20110919_Harshal A. Pawar et al, IJAPR.pdf - international journal ...

Harshal A. Pawar., et al. / International Journal of Advances in Pharmaceutical Research 

IJAPR 

Available Online through 

www.ijapronline.org 

Review Article 

ISSN: 2230 – 7583 

FUNCTIONAL FOODS AND THEIR HEALTH BENEFITS: AN OVERVIEW 

Harshal A. Pawar*, Nilesh M. Khutle, Suparna Shukla, Apoorva Ugarkar, Saumya Vijaykumar 

Dr.L.H.Hiranandani College of Pharmacy, Smt.CHM Campus, Opposite Railway Station, 

Ulhasnagar, Dist.Thane, Pin-421003, Maharashtra (India) 

Received on 13 – 05 - 2011 Revised on 11 – 06- 2011 Accepted on 20 – 06 – 2011 

ABSTRACT 

In last decades, there is growing interest in functional foods which provide health benefits and are alternative to 

modern medicines. The scientific research in the field of functional foods has demonstrated that nutrition plays a 

vital role in the prevention of chronic diseases as most of them can be related to diet. Nutrients, herbals and dietary 

supplements are major constituents of functional foods which make them instrumental in maintaining health, acts 

against various diseases and thus promote quality of life. Various products are claimed not only to reduce the risk of 

cancer and heart disease but also to prevent or treat hypertension, high cholesterol, excessive weight, osteoporosis, 

diabetes, arthritis, cataracts, digestive upsets and constipation and not to mention headache. Functional foods are 

marketed in various forms such as tea, bread, jam, jellies, biscuits, chocolate bars, corn flakes, ice creams; 

health drinks etc.functional foods constitute a rapidly growing focus for research, product development and 

consumer interest as well as regulatory efforts in recent years. The present article emphasizes on the general 

concept, design and development, health benefits and market review of functional foods. 

Key Words: Neutracuticals, Functional food, Health benefits, Nutrients, Botanical name. 

INTRODUCTION 

Now a days consumers are very much frustrated with 

the expensive, high tech, disease treatment approach 

predominant in modern medicine; they are looking 

for complementary or alternative beneficial product 

and the red tape of managed care makes functional 

foods appealing. Functional foods can be considered 

to be those whole, fortified, enriched or enhanced 

foods that provide health benefits beyond the 

provision of essential nutrients (e.g., vitamins and 

minerals), when they are consumed at efficacious 

levels as part of a varied diet on a regular basis. 

*Address for Correspondence 

Mr.Harshal Ashok Pawar 

Lecturer, 

Dr.L.H.Hiranandani College of Pharmacy, 

Smt.CHM Campus, Opposite Railway Station, 

Ulhasnagar, Dist.Thane, Pin-421003, 

Maharashtra (India) 

The primary role of food is to provide nutritional 

support to meet the nutritional requirements of an 

individual. There is now increased scientific 

interest to support the hypothesis that some foods 

and food components along with its normal 

nutritional value, provides health benefits 

including prevention of disease or promotion of 

health. Many traditional food products including 

fruits, vegetables, soya, whole grains and milk 

have been found to contain components with 

potential health benefits. In addition to these 

foods, new foods are being developed to enhance 

or incorporate these beneficial components for 

their health benefits or desirable physiological 

effects. Functional foods are marketed in various 

forms such as tea, bread, jam, jellies, biscuits, 

chocolate bars, corn flakes, ice creams; health 

drinks etc.functional foods constitute a rapidly 

growing focus for research, product development 

and consumer interest as well as regulatory 

efforts in recent years 1 . The present article 

emphasizes on the general concept, design and 

development, health benefits and market review of 

functional foods. 

IJAPR / July 2011/ Vol. 2 / Issue. 7 / 397 - 404 397


FUNCTIONAL FOODS VERSUS 

NEUTRACEUTICALS 

The term functional foods was first introduced in 

Japan in the mid-1980s and refers to processed foods 

containing ingredients that aid specific bodily 

functions in addition to being nutritious. Till date 

Japan is the only country that has formulated a 

specific regulatory approval process for functional 

foods, known as Foods for Specified Health Use 

(FOSHU), these foods are eligible to bear a seal of 

approval from the Japanese Ministry of Health and 

Welfare. Currently, 100 products are licensed as 

FOSHU foods in Japan 2 . 

Definition of Functional foods: 

Functional foods have no universally accepted 

definition. However, several organizations have 

proposed definitions for this new food category. 

