Nutraceuticals: A Boom to Medical Industry

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Jul 23, 2013 - $71 billion in 1998 with predictions of rapid growth to ... Analysis of Nutraceutical Definitions. A number ... Now day's nutraceuticals are booming in the market of the ..... Diabetes mellitus is diseases caused due to abnormally.
Research Gate: Pharmaceutical Sciences, 2 (2013) 1-8 Review Article

Research Gate: Pharmaceutical Sciences ISSN (online ) : 2319- 6831 w w w . i re s e a rc h . i n

Nutraceuticals: A Boom to Medical Industry Ravinder kumar1*, Gagandeep Singh2, Gaurav Swami2, Pawan Krishan3, Pratima Kumari1, Saeed Iqbal Rizwi2 and Surya Parkash Gautam1 1

3

Himachal Institute of Pharmaceutical Education and Drug Research, Nadaun (H.P). India 2 CT Institute of Pharmaceutical Sciences Jalandhar, Punjab. India Department of Pharmaceutical Sciences and Drug Research Punjabi University Patiala, Punjab. India

ARTICLE INFO

ABSTRACT

Keywords: Nutraceuticals, Nutrigenomics, Health, Food aids, Dietary supplement

Nutraceuticals is a combination of nutrition and pharmaceuticals. The definition of nutraceuticals includes vitamins, minerals, herbs and other botanicals, amino acids, and dietary substance for human used as a supplement diet. Nutraceuticals is a product isolated or purified from foods and sold in medicinal forms, (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease. Global sales of nutraceuticals were estimated at $71 billion in 1998 with predictions of rapid growth to $500 billion by 2010. Nutraceuticals provides extra health benefits in addition to the basic nutritional value found in foods. Nutraceuticals have been claimed to have a physiological benefit or provide protection against the various chronic diseases. Now day’s nutraceuticals are booming in the market of the world so the specific regulatory agencies are working for its purity, safety and efficacy. Nutrigenomics is recently developed methodology with combination of multiple genomic techniques and molecular biology technologies. Nutrigenomics contains the three omics disciplines gene, protein, and metabolite profiling (transcriptomics, proteomics, and metabolomics) as applied to the field of nutrition and health. The present review article discusses the current status of nutraceuticals and their importance in various diseases.

Article History: Received :23rd July 2013 Accepted : 17th September 2013

Introduction In the pharmaceutical growth process, clinical test are necessary for verification of the effects which results from animal tests and studies. On the other hand in the case of nutrition there was no verification required. In the recent years however, as food composition has been scientifically proven to cause life style related diseases, and has become a social issues1, around 2000 years ago, Hippocrates correctly highlighted “Let food be your medicine and medicine be your food"2. The definition of nutraceuticals includes vitamins, minerals, herbs and other botanicals, amino acids, and dietary substance for human use as a supplement diet3,4. Nutraceuticals is a combination of nutrition and pharmaceuticals.5 “Pharmaceuticals” may be considered as drugs used mainly to treat diseases, while “Nutraceuticals” are those that are intended to prevent diseases6. The term nutraceuticals is not well accepted on global, regulatory systems and has no regulatory definition while the dietary supplements are considered to be more prominent. Presently over 470 nutraceuticals and functional food products are available with documented health benefits7,8. In 1989 Dr. Stephen L. Defelice was first to introduced the term “Nutraceuticals” as a product isolated or purified from foods and sold in medicinal forms, (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease9. “Global sales of nutraceuticals were estimated at * Corresponding author : Ravinder Kumar : [email protected]

$71 billion in 1998 with predictions of rapid growth to $500 billion by 201010. There has been a boom in sale of Nutraceutical because of  Adverse effects of pharmaceuticals  Increased tendency of patients for self-medication  Aging population e.g. – arthritis9. Analysis of Nutraceutical Definitions A number of definitions are coinciding or cross reference the original Dr Stephen L. DeFelice definition11. Some of them define a nutraceutical as objective products with demonstrated health benefits that are generally sold in medicinal form (Table 1). A few definitions describe nutraceuticals as bioactive compounds or photo chemicals of food (Table 2). A few other definitions illustrate nutraceuticals as dietary supplements and functional foods, or as their active components (Table 3). A majority of the definitions relate nutraceuticals as food, food components, or nutrients providing health or physiological benefits beyond the basic nutritional value of the product. Table 1: Nutraceutical Definitions for Medicinal substances A nutraceuticals is any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such

A nutraceuticals is a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical is

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products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered designer foods, herbal products, and processed foods such as cereals, soups and beverages. Nutraceuticals are commodities derived from foods, but are used in the medicinal form of pills, capsules, portions and liquids and again render demonstrated physiological benefits.

demonstrated to have a physiological benefit or provide protection against chronic disease.

