1.

0 INTRODUCTION

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. The concept of functional foods was introduced in 1980 by Japanese to regulate the use of

food for medicinal purposes. Recently, the research was started to isolate or purify the food from

some specific bioactive compounds called “Nutraceuticals” that are generally sold in medicinal

form not associated and demonstrated to physiological benefits (or) provide protection against

chronic diseases. Functional foods play important role in promoting health and reducing health

risks. Functional foods may be defined as those with a traditional counter past, while

nutraceuticals are those derived from different edible source but consumed in medical form like

tablets or capsules or pills. Nutraceuticals can be prepared from chemical synthesis, fermentation

and genetic engineering (Shandilya and Sharma, 2017).

They include a range of agri-food ingredients or Photochemical extracted from edible

plants or animal products. The functional foods also known as designer foods medical foods,

fortified foods, nutritional foods, nutraceutical foods, therapeutic foods and healthy foods.

Consumer interest in the relationship between diet and health has increased the demand for

information about functional foods (Shandilya and Sharma, 2017).

As the food is essentially functional for supplying energy and nutrients that are needed to

subsistence otherwise, many pieces of evidence show that some food components, not

considered nutrients in the normal sense, may positively affect health. They may be somehow

diminished cancer, stroke, and atherosclerosis; these food components are called bioactive

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compounds. Foods containing these food components are called functional foods (Institute of

Food Technologists, 2012). Due to consumer interest in the relationship between diet and health,

the demand for information about the benefits and the risks of functional foods has increased

(Shandilya and Sharma, 2017). Functional foods are possibly considered as whole, fortified,

enriched or enhanced foods, providing potentially beneficial impacts on health when consumed

regularly at certain levels (Crowe and Francis, 2013). The Food and Drug Administration (FDA)

doesn't have an official definition for functional foods, but it issues regulations and guidance

providing for various health and nutrient claims that may appear on labels of foods and

beverages. Functional foods are divided into four categories: conventional foods, modified foods,

medical foods, and foods for special dietary use according to the Academy of Nutrition and

Dietetics (AND) (Hasler and Brown, 2009).

Maintaining accurate information on the composition of foods is a difficult and

challenging task even under the best of circumstances. The food supply changes over time. These

changes include the types of foods but also include changes in the underlying raw commodities

that are used to produce foods. Often these changes are unanticipated and transparent to the

consumer. To scientists who have the responsibility to determine nutrient content and maintain

food composition databases, these changes cannot be ignored. More recently, the food industry,

the agricultural community, and now consumers have shown a growing interest in the so-called

functional foods. Such foods present unique and difficult challenges to those in the food

composition community and the many entities and individuals that depend on high-quality food

composition data.

Functional foods were first described by Roberfroid (1999) as ‘‘Food similar in

appearance to conventional food that is intended to be consumed as part of a normal diet, but has

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been modified to subserve physiological roles beyond the provision of simple nutrient

requirements’’. More simply put, functional foods are foods that may provide health benefits

beyond basic nutrition. Functional foods can arise from a desire to provide additional benefits to

consumers in the way of enhanced nutrition. They can also be useful in making nutrients more

available by providing particular dietary components in foods that will increase their availability

and palatability beyond that which might normally be consumed.

This seminar review discuss functional foods, its concern and future challenges

3
2.0 FUNCTIONAL FOOD, CONCERN AND CHALLENGES

2.1 Functional Foods

All foods are functional to some extent because all foods provide taste, aroma and

nutritive value. However, foods are now being examined intensively for added physiologic

benefits, which may reduce chronic disease risk or otherwise optimize health. It is these research

efforts that have led to the global interest in the growing food category now recognized as

“functional foods.” Functional foods have no universally accepted definition. The concept was

first developed in Japan in the 1980s when, faced with escalating health care costs, the Ministry

of Health and Welfare initiated a regulatory system to approve certain foods with documented

health benefits in hopes of improving the health of the nation’s aging population (Arai, 2006).

These foods, which are eligible to bear a special seal, are now recognized as Foods for Specified

Health Use (FOSHU) (International Life Sciences Institute, 2009). As of July 2002, nearly 300

food products had been granted FOSHU status in Japan.