According to the International Food Information 

Council (IFIC), functional foods are “foods or dietary 

components that may provide a health benefit beyond 

basic nutrition”. In 1994, the National Academy of 

Sciences’ Food and Nutrition Board defined 

functional foods as "any modified food or food 

ingredient that may provide a health benefit beyond 

the traditional nutrients it contains" 3 . The 

International Life Sciences Institute defines them as 

"foods that, by virtue of the presence of 

physiologically-active components, provide a health 

benefit beyond basic nutrition" 4 . The American 

Dietetic Association defined functional foods as 

foods that are "whole, fortified, enriched, or 

enhanced, but more importantly, states that such 

foods must be consumed as part of a varied diet on a 

regular basis, at effective levels for consumers to reap 

their potential health benefits 5 . 

A FUNCTIONAL FOOD is similar in appearance to, 

or may be, a conventional food that is consumed as 

part of a usual diet, and is demonstrated to have 

physiological benefits and/or reduce the risk of 

chronic disease beyond basic nutritional functions, 

i.e. they contain bioactive compound 6 . 

Another term often used interchangeably with 

functional foods, although it is less favored by 

consumers, is "nutraceuticals," a term coined in 1979 

by Stephen DeFelice, founder and chairman of the 

foundation for Innovation in Medicines located in 

Cranford, New Jersey 7 .The term ‘neutraceutical’ is a 

hybrid or contraction of nutrition and 

pharmaceuticals. 

Definition of Neutraceuticals 

A NUTRACEUTICAL is defined as a substance 

which can be considered as a food or its part which in 

addition to its nutritional value provides health 

benefits including prevention of disease or promotion 

of health. With the passage of Dietary Supplement, 

Health and Education Act 1994, the definition of 

neutraceuticals 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 neutraceuticals 

dramatically 8, 9 . 

Based on this definition and how functional foods are 

characterized, as noted previously, neutraceuticals 

would be distinct from functional foods. 

DESIGN AND DEVELOPMENT OF 

FUNCTIONAL FOOD 10 

The Institute of Food Technologists (IFT) Expert 

Panel identified a seven step process that would 

address critical aspects in the design, development 

and marketing of functional foods. 

Step 1: Identify Relationship between Food 

Component and Health Benefit 

A wealth of scientific literature describes numerous 

types of research that can identify potential 

relationships between functional components and 

health benefits. 

Once potential links have been identified, rigorous 

investigations are needed to confirm the initial 

observations through controlled studies with 

appropriate test materials. 

Step 2: Demonstrate Efficacy and Determine 

Intake Level Necessary to Achieve Desired 

Effect 

This can be done by: 

a) Identifying the bioactive components in functional 

foods 

b) Developing suitable method of analysis for its 

accurate quantification 

c) Assessing stability and bioavailability of bioactive 

substances in Food Matrices. 

d) Demonstrating Efficacy using biological end 

points and biomarkers 

Step 3: Demonstrate Safety of the Functional 

Component at Efficacious Levels 

In general, the safety of functional foods should be 

based on the long-standing principle that foods are 

safe. Further, the safety assessment should accept the 

safety of components already considered through pre 

established programs such as generally recognized as 

safe (GRAS) substances and approved food additives. 

The most appropriate safety assessment for a 

functional food ingredient will be determined on a 

case-by-case basis. Typically, the safety assessment 

will include the following: 

1. Documented history of food use (if not a new 

chemical 

entity); 

2.Estimates of current and proposed intakes of the 

functional component(s) (Intake/consumption 



should be estimated for the general population and 

by age and gender, including consumers 

who are likely to consume higher than typical 

levels. Intake estimates should be realistic and 

not overly conservative.); and 

3.Toxicological/safety assessment of new intake 

levels. Substances without a prior history of 

safe use will require a comprehensive and critical 

review of the scientific literature on the 

biological effects of the ingredient and on 

chemically related substances. Based on an initial 

review, specific studies will generally be required 

to 

define: 

a) Bioavailability - likely modes of action in vivo (in 

the living organism); 

b) Estimated half-life in vivo; 

c) Estimated dose-response for a range of potential 

effects; 

d) Known pharmacologic/toxic effects; 

e) Evidence of allergenicity; and 

f) Toxicity and safety (human, experimental animals, 

and in vitro systems including 

microorganisms, cells in culture, and micro 

arrays). 

