“Nutraceutical and its Benefits”

PROJECT WORK SUBMITTED TO DEPARTMENT OF PHARMACY,

JAGAN NATH UNIVERSITY DELHI NCR BAHADURGARH

FOR THE PARTIAL FULFILLMENT AS PER THE REQUIREMENT

FOR THE COMPLETION OF B.PHARMACY 8TH SEMESTER

Under the guidance of

Ms. Preeti
(Assistant Professor),

Department of Pharmacy

SUBMITTED BY
Gourav
Roll No.:- 160120028
Jagannath University, Delhi NCR Bahadurgarh

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 CERTIFICATE

This is to certify that project report entitled “Nutraceutical and its Benefits” being submitted
by Pharmacy student of 8th semester of Department of Pharmacy, Jagannath University Delhi
NCR Bahadurgarh, Haryana is a record of student own work carried out by them under this
department.

Submitted by - Gourav Supervised by - Ms. Preeti

B.Pharm (8th Sem.) (Assistant Professor)

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 ACKNOWLEDGEMENT

Above all, great acknowledgement is made to Ms. Preeti, Assistant. Professor, Dept. Of
Pharmacy, JaganNath University Delhi NCR Bahadurgarh who imbibed inus, the knowledge &
skills. Since, most of the information in this report is a result of collection from various sources
such as books & Internet. The information gained anonymously has been instrumental in
completion of this report. So, again special thanks to these anonymous sources.

“Any accomplishment requires the effort of many people & this work is no different.”
Last but not the least, we would like to take this opportunity to thank all our teachers who have
taught us with all their dedication & effort and have always been a great blessing & support.

Once again, thanks to all those who contributed in the successful accomplishment of making of
this report that we could make this report effective? Without his guidance & support, making of
this report would have seemed a very-very difficult task. We wish to express our gratitude to
those who’ve contributed to our work, even though anonymously.

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 TABLEOF CONTENTS

S.NO. CONTENT PAGE NUMBER

1. Abstract 5

2. Introduction 5-6

3. Classification of Nutraceutical 6-9

4. Nutraceutical Revolution & 10-14

Market Trends

5. Benefits & Future Prospective 15-19

6. Conclusion 20

7. Bibliography 21-25

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Nutraceutical

Abstract

In recent years there is a growing interest in nutraceuticals which provide health benefits and are
alternative to modern medicine. Nutraceutical-rich vegetables and fruits are an important
component of a healthy diet. It has been shown that people consuming healthy diets, living active
lifestyles, not smoking and not indulging in excessive alcohol consumption tend to have a
reduced risk of CVD. There has been an explosion of consumer interest in the health enhancing
role of physiologically-active specific nutraceuticals. Such products include food supplements,
dietary supplements, value-added processed foods as well as non-food supplements such as
tablets, soft gels, capsules etc. Traditional use of medicines is recognized as a way to learn about
potential future medicines. The World Health Organization estimates that 80 percent of the
world’s population presently uses herbal medicine for some aspect of primary health care. The
concept of nutraceutical has been accepted internationally. The terms “functional foods” and
“nutraceuticals” are emerging out of benefits from foods that go beyond those attributable to
essential nutrients. In recent years there is a growing interest in nutraceuticals which provide
health benefits and are alternative to modern medicine. Nutrients, herbals and dietary
supplements are major constituents of nutraceuticals which make them instrumental in
maintaining health, act against various disease conditions and thus promote the quality of life.
The explosive growth, research developments, lack of standards, marketing zeal, quality
assurance and regulation will play a vital role in its success or failure.

