INTRODUCTION:

A dietary supplement is a substance that compassed the diet by increasing the total dietary intake. A dietary supplement is intended to provide nutrients. It includes vitamins, minerals and other less familiar substance-such as herbals, biochemical, amino acid, enzymes and animal extracts. Dietary supplement are also marketed in forms such as tablets, soft gels and gel caps. According to the United States food and drug administrations (FDA) dietary supplements are products which are not pharmaceutical drug, food additives or conventional food. It means products are not intended to prevent or treatment any disease.

Dietary supplements are regulated in United States law as a type of food rather than a type of drug. Generally government approval is not required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not. Food supplements are taken for various reasons, either to build good health, to compensate vitamins deficiency etc. Examples of food supplements include products like protein, vitamins and minerals or calories in the diet, and all these offer advantages and disadvantages⁽¹⁾. A company that is marketing dietary supplements is not required to prove that their products are safe or effective. Instead it is the responsibility of the U.S. Food and Drug Administration (FDA) to disprove the company’s claim if the claim has not been scientifically tested (FDA, 2006). This has caused consumers and providers to be misled by product quality.

Figure No 1. Shows the Global Vitamin and Supplement Market Share, (%), 2013

Dietary Supplements FDA Regulatory History:

The FDA regulates food and drug products listed in Figure 1. However, Dietary Supplements (DS) fall into their own category, exposing a loophole. Dietary supplements are not conventional foods, nor are they synthetic drugs, which can make clinical claims. Drugs are defined by the FDA as chemical compounds that can treat the effects of health conditions, alter any chemical part of the body, improve the quality of life, or cure ailments and diseases. Dietary Supplements are herbal supplements which use natural compounds to supplement an individual’s diet in order to improve the quality of life. They normally contain vitamins, minerals, herbs, or amino acids and are designed to supplement an individual’s diet, not as a replacement for food or medicine. This allowed DS to remain unregulated until congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994⁽²⁾.

FDA is responsible to prove that a DS is unsafe before pulling it from the market. Under DESHEA, companies were not required to report adverse effects from their products to the FDA. This was changed when congress passed the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act (NDCPA), which required manufactures of supplements to report serious adverse events. These reports must be submitted to the FDA so they can track trends and make determinations on the safety of the product in question. Requiring companies to report these serious adverse events holds manufactures responsible for their product. The table below shows the history of dietary supplement regulation.

Table No. 1 Shows that the history of dietary supplements regulation.

Year	Key event
1990	The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to require most foods, including dietary supplements, to bear nutrition labeling.
1994	DSHEA amended the Federal Food, Drug, and Cosmetic Act to create a new regulatory category, safety standard, labeling requirements, and other rules for dietary supplements. Under DSHEA, dietary supplements are generally presumed to be safe.
2002	The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act to require all food Companies, including dietary supplement companies, to register with FDA no later than December 12, 2003, to provide information on the name and address of the facility and, to some extent, the types of products they manufacture or sell.
2004	FDA was successful in banning ephedra after thousands of adverse events, including a number of deaths, and a lengthy legal process.
2006	The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the Federal Food, Drug, and Cosmetic Act to require dietary supplement companies that receive a serious adverse event report to submit information about the event to FDA.
2007	FDA finalized its Current Good Manufacturing Practice regulations to establish quality control standards for dietary supplements. The final rule became effective on August 24, 2007, but companies have 10, 22, or 34 months from the effective date of the rule to comply, depending on company size.
2007	Serious adverse event reporting requirements for dietary supplement companies became effective on December 22.

FDA Dietary Supplement Regulation: The FDA was created to help monitor the quality of food and prevent false claims. In 1906 a number of jam manufacturers were filling their product with less expensive materials to cut down the cost of each jar. This situation called for an increased regulation to protect the consumer. The legislation that passed would eventually become the template for the FDA. The modern FDA was born when Congress unanimously passed the Kefauver Harris Drug Amendments of 1962. This act was passed after a sedative used during pregnancy was linked to birth defects, showing Congress the need for an organization regulating food and drug companies. This new legislation tightened control over prescription drugs and required drug manufacturers to provide doctors with a complete list of the benefits as well as the risks. Since the Drug Act of 1962, hundreds of prescription drugs have been removed from the market because they failed to prove that they were safe and effective ⁽³⁾. FDA powers have continued to grow since their creation in 1976, when legislation was passed to insure the safety and effectiveness of medical devices. Since then the FDA’s powers and responsibilities have continued to grow, and currently their mandate includes assuring the safety and effectiveness of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation (FDA, 2012 Guidelines have been established concerning manufacturing practices in the production of ingested products. These guidelines are called Good Manufacturing Practice, or GMP, and provide companies with manufacturing standards to ensure that their products are not contaminated and maintain a high quality. Most importantly, the FDA monitors the process of bringing a new drug to the market and ensuring that a product is safe and effective before it can reach the market. Dietary Supplement and Nonprescription Drug Consumer Protection Act, was passed in 2006, by which FDA was empowered to oversee aspects of the dietary supplement market.⁽⁴⁾

Types of Food Supplements:

There are many types of dietary supplements.

