This document discusses nutraceuticals and functional foods. It defines nutraceuticals as pharmaceutical-grade nutrients that are regulated by the FDA. Functional foods are designed to provide extra health benefits through enriched foods rather than supplements. They include foods fortified with added nutrients. Dietary supplements are concentrated nutrient products taken orally to supplement the diet, while functional foods are whole foods enriched with added nutrients. The document emphasizes the importance of nutrition in early life and a plant-based diet high in fruits and vegetables for reducing chronic disease risk.

1. Nutraceuticals/Functional Foods
Nutraceutical is a pharmaceutical-grade and standardized
nutrient.Nutraceuticals are regulated by FDA under the authority of the
Federal Food,Drug, and Cosmetic Act.
Under Canadian law, a nutraceutical can either be marketed as a food or
as a drug; the terms "nutraceutical" and "functional food" have no legal
distinction referring to "a productisolated or purified from foods that is
generally sold in medicinal forms not usually associated with food [and] is
demonstrated to have a physiological benefitor provide protectionagainst
chronic disease."
Depending on its ingredients and the claims with which it is marketed, a
productis regulated as a drug, dietary supplement,food ingredient, or food
Classificationof nutraceuticals
Nutraceuticals are products derived from food sources that are purported to
provide extra health benefits,in addition to the basic nutritional value found
in foods.Depending on the jurisdiction, products may claim to
prevent chronic diseases, improve health, delay the aging process,
increase life expectancy, or supportthe structure or function of the body.
Where these are follows as .
1- Dietary supplements
2- Functional foods
A dietary supplement-;
is a product that contains nutrients derived from food products that are
concentrated in liquid or capsule form. In the US, the Dietary Supplement
Health and Education Act (DSHEA) of 1994 defined the term: “A dietary
supplementis a producttaken by mouth that contains a "dietary ingredient"
intended to supplementthe diet. The "dietary ingredients" in these products
may include: vitamins, minerals, herbs or other botanicals, amino acids,

2. and substances such as enzymes, organ tissues,glandulars,
and metabolites.Dietary supplements canalso be extracts or concentrates,
and may be found in many forms such as tablets, capsules,
softgels, gelcaps, liquids, or powders.”[11]
Dietary supplements do not have to be approved by the U.S. Food and
Drug Administration (FDA) before marketing, but companies must register
their manufacturing facilities with the FDA. With a few well-defined
exceptions,dietary supplements may only be marketed to supportthe
structure or function of the body, and may not claim to treat a disease or
condition, and must include a label that says: “These statements have not
been evaluated by the Food and Drug Administration. This productis not
intended to diagnose,treat, cure, or prevent any disease
Functional foods -;
are designed to allow consumers to eat enriched foods close to their
natural state, rather than by taking dietary supplements manufactured in
liquid or capsule form. Functional foods have been either enriched or
fortified,a process called nutrification. This practice restores the nutrient
content in a food back to similar levels from before the food was processed.
Sometimes,additional complementary nutrients are added,such
as vitamin D to milk.
Health Canada defines functional foods as “ordinary food that has components or
ingredients added to give it a specific medical or physiologicalbenefit, other than
a purely nutritional effect.”[12] In Japan, all functionalfoods must meet three
established requirements: foods should be (1) present in their naturally-occurring

3. form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often
as daily; and (3) should regulate a biological process in hopes of preventing or
controlling disease.
Food and Health
Food habits develop in early infancy. In fact, it is known that initial
phases of life (intra-uterine period and the first year of life) are
sensitive to nutritional factors .
Exclusive breastfeeding up to six months, with breastfeeding lasting up
to two years or longer in combination with the introduction of balanced
complementary feeding (CF), are emphasizedby the World Health
Organization (WHO) as important measures of public health, with
effective impact on the reduction in the risk of developing chronic
diseases.
It is now known that children after the age of two years should be fed a
nutritionally balanced diet similar to that of adults, particularly a diet
low in sugar, salt and fat, and rich in complex carbohydrates, fruits and
vegetables. Development of food habits is a complex process that may
be influenced by such factors as region, religion, family structure and
habits, income, prices, stress levels and technological advancements.
Several epidemiologic studies over the last 50 years have clearly shown
that diets dominated by fruits, vegetables and dietary fibers (plant
based foods) prevent and reduce the risk of chronic diseases (e.g.
cardiovascular diseases, obesity, diabetes) and promote sound human
health
Nutraceuticals" appears to be the favoured term used by industry which
includes functional foods and supplements. As yet the term has no legal
status.

4. In Europe "nutraceuticals" are subject to existing EU food laws which are
implemented on a national basis. This can make it particularly challenging
for a company to determine the best route to market. Companies also
have to consider whether the food or ingredient could be classed as
"novel" and therefore require authorisation under the EU procedures for
novel foods (regulation (EC) No 258/97).
To avoid any confusion, it is important that companies consult
professionals, such as Global Regulatory Services, who are familiar with
the regulations of governmental bodies such as the MHRA (UK Health
Authority) or the Food Standards Agency (FSA).
High dietary intake of fruits, vegetables and whole grains is strongly
associated with reduced risk of developing chronic diseases, such as
cancer and cardiovascular diseases (CVD), which are the highest causes
of death in Europe, United States and in most industrialized countries
[9,19]. It is estimated that one-third of all cancer deaths in
industrialised countries could be avoided through appropriate dietary
formulations. This suggests that dietary behavioral changes, such as
increasing consumption of fruits, vegetables, and whole grains, and
related changes in lifestyle, are practical strategies for significant
reduction of the incidence of cancer.
SUBMITTED BY -;
GAURAV
M.S(PHARM)- NIPER