Introduction
About 2000 years ago, Hippocrates correctly emphasized “Let food be your medicine and
medicine be your food.” The term “Nutraceutical” was first coined by Dr. Stephen L. Defelice as
“a product isolated or purified from foods and sold in medicinal forms. They have physiological
benefit” Nutraceutical is a Combination of two words, Nutrition and Pharmaceutical.
Nutraceuticals are food product that provides health as well as medical benefits, including the
prevention and treatment of disease. Phytochemicals and antioxidants are two specific types of
nutraceuticals. Research has proved that foods with phytochemicals may help to provide
protection from diseases such as cancer, diabetes, heart disease, and hypertension, e.g.
carotenoids found in carrots [1]. With the passage of the Dietary Supplement Health and
Education Act of 1994, the definition of nutraceuticals has been expanded to include vitamins,
minerals, herbs and other botanicals, amino acids and any dietary substance for use by humans to
supplement the diet by increasing total dietary intake and subsequently increased the use of
nutraceuticals dramatically. In recent years there is a growing interest in nutraceuticals which
provide health benefits and are alternative to modern medicine. Nutrients, herbals and dietary
supplements are major constituents of nutraceuticals which make them instrumental in
maintaining health, act against various disease conditions and thus promote the quality of
life.“Because of their perceived safety and possible nutritional and therapeutic advantages,
nutraceuticals and functional foods have attracted a lot of attention.” The nutraceutical and
functional food industries are in a good position to take advantage of consumer interest in these
products. Whether it’s a big pharmaceutical corporation, a nutritional company, a large food
multinational, or a tiny vitamin-selling company, all are aware of changing patterns and the

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growing health-conscious customer trend. As a result, there is a proliferation of these value-
added goods targeted at not only maintaining one’s health but also the prevention and treatment
of a variety of conditions ranging from heart disease to cancer [2].

Definitions
Several terms need to be defined in order to gain an understanding of nutraceuticals.

 Nutrient: As defined by AAFCO (1996), “a feed constituent in a form and at a level that
will help support the life of an animal.” The chief classes of feed nutrients are proteins,
fats, carbohydrates, minerals and vitamins.

 Feed: As defined by AAFCO (1996), “edible materials which are consumed by animals
and contribute energy and/or nutrients to the animal’s diet.”
 Food: As defined by the Food, Drug and Cosmetic Act (1968), “an article that provides
taste, aroma or nutritive value. Food and Drug Administration (FDA) considers food as
‘generally recognized as safe’ (GRAS)

 Drug: As defined by AAFCO (1996), “a substance intended for use in the diagnosis,
cure, mitigation, treatment or prevention of disease in man or other animals. A substance
other than food intended to affect the structure or any function of the body of man or
other animals.”

 Dietary Supplement: As defined by the Dietary Supplement Health and Education Act
(DSHEA, 1994), “a product that contains one or more of the dietary ingredients such as
vitamin, mineral, herb or other botanical, and amino acid (protein) also includes any
possible component of the diet as well as concentrates, constituents, extracts or
metabolites of these compounds.”

 Nutraceutical: As commonly defined by the dietary supplement industry, “any nontoxic

food component that has scientifically proven health benefits, including disease treatment
and prevention.”

 Veterinary Nutraceutical: As defined by the newly created North American

Veterinarian Nutraceutical Council, Inc. (NAVNC), “a substance which produced in a
purified or extracted form and administered orally to patients to provide agents required
for normal body structure and function and administered with the intent of improving the
health and wellbeing of animals.”

Classification of Nutraceutical
In order to distinguish between the wide varieties of products there are multiple different types of
products that fall under the category of nutraceuticals that are described below :-

1.) Dietary supplements

A dietary supplement is a product that contains nutrients derived from food products that are
concentrated in liquid or capsule form. Dietary supplements include- Vitamins, minerals, co-

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enzyme Q, carnitine, etc. The Dietary Supplementation Health Education Act (DSHEA) formally
defined “dietary supplement” using several criteria. A dietary supplement:
• 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, an herb or other botanical,
an amino acid, 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 conventional food or as the sole item of a meal/ diet.
• is labelled as a “dietary supplement.
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that
was marketed as a dietary supplement or food before approval, certification, or license (unless
the Secretary of Health and Human Services waives this provision) [3].

2.) Functional Foods

Functional foods are designed to allow eating enriched foods close to their natural state, rather
than by taking dietary supplements manufactured in liquid or capsule form. Sometimes,
additional complementary nutrients are added, such as vitamin D to milk [4]. (E.g. Oats, bran,
psyllium and lignins for heart disease and colon cancer Prebiotics – oligofructose for control of
intestinal flora, Canola oil with lowered triglycerides for cholesterol reduction, etc.