The safety assessment will vary depending on 

whether the component will be present at 

micronutrient or macronutrient levels. 

Step 4: Develop a Suitable Food Vehicle for 

Bioactive 

Ingredients 

The goal of this phase of development is to select a 

suitable food vehicle that is appropriate for the 

intended consumer and delivers the bioactive 

ingredient at the desired levels. Selection of a food 

vehicle depends on its acceptability, the stability and 

bioavailability of the bioactive ingredient within the 

food, and the consumption and lifestyle practices of 

the intended audience. 

Step 5: Demonstrate Scientific Sufficiency of 

Evidence for Efficacy 

Regulatory standards require that all functional food 

labeling be truthful and not misleading. Claims for 

the benefit of a functional food must be based on 

scientific evidence of safety and efficacy and should 

be confirmed by appropriate independent experts. 

Independent Peer Review 

The IFT Expert Panel believes the evaluation of 

efficacy and safety will be most effective and cost 

efficient if it is undertaken by panels of independent 

experts with appropriate scientific expertise. 

Establishing an independent expert panel to make a 

generally recognized as efficacious (GRAE) 

determination would encourage public confidence 

while conserving government resources. As 

envisioned by the IFT Expert Panel, GRAE panel 

reports (accompanied by relevant scientific literature 

and data) would be submitted to FDA under a GRAE 

notification process. 

The GRAE panel would be comprised of respected 

scientists qualified to determine efficacy of the 

component under consideration. The multidisciplinary 

nature of the panel would provide a 

broad context for data and assure that the resulting 

conclusions are scientifically defensible and relevant 

to consumer practices. The GRAE panel would use 

the Hill criteria to determine if the proposed claims 

are supported by the available evidence. 

Regulatory Approval When Necessary 

The process for obtaining approval to market a new 

functional food will vary based on the nature of the 

functional component and the proposed claims. 

As envisioned by the IFT Expert Panel, FDA would 

consider the comprehensive GRAE report as part of 

an orderly process similar to that used for GRAS 

notifications. FDA should establish a notification 

procedure whereby any person may notify FDA of a 

determination that a particular use of a substance is 

GRAE. FDA would evaluate whether each submitted 

notice provides a sufficient basis for a GRAE 

determination and whether information in the notice 

or otherwise available to FDA raises issues that lead 

the Agency to question whether use of the substance 

is GRAE. Following this evaluation, FDA would 

respond by letter to the notifier within a specified 

time frame (typically 90 days). 

FDA could respond in one of three ways: 

1) The Agency does not question the basis for the 

notifier’s GRAE determination; 

2) The Agency concludes that the notice does not 

provide a sufficient basis for a GRAE determination 

(e.g., because the notice does not include appropriate 

data and information or because the available data 

and information raise questions about the efficacy of 

the notified substance); or 

3) The Agency has, at the notifier’s request, ceased to 

evaluate the GRAE notice. If FDA does not reply 

within the specified time frame, it would be 

presumed that the Agency does not question the basis 

for the GRAE determination and the product could 

proceed to use the proposed claims. 

Step 6: Communicate Product Benefits to 

Consumers 

Once a science-based claim is validated, that 

information must be communicated to consumers. If 

consumers are uninformed about the potential 

benefits of functional foods, few will purchase and 

benefit from the foods, and the food industry will 

have little incentive to develop new functional foods. 

Regulatory policies must allow food manufacturers to 

accurately characterize a functional food’s health 

benefits and the science supporting those claims. All 

parties must ensure that the messages describing 



these relationships are properly understood by 

consumers. 

The food industry, health professionals, educators, 

government officials, and the media can provide this 

information to consumers through a variety of health 

messages. 

Step 7: Conduct In-market Surveillance to 

Confirm Efficacy and Safety 

The term “in-market surveillance” (IMS) refers to the 

process of obtaining information on the effects of the 

functional ingredient after it has been marketed. IMS 

can confirm the conclusions reached during premarket 

evaluations regarding safety and efficacy by 

monitoring actual consumption patterns and the 

impact on consumers’ dietary patterns and 

determining if there are any adverse health effects 

(complaints) that were not identified in pre-market 

testing. 

HEALTH BENEFITS OF FUNCTIONAL 

FOODS: 

Functional foods represent one of the most 

intensively investigated and widely promoted areas in 

the food and nutrition sciences today. 

