INTRODUCTION:

The word “Nutraceutical” is the fusion of the “nutrition” and “pharmaceutical. The term “nutraceutical’’ become coined in 1989 with the aid of the foundation for innovation in medicine (New York, US).¹ Nutraceutical is an any non-toxic food aspect that gives health blessings which includes prevention and remedy of sicknesses. Nowadays there is an adoption of fast food and packaged food which leads increase in the illnesses and to reduce those illnesses, the nutraceuticals are the alternatives to the prescription drugs. By means of the usage of nutraceuticals, the want for conventional medicine is decreased.²

Plants are one among the foremost important resources of human foods and medicines. Unexpectedly raising knowledge on nutrition, medicine, and plant biotechnology has dramatically changed the concepts about food, fitness and agriculture, and brought during a revolution out on them. With latest advances in medical and nutrition sciences, natural products and health-promoting foods have obtained significant attention from both health specialist and the public. The nutraceuticals source contains the bioactive phytochemicals such as alkaloid, various terpenoids and polyphenols.³

There is growing recognition of the potential role for nutraceuticals and dietary supplements in helping to scale back health risks and improve health quality. Within the global marketplace, nutraceuticals and functional foods became a multi-billion-dollar industry. Functional foods are found virtually altogether food categories; however, products aren’t homogeneously scattered over all segments of the growing market.⁴

Many nutraceuticals, functional foods and naturally occurring compounds that are investigated and pronounced in various studies revealed that these products are extremely active, have profound impact on cell metabolism and sometimes have less adverse effect. It is natural that people’s attention is transferring to positive approach for prevention of diseases to live wholesome. Nutraceuticals is scientific area generated all over the nations. In lot of instances, nutraceuticals have advantage over the synthetic drugs under development by the pharmaceuticals industry. It’s novel pharmacological activity that become interesting in their possible clinical use and thus helping in prevention and therapeutic in several diseases. Most of the pharmaceuticals companies often lack motivation on pursue these difficulties in obtaining the patents.⁴

Fortified Foods	Ayurvedic Nutraceuticals
Calcium enriched idli	Antioxidants and bone density enhancer
Probiotic fortified yoghurt	curcumin
Buttermilk	Green tea extract
Omega 3 fortified health drinks and	Fish oil, Bramhi, Senna, Lutin
Baby foods	Sugar free Ayurvedic supplements
Dal and Atta noodles	Low calories sweeteners

Figure 1: Concept of Nutraceuticals ⁴

Classification of Nutraceuticals:

Nutraceuticals are considered as a nonspecific biological remedy used to reserve health, prevent malignant processes and manage signs. The nutraceuticals are classified as-

1. Nutrient

2. Herbal

3. Dietary Supplements

1. Nutrient:

Nutrients are the chemical compounds in the food that are used by body to function properly and maintain health.^5,6

Nutrients	Sources	Health benefits
Vitamin A	Fish liver oil, liver cheese, butter carrots, spinach, pumpkin, papaya	Antioxidant, essential, for growth and development and in the treatment of certain skin disorders.
Vitamin B	Cereals, pulses, nuts, yeast, liver, meat	Produce the genetic material of cells, formation of RBCs, maintenance of central nervous system and synthesize amino acids and metabolism of fats, protein and carbohydrates, helps to convert food in to energy, essential in neurologic functions.
Vitamin C	Citrus fruits, kiwifruit, Potatoes	Antioxidant, for healthy bones, gums, teeth, and skin, in wound healing, prevent common cold and attenuate its symptoms
Vitamin E	Wheat germ oil, cotton seed oil, peanut oil	Antioxidant, helps form blood cells, muscles, lung, and nerve tissue, boosts the immune system
Vitamin K	Cabbage, cauliflower, tomatoes,	Essential for blood clotting.
Folic acid	Green vegetables	Produce the genetic materials of cells, in pregnancy for preventing birth defects, RBCs formation, protects against heart disease
Calcium	Milk, cheese, curly kale, okra, spinach	Bones and teeth and maintaining bone strength important in nerve, muscle, and glandular functions
Iron	Red meat, pork, seafood, beans, spinach, peas	Energy production, carry and transfer oxygen to tissues
Magnesium	Spinach, nuts, legumes, seeds, and whole grains.	Healthy nerve and muscle function and bone formation, may help prevent premenstrual syndrome
Phosphorous	Meats, seafood, fish and nuts, fat free or low-fat milk	Healthy nerve and muscle function and bone formation, may help prevent premenstrual syndrome (PMS)
Chromium	Meats, grain products, nuts spices, brewer’s yeast, beer, and wine	With insulin helps to convert carbohydrates and fats into energy
Cobalt	Fish ,nuts, broccoli, spinach, oats	Essential component of vitamin B12, but ingested cobalt is metabolized in vivo to form the B12 coenzymes
Copper	Beef, oysters, potatoes	Essential for haemoglobin and collagen production, healthy functioning of the heart, energy production, absorption of iron from digestive tract
Iodine	Fish, milk products	Essential for proper functioning of the thyroid