3.) Medical Foods

Medical foods are foods that are specially formulated and intended for the dietary management
of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.
Medical foods aren’t available as an over-the-counter product to consumers. The FDA considers
medical foods to be “formulated to be consumed or administered internally under the supervision
of a physician, and which is intended for the specific dietary management of a disease or
condition for which distinctive nutritional requirements, on the basis of recognized scientific
principles, are established by medical evaluation.” Medical foods can be ingested through the
mouth or through tube feeding. Medical foods are closely monitored by medical supervision [5].

4.) Farmaceuticals
The term farmaceuticals is more frequently associated, in agricultural circles, with medical
applications of genetically engineered crops or animals. Farmaceutical is a melding of the words
farm and pharmaceuticals. It refers to medically valuable compounds produced from modified
agricultural crops or animals (usually through biotechnology). E.g. Transgenic cows and
lactoferrin for immune enhancement, transgenic plants for oral vaccination against infectious
diseases. [6].

Macronutrients and micronutrients

1.) Vitamins

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There is much information about the essential roles of various vitamins in maintaining normal
metabolism and health status. Deficiency of any kind of vitamins can cause distinguishable
cinical symptoms. Scientific knowledge about vitamin metabolism and functions are well
accumulated. Therefore, most nutraceuticals or nutritional therapy products contain some
vitamins, such as common vitamins like vitamin A, vitamin B, vitamin C, vitamin D, and
vitamin E. Alarge portion of vitamin sources for human beings is from plant foods, plant
biotechnology thus has been used for improvement of contents of vitamins in crops. An excellent
example is “Golden Rice”, a transgenic rice with a high level of the pro-vitamin a β carotenoids
in its grains. Currently, absorption studies with Golden rice are being carried out with humans, to
test the efficiency of absorption and conversion of beta-carotene into vitamin A. The dairy
starterbacterium Lactococcuslactis has the potential to synthesize both folate (vitamin B 11)
andriboflavin (vitamin B2). Vitamin C is essential to prevent disease associated with
connectivetissue and improve cardiovascular and immune cell functions, and it is also used to
regenerate vitamin E. Vitamin E has been touted as a panacea for age related diseases, including
cardiovascular disease and Alzheimer’s disease and, thus, the demand for this nutraceutical has
increased dramatically in recent years. These vitamins over producing crops, such as soybean
and barley, not only increase nutritional value of foods, but also can make such foods as good
medicines served for vitamin-deficient people.

2.) Minerals
Ca, I, Zn, Fe, Mn, Mg, and other mineral elements are essential components for human health.
Deficiency of any one of these minerals may cause serious health problems. Dietary Ca, Zn, Fe,
and other minerals are taken from both meats and plant foods. Due to various reasons, mineral
deficiencies, mainly Ca, Zn, and Fe deficiencies, are the major health problems in developing
countries, particularly for infants and children. Zn or Fe deficiency causes poor growth, impaired
immune function, and delayed mental development. Although numerous mineral supplements or
mineral-containing nutraceuticals are available on the market, poor absorption of Ca, Zn, and Fe
by the humans significantly limits effectiveness of these supplements. Nevertheless, increasing
dietary Ca, Fe, and Zn in plant foods is an important strategy to enhance mineral nutrition [7].

Figure 1:-Nutraceuticals

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3.) Flavonoids
As multiple benefits of eating flavonoid rich plant foods for human health are well documented,
increasing particular bioactive flavonoid species in plant foods has become of great interest.
Genetically modified tomatoes contain high levels of flavonols such as quercetin, kaempferol,
and glycosides and flavones such asluteolin, lycopene and luteolin-7-glucosidein their peel
tissue, resveratrol level in Brassica napus seed has also dramatically increased. Most flavonoids
from flavonoid rich foods are extensively metabolized by human body, which can affect their
antioxidant capacity. Flavonoids are absorbed from the gastrointestinal tracts of humans and
animals and excreted either unchanged or as flavonoid metabolites in the urine and faeces. In
addition to flavonoids, fruits and vegetables contain many macro- and micronutrients that may
directly or indirectly affect their absorption, activity, and metabolism. Absorption and
metabolism of most plant secondary metabolites can occur either inside the gut (such as by
microorganisms) or inside liver cells by P-450 enzymes.