Functional foods are used basically to enhance 

certain physiological functions in order to prevent or 

even to cure disease. The functional food may be of 

plant or animal or sometimes microbial origin. A 

number of health benefits have been reported in 

literature for functional foods. The list of few 

commonly available Functional foods obtained from 

plant origin and their health benefits are summarized 

in table-1 11-45 . 

There are several methods used to obtain functional 

foods which include addition or removal of a 

component, modification of the food processing, 

genetic engineering etc. which is allowing the food 

industry to develop new product with additional 

value for the market. 

MARKET REVIEW OF FUNCTIONAL FOODS: 

The global functional foods market is a dynamic 

and growing segment of the food industry. Rapid 

growth will continue for several years, when 

functional foods are expected to represent five 

percent of the total global food market. According 

to the French Technology Press Office (2008), the 

market is currently estimated at over $129 

billion. Global market size has been estimated 

between US$30 and US$60 billion with Japan, 

United States, and Europe being the leading 

markets 46 . Although this is a new concept in India 

and the market is still in infancy but the demand for 

functional foods would continue to increase due to 

their specific health benefits and Government’s plan 

to invest $ 21.5 billion in food processing industry in 

next five years. Overall market growth estimated at 

4.5% to 6.5% per year over the next 5 years. 

CONCLUSION 

Consumers are becoming more health conscious and 

are interested in what they eat and its relationship to 

health. People are now seeking to optimize their 

performance, health and wellness in addition to 

reducing risk of most of lifestyle diseases. Hence the 

demand and market value for promoting foods and 

food components is expected to grow. 

Functional foods are an effective way to deliver 

beneficial agents and should become an integral part 

of public health programs aimed at reducing disease 

risk. The major needs are prevention of disease, 

promotion of health and well being, reduction of risk 

or delaying the onset of major diseases and thus 

reduction in the health care costs. Important role of 

foods such as fruits and vegetables and wholegrain 

cereals in disease prevention and the latest research 

on dietary antioxidants and combinations of 

protective substances in plants has helped to provide 

the impetus for further developments in the 

functional food market. Recent trends in population 

demographics and socio-economic changes also point 

to the need for foods with added health benefits. 

Combined with a healthy lifestyle, functional foods 

can make a positive contribution to health and well 

being. 

Although many functional foods may hold promise 

for public health, there are concerns that the 

promotion of functional foods and structure/function 

claims may not rest on sufficiently strong scientific 

evidence. Confusion also exists about claims applied 

to foods and those applied to dietary supplements. 

The explosive growth, research and developments, 

lacks of standards, marketing zeal, quality assurance 

and regulation will play vital role in success or failure 

of the functional foods. 

ACKNOWLEDGEMENT 

Authors are very much thankful to Dr. (Mrs.) S.S. 

Bhalerao, Principal of Hyderabad Sindh National 

Collegiate Boards (HSNCB’s) Dr.L.H.Hiranandani 

College of Pharmacy, Ulhasnagar for her continuous 

support and encouragement. 



Table-1: List of Functional Foods obtained From Plant Source and their health benefits 

S. No. Plant Source Botanical Name Health Benefits 

1. Almond Prunus dulcis Prevention of cancer, lowers LDL levels, anti-inflammatory, boost 

immunity, anti-hepatotoxicity effects, reduces anemia and 

maintains blood sugar level. 

2. Aloe Aloe vera Treats arthritis, asthma, bronchitis, healing of first to second degree 

burns, maintains blood glucose levels, treats hyperlipidaemia, 

protection from sunburn, improves immune system, promotes rates 

of healing, neutralizes toxins, anti-cancer, anti-wrinkle, treatment 

of skin diseases. 

3. Amla Phyllanthus emblica Improves eyesight, lowers blood glucose, boost immunity, 

appetizer, relieves acidity, treats rheumatoid arthritis and 

osteoporosis, treats inflammation, cancer, age-related renal disease, 

reduction of blood cholesterol levels, improvement of the liver 

function, strengthens heart muscle. 

4. Apple Malus domestica Reduce the risk of colon prostate and lung cancer, lowers lipid 

oxidatation, maintains blood sugar level and relieves stress. 

5. Banana Musa sapientum Reduced risk of colorectal cancer, breast cancer, renal cell 

carcinoma, treats kidney stones and high blood pressure. Boost 

metabolism, relieves constipation, treats anemia. 

6. Beet root Beta vulgaris Protect against liver disease, lower blood pressure, prevent 

cardiovascular, increased blood flow, detoxifies organs like kidney, 

gall bladder, liver. Increases blood count, relieves constipation and 

prevents cancer. 