2. Herbals:

Herbal nutraceutical is powerful instrument in maintaining health and to act against nutritional induced acute and chronic diseases.⁶

Herbs	Constitutes	Health benefits
Aloes	(Liliaceae) Aloins and aloesin Aloins, aloesin	Dilates capillaries, anti-inflammatory, emollien Dilates capillary, anti inflammatory, wound healing, emollient
Garlic	Allin, allicin	Anti-inflammatory, antibacterial, antigout
Ginger	Zingiberene, gingerols	Stimulants, hyperglycaemia, chronic bronchitis
Ginseng	Ginsenosides, panaxosides	Stimulating immune and nervous system
Green tea	Catechin, epicatechin	Prevent cardiovascular diseases, increasing the fat burning, antioxidants
Turmeric	Curcumin	Anti-inflammatory, antiarthritic, anticancer, antiseptic
Senna	Sennosides	Purgative
Liquorice	Glycyrrhizin, liquirtin	Anti-inflammatory, antiallergic, purgative
Valeriana	Valerenic acid, valerate	Tranquilizers, migraine and menstrual pain, intestinal cramps, bronchial spasm
Onion	Allicin, alliin	Hypoglycaemic activity, antibiotics, antiatherosclerosis
Echinacea	Alkylamide, echinacoside	Anti-inflammatory, immunomodulator, antiviral
Asafoetida	Ferulic acid, umbellic acid	Stimulant, carminative, expectorant

3. Dietary supplements:

Dietary supplements assure that one can get enough of the vital substances the body needs to function; others may help to reduce the risk of disease.⁵

Dietary supplements	Source	Health benefits
Ketogenic diet	Seafood, eggs, coconut oil, yogurt, cheese	Antiacne, weight loss, reduces the risk of cancer, improve heart health
Minimal refined grains	White flour, white bread, white rice	Anticancer, antidiabetics, reduce risk of obesity, lower the risk of stroke
Phytoestrogens	Soybeans, tofu, linseed, sesame seeds, wheat, berries, oats	Antiacne, prevent osteoporosis, fighting breast cancer, promoting heart health
Edible mushrooms	Agaricus bisporus, lentinus edodes, pleurotus spp.	Immunomudulator, lipid lowering, antitumor
Peptides/ hydrolysates	Eggs, meat, milk, beans soya, oats, flaxseeds	ACE inhibitor activity, reduces cholesterol, improve constipation and obesity
Glucosamine sulphate and chondroitin sulphate	Shellfish shells or fungi	Prevent osteoarthritis

Regulations of Nutraceuticals:

Due to increase in demand for nutraceutical products it needs regulatory authorities on product quality and safety to minimise the adverse events, toxicity, adulteration, misuse, overdose during human consumption. The goals of nutraceuticals regulation have been focused on safety and labelling with a lesser emphasis as compared to nutraceuticals on the product claims and intended use.