4.) Terpenoids
Terpenoids are the most diverse and largest class of plant natural products with wide industrial
application, as pro-vitamin A, vitamin E, flavours, pharmaceuticals, perfumes, insecticides, and
anti-microbial agents. Other valuable terpenoid compounds that have been modified include the
introduction of b-carotene to tomato fruits and rice and zeaxanthin to potato tubers. Tomato is a
major food crop and the principal source of the carotenoidlycopene. Epidemiological studies
have clearly shown the great benefits of consumption of tomato to human health due to tomato
carotenoids, mainly lycopene, β-carotene, and lutein [8].

Importance of Nutraceuticals
Today consumers are strongly concerned about their food habits, health and lifestyle. With
globalisation and economic development the quality of life has improved. Besides development a
major challenge in the form of lifestyle diseases has also grown up. 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.
The word nutraceutical arises from two broad terms- “Nutrition” and “Pharmaceutical”. These
products may range from isolated nutrients, dietary supplements and specific diets to genetically
engineered designer foods and herbal products [9-10]. Nutraceuticals can be defined as
“alternative beneficial products designed wholly or partly from food that maintains optimal
health and act against nutritionally induced diseases, thereby promoting the quality of life.”From
the consumers’ point of view functional foods and nutraceuticals offer many benefits.
• Increase the health value of our diet.
• Help us live longer.
• Help us to avoid particular medical conditions
• Perceived to be more “natural” than traditional medicine and less likely to produce unpleasant
side-effects
• May present food for populations with special needs (e.g. nutrient-dense foods for the elderly)

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[11].
• Used for the prevention, treatment or cure of a condition or disease
• It can be administered with a view to restoring, correcting or modifying physiological functions
in human beings.
• Nutraceuticals not only supplement the diet but also aid in the prevention and/or treatment of
disease and/or disorder.
• Nutraceuticals are represented for use as a conventional food or as the sole item of meal or diet
[12].

Nutraceutical Differ From Functional Food

Nutraceuticals slightly differ from functional foods. 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 anaemia,
it is called a nutraceutical. (Since most of the functional foods act in some way or the other as
antianemic, the exception to anaemia is considered so as to have a clear distinction between the
two terms, functional food and nutraceutical.) Examples of nutraceuticals include fortified dairy
products (e.g. milk) and citrus fruits (e.g. orange juice)[13].

Nutraceutical 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[14].
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.

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 [15-
16].

Research and Development

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

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investments [17]. Powerful market forces are fueling the interest in nutraceuticals: [18]
• 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 nutraceutical

• 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 supplements[19].

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 nutraceuticals shown in Figure 1 [20].

Figure 2 :- Percentage Area Covered By Nutraceutical Products

Various Nutraceutical Used in Different Disease[21]

Nutraceuticals have been claimed to provide physiological benefits or provide protection against
the diseases listed below (and/or have been discovered to behave as) :-

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  Cardiovascular agents
 Antiobese agents
 Antidiabetics
 Anticancer agents
 Immune boosters
 Chronic inflammatory disorders
 Degenerative diseases
 Rheumatoid Arthritis
 Cholesterol Lowering
 Blood pressure
 Digestive problems
 Osteoporosis

Sr. No. Disease Examples

1 Alzheimer Vitamin E and Vitamin C

2 Cardiovascular Flavonoids(onion, black grapes)

3 Parkinson Vitamin E

4 Obesity Chitosan, Vitamin C

5 Diabetes Calcium, Vitamin D,

Emblicaofficinalis

6 Osteoarthritis Glucosamine, Chomdroitinsulfate

7 Constipation Buck wheat

8 Vision improving Carrot, Mangoes, Spinach, Kiwi

9 Antioxidant Oats, Fruits, Carrots

10 Anti-inflammatory Turmeric

11 Hypertension Curry leaf, Green tea

12 Hyperlipidemia Emblicaofficinalis

Market Trends for Nutraceutical

The nutraceutical industry’s three main segments include functional foods, dietary supplements,

