Nutraceuticals

UNIT 9 NUTRACEUTICALS
Structure

9.1 Introduction
Objectives
9.2 Definition of Nutraceuticals
9.3 Nutraceutical Product
Ingredients of Nutraceuticals
9.4 Food and Nutraceutical
9.5 Nutraceuticals and Herbal Medicines
9.6 Nutrification
Food and Functional Food
Phytochemicals and Nutrients
Functional Foods in the Market and their Claims
Advantages and Disadvantages of Functional Foods
9.7 Dietary Supplements or Food Supplements
Dietary Supplement in USA
9.8 Nutraceutical Market in India
Antioxidants
Chicory
Soya Bean and Tofu
Oats, Barley and Ragi
9.9 Nutraceuticals and the Elderly
9.10 Regulations of Nutraceuticals
How to Regulate Marketing of Nutraceuticals in India?
The Prevention of Food Adulteration Act, 1954
Regulation of Nutraceuticals in Other Countries
9.11 Summary
9.12 Terminal Questions
9.13 Answers

9.1 INTRODUCTION

In Unit 8 on Cosmaceuticals we had studied what are cosmaceuticals and how

the term is related to cosmetics along with certain aspects of cosmetics
including their definition, classification and examples. We could see that most
of the cosmetic and cosmaceutical preparations are for external use and aimed
at maintaining and improving the beauty and attraction of human beings. In
this Unit, we are going to study another section of products which are having
a good demand in our day-to-day life known as nutraceuticals. Unlike
cosmetics, the majority of nutraceuticals are used internally for the purpose of
certain health benefits.

Objectives

After studying this unit, you should be able to know: 179

Pharmaceutics • the concept, origin and definition of the term nutraceuticals;
• examples of nutraceuticals and the regulation of nutraceuticals;
• nutrification, ingredients of nutraceuticals and their nutritive value;
• distinguish between food, functional food and dietary supplements; and
• phytochemicals and their importance.

9.2 DEFINITION OF NUTRACEUTICALS

The term “nutraceutical” was first coined by Stephen DeFelice, MD, founder
and chairman of the Foundation for Innovation in Medicine (FIM), in 1989
from the two terms ‘nutrition’ and ‘pharmaceutical’. According to DeFelice,
nutraceutical can be defined as, "a food (or part of a food) that provides
medical or health benefits, including the prevention and /or treatment of a
disease.

Nutraceutical can be defined as a product containing food substance or

substances presented in the form of a formulation or recipe and are having
useful properties for treating or preventing disease in human beings. A
nutraceutical can prevent a disease or aliment, relieve the symptoms or cure a
specific disease. Nutraceuticals can contribute towards health care because of
their complementary role. They help to maintain health or a healthy lifestyle.

Sometimes nutraceuticals are defined as pharmaceutical preparations having

nutritional and food supplement values having a significant role in modifying
the life style pattern of people. They are food derivatives containing nutritious
extracts from food stuff which are claimed to have medicinal effect on health.
Nutraceuticals are consumed in a medicinal format and are prescribed with
dosage by a medical practitioner or dietician. These are taken in various forms
like tablet, capsule, powder, liquid or semi-solid. Nutraceuticals provide
medical and physiological advantage other than purely nutritional benefits.
They are believed to be capable of preventing chronic diseases. If a
nutraceutical claims medicinal benefits, then it needs to qualify the norms for
the medicinal product. Accordingly it has to undergo regulatory formalities for
its approval and marketing. On the other hand, if the nutraceutical claims to be
have nutritional benefits only and is regarded as a food product.

SAQ 1
Who was Stephen DeFelice?

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………
180
9.3 NUTRACEUTICAL PRODUCT Nutraceuticals

The term ‘nutraceutical product’ was coined by the Foundation for Innovation
in Medicine (FIM) in 1991. FIM defined nutraceutical product as ‘any
substance that may be considered a food or part of a food that provides
medical or health benefits including the prevention and treatment of disease’.
Nutraceutical 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.

9.3.1 Ingredients of Nutraceuticals

The ingredients of nutraceuticals include trace elements, minerals, vitamins,

proteins, carbohydrates, amino acids etc. Many diseases are believed to have a
close relation with nutrients and food supplements. Proteins are essential in
building body and making it fit. Basically protein and protein supplements are
required in building muscles. However overdose of protein is not good and can
even cause harm to kidneys.

Most of the vitamins were discovered based on their correlation to diseases.

Vitamin A is associated with xerophthalmia and keratomalacia. Other common
examples are Vitamin C (scurvy) Vitamin D (rickets and Osteomalacia) Niacin
(pellagra), Vitamin E (creatinurea and hemolysis of RBC), Vitamin B6
(peripheral neuropathy and lymphopenia) and Vitamin B12 and Folic Acid
(Megaloblastic anemia). Certain minerals and trace elements like calcium,
magnesium, iron, iodine, copper, zinc, phosphorous, manganese etc. are
believed to be essential for the vital function of human body. A large number
of herbal/ plant products are also used as part of the complementary medicine.
One of the common characteristics of all of them is that they are naturally
occurring.