7. Bitter gourd Monordica 

charantia 

Stomachic, dyspepsia, stimulates digestion, treatment of HIV 

infection, increases insulin sensitivity, prevents breast cancer, has 

hypoglycemic and hypolipidemic effect. 

8. Broccoli Brassica oleracea Anti-viral, anti-bacterial, reduce the risk of prostate cancer, 

prevention of heart disease, lowers blood sugar level, anti-ulcer 

activity and reduces cholesterol level. 

9. Cauliflower Brassica oleracea Anti-cancer, reduce the risk of aggressive prostate cancer, improve 

the liver's ability to detoxify carcinogenic substances. 

10. Clove Syzygium 

aromaticum 

Carminative, anthelmentic, improve peristalsis, dental analgesic, 

treat hiccough, reduce blood sugar levels, anti-herpes virus. 

11. Coriander Coriandrum sativum Anxiolytic, carminative and as a digestive aid, treats hepatitis and 

colitis, lower blood cholesterol, treats diarrhea, treating 

conjunctivitis, promote good health. 

12. Curry leaves Murraya koenigii Delay onset of grey hair, antidiabetic, antioxidant, antimicrobial, 

anti-inflammatory, hepatoprotective, anti-hypercholesterolemic, 

prevents development of cataract. 

13. Fennel Foeniculum vulgare Treatment of glaucoma, diuretic, treatment of hypertension, 

prevention of colon cancer, lower blood pressure. 

14. Fenugreek 

seeds 

Trigonella foenumgraecum 

Improving glucose tolerance, lower serum low-density lipoprotein, 

has cardiovascular benefits, cure skin problems, cure acid reflux, 

reduce menstrual pain, treat arthritis, asthma, bronchitis, improve 

digestion, maintain a healthy metabolism. 



15. Garlic Allium sativum Anti-oxidant, antibacterial, antiviral, antifungal, high blood 

pressure, prevents cancer, lowers cholesterol level, detoxifier, 

reduce platelet aggregation, regulate blood sugar levels, enhances 

immunity, treats intestinal, respiratory, skin infection. 

16. Ginger Zingiber officinale Stimulant, carminative, treats arthritis, lowers cholesterol, treating 

heart disease, reduces menstrual pain, treating nausea caused by 

seasickness, morning sickness and chemotherapy. 

17. Grapes Vitis vinifera Cardio tonic, inhibit cancer, heart disease, degenerative nerve 

disease, viral infections and Alzheimer's disease, improve blood 

flow, reduces kidney stones, cures migraine, prevents heart attack 

and stroke. 

18. Ground-nut Arachis hypogaea Anti-aging, reduced cardiovascular disease, reduced cancer risk. 

19. Lettuce Lactuca sativa Ease insomnia, aids digestion, promotes liver health; reduce risk of 

heart disease, stroke, cataract, cancer. Prevents spinal bifida, 

prevents anemia. 

20. Linseed Linum usitatissimum Prevention of breast, and prostate cancers, renal failure, maintains 

blood-sugar levels. 

21. Nutmeg Myristica fragrans Stimulant, carminative, treat rheumatism, treating menstrual 

cramps, muscular and joint pain. Tonic for heart, kidney detoxifier, 

brain booster. 

22. Olive Olea europaea Reduction in the risk of coronary heart disease, lowers cholesterol 

levels, lower blood sugar levels and blood pressure. 

23. Onion Allium cepa Reduces the risk of head and neck cancers, lowers cholesterol 

level, aids circulation, decreases blood glucose level. 

24. Pomegranate Punica granatum Cardiotonic, treating hemorrhoids, anti-oxidant, antibacterial, 

inhibit LDL oxidation, atherosclerosis, reduce systolic blood 

pressure. 

25. Soya bean Glycine max Antihyperlipidemic, antidiabetic, prevent cancers of the breast, 

uterus or prostate, minimizing diabetes and reducing inflammation, 

prevents ageing, Alzheimer and heart disease, improves bone 

health. 

26. Tomato Solanum 

lycopersicum 

27. Tulsi Ocimum 

tenuiflorum 

Decreased risk of breast cancer, head and neck cancers , protects 

against coronary heart disease, Removes acne scars, protects cells 

from damage. 

Remedies for colds, headaches, stomach disorders, inflammation, 

malaria, reducing blood glucose levels, cataracts, lowers blood 

cholesterol level. 

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