In the United States, functional foods have no such regulatory identity. However, several

organizations have proposed definitions for this new food category. 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”

(National Academy Press, 2004). 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” (International Life Sciences Institute, 2009). In a 1999 position

paper, 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

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as “part of a varied diet on a regular basis, at effective levels” for consumers to reap their

potential health benefits (American Dietetic Association, 2009).

Another term often used interchangeably with functional foods, although it is less favored

by consumers, is “nutraceuticals,” a term coined in 1991 by the Foundation for Innovation in

Medicine to refer to nearly any bioactive component that delivers a health benefit. In a 1999

policy paper, Zeisel (2009) astutely distinguished whole foods from the isolated components

derived from them in his following definition of nutraceuticals: “those diet supplements that

deliver a concentrated form of a presumed bioactive agent from a food, presented in a nonfood

matrix, and used to enhance health in dosages that exceed those that could be obtained from

normal food.” Several factors are responsible for the fact that this is one of the most active areas

of research in the nutrition sciences today: 1) an emphasis in nutritional and medical research on

associations between diet and dietary constituents and health benefits, 2) a favorable regulatory

environment, 3) the consumer self-care phenomenon, and 4) rapid growth in the market for

health and wellness products.

2.1.1 Functional foods of animal origin

Probably the most intensively investigated class of physiologically-active components

derived from animal products are the (n-3) fatty acids, predominantly found in fatty fish such as

salmon, tuna, mackerel, sardines and herring (8). The two primary (n-3) fatty acids are

eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6). DHA is an essential

component of the phospholipids of cellular membranes, especially in the brain and retina of the

eye, and is necessary for their proper functioning. DHA is particularly important for the

development of these two organs in infants (Crawford, 2000), and just recently, the FDA cleared

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the use of DHA and arachidonic acid for use in formula for full-term infants (Crawford, 2000).

Hundreds of clinical studies have been conducted investigating the physiologic effects of (n-3)

fatty acids in such chronic conditions as cancer, rheumatoid arthritis, psoriasis, Crohn’s disease,

cognitive dysfunction and cardiovascular disease (Rice, 2009), with the best-documented health

benefit being their role in heart health.

A recent meta-analysis of 11 randomized control trials suggests that intake of (n-3) fatty

acids reduces overall mortality, mortality due to myocardial infarction and sudden death in

patients with CHD (Bucher et al., 2002). The 2000 American Heart Association Dietary

Guidelines recommend two servings of fatty fish per week for a healthy heart (Krauss et al.,

2000), and the FDA authorized a qualified health claim on dietary supplements linking the

consumption of EPA and DHA (n-3) fatty acids to a reduction of coronary heart disease risk

(Krauss et al., 2000). The qualified claim states: “Consumption of omega-3 fatty acids may

reduce the risk of coronary heart disease. FDA evaluated the evidence and determined that,

although there is scientific evidence supporting the claim, the evidence is not conclusive.” A

“qualified” claim was authorized because of certain safety concerns regarding the consumption

of high levels of (n-3) fatty acids, including: 1) increased bleeding times; 2) increased risk for

hemorrhagic stroke; 3) the formation of biologically active oxidation products from the oxidation

of (n-3) fatty acids; 4) increased levels of LDL cholesterol; and 5) reduced glycemic control

among people with diabetes. The FDA concluded that use of (n-3) fatty acid supplements is safe,

provided daily intakes of EPA and DHA from supplements do not exceed 2 g/d (Krauss et al.,

2000).

Another class of biologically active animal-derived components that has received

increasing attention in recent years is probiotics. Defined as “viable microorganisms that are

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beneficial to human health” (15), the health benefits of probiotics have been considered since the

turn of the century when the Nobel prize-winning microbiologist Metchnikoff first postulated

that lactic acid bacteria contributed to the longevity of Bulgarian peasants (Fuller, 2002). It is

thought that a wide variety of live microorganisms can contribute to human health, although the

evidence is mainly from animal studies. In addition to numerous strains of Lactobacillus

acidophilus, other strains of lactobacillus are being incorporated into functional food products

now on the market including L. johnsonii La1, L. reuteri, L. GG, and L. casei Shirota. A recent

Scientific Status Summary on probiotics from the Institute of Food Technologists summarized

the scientific support for the therapeutic and/or preventive use of these functional ingredients for

various health concerns including cancer, intestinal tract function, immune function, allergy,

stomach health, urogenital health, cholesterol lowering and hypertension (Sanders, 2009).