With our increasing understanding of the nutritive value of various food items,
and the basic biochemical roles that they play, we are getting to appreciate the
values of the menu that various societies have adopted around the world.
Nutritionists in the West now believe that the diet that offers the best value to
bodily health is the Mediterranean cuisine like fish, whole wheat bread, olive
oil, tomato and greens in the salad, garlic and onion, red wine and fruits.

A high fibre intake does a lot of good to the body. It helps in lowering
cholesterol levels in the blood and leads to less plaque formation. Fibre intake
also prevents the blocking of blood vessels and thereby reduces the risk of
hypertension and stroke. It helps in enhancing weight control, and for better
control of blood sugar (useful for diabetics). High fibre diets also help in
reducing the risk of certain forms of cancer, improving gastro-intestinal
function and so on.

181
Pharmaceutics SAQ 2
What is nutraceuticals product?

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

9.4 FOOD AND NUTRACEUTICAL

Diseases are as old as human beings. Men identified early medicines from their
food items. Even in the near past medicines were prepared mainly from plant,
animal or other natural sources. Items like ginger, coriander, honey, fenugreek
etc are used as culinary items while they form part of high value home
remedies in herbal or Ayurvedic formulations. As we learn more about the
health aspects of the food we eat, we discover new ways of preparing and using
plant material for food, and also rediscover the value of some of the old
practices.

The nutraceuticals can to be distinguished from pharmaceuticals different

perspectives including the regulatory aspects. Nutraceuticals are not routed
through the parameters and protocols specified for modern medicine like
animal studies, clinical studies and toxicity studies.

9.5 NUTRACEUTICALS AND HERBAL MEDICINES

The World Health Organization (WHO) estimates that 80 percent of the world
population uses herbal medicine for some aspect of primary healthcare. WHO
notes that of 119 plant-derived pharmaceutical medicines, about 74 percent are
used in modern medicine in ways that correlate directly with their traditional
uses as plant medicines by native cultures. Major pharmaceutical companies
are currently conducting extensive research on plant materials gathered from
rain forests and other places for their potential medicinal value.

Like ayurveda, there are many other alternative medical sciences in the world.
Traditional Chinese medicine (TCM), Tibetian herbal medicine, Japanese
herbal medicine (Kampo), Indonesian traditional medicine (Jamu) are some of
the oldest medical sciences from other parts of the world which are now
becoming quite popular. Due to aggressive marketing tactics of the Chinese,
182
TCM has developed very good market throughout the world. Ayurveda has a Nutraceuticals
relatively minor share in the global market. Every corner of the world is now
easily contactable through internet and other advanced facilities. Therefore, the
knowledge is spreading at lightning speed. As the technology is spreading at a
high speed, the popularity of herbal medicines, plant medicines, nutraceuticals,
organic foods and cosmaceuticals reach to even remote places in the world.

SAQ 3
Fill in the blanks:

i) Jamu is the herbal medicine of .……………………

ii) ……………… is the herbal medicine of Japan.
iii) In the earlier days medicines were prepared from ………….. or …………..
iv) ………..% of the world population uses herbal medicine for their primary
healthcare.

9.6 NUTRIFICATION

Nutrification is the process of enriching or fortifying foods with nutrients.

Enrichment of food is the process of restoration of natural nutritive value of a
food before it was processed. Fortification is the adding of nutrients like
vitamins and minerals to a food at levels higher than it possessed. Adding
iodine to salt fluoride to potable water or vitamin D to milk are examples of
fortification process commonly practiced.

9.6.1 Food and Functional Food

When food is cooked or processed utilizing the principles and knowledge of

science and its findings that can be called as functional food. Terms like
functional food, ‘designer food’ and ‘techno food’ are also used to denote
functional food manufactured by food companies for promoting health.
Generally the functional food can give its user some specified or predetermined
amount of effective nutrients like vitamins, fats, proteins, carbohydrates, fibers
etc, needed for our growth, development and maintenance of health.
Functional food can be defined as any food that exerts health properties beyond
the traditional nutrients it contains. If the functional food helps in the
prevention of a disease or its treatment it can be called ‘nutraceutical’. There
are two categories of functional foods.

i) Foods that naturally contain biologically active, non-nutrient compounds

known as phytochemicals that provides health benefits. All plant foods are
rich in phytochemicals.

ii) Food products specifically formulated to have higher amounts of nutrients

or phytochemicals than would naturally occur in that food. These are also
called “designer foods.”
183
Pharmaceutics Manufactured functional foods cannot duplicate all of the benefits of whole
plant foods, some of which are not yet known. For example, plant foods like
leafy green vegetables, which are naturally rich in calcium, also provide
vitamin K and vitamin C, both of which are needed for healthy bones, as well
as numerous nutrients and phytochemicals that protect against chronic disease.
A diet based on whole plant foods is likely to be more healthful than one based
on functional foods. When a functional food aids in the prevention and/or
treatment of a disease or a disorder, it is called a nutraceutical. A functional
food for one consumer can act as a nutraceutical for another consumer.