Nutraceutical is any substance that may be considered a food or part of a food and provides medical or health benefits, encompassing, prevention and treatment of diseases.

improve body composition n-3 FA(DHA,EPA)

Fish oil, mustard, linseed,

Reduces CVD, Improve mental and visual functions

Omega 3 Fatty acids

Salmon, Flax seed

improved outcomes

Mono saturated fatty acids

Tree nuts

Reduce risk of coronary heart disease

POLYPHENOLS Anthocyanidine

Fruits

Catechins

Rapeseed, salseed, tea, mustard cake

Nutraceuticals are naturally occurring/derived bioactive compounds that are reported to have health benefits. The delivery systems for nutraceuticals are foods (functional foods), supplements, or both.

Flavonone

Citrus

Flavones

Soya bean, fruits, vegetables, buckwheat

Flavonols

Onions ,apples, broccoli

Antioxidant

Dietary supplements deliver a concentrated form of a presumed bioactive ingredient (nutraceutical) from a food, in a nonfood matrix (usually in a tablet or capsule form), to enhance health in dosages that exceed those that can be obtained from normal food.

Proanthocyanidine

Coca, chocolate, tea, rapeseed

Reduces CVD

Anthocyanins

Blueberries, blackberries

Anti-oxidants, counteracts inflammation in the body, Anti diabetic.

Phenolic acids

Berries, legumes, whole wheat bran

Reduce oxidation of LDL

Table 2: Nutraceutical Definitions for Bioactive Compounds Nutraceutical generally refers to dietary supplements that contain a concentrated form of a bioactive substance originally derived from a food

Nutraceutical is the term used to describe a medicinal or nutritional component that includes a food, plant or naturally occurring material, which may have been purified or concentrated, and that is used for the improvement of health, by preventing or treating disease

cardiovascular

Table 3: Nutraceutical Definitions for Functional Foods Nutraceuticals are diet supplements that deliver a concentrated form of a presumed bioactive agent from a food, presented in a non‐food matrix, and used with the purpose of enhancing health in dosages that exceed those that could be obtained from normal foods.

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.

The term “Nutraceutical” is used to describe medicinally or nutritionally functional foods.

Nutraceuticals are foodstuffs, food additives or dietary supplements that make health claims

CLASSIFICATION OF NUTRACEUTICALS Nutraceuticals is a broad term used to describe any product derived from food sources that provides extra health benefits in addition to the basic nutritional value found in foods. There are two types of products that may fall under the class of nutraceuticals12. Nutraceuticals are usually divided into two categories:  Functional foods: Products that are used to treat or prevent a condition are considered medicine, while those used to improve health and reduce a risk of developing a disease could be classified as functional foods (Table 4)if they are presented in the form of food or drink, and meet other safety and quality conditions set for this category13. Table 4: Functional foods and their

relevance 5-6,14

CLASS/CONSTIT UENTS

SOURCES

HEALTH BENEFITS

Fatty acids

Milk & meat

Reduces cancer and also

Cholesterol, Reduce cancer, strong antioxidant.

Resveratrol

Dark grapes, raisins, Berries

lowers total serum cholesterol increasing HDL

Curcumin

Turmeric root

anti-inflammatory and antioxidant, anti-clotting agent

Glucosinolates

Cruciferous vegetables,

Anti cancer

Cauliflower Saponins

Soybeans, lucerne, chick pea

Probiotics Synbiotics

/

Lactobacillus Bifidobacteria

/

Fructo– oligosaccharides

Anti cancer (effective against colon Cancer), Lowers cholesterol

Yogurt, dahi Improve GIT & Systematic immunity

PHYTOESTROGENS Isoflavones (genistein,daidzei n)

Lignans

Soy bean, legumes, lentil seed, maize, berseem, subabul fodder

Lowers LDL cholesterol (bad cholesterol) antioxidants, prostate, breast, bowel, and other cancers

Flaxseed, rye, vegetables

Inhibit the development of breast colon cancer

Oat, vegetables, fruits, carrots, berseem, maize fodder

Antioxidant, protect cornea against UV light

Corn, avocado, egg yolk , spinach, citrus, rice bran

Improve

CAROTENOIDS β-Carotene

Lutein

&

vision,

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Zeoxanthine

Cataracts,

Liquorice

Anticancer (colon), Lycopene

Tomatoes, watermelon, grapefruit, Papaya

Guava,

Antioxidant, anti cancers (Prostate, Bladder, Cervical, lowers level.