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and herbal/natural products [22]. Nutrition BusinessJournal (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) [23]. 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 (Figure 4)
[24].
Global market of nutraceutical is very huge. Nutraceuticals are hugely popular among consumers
in the U.S. and other parts of the world. In Japan, England and other countries,Nutraceuticals
already have become part of the dietary landscape. Indian nutraceutical market is in infant stage
but growing at very fast rate. Indian society has always been open to new concepts and quick to
adapt. Due to increased physician acceptance of the medical benefits of nutritional products
increased market demand of nutraceuticals. Consumers dissatisfied with drug costs and
conventional healthcare are turning to unproven and untested natural products for treatment and
prevention.
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. Future demand of nutraceutical
depends on consumer perception of the relationship between diet and disease.

Figure 3 :- Nutraceutical Market in different countries.

Global Nutraceutical Products Market, by Region

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  North America – U.S, Canada. Europe – Germany, U.K, France, Italy, Spain and Rest of
Europe.
 Asia Pacific – China, India, Japan, Australia, New Zealand and Rest of Asia Pacific.
 Latin America – Brazil, Mexico, Rest of Latin America.
 Middle East & Africa – GCC Countries, South Africa, Rest of middle East & Africa.

On the basis of type, the nutraceutical products market has been segmented as
follows:
 Food – Snacks, Confectionery products, Bakery products, dairy products, Infant products
 Beverages – Health drinks, Energy drinks, Juices. Dietary
 Supplements – Tablets, Liquid, Powder, Others (gummies,and chewable products)

On the basis of distribution channel, the market has been segmented as

follows:
 Conventional stores – Grocery stores, Mass merchandisers, Warehouse clubs, Online
retailers.
 Specialty stores – Bakery stores, Confectionery stores, Gourmet stores, Health centres.

Nutraceuticals as Clinical Study

1.) Healthy Fats (MUFA ω-9 and PUFAs ω-3 and ω-6).
Monounsaturated fatty acids and polyunsaturated fatty acids are linked or connected with a
reduced chance of coronary heart disease [25].

2.) Monounsaturated Fatty Acids (MUFA/ω-9).

On the basis of 7 nations’ statistics, the death rate from “CHD” became specifically low in
Mediterranean nations, wherein the olive oil has been used, which is exceedingly enhanced with
MUFA and fats. The protective impact of MUFA inCompetition with CHD became additionally
supported via using a retrogression investigation of information from the“nurse health” look at of
80082 females observed for much less than 14 years and additionally found a fantastic affiliation
amongst consumption of MUFA and CHD danger[26–28]. We have got presently stated in
asymptomatic excessive cardiovascular chance topics that consumption of traditional
Mediterranean weight-reduction plan augmented with virgin olive oil actively regulates the
articulation of lead chromosome concerned in vascular irritation, foam cell process, and
thrombosis inside the course of an thrombotic profile [29].

3.) Polyunsaturated Fatty Acids (PUFAs).

ALA (“α-linolenic acid”) and LA (“linoleic acid”) belong to the ω-three(“omega-3”) and ω-6
(“omega-6”) collection of PUFA separately. The resources of omega three and omega six are
sea-food and fatty fish, optimum vegetable oils, grains, and walnuts. PUFA omega-three fatty
acids show potent primary and secondary prevention or cure of cardiovascular disorder[30].

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Polyunsaturated fatty acids are traditionally useful for human health [31, 32] which is based on
the two types of omega-3 and omega-6 series. The health benefit of the ω-three and ω-six ratio in
macroalgae allows their use in the method of practical meals and convenience food. These fatty
acids lessen the possibility of chest, colon, prostate, and renal cancers, and other effects are
suppressing inflammation, asthma, and rheumatoid arthritis [33]. It is especially used in
cardiovascular and inflammatory diseases and skin health [34].

4.) Cholesterol Reduction.