1. Vitamins:

Vitamin is an organic compound required by an organism as a vital nutrient in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism and must be obtained from the diet. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals. Vitamin supplement is important for the treatment of certain health problems but there is less evidence of benefit when it is used in healthy persons.

Vitamin classification:

Vitamins are classified as either fat-soluble or water-soluble. The fat-soluble vitamins (vitamins that can mix with fat, but usually not with water) are vitamins A, D, E, and K; the water-soluble vitamins (can be dissolved/mixed in water) are vitamin C and the B-complex vitamins (based on their common source distribution and common functional relationships). Today we will narrow in on the later group.

Water-soluble vitamins, with the exception of vitamin C, are members of the B complex. Most of the B-complex group can be further divided according to general function: energy releasing, hematopoietic (refers to an agent or process that affects or promotes the formation of blood cells) and others. Other vitamins cannot be classified this narrowly because of their wide range of functions.

The water-soluble vitamins act largely as coenzymes, with small molecules combing with a larger protein compound (apoenzyme) to form an active enzyme that accelerates the interconversion of chemical compounds. Coenzymes participate directly in chemical reactions; when the reaction runs its course, coenzymes remain intact and participate in additional reactions. Water-soluble vitamins, similar to their fat-soluble counterparts, consist of carbon, hydrogen, and oxygen atoms. They also contain nitrogen and metal ions including iron, molybdenum, copper, sulfur, and cobalt. Because of their solubility in water, water-soluble vitamins disperse in the body fluids without being stored to any appreciable extent. If the diet regularly contains less than 50% of the recommended values for water-soluble vitamins, marginal deficiencies may develop within 4 weeks ⁽⁵⁾.

Vitamin B complex:

B-complex consists of eight different vitamins, which include thiamine (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5), piroxidine (B6), folic acid (B9), cyanocobalamin (B12), and biotin. All of the above are water soluble, and play a key role in several bodily functions, such as protein, fat, carbohydrate, and mitochondrial energy metabolism; maintenance of the liver, skin, hair, mouth, and eyes; plus so much more, which will be covered thoroughly within the following paragraphs. Vitamin B complex can also be classified into to 3 other categories i.e, energy releasing, hematopoietic, or other. And some fit in both categories. Here is a list:

Energy releasing-

Thiamine (B1), Riboflavin (B2), Niacin (B3), Pantothenic acid (B5), Piroxidine (B6), and Biotin.

Hematopoietic-

Folic acid (B9), Cyanocobalamin (B12), Pantothenic acid (B5), and Piroxidine (B6).

Others- Thiamine (B1), Niacin (B3), Piroxidine (B6), Folic acid (B9), and

Cyanocobalamin (B12). ⁽⁵⁾

There are 13 vitamins to maintain health – vitamins A, C, D, E, K and the eight B vitamins. Each has specific functions in the body: vitamin C helps to keep cells healthy, vitamin A is good for eyesight and healthy skin, vitamin D helps to regulate calcium and is essential for strong bones and teeth, and vitamin E is needed to maintain cell structure. With a few exceptions (niacin and vitamin D), our bodies cannot make these substances, meaning we need to obtain them from other sources such as food. If you have low levels of certain vitamins, you may develop a deficiency disease. Too little vitamin D, for example, could lead to rickets in children ⁽⁶⁾.

Figure No 2. Shows the Vitamins and dietary supplements, Euro monitor International 2010

2. Dietary supplements:

These are required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules. The term "dietary mineral" is archaic, as the substances it refers are chemical elements rather than actual minerals. ⁽⁷⁾

3. Herbal medicine:

Plants have been the basis for medical treatments through much of human history, and such traditional medicine is still widely practiced today. These are the form of alternative medicine, is not strictly based on evidence collected by the scientific method. Modern medicine, uses many plant-derived compounds as the basis for evidence-tested pharmaceutical drugs, and physiotherapy works to apply modern standards of effectiveness testing to herbs and medicines that are derived from natural sources.

4. Amino acids and proteins:

These are important organic compounds consists of of amine (-NH2) and carboxylic acid (-COOH) functional groups, along with a side-chain specific to each amino acid. Carbon, Hydrogen, Oxygen, and nitrogen are the major elements of Amino acids, though other elements are found in the side-chains of certain amino acids.

Amino acids can be divided into three categories: essential amino acids, non-essential amino acids, and conditional amino acids. Human body cannot synthesis Essential amino acids, and must be supplied by food. Non-essential amino acids are made by the body from essential amino acids or in the normal breakdown of proteins. Conditional amino acids are not essential, apart from conditions like illness, stress, or for someone challenged with a lifelong medical condition.