Tocotrienol

Grains, Palm oil

uralensis Fisch

Anticancer (breast cancer), reduces risk of CVD

Soluble fiber (βGlucan)

Oats, barley, rice bran, Legumes, some fruits, Psyllium

Hypercholesterolemi a, hypoglycemia, reduces colon cancer, ulcerative colitis.

Insoluble fiber

Rice bran, wheat bran

Reduce breast, colon cancer

 Dietary supplements: It is a product that is intended to supplement the diet that bears or contains one or more ingredients like, vitamin, mineral, a herb, an amino acid or a concentrate, metabolite, constituent, extract, or combinations of these2 (Table 5).They are sold in many forms, including tablets, capsules, liquids, powders, extracts, and concentrate4. Potential benefits of nutrients which are available in neutaceuticals are reported in Table 6.

Hydrastis Canadensis L.

Antimicrobial, astringent, antihemorrhagic, treatment of mucosal inflammation dyspepsia and gastritis.

Plantago seed

Plantago arenaria Kit.

Cathartic.

Slippery elm

Ulmus rubra Muhl.

Ulcerations of digestive tract.

Valerian

Valeriana officinalis L.

Spasmolytic, mild sedative and sleep aid.

Melissa

Melissa offi cinalis L.

Topical antibacterial and antiviral.

St. John’s wart

Hypericum perforatum L.

Anxiolytic, inflammatory, antidepressant, monoamine inhibitor.

Willow bark

Ephedra

Ephedra Schrank

Aloe Vera gel

POTENTIAL BENEFITS intermedia

Aloe vera L. N.L. Burm

Vasoconstrictor, bronchodilator and appetite suppressant Anti-inflammatory, emollient & wound healing properties

Chamomile

Matricaria recutita L.

Anti-inflammatory, spasmolytic, antimicrobial.

Echinacea

Echinacea purpurea L.

immune stimulant and treatment of cold and flu symptoms

Feverfew

Tanacetum parthenium L.

Headache, treatment of fever and menstrual problems, reduces frequency, severity and duration of migraine.

Garlic

Allium sativum L

Ginger

Zingiber Rose

Ginkgo

Ginkgo biloba L.

Ginseng

officinale

Panax ginseng

Antibacterial, antifungal, antithrombotic, hypotensive, antihyperlipidemic and anti-inflammatory Carminative, antiemetic, cholagogue and treatment of dizziness. Vasodilation, treatment of post thrombotic syndrome, short term memory loss, dementia, and vertigo Adaptogen.

Salix alba L.

the

antioxidase

Anti-inflammatory, analgesic, antipyretic, astringent, treatment of rheumatic and arthritic.

NUTRIENTS

POTENTIAL BENEFITS

Vitamin A

Antioxidant and treatment of certain skin disorders.

Vitamin E

Helps in formation of blood cells, muscle, lung and nerve tissue, boosts the immune system.

Vitamin C

Beneficial for bones, gums, teeth and skin, wound healing and also prevent common cold and soothe its symptoms.

Vitamin K

Vital for blood clotting.

Vitamin B1

Essential in neurologic functions & helps to convert food in to energy.

Vitamin B2

Helps in energy production and other chemical processes in the body, helps maintain healthy eyes, skin and nerve functions.

Vitamin B3

Maintain proper brain functions.

Vitamin B6

Synthesize amino acids and metabolism of fats, protein and carbohydrate, helps to produce the genetic material of cells, RBCs formation, maintain CNS system RBCs formation protects against cardiovascular diseases.

Table 5: Dietary supplements and their relevance3, 5 SOURCES

Expectorant, secretolytic and in treatment of peptic ulcer

Goldenseal

Leukemia) cholesterol

DIETARY FIBER

HERBS

Glycyrrhiza glabra L,G.

Folic acid Calcium

Fortify bones and teeth, important functioning of nerve, muscle and glands.