All agents reduce LDL cholesterol absorption in the intestinal gut and additionally reduce plasma
LDL concentrations. A metaevaluation of forty-one trials showed that consumption of 2 gm/day
of stanols or sterols decreased LDL concentration by using about teneleven% [35]. The
“American Heart Association” and “European Current Dietary Guideline” aid plant sterols as a
healing option for people with improved levels of cholesterol [36,37]. In a pooled evaluation of
ten prospective cohorts, each10 gm/day increment of energy-adjusted general nutritionalfiber
becomes associated with a 14% lower hazard ofcoronary activities and a 27% decrease in the
hazard of coronary loss of life [38].

5.) Coenzyme Q-10 (CoQ-10).

CoQ-10 is an herbal food substance, and its miles are used for functional food and dietary
supplements. It is an internal lipophilic substance, which is a crucial or useful substance of
mitochondrial strength biotransformation and additionally effective for antioxidants and effective
for human fitness [39,40]. CoQ-10 limited deterioration of viscoelasticity and reduce the wrinkle
7 microrelief lines and improved/increased skin smoothness/fairness [41].

Benefits of Nutraceutical
From the consumers’ point of view, functional food 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 present food for populations with special needs (e.g. nutrient-dense foods for the elderly)
[42].

Bridging the gap between food and medicine

Hippocrates highlighted around 2000year ago “Let food be your medicine and medicine be your
food”[43]. Nutraceuticals are foods or food ingredients that provide medical or health benefits.
This emerging class of products blurs the line between food and drugs [44].
They do not easily fall into the legal Categories of food or drug and often inhabit a greyarea
between the two [45]. 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.

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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 (Figure 4) [46]. 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 [47].

Figure 4 :-Nutraceutical inhabit a grey area between the food andthe drug.

Effectiveness and Safety

1. Regulatory Aspects. The regulation of nutraceuticals presents a noteworthy challenge to

the globalization of nutraceuticals, with a murky and somewhat dissimilar definition of
these products that are used in different countries. In general, the goals of nutraceutical
regulation have been focused on safety and labeling with a lesser emphasis, as compared
to pharmaceuticals, on product claims and intended use. The first step in food regulation
in Europe was established in1997 with the Green Paper after that the safety and use of
food were set by the United Nations Food and Agricultural Organization (FAO) and the
World Health Organization(WHO) in the Codex Alimentarius (FAO/WHO1992). In the
USA, the FDA, which focuses on safety aspects and food supplements, acknowledges the
term nutraceutical and applies a different set of regulations to them than those of
conventional foods and drugs. As per the Dietary Supplement Health and Education Act
established in 1994(DSHEA), it is the manufacturer’s responsibility to ensure that a
nutraceutical is safe before it is marketed. The Food and Drug Administration
Modernization Act of 1997 contains sections that enable health claims and nutrient
content claims on food labeling to be authorized based on an authoritative statement from
the Academy of Sciences or other federal authorities after notifying the FDA at least four
months before the introduction of the supplement on the market [48].

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  The government of India established the Food Safety and standards Act (FSSA) in 2006
to introduce a legislation system. FSSA does not separate functional foods,
nutraceuticals, and dietary supplements; instead, each is indicated as food for a special
dietary application. In 2015, India notified the World Trade Organization of a draft
regulation for nutraceuticals and foods for special diets and medical purposes. In general,
many countries, such as Australia or China, regulate nutraceuticals simply as a category
of food, and the national regulations are valid for food application. Moreover, a health
claim should be authorized and attributed only after a complete clinical study is proposed
to the appropriate authority for approval with the aim of substantiating its safety and
efficacy with respect to the claimed beneficial health effect based on an understanding of
the mechanism of action and the absence of undesired side effects [49].

2. Impact of Placebo Effect. The impact of nutraceuticals is just like pharmaceuticals and a
part of the effectiveness of nutraceuticals, which can be attributed to the placebo effect.
People have used nutraceuticals as a healing illness and are often able to recover on their
own. The Nobel Prize winne(Linus Pauling and Abrahm Hoffer) suggested that the
provision of these nutrients might also in truth encourage the restoration mechanism; ill
individuals may additionally require more nutrients to cause the mechanism [50].

TOP 10 NUTRACEUTICAL PRODUCTS

This industry is continuing to grow and expand as health-conscious customers look for ways to
stay healthy and fit. Here, we’ve taken a closer look at the top 10 nutraceutical products on the
market right now.