9.6.2 Phytochemicals and Nutrients

Phytochemicals are plant chemicals that differ from nutrients in some

important ways. Essential nutrients are those essential for life and include
substances like protein, fats, minerals, and vitamins. Without them, people
develop acute deficiency disease symptoms that can eventually cause ill health
and death. Nutrients are found in all of the food groups. Phytochemicals are
not necessary for life but they help to promote optimal health by lowering risk
for chronic diseases, such as cancer and heart disease. They are found only in
plant foods. Fruits and vegetables are among the best sources of these
compounds. Phytochemicals are believed to have many health benefits.

Examples of phytochemicals include the following:

Allyl sulfides: Allyl sulfides can stimulate activity of enzymes that help to
eliminate toxic compounds. They are found in onions, scallions, and leeks.

Dithiolthiones and isothiocyanates: These are phytochemicals which can

increase activity of enzymes that help to detoxify carcinogens and are found in
the cruciferous family of vegetables — broccoli, cauliflower, brussels sprouts,
cabbage, turnips, and others.

Indoles: These phytochemicals can interfere with estrogen metabolism and

therefore could reduce risk for some estrogen-related cancers such as breast
cancer. Indoles are also found in cruciferous vegetables.

Isoflavones: They are found in soy foods and have a number of effects that
may affect cancer risk.

Lignans: They are found in rye and flaxseed and may reduce breast cancer risk
because they act as anti-estrogens.

Flavonoids: Flavonoids are a special class of phytochemicals that includes

hundreds of different compounds. Most are excellent antioxidants and some
have hormonal properties. Among some of the most studied flavonoids are
quercetin, which is found in tomatoes, potatoes, broccoli, and onions and
kaempferol, which is found in kale and endive.

Carotenoids: Carotenoids are a group of phytochemicals that act as pigments,

giving plants their bright green, orange, yellow, red, and blue colours.
184
Carotenoids include: Nutraceuticals

Beta-carotene found in carrots, sweet potatoes, leafy green vegetables, red

peppers, and pumpkin. Beta-carotene from foods has been linked to a reduced
risk for lung cancer.

Lycopene found in tomatoes and strongly linked to reduced risk for prostate
cancer.

Lutein found in leafy green vegetables and linked to reduced risk for cancer
and macular degeneration.

9.6.3 Functional Foods in the Market and their Claims

Examples of claims made for nutraceuticals include ‘resveratrol’ from red

grape products as an antioxidant, soluble dietary fiber products like psyllium
seed husk for reducing hypercholesterolemia, broccoli (sulforaphane) as a
cancer preventive and soy or clover (isoflavonoids) to improve arterial health.
Most nutraceuticals are sold openly and are also made available through
internet. Consumers adversely affected by the increasing drug costs and
dissatisfied with the traditional health care often go natural products for
treatment and prevention of diseases even though many of them are unproven
or untested for such purposes. Society has a belief that natural is always god
and safe.

In the past, foods were commonly fortified with nutrients to help prevent
specific nutritional deficiencies. Technically, any fortified food could be
considered a functional food. Some examples are iron-fortified cereals, vitamin
D-fortified milk, fortified dairy products and iodized salt. Today, many
functional foods are aimed at boosting intakes of phytochemicals to reduce risk
for chronic disease like cancer and heart disease.

Examples of functional foods you can find at the store include:

• Cereals and breads with added isoflavones.

• Fruit juices with herbs that have alleged immune-enhancing properties,
such as Echinacea.
• Margarine with added phytosterols, which help to reduce cholesterol.

9.6.4 Advantages and Disadvantages of Functional Foods

Some functional foods make it easier to meet requirements for nutrients that
are often deficient in the diets. The addition of calcium to orange juice and the
B-vitamin folate to enriched flour are examples. Some functional foods make it
possible to achieve higher intakes of nutrients or phytochemicals than would be
realistic with natural food sources of these compounds. Moderate amounts of
manufactured functional foods can provide some benefits to the diet and may
help to reduce disease risk. However, they don’t offer any benefits over well-
planned diets based on whole grains, fruits, and vegetables. Eating foods that
are naturally rich in a wide array of phytochemicals makes good nutrition
185
Pharmaceutics sense, though. The best approach to dietary planning is to use functional foods
in moderation in addition to a healthful diet.

Functional foods that contain added nutrients or phytochemicals may send

confusing messages about how to plan healthful diets. Calcium-fortified orange
juice is an improvement on a food that is already healthful. Calcium-fortified
candy or fibre-enriched white bread, on the other hand, involve addition of
beneficial substances to foods that are otherwise devoid of healthful properties.

SAQ 4
What are designer foods?

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

SAQ 5
What are the advantages of functional foods?

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

9.7 DIETARY SUPPLEMENTS OR FOOD

SUPPLEMENTS

Dietary supplements are also called food supplements or nutritional

supplements. They are designed to provide nutrients which are missing in our
daily diet. In different countries, dietary supplements are classified differently.
In some countries, they are categorized under foods whilst in some as drugs.
186
They are preparations intended to supply nutrients, such as vitamins, Nutraceuticals
minerals, fatty acids or amino acids, that are missing or are not consumed in
sufficient quantity in a person’s diets. Some countries define dietary
supplements as foods, while in others they are defined as drugs.