More recently, research efforts have focused on prebiotics, i.e., non-digestible food

ingredients that beneficially affect the host by selectively stimulating the growth and/or activity

of one or a limited number of beneficial bacteria in the colon, thus improving host health

(Gibson and Roberfroid, 2005). Prebiotics include shortchain carbohydrates such as

fructooligosaccharides and inulin, which enter the colon and serve as substrates for the

endogenous colonic bacteria. Newer still is the concept of “synbiotics,” which are mixtures of

probiotics and prebiotics that beneficially affect the host by improving the survival and

implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively

stimulating the growth and/or by activating the metabolism of one or a limited number of health-

promoting bacteria, and thus improving host welfare (Gibson and Roberfroid, 2005).

Another non-plant ingredient that has been the focus of increased research efforts in

recent years is conjugated linoleic acid (CLA). This component, which was first identified as a

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potent antimutagenic agent in fried ground beef by Pariza and co-workers (Ha et al., 2007), is a

mixture of structurally similar forms of linoleic acid (cis-9, trans-11 octadecadienoic acid). CLA

is present in almost all foods, but occurs in particularly large quantities in dairy products and

foods derived from ruminant animals (Yurawecz et al., 2009). For example, uncooked beef

contains 2.9–4.3 mg CLA/g fat, whereas lamb, chicken, pork and salmon contain 5.6, 0.9, 0.6,

and 0.3 mg CLA/g fat, respectively, and dairy products contain 3.1–6.1 mg CLA/g fat (Chin et

al., 2002). The inhibition of mammary carcinogenesis in animals is the most extensively

documented physiologic effect of CLA (Belury, 2005), and there is also emerging evidence that

CLA may decrease body fat and increase muscle mass both in rodent models (Park et al., 2009)

and in humans (Blankson et al., 2000), although not all human studies have been positive in this

regard. There is also preliminary evidence that CLA may increase bone density in animal models

(Watkins et al., 2009).

2.1.2 Functional foods of plant origin

Numerous plant foods or physiologically active ingredients derived from plants have

been investigated for their role in disease prevention and health. However, only a small number

of these have had substantive clinical documentation of their health benefits. An even smaller

number have surpassed the rigorous standard of “significant scientific agreement” required by

the FDA for authorization of a health claim, which will be discussed in further detail below.

Those plant foods currently eligible to bear an FDA-approved health claim include oat soluble ( β

-glucan) fiber (U. S. Food and Drug Administration, 2007), soluble fiber from psyllium seed

husk (U. S. Food and Drug Administration, 2008), soy protein (U. S. Food and Drug

Administration, 2009) and sterol- and stanol-ester–fortified margarine (U. S. Food and Drug

Administration, 2000). Some plant-based foods or food constituents currently do not have

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approved health claims, but have growing clinical research supporting their potential health

benefits, and thus would be described as having moderately strong evidence. These include

cranberries, garlic, nuts, grapes and chocolate and are discussed briefly below.

Cranberries have been recognized since the 1920s for their efficacy in treating urinary

tract infections. A landmark clinical trial (Avorn et al., 2004) confirmed this therapeutic effect in

a well-controlled study involving 153 elderly women. More recent research has confirmed that

condensed tannins (proanthocyanidins) in cranberry are the biologically active component and

prevent E. coli from adhering to the epithelial cells lining the urinary tract (Howell et al., 2008).

New preliminary research suggests that the antiadhesion properties of the cranberry may also

provide other health benefits, including in the oral cavity (Leahy et al., 2001).

Garlic (Allium sativum) has been used for thousands of years for a wide variety of

medicinal purposes; its effects are likely attributable to the presence of numerous physiologically

active organosulfur components (e.g., allicin, allylic sulfides) (Block et al., 2002). Garlic has

been shown to have a modest blood pressure– lowering effect in clinical studies (Silagy and Neil,

2004), while a growing body of epidemiologic data suggests an inverse relationship between

garlic consumption and certain types of cancer (Fleischauer et al., 2000), particularly of the

stomach (Takezaki et al., 2009). The latter may be due in part to garlic’s ability to inhibit the

activity of Helicobacter pylori (the bacterium that causes ulcers). The best-documented clinical

effect of garlic, however, concerns its ability to reduce blood cholesterol. A meta-analysis of 13

placebo-controlled double blind trials (Stevinson et al., 2000) indicated that garlic component(s)

(10 mg steam distilled oil or 600–900 mg standardized garlic powder) significantly reduced total

cholesterol compared with placebo by 4–6%.