Iron

Helps to produce energy,

in

carry and transfer oxygen to tissues. Magnesium

Maintain a healthy nerve and muscle function, useful in bone formation, may help to prevent premenstrual syndrome.

Phosphorous

Strong bones and teeth, helps in formation of genetic material, energy production and storage.

Chromium

Helps to convert carbohydrates and fats into energy.

Cobalt

Essential component of vitamin B12, but ingested cobalt is metabolized in vivo to form

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the B12 coenzymes. Copper

Vital for production of hemoglobin and collagen, healthy functioning of the heart, energy production, absorption of iron from digestive tract.

Iodine

Proper functioning of thyroid gland.

cornerstone for the management of gestational diabetes mellitus. Although there is widespread use of herbal dietary supplements that are believed to benefit type 2 diabetes mellitus, few have been proven to do so in properly designed randomized trials. Table 8: Nutraceuticals used in diabetes DISEASE

Nutraceuticals and Diseases

Lipoic acid, an antioxidant, for treatment of diabetic neuropathy.

Nutraceuticals have been claimed to have a physiological benefit or provide protection against the following diseases such as:          

Cardiovascular (Table 7) Diabetes (Table 8) Obesity (Table 9) Parkinson’s (Table 10) Alzheimer ’s (Table 11) Cancer (Table 12) Allergy (Table 13) Osteoarthritis (Table 14) Vision improving (Table 15) Oral health (Table 16)

Ethyl esters of n-3 fatty acids may be beneficial in diabetic patients.

Diabetes2-3,5,12,14

Table 7: Nutraceuticals used in cardiovascular diseases DISEASE

NUTRACEUTICALS USED

Cardiovascular diseases2-3,5,14

Anti-oxidants, Dietary fibers, Omega-3 poly unsaturated fatty acids, Vitamins, minerals for prevention and treatment of CVD. Polyphenols (in grape) prevent and control arterial diseases. Flavonoids (in onion, vegetables, grapes, red wine, apples, and cherries) block the ACE and strengthen the tiny capillaries that carry oxygen and essential nutrients to all cells.

Dietary fibers from psyllium have been used for glucose control in diabetic patients and to reduce lipid levels in hyperlipidemia.

People with diabetes are at higher risk of blood vessel damage from free radicals. Quercetin class of flavonoids called flavonols works as an antioxidant by scavenging damaging particles in the body known as free radicals.

Obesity Obesity2,12 is now a global public health problem, defined as an unhealthy amount of body fat, which is responsible for many disorders like angina pectoris, congestive heart failure, hypertension, hyperlipidemia, respiratory disorders, renal vein thrombosis, osteoarthritis, cancer, reduced fertility etc. The principal causes this rapid rise in obesity rates is the increased accessibility of high-fat, energy dense foods such as energy-rich foods (snacks, drinks, burger, pizzas etc) can encourage weight gain, which calls for a limit in the consumption of saturated and trans fats apart from sugars and salt in the diet about 315 million people are estimated to fall into the WHO-defined obesity categories. Nutraceutical interventions are currently being investigated on a large-scale basis as potential treatments for obesity and weight management. Table 9: Nutraceuticals used in obesitys DISEASE

NUTRACEUTICALS USED Buckwheat is a crop has special biological activities of cholesterol lowering effect, anti hypertension effects and improving the constipation and obesity condition by acting similar as to dietary fiber present in food.

Milk and eggs having gamma linolenic acid (GLA) which has many benefits, including prevention and management of cardiovascular diseases.

Diabetes Diabetes mellitus is diseases caused due to abnormally high levels of blood glucose, either due to insufficient insulin production, or due to its ineffectiveness. There are two types of diabetes mellitus are type 1 diabetes (5%), an autoimmune disorder, and type 2 diabetes (95%), which is associated with obesity. Globally the total number of people with diabetes is projected to rise from 171 million in 2000 to 366 million in 2003. Diet therapy is the

Docosahexaenoic acid modulates insulin resistance and is also vital for neurovisual development.

Herbal stimulants, such as ephedrine, caffeine, ma huang-guarana, chitosan and green tea help in body weight loss.

Cardiovascular Disease Cardiovascular diseases (CVD) is a chronic disease by means of disorders of the heart and blood vessels which generally include hypertension (high blood pressure), coronary heart disease (heart attack), cerebro-vascular disease (stroke), heart failure, peripheral vascular disease, etc2. In cardiac heart disease, atherosclerotic plaques form on the inner surface of arteries, which narrow the lumen and reduced the blood flow9. Further it would be the leading cause of death in developing countries. Majority of these diseases would be preventable and controllable2.