Dietary supplements also include non medicinal herbal supplements and

hormones like pregnenolone and melatonin. Generally, a dietary supplement
contains ingredients like vitamins, minerals, amino acids, herb, concentrate,
metabolite, extract, or their combinations. Dietary supplements are also used to
increase the performance of athletes and sports players. Food supplements are
the best way to get our daily dose of vitamins and minerals especially in
children. Vegetarian diet often lacks vitamin B12, hence Vitamin B12
supplement is useful for the vegetarians

After recognizing the success and potential of dietary formulations,

pharmaceutical companies got into the area of manufacturing dietary
supplements with the help of sophisticated equipment and techniques. They are
using attractive and high-tech expensive packaging for their products. The
dietary products attract not only the pharmaceutical market, but also the
general market.

Since the concept of food supplements was based on the dietary component,
the regulatory norms applicable to the foods are currently used for approving
the formulations. Some experts are of opinion that it is ideal to call them
recipes than formulations. The traditional or natural medicines were in use for
thousands of years. Various countries have defined their norms for such
formulations.

9.7.1 Dietary Supplement in USA

In the United States, a dietary supplement is defined under the Dietary

Supplement Health and Education Act of 1994 (DSHEA). It defines a dietary
supplement as a product that is intended to supplement the diet and contains
any of the following dietary ingredients:

• a vitamin
• a mineral
• an herb or other botanical (excluding tobacco)
• an amino acid
• a dietary substance for use by people to supplement the diet by increasing
the total dietary intake, or
• a concentrate, metabolite, constituent, extract, or combination of any of the
above
Furthermore, it has to conform to the following criteria:
• intended for ingestion in pill, capsule, tablet, powder or liquid form.
• not represented for use as a conventional food or as the sole item of a meal
or diet.
• labeled as a “dietary supplement”. 187
Pharmaceutics The steroidal hormones DHEA and pregnenolone the pineal hormone
melatonin are marketed as dietary supplements in the US. Nutraceuticals can
be distinguished from dietary supplements. Nutraceuticals not only supplement
the diet but should also aid in the prevention and/or treatment of disease and/or
disorder. They are represented for use as a conventional food or as the sole
item of meal or diet.

SAQ 6
What are the dietary supplements in USA?

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

9.8 NUTRACEUTICAL MARKET IN INDIA

India is one among the few countries with no fixed parameters for classifying
dietary supplement either as diet or medicine. Nutraceuticals involve health-
enhancing or disease-preventing products that are not as strictly regulated as
the bulk pharmaceutical industry. The Indian pharmaceutical firms are utilizing
the facility and market a variety nutraceuticals aimed at various sections of the
society. The amount of products ‘enriched’ with vitamins and other health
related items entering the market are increasing day-by-day. The preference for
the discovery and production of nutraceuticals over pharmaceuticals is well
seen in pharmaceutical and biotechnology companies.

Nutraceuticals are gaining acceptance for their ability to address several

diseases. Vitamins, Minerals and Nutrients constitute about 80% of the market
while antioxidants and anti-aging products account for 10%. The other
segments are occupied by herbal extracts.

The global nutraceuticals market was estimated to be 120 billion US dollar in

2007. The US has been the major market for nutraceuticals, with India and
China becoming the fastest growing markets. The nutraceuticals market in
India was about rupees 20 billion in 2008 and is expected to be about 30 billion
by the end of 2009.

The use of nutraceuticals, as an attempt to accomplish desirable therapeutic

outcomes with reduced side effects has met with great monetary success.
However, with all of the aforementioned positive points, nutraceuticals still
need support of an extensive scientific study to prove “their effects with
reduced side effects”.
188
9.8.1 Antioxidants Nutraceuticals

Oxidation is a chemical reaction that involves transfer of electrons from a

substance to an oxidising agent. An antioxidant is an agent or substance
capable of preventing or slowing the oxidation of other agents or substances.
Antioxidant can stop the chain reactions in the body by removing the free
radical intermediates. In this process the antioxidants get themselves oxidized.
They have a significant role in the prevention of effects of free oxygen radicals
in body tissues.

In human body oxidation reaction produces free radicals and the free radicals
initiate chain or reactions that can result in the damage of cells and tissues.
The free oxygen radicals are formed as by-products during the process of
cellular metabolism and are capable of causing damage to the tissues of vital
organs like kidney, liver, brain, heart and lungs. Antioxidants are believed to
have the capacity to bind with the free radicals and convert them into benign
products. Hence they are useful to slow down the degenerative process of the
body and to protect the vital organs. Antioxidants are believed to have the
ability to ward off heart diseases, cataract, age related diabetes and other
similar diseases. Though oxidation reactions are very important for life, they
can quite often cause damages to the body. This is the reason why plants and
animals maintain complex system of antioxidants in their system. Vitamin C,
Vitamin E, glutathione, enzymes like catalase and various peroxidases are
examples of antioxidants. Selenium is a mineral, but a component of
antioxidant enzymes. Antioxidants can be classified into water soluble group
and lipid soluble group. Vitamin C is water soluble, whereas Vitamin E is fat
soluble. Water soluble antioxidants generally react with oxidants in the cell
cytoplasm and blood plasma while the lipid soluble antioxidants protect the
cell membranes from lipid per-oxidation. In addition to their use in medicine,
antioxidants have many other uses in industries like food, cosmetics, rubber
and gasoline.