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 However, the Agency for Healthcare Research & Quality (Stevinson et al., 2000), which

examined randomized, controlled trials at least 1 mo in duration, concluded that, although

clinical trials show several promising, modest, short-term effects of garlic supplementation on

lipid and antithrombotic factors, “effects on clinical outcomes are not established...” This is

likely due to lack of consistency among studies in type of preparation used and overall study

design. Although foods high in fat have traditionally not been regarded as “heart-healthy”

(except for fatty fish), evidence is accumulating on the cardiovascular benefits of a variety of

nuts, when they are part of a diet that is low in saturated fat and cholesterol (Hu et al., 2008).

Clinical trials, which have specifically examined the effect of almonds on blood lipids, have

found that these tree nuts significantly reduced total cholesterol by 4–12% and LDL cholesterol

by 6–15% (40). More recently, a Life Sciences Research Office review of six clinical

intervention trials with walnuts consistently demonstrated decreases in total and LDL cholesterol

that should lower the risk of CHD (Feldman, 2002).

In the late 1970s researchers noted that residents in certain areas of France, who were

avid drinkers of red wine, had less heart disease than other Western populations even though

they consumed more fat in their diet. This observation triggered numerous investigations into

this so-called “French Paradox” (Constant, 2007) and subsequent research confirmed the

presence of high concentrations of antioxidant polyphenolics in red grape skins. It must be noted

however, that moderate consumption of any alcoholic beverage, e.g., beer, wine or distilled

spirits, has been shown in a number of studies to reduce the risk of heart disease in selected

populations (Meister et al., 2000). For those wishing to abstain from alcohol, recent clinical trials

demonstrate that grape juice may also exert beneficial effects similar to those of red wine

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because both are rich in phenolic antioxidant compounds. Consumption of grape juice has been

shown to reduce platelet aggregation (Keevil et al., 2000).

Another food that is a source of polyphenolics and is just beginning to be investigated for

its potential benefits to heart health (Bruinsma and Taren, 2009) is chocolate. Chocolate contains

flavonoids (procyanidins), which may reduce oxidative stress on LDL cholesterol. In a recent

clinical trial involving 23 subjects consuming a diet supplemented with chocolate and cocoa

powder providing 466 mg procyanidins/d, time to oxidation of LDL cholesterol was increased by

8% compared with subjects consuming a normal American diet (Wan et al., 2001).

Epidemiologic data are accumulating on the health benefits of several additional functional foods

or food components of plant origin, including tea (catechins), lycopene from tomatoes,

particularly cooked and/or processed tomato products, and the carotenoids lutein and zeaxanthin

from green leafy vegetables.

The effect of green or black tea consumption on cancer risk (Yang et al., 2000) has been

the focus of numerous studies. Studies in animals consistently show that consumption of green

tea reduces the risk of various types of cancers. Only a few studies have thus far assessed the

effects of black tea. Green tea is particularly abundant in specific polyphenolic components

known as catechins (Mukhtar and Ahmad, 2009). The major catechins in green tea are (-)-

epicatechin, (-)-epicatechin-3-gallate, (-)-epigallocatechin and (-)-epigallocatechin-3-gallate

(EGCG) (Harbowy and Balentine, 2007). One cup (240 mL) of brewed green tea contains up to

200 mg EGCG, the major polyphenolic constituent of green tea. Although 100 epidemiological

studies have examined the effect of tea consumption on cancer risk, the data are conflicting

(Yang and Wang, 2003). A recent study (Tsubono et al., 2001) involving 26,311 residents from

three municipalities in northern Japan found no association of green tea consumption with the

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risk of gastric cancer. Phase I clinical trials are currently ongoing at the MD Anderson Cancer

Center (Houston, TX) in collaboration with the Memorial Sloan-Kettering Cancer Center in New

York on the safety and efficacy of consuming the equivalent of 10 cups of green tea by 30 cancer

patients with advanced solid tumors.