1. Regulation of nutraceuticals in India:

The regulatory authority of nutraceutical in India is Food Safety and Standards Authority of India (FSSAI) which came into existence in 2011.⁷ In Food Safety and Standards Authority of India (FSSAI) has defined regulatory guidelines for approval of nutraceuticals in the Indian markets. The FSSAI act consist of 21 Chapters and in that the 1 article that means 22 of the acts says about nutraceuticals, dietary supplements and various functional foods. The FSSAI regulates the nutraceuticals through the food safety and standards (FSS) act in which the FSSAI has notified the Food Safety and Standards regulations 2016 in the official Gazette 23 Dec 2016.

These regulations cover eight categories of food such as-

· Health supplements

· Nutraceuticals food for special dietary use.

· Food for special medical purposes.

· Specialty food containing plants or botanical.

· Foods containing Probiotics.

· Foods containing Prebiotics.

These foods are not permitted to contain harmonies, psychotropic ingredients but may approved use of colour and additives as permitted under the food safety and standards regulations, 2011.

FSSAI key requirement for manufacturing Nutraceuticals-

The FSSAI has standardized nutraceuticals so they will incorporate best of the elements are particular within the following schedules:

Schedule 1: list of vitamins and minerals.

Schedule 2: List of essential amino acids and other nutrients.

Schedule 4: List of plants and botanical ingredients.

Schedule 6: List of ingredients as nutraceuticals.

Schedule 7: List of strains of Probiotics.

Schedule 8: List of Prebiotics compound.

2. Regulations of Nutraceuticals in USA:

In US the nomenclature of nutraceuticals is dietary supplement and the regulations came in 1994.⁸ The nutraceuticals do not fall under the remit of FDA; they are monitored as dietary supplement. According to the dietary supplement, health, and education act (DSHEA) of 1994, the DSHEA defines a dietary supplement as a product intended to supplement the diet that bears one or more of the dietary ingredients such as vitamins, minerals, amino acids, herbs or other botanicals; a concentrate metabolite constituent extract or the combination of the above ingredients.⁶. The DSHEA removes the authority of FDA to regulate so called dietary supplement and considered them to be a separate regulatory category of food. Under the DSHEA the dietary supplement or dietary ingredients manufacturer is responsible for ensuring that the dietary supplement or ingredient is safe before it is marketed. The dietary supplement are consider safe until proven. The DSHEA says that the dietary supplement cannot contains anything that may have “a significant or unreasonable risk of illness or injury”.

According to the DSHEA a dietary supplement label must include the following:

· Name of each ingredient.

· Quantity of each ingredient.

· Total weight of all ingredients. (If a blend)

· Identity of a plant part used.

· The term dietary supplement

· Nutritional labelling information (calories, fat, sodium)

3. Regulations of Nutraceuticals in Europe:

The regulations of nutraceuticals are governed by the European Food Safety authority (EFSA). Within European Union (EU) law, the legal categorization of a nutraceutical is made on the basis of its effects on the body. If the substance contributes only to the maintenance of healthy tissues and organs it is considered to be a food ingredient. However, if it show a modifying effect on one or more of the body’s physiological processes, it is consider to be a medical substance. According to EU regulations, claims regarding the beneficial effects of nutraceuticals can only be “health claims” and not “medicinal claims”. Nutraceuticals are regulated as “food supplements” according to Directive 2002/46/EC of the European Parliament and Council of 2002 on the approximation of the laws of Member States relating to food supplements.

Current status of Nutraceuticals:

Within the era of packaged food and fast food, fitness conscious customers are ending. In the contemporary situation the end customers could be much more likely to be aware of the natural food as medication than tablet. There is a growing consciousness at the significance of vitamins and eating regimen for long term correct fitness.⁹ Due to the increasing importance of nutraceuticals they contributed to a favorable market conditions for Nutraceutical industry in India.