Since antioxidants are grouped under nutraceuticals we have to take extra care
in the marketing and use of antioxidants. Antioxidants can be synthesized in
the body or obtained from the diet. A large variety of fruits and vegetables are
good source of antioxidants. Packaged antioxidants generally contain
substances like Vitamin C, Vitamin E, Carotenoids, curcumin, co-enzymes,
alphalipoic acid and similar items. Carrots, sweet potatoes, tomatoes, peaches,
apricots, citrus fruits (orange, lemon etc.), pepper, leafy vegetables, nuts, whole
grains, vegetable oils, liver oil etc. are good sources of dietary antioxidants.
Fish, shell fish, eggs, red meat, chicken, grains and garlic are rich in selenium.

SAQ 7
What are antioxidants?

……………………………………………………………………………………

……………………………………………………………………………………
189
Pharmaceutics ……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

9.8.2 Chicory

A notable aspect of the South Indian food habit is taking coffee mixed with
chicory. Chicory is a perennial plant with bright blue flowers, cultivated as a
salad plant. Its root is roasted and ground as an additive in coffee. The widely
used practice is to mix coffee – chicory in 60:40 ratio. Some instant coffee
manufacturers add chicory in their product so as to cater to the taste of the fast-
life.
Chicory is rich in the fibrous polysaccharide inulin. While cellulose is made of
glucose molecules chained together as a polymer, inulin is a polymer of the
fruit sugar fructose. Unlike cellulose, which does not easily dissolve in water,
inulin is a soluble dietary fibre. Since it is resistant to digestion by the
commonly occurring enzymes, it serves its fibrous function well. Not easily
absorbed in the small intestines, it reaches the large intestines or colon
essentially intact, where it is fermented by the resident bacteria. It is for this
reason that a molecule like inulin is called a pre- biotic, namely non-digestible
food material that selectively stimulates the growth of health - promoting
bacteria like lactobacilli and bifidobacteria, which digest it and feed themselves
and the host. These symbiotic microbes colonize our large bowels at the
expense of harmful ones such as coliform. A pre-biotic is a "fertilizer" for the
symbiotic bacteria that thrive in our bodies. The safety of inulin has been
evaluated and accepted by several European countries and the Food and Drug
Administration of the US. Inulin or chicory saccharide is thus a good example
of a functional food or nutraceutical.

9.8.3 Soya Bean and Tofu

Tofu is soya bean curd, long favoured by the Chinese, and a special food of
their emperors. Today the value of tofu and soya bean as a nutraceutical has
been realized. They are available in supermarkets and food stores. A large
section of diet-conscious people including a good section of the Americans use
soya beans, not just as tofu but also as soya milk, soya burgers and infant
formula. The Food and Drug Administration (FDA) has also approved the
products. It has fast caught on in the Indian market. Soya is low in cholesterol
and saturated fat and contains compounds called isoflavones that may help
prevent many diseases and ailments. Of 25 grams of soy protein that is
recommended in our daily diet, 45 mg are isoflavones. These are compounds
that act as antioxidants.
190
9.8.4 Oats, Barley and Ragi Nutraceuticals

Oats and barley are examples of good old grains known to man for thousands
of years. They are now elevated to status of nutraceuticals. Oat was till recently
less popular. It was due to a misconception that oat is not easily digestible.
However it is not true and preparations like oat porridge, Quaker Oats and
Champion Oats are eaten largely as breakfast meals. It is free from gluten and
has a high fibre content. Oatrim is a popular food in US which is made by the
enzymatic digestion of oat flour or oat bran to produce soluble fibre, quite like
inulin. Oat fibre can reduce cholesterol in the body and eliminate body fat.
Hence it is often used to reduce the body weight. The biological effects are
essentially the same as those of chicory and soya. Barley has been known and
used since the Vedic times. It has been used as gruel and as the preferred diet
for convalescing patients. The biological benefits of ragi are same as that of
oats and barely.

SAQ 8
Fill in the blanks:

i) Oat fibre can reduce cholesterol in the body and eliminate body ……….

ii) ……………… is a water soluble dietary fibre.

iii) Soya is low in cholesterol and saturated fat and contains ……………….

iv) Vitamin ……….. is water soluble while vitamin ………. is lipid soluble.

v) In human body oxidation reaction produces ………………..

vi) Selenium is a component of ……………………… enzyme.