Tomatoes and tomato products are also being investigated for their role in cancer

chemoprevention and are unique because they are the most significant dietary source of

lycopene, a non-provitamin A carotenoid that is also a potent antioxidant (Clinton, 2008). A

comprehensive review of 72 epidemiologic studies (Giovannucci, 2009) found an inverse

association between tomato intake or plasma lycopene concentration and the risk of cancer at a

defined anatomical site in 57 of the 72 studies reviewed (79%); in 35 of these studies, the inverse

associations were statistically significant. No study indicated higher risk with increasing tomato

consumption or lycopene blood levels. Further, the risk reduction for about half of all studies

reviewed was 40% (i.e., a relative risk estimate of 0.6). Cancers of the prostate, lung and

stomach showed the strongest inverse associations, whereas data were suggestive for cancers of

the pancreas, colon and rectum, esophagus, oral cavity, breast and cervix.

2.2 Types of Functional Foods

The variety of functional foods that can be developed is limited by our imagination, the

perceived benefits, and the willingness of consumers to pay for those benefits. Examples of each

of these types of foods can be found commonly in the marketplace. Some may be obvious that

they are functional foods, but some such products in the marketplace are relatively transparent.

This fact adds to the challenge of maintaining accurate food composition data and nutrition

12
monitoring (Silagy and Neil, 2004). Some examples of functional foods in each of the categories

and the challenges that they present with regard to food composition are noted below.

2.2.1 Fortified foods

The simplest types of functional foods are those products that are fortified with additional

nutrients. The food supply has abundant examples of such foods. Examples include the recent

fortification of grain products with folic acid and various fruit juices that are fortified with

additional vitamin C. This approach of fortification has proven to be an effective and economical

way to improve nutrient quality and provide benefits to consumers. However, one can easily see

the problems that it presents with regard to food composition. In instances such as folic acid

fortification, the amounts are mandated, but in other instances the fortification is optional and

dependent on the particular food item or brand of product. In addition, an added problem can

exist in that the amount of fortification may not be accurate, and that fortification of identical

products at differing manufacturing plants can lead to the same product with differing amounts

of the nutrient that has been used to fortify the product (U. S. Food and Drug Administration,

2009).

2.2.2 Enriched foods

Other examples of functional foods are enriched products that might add additional

components or components not normally found in great quantity in a particular food. An

example of this type of food, with widespread availability, is orange juice that has added

calcium. Another example is the inclusion in margarines of plant sterol esters that have been

shown to lower blood lipids and cholesterol. These types of products provide clear benefits in

dealing with a problem nutrient such as calcium, or have been shown to be effective in

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promoting cardiovascular health, respectively. However, with regard to food composition, this

can create problems. The growing dissimilarity of what only a few years ago was a single

product adds a higher degree of complexity in tracking food composition data. Another

interesting area of functional foods and one that has reached the grocery shelf is that of

components classified as probiotics and prebiotics (U. S. Food and Drug Administration, 2008).

Probiotics are live microbial food ingredients that have a beneficial effect on human

health; they are traditionally found in fermented dairy products and fermented vegetables.

Prebiotics are typically fermentable dietary fibres that provide a gastrointestinal environment in

which beneficial bacteria can thrive. The health benefits of enhancing the microbial environment

of the gastrointestinal tract are well documented and include systemic effects such as lowering of

cholesterol and enhanced liver metabolism of xenobiotics (Roberfroid et al., 1995). Although not

nutrients in the strictest sense of the word, foods that contain probiotics and prebiotics clearly

have nutritional effects. As foods that contain them are more widely consumed, they have the

potential for providing real health benefits. At the same time, such foods present a unique

challenge with regard to food composition. Many probiotics and prebiotics are proprietary

ingredients. Do we ignore such food components in terms of food composition or will there have

to be some determination of their presence in functional foods? These types of food components

might suggest that some functional foods might require that functional assays for biological

activity are needed in order to fully understand the composition of foods.