5. Essential fatty acids:

These are also very important for good and healthy growth of human body. Essential fatty acids are the important elements that humans and other animals must ingest because the body requires them for good health but cannot synthesize them. "Essential fatty acid" defined as fatty acids required for biological processes but does not include the fats that only act as fuel ⁽⁸⁾

6. Bodybuilding supplements:

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding and athletics. These may be used to replace meals, enhance weight gain, improve weight loss or improve athletic performance. Glutamine, essential fatty acids, meal replacement products, creatine, weight loss products and testosterone boosters are used mostly over all. Supplements are marketed either as single ingredient preparations or in the form of "stacks" - proprietary blends of various supplements marketed as offering synergistic advantages⁴.

7. Omega 3 Supplements:

In the past 10 years, many Americans have turned to omega-3 fish oil supplements, which have benefits for healthy people and also those with heart disease.Omega-3 fish oil contains both docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Omega-3 fatty acids are essential nutrients that are important in preventing and managing heart disease.

Findings show omega-3 fatty acids may help to:

1. Lower blood pressure

2. Reduce triglycerides

3. Slow the development of plaque in the arteries

4. Reduce the chance of abnormal heart rhythm

5. Reduce the likelihood of heart attack and stroke

6. Lessen the chance of sudden cardiac death in people with heart disease

The American Heart Association (AHA) recommends that everyone eats fish (particularly fatty, cold water fish) at least twice a week. Mackerel, herring, sardines, lake trout, Salmon and tuna contain high omega-3 fatty acids.

8. Fibre Supplement:

Fibre supplements are the subgroup of functional dietary fibre, and in the United States are defined by the Institute of Medicine (IOM). According to them, functional fibre "consists of isolated, non-digestible carbohydrates which are beneficial physiological effects in humans". Fibre supplements are available in the forms such as powders, tablets, and capsules. It helps in lowering blood cholesterol, alleviating irritable bowel syndrome, reducing the risk of colon cancer, and increasing feelings of satiety ⁽⁸⁾.

9. Minerals Supplements:

Minerals support a wide variety of functions in human body. These are especially helpful when one is on a calorie-restricted diet or because you don’t like eating particular foods containing a specific nutrient. However, consuming too much of some vitamins or minerals can adversely affect well-being of human body. Toxicity can also occur from overconsumption of minerals. Vitamins act as a catalyst in the metabolic reaction that produces energy from the fuel stores and assist in the production of red blood cells, the repair of tissues and protein synthesis. Minerals activate enzymes for energy production through glycolysis and improve immune system. Electrolytes available in minerals affect muscle concentration and iron is important for the formation of haemoglobin.

10. Calorie Supplements:

High-calorie supplements are beneficial when dealing with some health conditions. AIDS and anorexia can also result in body wasting. Protein, carbohydrates and healthy fats add both nutrients and calories to prevent weight loss during recovery. Picky eaters, rapidly growing children or extreme athletes might also benefit from high-calorie supplements. In the absence of any of these conditions, however, consuming this type of food supplement may merely add extraneous calories to your diet, resulting in accumulation of excess body fat.

Significance of Food Supplements:

Supplements improve overall physical performance. These are often taken by athletes to improve their performance. Food supplements can also prevent a variety of diseases and health conditions. For example, pregnant women are advised to take folic acid to prevent birth defects. Sometimes supplements are used in combination with drugs as a method of complementary or alternative treatment for health conditions⁽⁹⁾.

Disadvantages of Food Supplements:

Because dietary supplements are not as strictly regulated as drugs, their effectiveness may not be as dependable. Some supplements may be toxic and cause serious side effects hen taken in a excess dose. Vitamin A toxicity, for example, can cause liver damage, blurred vision, headaches, bone pain and swelling, drowsiness and nausea. Supplements can cause interaction with medications, which can cause unwanted side effects and decrease the efficacy of the medicine.

Food Supplement Markets in India:

India is still a nascent market for nutraceuticals and dietary supplements. The Indian dietary supplements market has now become highly attractive because of growing health consciousness and affluence among consumers. It is projected to grow at a CAGR of 18.46 percent from 2013 to 2018 vitamin and minerals segment dominates the sector. Herbal supplements has also been witnessing rapid rise in demand with more and more people shifting away from synthetic products to natural products. Dietary supplements targeted at women and children have a bright future. Preventive dietary supplements for diseases such as cancer, diabetes, obesity and arthritis are also much sought after. Vitamins supplements have a strong market share at present followed by protein and iron supplement. The dietary supplement market in India is largely untapped. To realize its full potential, it is necessary for players in the sector to adopt an FMCG marketing model to understand consumers’ taste and devise appropriate strategies. The sector also needs to invest time and money in research and development. Potential entrants into this segment need to assess various influencing elements such as the classification of the product, regulations, route to market and target customer. Dietary supplements play an important role in the development of India’s nutraceutical market. However, this will depend on purity control, efficiency and safety. Hence, a strong regulatory framework is an urgent requirement ⁽¹⁰⁾.