9.9 NUTRACEUTICALS AND THE ELDERLY

The largest growing age category of the population is the elderly and they
witness all the advertisements targeted to them. The elderly are quite often
vulnerable to adverse effects from medications. Pharmaceutical and other firms
have started manufacturing and marketing special nutraceuticals for elderly.
Market studies indicate that the elderly are one of the largest users of health
care products. Products composed of long-chain poly-unsaturated fatty acids
(PUFAs), Omega-3 and omega-6 fatty acids (known as docosal-hexaenoic acid
or DHA), arachidonic acid (AA), and items that takes advantage of some
combination of chemical knowledge and biotechnology expertise are
increasing entering the market under the label of nutraceuticals.

Docosal-hexaenoic acid (DHA) can be produced by microbial fermentation and

also by extraction from the oil of fatty fish such as tuna. It is also found in
breast milk and is the predominant structural fatty acid in brain gray matter.
This opens its use in the infant formula supplementation market as well as in
individuals experiencing cognitive decline. Manufacturers of nutraceuticals
191
Pharmaceutics claim that omega fatty oils can provide cardiovascular health. Nutritional
supplement lecithin-derived phospholipids is claimed to improve memory.

9.10 REGULATIONS OF NUTRACEUTICALS

Along with the growing healthcare industry in India there is an emerging trend
in ‘Fast Moving Healthcare Goods (FMHG)’ which is worldwide known as
Nutraceuticals. However Nutraceuticals as they are marked in India has no
regulatory definition. The existing provision of the Drugs and Cosmetics Act
1940 does not cover products like nutraceuticals. Till 2008, India is not having
a legislation to control the manufacture and marketing of nutraceuticals or for a
proper definition of the item. Nutraceuticals are a new frontier needing
continuing excellent science and high standards if they are to take their place in
the health armamentarium.

9.10.1 How to Regulate Marketing of Nutraceuticals in India?

In India there are many issues to be addressed in the case of nutraceuticals due
to the absence of an effective regulation for them. The main hurdle appears to
be at the level of quality and claim parameters. Manufacturers and their
marketing agent want all possible benefits with tall label claims. It is essential
to govern the disorganized sector with rational attitude. Ayurvedic and unani
medicines are herbo-mineral based and sufficient numbers of ancient books are
available as a base to accredit therapeutic claims. Modern medicine has
prescribed parameters related to drug discovery, but they cannot be applied to
the nutraceuticals as such. The guidelines for nutraceuticals shall, therefore, be
similar to regulatory requirements for ayurveda, siddha, unani or homeopathy
medicines. The nutraceuticals that are purely herbal can be regulated through
the Prevention Food Adulteration Act. All the GMP parameters applicable to
ayurvedic manufacturing units have to be made applicable to herbo-mineral
formulations. The provisions of the Drugs and Magic Remedies Objectionable
Advertisement Act have to apply to the nutraceuticals. The nutraceutical
manufacturers should be directed to insert printed material with information to
empower the user.
Some Indian nutraceutical manufacturers have done their labeling as per the
law of US Government. ‘This product should not be consumed during
pregnancy’ is one example very commonly seen on the labels. Ayurvedic
products are not supposed to mention any such clause. Therefore, the law for
nutraceuticals for the Indian market should also include such considerations.
India has the base of ayurveda, and therefore it is easier for Indians to study
nutraceuticals and explain and conceive their clinical efficacy. Is there a need
to mention the dosage on the sale pack of nutraceuticals? We are not specifying
the dose of nutrients like biscuit or sugar sweets. Then why for nutraceuticals?
It appears to be a reasonable question. However, we had seen that often the
nutraceuticals are enriched with substances like vitamins and minerals which
are to be taken in regulated quantities and manner.
192
9.10.2 The Prevention of Food Adulteration Act, 1954 Nutraceuticals

Food is one of the basic necessities for sustenance of life. Pure, fresh and
healthy diet is most essential for the health of the people. Community health is
national wealth. Adulteration of food-stuffs was always a common practice by
the crude section of business group. It was with the objective of governing the
anti-social evil of adulteration of food items that a concerted and determined
effort was launched immediately after independence leading to the enactment
of Prevention of Food Adulteration Act 1954 in India.
The Act defines terms like ‘adulterated food in clear and elaborate terms. It
prohibits the manufacture, import and sales of adulterated food, misbranded
food and any article of food for the import of which a licence is prescribed,
except in accordance with the conditions of the licence. The Act empowers the
Central Government or the State Government to appoint inspectors known as
food inspectors to supervise, regulate and monitor the production, import or
sale of food items injurious to the health of the society. The food inspectors
shall not have any financial interest in the manufacture, import or sale of any
article of food. Every food inspector is a public servant within the meaning of
section 21 of the Indian Penal Code.

The Act defines the term ‘dietary supplement’ as a product (other than tobacco)
intended to supplement the diet that bears or contains one or more of the
dietary ingredients namely (A) a vitamin, (B) a mineral, (C) an herb or other
botanical, (D) an amino acid and (E) a dietary substance for use by man to
supplement the diet by increasing the total dietary intake or a combination of
these items.