2.2.3 Altered products

Using different ingredients, food products can be developed whereby some potentially

harmful or undesirable constituents could be replaced by more beneficial components, ideally

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without affecting product quality. A good example of this is the use of high fibre fat replacers,

produced from grain products (Inglett, 2001; RomanchikCerpovic et al., 2002). A variety of

these reduced fat and fat-free items have been available commercially for some time. Products

that have reduced fat are widely consumed and largely unrecognized by consumers. The

consumer knows the product is reduced in fat, but does not know how or what other changes

have been made to the food. Scientists involved with food composition and those involved in

nutrition monitoring face challenges trying to understand just how the foods have been altered

and if there are any other nutritionally important changes, such as increased fibre content, that

are important to measure and track in food composition databases.

2.2.4 Enhanced commodities

An exciting class of functional foods is enhanced commodities. Plant breeders can

develop amazing varieties of products that have potentially important benefits to consumers.

Examples include high lysine corn, fruits and vegetables with enhanced content of vitamins, and

overproduction of phytonutrients in a variety of fruits and vegetables including the insertion of

some of those components into food plants that do not normally produce those dietary

components, such as golden rice or carotenoid containing potatoes. While such products can

provide tremendous health benefits, they can create problems with regard to food composition.

Many times, consumers may not be aware of what they are eating. What will it mean if one

consumes a tomato when there will be large differences in the nutrient content of tomatoes or

that a meal might include a potato that might contain β -carotene?

There are additional pitfalls with enhanced commodities. Tomatoes that have increased

production of the phytonutrient lycopene have been developed by Mehta et al. (2002). The fruits

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offer potential benefits to the public based on some evidence that lycopene is beneficial for

health. Obviously, for accurate food composition, one needs to know the content of the lycopene

in the tomato. When looking at other components in these lycopene-enhanced tomatoes, it was

noted that the synthesis of carnitine was also increased (Mehta, personal communication). Thus,

it is highly likely that as we alter plants to overproduce certain compounds, the content of other

plant components are also affected. Some of these additional components may or may not share

common biosynthetic pathways, but potentially some of these will be nutritionally important. It

may be that for accurate nutrient content, such enhanced commodities must not only be

measured for their increased content of a particular nutrient but also for all other nutrients as

well.

2.3 Functional Foods and their Nutritional Significance

Hardy et al. (2000) reported the term ‘‘functional food’’ itself was first used in Japan, in

the1980s, for food products fortified with special constituents that possess advantageous

physiological effects and health claims. Several functional foods have consistently demonstrated

LDL-cholesterol-lowering effects. Significant interest has focused on dietary factors for the

prevention of cardiovascular disease (CVD) (Mishra and Geetha, 2009). Functional foods have

been developed in virtually all food categories. According to alternative classification some

functional products 1) Improve the regular stomach and colon functions (pre- and probiotics) or

‘‘improve children’s life’’ by supporting their learning capability and behaviour. 2) Functional

food is designed for reducing an existing health risk problem such as high cholesterol, high blood

pressure. 3) Lactose-free, gluten-free products (Ma kinen-Aakula, 2006).

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 In particular, new food products with health attributes have raised in popularity because

they are believed to offer consumers an increased ability to reduce the risk of certain diseases

(Dhar and Foltz, 2005). The global market for functional foods is estimated to be worth about

US$33 billion (Hilliam, 2000). The soft drink segment include non-alcoholic beverages with

vitamins or other enhanced ingredients; in the confectionery segments, innovations include

chewing gum for dental hygiene, while omega-3 milk was an important functional food

innovation in the dairy product sector; functional bakery products included breakfast cereals with

cholesterol-lowering ingredients. Other product segments contribute to only 16% of new

functional products compared with 41% of products innovations in the total food and drinks

market (Menrad, 2003).

Willett (2002) reported that 60 per cent of the risk of chronic diseases potentially is

preventable with lifestyle modifications, including changes in diet. Von Alvensleben (2001)

provides a useful schematic representation of the relative position of functional food. The

members of the Institute of Food Technologists (IFT) recognize that the foods already on the

market represent a small fraction of the potential for functional foods. Today’s science and

technology can be used to provide many additional functional foods, and future scientific and

technological advances promise an even greater range of health benefits for consumers.

Functional foods can provide health benefits by reducing the risk of chronic disease and

enhancing the ability to manage chronic disease, thus improving the quality of life. Functional

foods also can promote growth and development and enhance performance.

Functional foods can be used to reduce the human diseases and because it contains

functional ingredients which will have a functional properties like antimicrobial activity,

antoxidant, anticancer. Functional foods can take many forms. Some may be conventional foods

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with bioactive components that can now be identified and linked to positive health outcomes.