NUTRACEUTICALS USED

Obesity2,6,12

5-hydroxytryptophan and green tea extract may promote weight loss, while the former decreases appetite, the later increases the energy expenditure Herbal stimulants, such as ephedrine, caffeine, ma huang-guarana, chitosen and green tea help in body weight loss. A blend of glucomannan, chitosan, fenugreek, G sylvestre, and vitamin C in the dietary supplement significantly reduced body

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weight.

DISEASE

Conjugated linoleic acid (CLA), capsaicin, Momordica Charantia (MC) possesses potential anti obese properties.

Lycopene concentrates in the skin, testes, adrenal and prostate where it protects against cancer. Lycopene is one of the major carotenoids in western diets and is found almost exclusively in tomatoes, water melon, guava, pink grapefruit and papaya.

Parkinson’s disease

Phytochemicals derived from herbs and spices also have potential ant carcinogenic and anti mutagenic activities, A broad range of "phyto-estrogens" with a claimed hormonal activity, is recommended for prevention of prostate/breast cancer.

Parkinson’s disease is defined as brain disorder or motor disorder that results from nerve damage in certain regions of the brain causing muscle rigidity, shaking, and difficult walking, usually occurring in mid to late adult life. Nutritional supplements have shown some promising results in preliminary studies, it is important to remember that there is not sufficient scientific data to recommend them for Parkinson's disease at present. Table 10: Nutraceuticals used in Parkinson’s diseases DISEASE

Parkinson’s disease2

Flavonoids found in citrus fruit appear to protect against cancer by acting as antioxidants Soy foods source of isoflavones, curcumin from curry and soya isoflavones possess cancer chemo preventive properties. Cancer2,3,5,14

NUTRACEUTICALS USED

Creatine modifies Parkinson’s disease features as measured by a decline in the clinical signs.

Tannins present in blackberries, blueberries, cranberries, grapes, lentils, tea and wine with advantage to detoxify carcinogens and scavenge harmful free radicals. Curcumin (diferuloylmethane) which is a polyphenol of turmeric possesses anticarcinogenic, antioxidative and anti-inflammatory properties.

Alzheimer ’s Disease

Table 11: Nutraceuticals used in Alzheimer’s diseases DISEASE

Alzheimer ’s disease2,3

NUTRACEUTICALS USED β-Carotene, curcumin, lutein, lycopene, turmeric etc may exert positive effects on specific diseases by neutralizing the negative effects of oxidative stress, mitochondrial dysfunction, and various forms of neural degeneration.

Ellagic acid is a proven anti-carcinogen present in strawberries, cranberries and walnuts. Top of form Beet roots, cucumber fruits, spinach leaves, and turmeric rhizomes, were reported to possess anti tumor activity

Vitamin E in food may be protective against Parkinson’s disease.

Alzheimer's disease (AD) is characterized by progressive dementia with memory loss as the major clinical symptom. In year 1996, approximately 4 million people in the United States were clinically diagnosed with Alzheimer disease. Several lines of evidence strongly suggest that oxidative stress is etiologically related to a number of neurodegenerative disorders including Alzheimer's disease. The rising trend in nutraceutical intake is in part a result of the belief that they postpone the growth of dementias.

NUTRACEUTICALS USED

Pectin (apples) prevents prostate cancer by inhibiting cancer cells from adhering to other body cells.

Allergy Allergy2 is a condition in which the body has an inflated response to a drug or food, Allergic and inflammatory reactions arise due to histamines. Table 13: Nutraceuticals used in allergy DISEASE

Allergy

NUTRACEUTICALS USED Quercetin (QR) belongs to a group of polyphenolic substances known as flavonoids. Quercetin found in onions, red wine and green tea work as natural antihistamine and opposes the actions of the histamine in the body.

Cancer

Osteoarthritis

Cancer has emerged as a major public health problem in developing countries. A high risk of cancer is associated with chronic inflammation risk. Chronic inflammation is also linked with immune suppression, which is a risk factor for cancer. At the molecular level, free radicals and aldehydes, produced during chronic inflammation, can induce deleterious gene mutation and posttranslational modifications of key cancer-related proteins. In year 2000, malignant tumors were responsible for 12 per cent of the nearly 56 million deaths worldwide from all causes. According to the World Cancer Report the cancer rates there would be 15 million new cases in the year 2020 i.e. a rise in 50%.