9.10.2 Regulation of Nutraceuticals in Other Countries

The DSHEA stands for the Dietary Supplement Health and Education Act of
1994 in USA. It formally defined “dietary supplement” using several criteria.
The DSHEA defines dietary supplement as a product (other than tobacco) that
is intended to supplement the diet that bears or contains one or more of the
dietary ingredients like 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 any ingredient described above and intended for
ingestion in the form of a capsule, powder, soft gel or gel cap and not
represented as a conventional food or as a sole item of a meal or the diet.

In USA, pursuant to the DSHEA, the Food and Drug Administration (FDA)
regulates dietary supplements as foods, and not as drugs. While pharmaceutical
companies are required to prove the safety or effectiveness of their products,
until recently dietary supplement manufacturers were not, and the FDA could
take action only after a dietary supplement had been proven harmful.
However, the proposed FDA rules will, by June 2010, ensure that all
production of dietary supplements must comply with current good
manufacturing practices, and be manufactured with “controls that result in a
193
Pharmaceutics consistent product free of contamination, with accurate labeling.” In addition,
the industry is now required to report to the FDA all serious dietary supplement
related adverse events.

The DSHEA, passed in 1994, was the subject of lobbying efforts by the
manufacturers of dietary supplements. At the time of its passage DSHEA
received strong support from consumer grassroots organizations, and Members
of Congress. In recognition of this, President Bill Clinton after signing DSHEA
law, stated that “After several years of intense efforts, manufacturers, experts
in nutrition, and legislators, acting in a conscientious alliance with consumers
at the grassroots level, have moved successfully to bring common sense to the
treatment of dietary supplements under regulation and law.” He also noted that
the passage of DSHEA" speaks to the diligence with which an unofficial army
of nutritionally conscious people worked democratically to change the laws in
an area deeply important to them” and that “In an era of greater consciousness
among people about the impact of what they eat on how they live, indeed, how
long they live, it is appropriate that we have finally reformed the way
Government treats consumers and these supplements in a way that encourages
good health.”

It is not legally permitted to market a dietary supplement product as a treatment

or cure for a specific disease or condition. A product sold as a dietary
supplement and promoted on its label as a treatment, prevention or cure for a
specific disease or condition would be considered as an unapproved drug. To
maintain the product’s status as a dietary supplement, the label and labeling
must be consistent with the provisions in the Dietary Supplement Health and
Education Act (DSHEA) of 1994.
Dietary supplements are permitted to make structure/function claims. These are
broad claims that the product can support the structure or function of the body.
Claims like ‘glucosamine helps support healthy joints’ or ‘the hormone
melatonin helps establish normal sleep patterns’ are permitted. However the
FDA must be notified of these claims within 30 days of their first use, and
there is a requirement that these claims be substantiated.

The European Union’s Food Supplements Directive requires that supplements

be demonstrated to be safe, both in quantity and quality. Some vitamins are
essential in small quantities. However they are dangerous in large quantities, as
in the case of Vitamin A. Only such supplements that have been proven to be
safe can be sold without prescription. In practice, however, there appears to be
little risk to supplement users of experiencing adverse side effects due to
excessive intakes of micronutrients. In Europe, it is also an established view
that food supplements should not be labeled with drug claims but can bear
health claims, although to a degree that differs from one member state to the
other.

In Russia there is a legislation to regulate the nutraceuticals. The Ministry of

Health’s order number 117 dated as of 15 April 1997, under the title
“Concerning the procedure for the examination and health certification of
194
Biologically Active Dietary Supplements” (BADS) helps to govern the Nutraceuticals
nutraceuticals. As a rule, BADSs are foodstuffs with clinically proven
effectiveness. BADSs are recommended not only for prophylactics, but can be
included into a complex therapy for the prevention of pharmaceutical therapy's
side effects and for the achievement of complete remission. The development
of BADSs and their applications has been very fast moving. They were
originally considered as dietary supplements for people who had heightened
requirements for some normal dietary components (for example, sportsmen).
Later, they were employed as preventive medicines against chronic diseases.

SAQ 9
What is Food Adulteration Act, 1954?

……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

9.11 SUMMARY

Nutraceuticals are substances containing food products and have useful

properties for treatment or prevention of disease in human beings.
Nutraceuticals help us maintain health or healthy life style. Nutraceuticals
contain nutritious extact from food stuff which have a medicinal effect on
health. These are taken in various form like tablet, capsule, powder, liquid or
semi solid. The ingredients of nutraceuticals include trace elements, minerals,
vitamins, proteins, carbohydrate, amino-acid etc. These substances are essential
for proper functioning of our body. Although nutraceuticals can provide
treatment or prevention against disease, these cannot be substituted to
medicines. Nutraceuticals also differ from pharmaceutical preparation from
being subjected to different regulatory aspects and are not subject to
parameters like animal studies, clinical studies and toxicity studies. A major
advantage of nutraceutical over traditional food product is that these provide
the balanced nutritional value from a very small quantity which is sometimes
lacking in traditional food product. Sometimes these nutraceuticals even
provide much higher nutritional value which is sometimes cannot be obtained
from food products. Functional food although provide the desirable nutritional
value, these cannot be a substitute for natural food and may send a confusing 195
Pharmaceutics messages about how to maintain healthful diet. The existing provisions of Drug
and Cosmetics Act, 1940 does not cover products like nutraceuticals, therefore,
there is an emerging trend in FMHG or nutraceutical industry. It is proposed
that like pharmaceuticals, nutraceuticals should also be subjected to stringent
regulatory guidelines because majority of these product have misleading
information which may be fatal also to reduce cost these substances are added
with adulterant.