Some may be fortified or enhanced foods, specifically created to reduce disease risk for a certain

group of people. Consumers can already select from a wide spectrum of foods that contain

functional components either inherently (e.g., soy protein, cranberries) or via fortification (e.g.,

folate-fortified foods). Health benefits may result from increasing the consumption of substances

already part of an individual’s diet or from adding new substances to an individual’s diet. As

additional bioactive components are identified, the opportunities for developing functional foods

will be broad (O’Donnell, 2003). Foods that naturally provide a bioactive substance may be

enhanced to increase the level present in the food (e.g., eggs with increased levels of omega-3

fatty acids). Alternately, foods that do not naturally contain a substance can be fortified to

provide consumers with a broader selection of food sources for a particular component and its

health benefit (e.g., calcium-fortified orange juice).

2.4 Concerns and Challenges of Functional Foods

2.4.1 Major health issues

Based on decades of scientific inquiry, it is clear that diet plays an important role in

affecting our risk for a variety of chronic diseases and disorders, including cancer, heart disease,

type II diabetes, and obesity (World Health Organization, 2003), and there is continued interest

in characterizing the contribution of diet to bone, joint, and eye health as well as to cognitive

function. Increased consumption of fruits/vegetables is associated with a lowering of risk for a

variety of cancers (Steinmetz and Potter, 1996). Although this health benefit is most likely due to

the collective presence of many nutrient and non-nutrient plant components (a “cocktail of

phytochemicals”), there is considerable ongoing research aimed at determining how individual

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phytochemicals such as lycopene in tomatoes, polyphenolics in fruits, isothiocyanates in

broccoli, and antioxidants, to name a few, contribute to this cancer-protective effect. In relation

to heart health, increasing consumption of plant-based foods is again considered a key lifestyle

recommendation for Americans, for whom heart disease is a leading cause of death. Food

products enriched for soy protein, plant sterols and stanols, omega-3 fatty acids, antioxidants,

and fiber are being formulated and offered to the consumer (Meister, 2002).

With a growing number of aging American baby-boomers, food products are being

promoted that purport improvements in the health of joints, muscles, and bones due to the

actions of such ingredients as glucosamine, calcium, and anti-inflammatory and anti-oxidant

nutrients and phytochemicals. Furthermore, there is intriguing evidence that xanthophylls (such

as lutein) may play a role in eye health (e.g. decreasing the development of macular

degeneration) and that conjugated linoleic acid (CLA) and tea phenolics may improve weight

maintenance and the balance between muscle mass and fatty tissue. Yet, as discussed below, the

amount and quality of scientific data supporting such claims can vary, and in some cases there is

a lack of scientific agreement as to the efficacy of the specific constituents. In addition, there

may be inadequate information affirming overall safety, especially when consumed in purified

forms by individuals in different stages of the life cycle and/or at high levels of intake.

Keeping these caveats in mind, progress in understanding the role of diet, lifestyle, and

health, as well as in developing a number of creative new food technologies, has enabled food

manufacturers to craft and market health-improving food products with strong consumer appeal.

Foods with a low glycemic index, low levels of trans-fatty acids, enhanced color stability and

pleasing texture characteristics and mouth-feel exemplify advances that offer consumers a

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greater variety of healthy and attractive foods from which to choose (Milo Ohr, 2003; Pszczola,

2003).

2.4.2 Nutritional issues

While functional foods can offer potential benefits, there are a number of concerns that

need to be considered before we can change the food supply in beneficial ways. Foods contain a

variety of nutrients and nutritionally beneficial components—many of which are known, but

many of which are not yet determined. Despite the fact that technology has progressed to a point

where changes in foods can be made easily, one could reasonably argue that we do not know

enough about the role of all dietary components, particularly the non-traditional or emerging

nutrients such as phytonutrients, to make meaningful changes to the food supply.

Several years ago, it was widely assumed that b-carotene provided protection against the

development of cancer or heart disease, leading to increased consumption of this carotenoid in

foods and supplements. However, as reported by Omenn et al. (1996) as well as others, this

compound may increase the risk for cancer or heart disease in certain situations. Such findings

highlight the need to look at the overall diet when looking at adequacy and desirability of an

individual’s diet. In addition, in light of the potential for misunderstanding of the role of

emerging nutrients or potentially bioactive food components in maintaining health, the design of

functional foods must take a well-reasoned and careful approach in order to achieve the potential

promise of functional foods.