Figure No 3. Shows the Nutraceuticals Market in India (2010-20)

Increasing rate of chronic diseases has emphasized the need of Prevention over Intervention. The Nutraceutical industry is already facing intense competitive pressure wherein companies are seeking new opportunities or geography expansion in the functional food, beverage, and supplement (FBS) market.

The key reasons for this have been the increased incidence of lifestyle diseases the world over, increase in life expectancy and inadequate nutrition. The current lifestyle has helped the global market to grow over $160 billion. India and China have a long history of using herbs to treat illness and diseases. Japan and China have historically been the largest markets of the nutraceuticals sector in the entire Asia-Pacific region, while India in the recent past has observed a robust growth. Japan continued to dominate the Asia-Pacific market for nutraceuticals in 2013 with an estimated market size of -$40 billion. The nutraceutical market in India is growing at a compound annual growth rate (CAGR) of -18% and is expected to be worth -US$ 2.4 billion by the end of 2014.

In this report, we have discussed Dietary Supplements market in India and global, and the key ingredient manufacturer in India. Report also highlights the ongoing Research and development going in these companies. Acquisition of Natrol Inc. by Aurobindo Pharma for $130m is another example where an Indian Pharma companies entering into nutraceutical space was well received and seen a positive move by the market and investors⁽¹¹⁾.

Figure No 4. Shows the Percentage Market Share of Nutraceuticals in the World

Table No. 3 Shows the Market- Overview of Food Supplements, Vitamins and Minerals

CONCLUTION:

Dietary supplements should not be taken to treat a health condition, without consulting a health care provider. The term "natural" doesn't always mean safe, a supplement's safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used. Certain herbs (for example, comfrey and kava) can harm the liver. Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of unexpected side effects, especially when taking a new product.

Supplements can cause harm when people take them instead of prescribed medicines or when people take many supplements in combination. Some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person's response to anesthesia. Here are just a few examples: Vitamin K can reduce the ability of the blood thinner Coumadin® to prevent blood from clotting. St. John's wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs' effectiveness. Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy. As a result, someone may be getting more of these ingredients than they think, and more might not be better. For example, getting too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.

Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of unexpected side effects, especially when taking a new product.

REFERENCE:

1. Available at:

http://www.gyananalytics.com/toc2015/Synopsis%20and%20TOC%20-%20%20Sectoral%20Capsule%20-%20Dietary%20supplement%20market%20in%20India%20(2013%20-%202018).pdf, collected on 02/09/2015.

2. Available at:

http://www.prnewswire.com/news-releases/dietary-supplements-world-of-opportunities-in-the-indian-healthcare-market-2015-300061952.html, collected on 02/09/2015.

3. Available at:

https://en.wikipedia.org/wiki/Dietary_supplement, collected on 08/09/2015.

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https://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx, collected on 08/09/2015.

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https://www.wpi.edu/.../Dietary_Supplement_Company_Evaluation.pdf, collected on 08/09/2015.

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http://www.webmd.com/hypertension-high-blood-pressure/guide/omega-3-fish-oil-supplements-for-high-blood-pressure, collected on 08/09/2015.

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Received on 18.02.2018 Modified on 04.03.2018

AsianJ.ResearchChem.2018;11(3):691-697.

DOI: 10.5958/0974-4150.2018.00122.0

Vitamin	Physiologic roles	Deficiency
Thiamin (B₁)	Co-enzyme functions in metabolism of carbohydrates and branched-chain amino acids	Beri-beri, polyneuritis, and Wernicke-Korsakoff Syndrome
Riboflavin (B₂)	Co-enzyme functions in numerous oxidation and reduction reactions	Growth, cheilosis, angular stomatitis, and dermatitis
Niacin (nicotinic acid and nicotinamide)	Co-substrate/co-enzyme for hydrogen transfer with numerous Dehydrogenases	Pellagra with diarrhoea, dermatitis, and dementia
Vitamin B₆ (pyridoxine, pyridoxamine, and pyridoxal)	Co-enzyme functions in metabolism of amino acids, glycogen, and sphingoid bases	Naso-lateral seborrhoea, glossitis, and peripheral neuropathy (epileptiform convulsions in infants)
Pantothenic acid	Constituent of co-enzyme A and phosphopantetheine involved in fatty acid metabolism	Fatigue, sleep disturbances, impaired coordination, and Nausea
Biotin	Co-enzyme functions in bicarbonate-dependent Carboxylations	Fatigue, depression, nausea, dermatitis, and muscular Pains