9.12 TERMINAL QUESTIONS

1. How will you define nutraceuticals?

2. What are the clinically important ingredients of nutraceuticals?

3. Give five examples of phytochemicals.

4. What are functional foods?

5. What are the disadvantages of functional foods?

6. Give the full form of the followings:

i) DSHEA
ii) BADS
iii) FDA
iv) PUFA
v) AA
vi) FIM
vii) WHO
viii) TCM
ix) DHA
x) FMHG

9.13 ANSWERS

Self Assessment Questions

1. Stephen DeFelice, MD, Founder and Chairman of the Foundation for

Innovation in Medicine (FIM) in 1989.

2. The nutraceutical product as ‘any substance that may be considered a food

or part of a food that provides medical or health benefits including the
prevention and treatment of disease’.

3. i) Indonesia ii) Kampo

196 iii) plant, animal iv) 80

4. Food products specifically formulated to have higher amounts of nutrients Nutraceuticals
or phytochemicals than would naturally occur in that food.

5. Functional foods make it easier to meet requirements for nutrients that are
often deficient in the diets. The addition of calcium to orange juice and the
B-vitamin folate to enriched flour are examples. Some functional foods
make it possible to achieve higher intakes of nutrients or phytochemicals
than would be realistic with natural food sources of these compounds.
(Please see Section 9.6.4)
6. Dietary supplement is a product that is intended to supplement the diet and
contains any of the following dietary ingredients:

• a vitamin
• a mineral
• an herb or other botanical (excluding tobacco)
• an amino acid
• a dietary substance for use by people to supplement the diet by
increasing the total dietary intake, or
• a concentrate, metabolite, constituent, extract, or combination of any of
the above.

7. An antioxidant is an agent or substance capable of preventing or slowing

the oxidation of other agents or substances. Antioxidant can stop the chain
reactions in the body by removing the free radical intermediates.

8. i) fat ii) inulin iii) isoflavones

iv) C, E v) free radical vi) antioxidant
9. See Section 9.10.2.

Terminal Questions

1. Nutraceutical is defined as a food or part of a food that provides medical or

health benefits, including the prevention and /or treatment of a disease.

2. The ingredients of nutraceuticals include trace elements, minerals,

vitamins, proteins, carbohydrates, amino acids etc.

3. Any five of the following:

i) Allyl sulfides: Allyl sulfides can stimulate activity of enzymes that help
to eliminate toxic compounds. They are found in onions, scallions, and
leeks.
ii) Dithiolthiones and isothiocyanates: These are phytochemicals which
can increase activity of enzymes that help to detoxify carcinogens and
are found in the cruciferous family of vegetables — broccoli,
cauliflower, brussels sprouts, cabbage, turnips, and others.
197
Pharmaceutics iii) Indoles: These phytochemicals can interfere with estrogen metabolism
and therefore could reduce risk for some estrogen-related cancers such
as breast cancer. Indoles are also found in cruciferous vegetables.
iv) Isoflavones: They are found in soy foods and have a number of effects
that may affect cancer risk.
v) Lignans: They are found in rye and flaxseed and may reduce breast
cancer risk because they act as anti-estrogens.
vi) Flavonoids: Flavonoids are a special class of phytochemicals that
includes hundreds of different compounds. Most are excellent
antioxidants and some have hormonal properties. Among some of the
most studied flavonoids are quercetin, which is found in tomatoes,
potatoes, broccoli, and onions and kaempferol, which is found in kale
and endive.
vii) Carotenoids: Carotenoids are a group of phytochemicals that act as
pigments, giving plants their bright green, orange, yellow, red, and blue
colours.

4. When food is cooked or processed utilizing the principles and knowledge

of science and its findings that can be called as functional food.

5. Functional foods that contain added nutrients or phytochemicals may send

confusing messages about how to plan healthful diets. Calcium-fortified
orange juice is an improvement on a food that is already healthful.
Calcium-fortified candy or fiber-enriched white bread, on the other hand,
involve addition of beneficial substances to foods that are otherwise devoid
of healthful properties.

6. i) Dietary Supplement Health and Education Act

ii) Biologically Active Dietary Supplements
iii) Food and Drug Administration
iv) Poly-unsaturated Fatty Acids
v) Arachidonic Acid
vi) Foundation for Innovation in Medicine
vii) World Health Organization
viii) Traditional Chinese Medicine
ix) Docosal-hexaenoic Acid
x) Fast Moving Healthcare Goods

198