The nutraceuticals enterprise in India is one of the rapid growing markets within the Asia-Pacific location.³ To keep up with the growing competition, nutraceutical corporations are focusing their energies in growing new product and revolutionary formulations and the usage of right advertising strategies to assist consumers pick out the right products. The Indian dietary complement market consists of over 500 contributors. Nutrients and Minerals complement market is the maximum competitive with over 100 participants. The electricity of the Indian nutraceuticals market also emanates from certain deliver drivers, which location it amongst the strongest markets inside the global. Many of the supply drivers associated with the market are:

Higher GDP growth rate among the trillion-dollar economies.

A massive coastline spanning over 7,500 kms, with over 12 major and 200 minor ports make it a super manufacturing hub for the global value chain.

India is home to largest number of US FDA approved plants located outside the US, a sturdy testament to its ability to line itself towards global competitors.

India has the lowest labor costs among South Asia and South East Asian Nations.

India has adequate quantity of ingredients – India is the world’s second largest producer of fruits and greens, largest producer of milk and as of 2016, was the third largest market for active pharmaceutical ingredients; India has a big share of the international functional food and nutraceutical market, and exports products to various international location.

A few principles organizing marketing nutraceuticals in India are GlaxoSmithKline consumer healthcare, Dabur India, Cadila Health care, EID Parry’s, Zandu Pharmaceuticals, Himalaya herbal Healthcare, Amway, Sami labs, Elder pharmaceuticals and Ranbaxy.⁵

Marketed Formulations of Nutraceuticals:

For the health benefits of human beings, there are many nutraceutical products which are marketed by the different manufacturers.¹⁰ The nutraceuticals can be prepared and sold in the food format of capsules, tablet, granules, powder, liquid, jelly/gel, semi-solid etc. The primary challenge being faced by these products is the difficulty in formulating these products using the right dosage form. Besides, flavours and fragrance masking, the dosage form also needs to increase the stability of ingredients in the final product.

1. Capsules:

Consumer prefers dosage form like capsule as they are easier to swallow. Especially liquid filled capsules are considered to work faster and better. For nutraceutical companies capsules is an ideal formulation as it requires fewer excipients and manufacturing steps which leads to the faster development and offer more formulation flexibility.

Example:

a) Antioxidants with multivitamin and minerals capsules.

b) Biotin, minerals and amino acid capsules.

c) Carbonyl iron, folic acid, vitamin B12, vitamin C and zinc capsule.

2. Tablet:

Orally Disintegrating Tablets (ODTs) and chewable tablets offer young children, seniors and consumers known to have difficulty swallowing tablets a way to consume tablets virtually the same way as they do food, It's provide prolonged stability to medication.

Example:

1. Ferrous Ascorbate with folic + Zinc Tab

2. Carica Papaya Tablet

3. Vitamin D3 tablet

3. Liquid Dosage form:

The liquid dose is designed to offer short release of an ingredient. Nutralab gives diverse forms for liquid natural health products along with oral suspension, clear liquid solution, syrups and liquid sachet.

Example:

Natural fish oil with multivitamins

Claudine syrup (vit D3+magnesium+zinc)

Oxyclaps syrup (ascorbic acid+vit Essentially+zinc)

CONCLUSION:

In the modern era, nutraceutical substances have been used as an immunity booster and is the fastest growing segment of todays food industry. The importance of nutraceuticals to the human organism is that they provide all the essential substances that should be present in a healthy diet. So, it is natural that people’s focus is shifting to a positive approach i.e., nutraceuticals for prevention of diseases to stay health. In the present scenario of self-medication nutraceuticals play major role in therapeutic development. But their success depends on maintaining on their quality, purity, safety, and efficacy. In case of plant extracts and phytochemicals, various Indian companies have entered their place as supplier both locally just as around the world, which will help in prospering nutraceuticals sector in near future.

REFERENCE:

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Received on 12.04.2021 Modified on 17.05.2021

Res. J. Pharmacognosy and Phytochem. 2021; 13(3):126-130.

DOI: 10.52711/0975-4385.2021.00021