Osteoarthritis is degenerative damage and loss of the articular cartilage of the joint due to loss of protein substance between the bones of joints. Osteoarthritis (OA), a debilitating joint disorder, is the most common form of arthritis in the United States, where it affects an estimated 21 million people. Joint disorders may reduce physical activity in individuals resulting in energy imbalance and weight gain.

Table 12: Nutraceuticals used in cancer

Table 14: Nutraceuticals used in osteoarthritis DISEASE

NUTRACEUTICALS USED Glucosamine (GLN) and chondroitin sulfate (CS) are widely used to improve symptoms of osteoarthritis.

Osteoarthritis2,9

Methylsulfonyl

Methane

(MSM)

used

in

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combination with glucosamine and chondroitin for helping to treat or prevent osteoarthritis or joint disoder.

Vision Improving Table 15: Nutraceuticals used in vision DISEASE

Vision problems3,14

NUTRACEUTICALS USED Lutein (found in mangoes, corn, sweet potatoes, carrots, squash, tomatoes and dark, leafy greens such as kale, collards and bok choy) also known as helenien is used for the treatment of visual disorders. Zeaxanthin (found in corn, egg yolks and gree vegetables and fruits, such as Broccoli, green beans, green peas, brussel sprouts, cabbage, kale, collard greens, Spinach, lettuce, kiwi and honeydew) used in traditional Chinese Medicine mainly for the treatment of Visual Disorders.

Oral Health Table 16: Nutraceuticals used in oral problems DISEASE

NUTRACEUTICALS USED

Oral health5

Pycnogenol, coenzyme

Regulations Regulatory agencies are required to add specific legal and scientific criteria to maintain standards for nutraceuticals5,14-15. The lack of quality control is a major area of concern for nutraceuticals. Plant materials and manufacturing processes used for nutraceuticals are regulated by food laws, which lack the specificity required for botanical drugs. This can have serious consequences. Contamination, for instance with the toxins after fungal infections of raw plant material or toxins after the fungal infections of raw plant materials or with other ingredients has been repeatedly reported and can have potential fatal consequences. Adulterations and many other types of impurity of nutraceuticals remain undetected, because there is an almost total absence of specific quality control. Now day’s nutraceuticals are booming in the market of the world so the specific regulatory agencies are working for its purity, safety and efficacy are given below:  United States has mentioned the terminologies in Federal Food Drug and Cosmetic Act and given guidelines for it. Canada government has adopted the term Nutraceuticals and framed its own definition. Health Canada has given guidelines for nutraceuticals under the Food and Drugs Act.  FDA regulated dietary supplements as foods to ensure that they were safe and wholesome and that their labeling was truthful and not misleading.  Nutrition Labeling and Education Act of 1990 (NLEA) defines how food is labeled, including nutrition labeling, in accordance with definitions

established by FDA, and providing for the use of claims about the relationship between nutrients and diseases or health related conditions.  In 1994, DSHEA was passed as an amendment to the Federal Food, Drug, and Cosmetic Act (1938) to establish standards with respect to dietary supplements. Health Claims for Food FDA initially authorized seven health claims in 1993 as part of NLEA Since 1993, FDA has authorized four more, last was in October 1999.  The Indian Health and Dietary Supplement Association was created to represent pharmaceutical, nutraceutical, herbal, direct selling and other service oriented industry companies and plans to affiliate with the International Alliance of Dietary Supplement associations in the near future. The association is planning a scientific conference to bring the industry and government together to share information, experience and perspectives on the use and regulation of dietary supplements. The pressure from the industry and stakeholders for a single regulatory body and an integrated modern food law, the Food Safety and Standards Act, 2006 (FSSA) was enacted by the Government of India (GOI) after extensive consultation and formal legislative procedures.  In 1993, the Ministry of Health and Welfare in Japan established a policy of “Foods for Specified Health Uses” (FOSHU) by which health claims of some selected functional foods are legally permitted. In 2001, a new regulatory system, foods with health claims (FHC) with a ‘foods with nutrient function claims’ (FNFC) system and newly established FOSHU was introduced. In addition, the Govt. changed the existing FOSHU, FNFC and other systems in 2005. Such changes include the new Subsystems of FOSHU such as, Standardized FOSHU, Qualified FOSHU, Disease risk reduction claims for FOSHU. Further, there is lack of clarity in classifying functional foods and nutraceuticals. This causes confusion amongst the regulators. At times, the drug regulators are tempted to classify these products as drugs. This has resulted in trouble for genuine manufacturers. The revolutionary step to introduce Food Safety and Standards Act will replace the old PFA. The new act will take India on the path of new regulatory framework to make it capable of global competition. Innovative Concept of Nutragenomic The Term ‘Nutragenomics’ was first defined by R.O.Brennan in 1975 in his book nutrigenetics. Combination of genome science and technology find a new concept of food with a new function to prevent diseases, which is now termed as Nutraceuticals, further genome technique is called Nutragenomics3. Nutragenomics forms the scientific basis for developing nutrition adapted to the needs of consumer groups, to be healthy, at risk, or diseased. Nutrigenomics is recently developed

