In 1997, industry sales totaled $91.7 billion (NBJ 1998). The most rapidly growing segments of the industry were dietary supplements (19.5 percent per year) and natural/herbal products (11.6 percent per year) ²². According to BCC Research - The global nutraceuticals market grew to $46.7 billion in 2002, at an AAGR of nearly 7%. In 2007 nutraceuticals sale is projected to reach $74.7 billion at an AAGR of 9.9%. This assumes a world economic recovery in 2003 and an end to price competition^23.

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.

CONCLUSION:

The nutraceutical industry is growing at a rate far exceeding expansion in the food and pharmaceutical industries. In tomorrow’s market, the most successful nutraceutical players are likely to be those companies in which functional product are just a part of a broad line of goods satisfying both conventional and health value point. Future demand of nutraceutical depends on consumer perception of the relationship between diet and disease. Although nutraceuticals have significant promise in the promotion of human health and disease prevention ,health professional, nutritionists and regulatory toxicologist should strategically work together to plan appropriate regulation to provide the ultimate health and therapeutic benefit to mankind. Long-term clinical studies are required to scientifically validate the nutraceuticals in various medical conditions. The interaction of nutraceuticals with food and drugs is another area, which should be taken into consideration. The effect of different processing methods on the biological availability and effectiveness of nutraceuticals remains to be determined. As like drugs, there should be strict regulatory controls for nutraceuticals.

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Received on 12.02.2018 Modified on 13.04.2018

Research J. Pharm. and Tech 2018; 11(8): 3572-3576.

DOI: 10.5958/0974-360X.2018.00657.1