1. Liquid Prenatal Vitamins- Liquids have become a hot commodity within the
nutraceutical industry. Prenatal vitamins continue to be one of the top 10 nutraceutical
products. Not only do they supply the body with sufficient energy levels, but they also
maintain these energy levels before, during and after pregnancy.

2. Vitamin D3- It is important for maintaining good health, development and maintenance
of healthy bones and teeth. Some studies have shown the Vitamin D3 can also boost your
immune system and put you in a good mood. Combining Vitamin D3 with calcium, a
healthy diet, and regular exercise can reduce the risk of developing osteoporosis.

3. Garcinia Cambogia –Weight loss is a hot commodity in the health and fitness industry.
As a result, it has pushed Garcinia Cambogia to the top of the nutraceutical product list.
Garcinia Cambogia can help boost your metabolic rate, which will help you burn
calories. In addition, it can help curb food cravings and increase your mood.

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 4. Raspberry Ketones –Another health supplement, raspberry ketones act as a thermogenic
agent and work excellently as a fat-blocking agent.

5. Green Tea Supplements –There is an incredibly popular market for green tea
supplements. In fact, green tea supplements have topped $135 million in the
nutraceuticals industry. Known as a powerful antioxidant, it’s also a great alternative to
coffee for a caffeine buzz.

6. Echinacea –It is used against many infections including UTI’s, herpes, bloodstream
infections, syphilis, and more. It is also used for skin problems like eczema, psoriasis, sun
related skin damage, and bee stings.

7. Probiotics –It can help you maintain the good bacteria in your body. By supplementing
your healthy diet with probiotics, it can help move food through your gut.

8. Omega 3 Fatty Acids –These essential fatty acids are necessary for human health, but
the body can’t make them. Omega-3 fatty acids reduce inflammation and may help lower
the risk of chronic diseases such as heart disease, cancer, and arthritis.

9. Alpha-lipoic Acid –Alpha-lipoic acid is a naturally occurring fatty acid that has been
used in alternative medicine as an aid in weight loss, treating diabetic nerve pain, healing
wounds, lowering blood sugar, and treating rheumatoid arthritis.

10. Vitamin B12 – can help with one’s metabolism and has been shown to increase energy
levels.[51,52]
In order to boost the immunity, many famous brands like Delhi-NCR based milk supplier Mother
Dairy launched haldi dhoodh or turmeric milk. There are also combo meals, with all the key
ingredients like broccoli, spinach, bell peppers, garlic, dark chocolate, lime, parsley, cinnamon,
etc in vogue these days. The market is thriving with more new products being launched every
single day (Dr.Pragya Khanna Nutraceutical Conundrum: A New Challenge, Early times
Newspaper, 8/31/2020).Besides this, GlaxoSmithKline consumer Healthcare, Dabur India,
Cadila Health care, EID Parry‟s, Zandu Pharmaceuticals, Himalaya Herbal Healthcare.

The Reasons for Shift Towards Nutraceuticals Are :

✓ Nutraceuticals cover most of the therapeutic areas, such as anti-arthritic, cold and cough,
sleeping disorders, digestion and prevention of certain cancers, osteoporosis, blood pressure,
cholesterol control, pain killers, depression and diabetes.
✓ Dissatisfied with pharmaceutical agents in promoting health, are turning to nutraceuticals to

18
improve their health and prevent chronic disease.
✓ Health care provider recognize the fact that our heavily processed food supply coming from
crops grown with chemical fertilizers, pesticides, herbicides, and often genetically modified
seeds, lacks sufficient nutrients necessary for optimum health.
✓ Nutraceuticals show an ample scope to flourish in future as therapeutic agents with preventive
and curative properties.
✓ People who have chronic diseases and have found no solution in allopathic medicines.
✓ Nutraceuticals are quickly replacing pharmaceuticals in prevention and management of acute
and chronic health problems.
✓ Economically challenged patients, People believing more in prevention than a cure.
✓ Increasing numbers of consumers, concerned about healthcare costs.[53,54]