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methodology with combination of multiple genomic techniques and molecular biology technologies. Nutrigenomics contains the three omics disciplines gene, protein, and metabolite profiling (transcriptomics, proteomics, and metabolomics) as applied to the field of nutrition and health. Recently study on yeast showed that increasing the activity of a single gene, SIR2 could extend their life span. An analogous gene, SIRT1 was located in humans.  Polyphenols such as Quercetin found in apples and tea, found to increase SRT1 activity in a laboratory screening.  Resveratrol (found in grape and red wine) were found to increase SRT1 activity in a laboratory screening. Interestingly, Resveratrol was found to increase SRT1 activity 13-fold. 

In terms of chronic diseases, particularly relevant are the effects of dietary cholesterol and fatty acids on gene expression. Dietary cholesterol exerts a profound inhibitory effect on the transcription of the gene for β-hydroxy-β-methylglutaryl (HMG)- CoA reductase.

Role of R & D in Nutraceuticals1  To test safety, purity and potency of the products.  To develop more effective and efficient means of producing ingredients for use in products.  Develop the new products either by either by combining existing ingredients used in nutritional. Safety and Efficacy Now a day’s peoples are more conscious about their health and nutraceutical products offer the promised health benefits, but danger is associated with some product due to lacking of information about interaction and side effect. Nutraceuticals hold great potential, as an alternative to substance obtained by plant. Safety of a nutraceuticals product is often easier to establish than efficacy9,15. Studies that test doses of nutraceuticals several folds greater than the intended dose help to establish toxicity date. These studies must test the animals reactions to the product both short and long term. Finally, a lack of reported toxicity problems with any nutraceuticals should not be interpreted as evidence of safety. Yet, some time they also cause harmful effect as seen with ephedrine, a widely used botanical ingredient in weight-loss products. Above anything else, nutraceuticals should be safe. Stock should not be taken in the old adages, “if little is good, a lot is better” of “it can hurt”. Nutraceuticals, like many substances, may cause problems due to direct toxic effects, or by delay of more appropriate treatment. Cost is another factor that receives scant attention. These products sell for substantial amounts more than mainstream products, in as much as botanicals are costly to produce. New clinical applications of nutraceuticals are increasingly being reported, but there are fundamental differences between formulations, production and the evidences supporting clinical use. Nutraceuticals generally fall within the novel

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foods and ingredients regulations but their purity, dosage requirement and clinical consequence exceed those of most “health foods”. Conclusion Nutraceuticals is scientific area generated all over the world. In many cases nutraceuticals offer an advantage over the synthetic drugs under development by the pharmaceuticals industry. It is novel pharmacological activity that are become interesting in their possible clinical use and thus helping in prevention and therapeutic in several diseases, as nutraceuticals are beneficial in coronary heart disease, obesity, diabetes, cancer, osteoporosis and other chronic and degenerative diseases such as Parkinson's and Alzheimer's diseases. Evidences indicate that the mechanistic actions of natural compounds involve a wide array of biological processes, including activation of antioxidant defenses, signal transduction pathways, cell survival-associated gene expression, cell proliferation and differentiation and preservation of mitochondrial integrity. It appears that these properties play a crucial role in the protection against the pathologies of numerous age-related or chronic diseases. Now “nutraceutical a day may keep the doctor away” replace the old proverb “an apple a day will keep the doctor away”. Pharmaceuticals fail where consumers are turning massively to food supplements to improve well being. Reference 1.

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Diane E. Judge: What You Should Know About Nutraceuticals. The Female Patient 2006; 51-52.

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