Future Prospective
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.
The increasing demand for nutraceuticals, such as food for fitness and health, is responsible for
their positive and therapeutic uses for different kinds of diseases. The development and growth
of new functional food or specially nutraceutical industry seem destined to occupy the landscape
in the new millennium. The enzymes are used in various nutraceutical processes and play a
crucial part in nutraceuticals. The next area of high consideration is the interaction between
nutraceuticals and FDA. The therapeutic effectiveness of nutraceuticals remains to be determined
as like drugs [55]. It is a big challenge for nutraceuticals, for the future prevention and therapy of
triggering tools in the medicine area.The future possibility of nutraceuticals to prevent or support
a pharmacological therapy is now recently based on pharmaceuticals, which can be a powerful
tool to face pathological, chronic, and long-term diseases. The clinical study data evaluation is
based on the beneficial effect of nutraceuticals, through “in vitro and in vivo” representation,
which may be dispensed in an individual nutritive supplementation observed in animals [56,57].

FOCUS ON INDIA
India has a long heritage of traditional medicine, which includes a conglomerate of Ayurveda,
Siddha and Unani. It is one of the greatest living traditions and maintains a highly respectable
place in the officially recognized healthcare system of the country. In recent times, the Indian
healthcare market has emerged as a new and profitable growth avenue for both existing players
and new entrants. The Indian healthcare industry has been seen to offer investors a cheap entry

19
into the relatively stable consumer and retail segment, which is benefiting from rising consumer
sentiments and affluence. According to Cygnus estimates, nutraceutical market in 2007 was INR
18.75 billion. Total market for nutraceutical in India is valued at INR 44 bn in 2009; it is
estimated to reach INR 95 bn in 2013. India has now become a centre of attraction for everyone
because of its huge population. In fact, India is currently experiencing massive internal
consumption, due to a prosperous middle class, which has the money to invest in “nutraceutical”
products. The middle class has doubled and today is the fastest growing portion of the
population. In the last 60 years of independence India has met remarkable educational goals and
today has moved beyond basic food security issues. India has also evolved from a savings
economy to consumption economy [58].

Challenges and Opportunities:

 A huge number ofchallenges in the growth of nutraceuticals are still facedbyIndia, due to
the lack of awareness among the Indian consumers about the use and ability of
conventional nutraceutical ingredients. Methods for their handling and measurement are
lacking as most of the bioactive phytochemicals are still under investigation (Borkar et al.
2015).
 Challenges are also faced by the Government regulatory bodies in this new category of
health products. The safety and efficiency of nutraceuticals needs further research. There
is oftenconfusion in the field of nutraceuticals and functional foods, as it is lumped
together with the field of biotechnology and genetic modification.

Conclusion

Nutraceuticals provide benefits in the prevention and treatment of various diseases. With
increasing incidences of lifestyle-related health problems, they have emerged as an essential
component of the diet for the common consumer.Nutraceuticals are now serving as a primary
dietary supplement for health-conscious masses in India. Nutraceuticals(nutritional supplements)
have fast become a staple in the healthcare market in numerous forms, including tablets, syrups,
gums, and capsules. The combined and concerted action of nutrient and biologically active
compounds is flagged as an indicator of a possible beneficial role for health.Nutraceutical use is
growing fast and is well accepted by people for its all-natural origin. The demand for fewer
synthetic pharmaceuticals is triggering this interest and stimulating also the industry to develop
and put on the market new products which claim beneficial health effects. Nutraceuticals cannot
replace pharmaceuticals but can be a strong high-value tool for prevention and aid in therapy of
some pathological conditions. The present review provides comprehensive knowledge about all
these aspects related to nutraceutical sources, formulations, scopes, challenges, quality control,
stability, and safety evaluation in brief. In recent years there is a growing interest in
nutraceuticals which provide health benefits and are alternative to modern medicine.
Nutraceuticals hold great potential for the future because they are convenient for today’s
lifestyle. Consumer interest in the relationship between diet and health has increased the demand
for information on nutraceuticals. Although nutraceuticals have significant promise in the
promotion of human health and disease prevention, long-term clinical studies are required to
scientifically validate the nutraceuticals in various medical conditions. State is not far where
nutraceuticals will be our preferred prescription of tomorrow.

20
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