Another nutritional concern with functional foods is the possibility of consuming an

excess of nutrients, some of which may have toxic properties. While a functional foods approach

might be desirable to increase the intake of particular nutrients, one of the concerns related to

20
functional foods could be that by enhancing nutrient content, we may be reducing the variety in

the diet as consumers rely on a smaller number of foods to meet their dietary needs. Most would

agree that variety in the diet is essential, and functional foods can have the undesirable effect of

reducing variety.

2.4.3 Factors influencing consumption of functional foods

There are differences in what affects consumer willingness to consume functional foods

between different consumers (Kastenholz et al., 2008). Previous studies made in Taiwan (Chen,

2011) and Finland (Lähteenmäki and Urala. 2007) have shown that in addition to demographic

data, consumers attitudes on functional foods are also affected by the consumers lifestyle and

that their lifestyles affect their willingness to use functional food products. A model for

measuring consumer willingness to buy functional food was developed buy Lähteenmäki and

Urala (2007). This model provided the researcher with a scale, high in reliability and validity in

regards to consumer attitudes towards functional food (Chen, 2011). The scale looks at four areas

of consumer willingness to consume functional food (Ibid) Reward, Necessity, Confidence and

Safety. Reward from using functional foods focuses primarily on health, mood and the general

wellbeing that comes from using functional foods, the beneficial rewards must be linked to an

individual that eats functional food as a way of taking better care of oneself. Necessity for

functional foods revolves around consumers attitudes and how they perceive the need for

functional food as something with medical properties.

Confidence in functional foods provides a picture of how much confidence the consumers

have in functional foods and whether or not they perceive functional foods as something that is

safe and healthy to consume. Safety of functional foods focuses on determining the possible

21
nutritional risks the consumers experience if, and when, they would consume functional food

(Lähteenmäki and Urala, 2007; Chen, 2011).

2.5 Regulation of Functional Foods

Japan has been the leader in regulation of functional foods (Yamada et al., 2008). For

example, the Japanese Ministry of Health, Labor, and Welfare was the first regulatory agency to

recognize functional foods as a unique food category (International Life Sciences Institute,

2009). The Food for Specified Health Uses (FOSHU) program, which began in 1991, was the

first to use scientific evidence to allow health claims for functional foods. Products approved as

FOSHU are allowed to use the FOSHU seal of approval on their product labels (Shimizu and

Hachimura, 2011). As of 2010, the number of FOSHU-approved products has risen steadily to

more than 950 foods (Shimizu and Hachimura, 2011).

In the United States, foods are regulated under the Federal Food, Drug, and Cosmetic Act

of 1938, which makes no provision for a definition of functional foods (Ross, 2000). This is

because of the thought that there are already regulations concerning the use of food ingredients

that are adequate to cover functional food ingredients (Ross, 2000). According to the Food and

Drug Administration (FDA) (Ross, 2000) the intended use of a food is the main determinant for

regulatory status. Products determined to be foods are regulated as food in conventional form,

which includes functional foods and foods for special dietary use (Ross, 2000). The Nutritional

Labeling and Education Act of 1990 includes both conventional foods and foods for special

dietary use (Ross, 2000).

There are currently four categories of claims that food manufacturers can use on labels to

communicate health information to consumers. These categories include:

22
  Nutrient content claims;

 Structure/function claims;

 Health claims; and

 Qualified health claims.

All four types of claims are allowed on functional food labels if the claim meets the

defined criteria outlined for each claim type (US General Accounting Office, 2000). More

information about types of claims that can be used on functional foods in the United States can

be found on the FDA website (US Food and Drug Administration, 2003). According to the

Nutritional Labeling and Education Act, a product is allowed to bear a health claim after

extensive review of the scientific evidence submitted to the FDA. Such claims are authorized

based on significant scientific agreement or on an authoritative statement from a scientific body

of the US government or the National Academy of Sciences. Health claims must be authorized

by the FDA before they can be used on food labels. Currently, there are 12 health claims that

meet this significant scientific standard and 4 health claims that are authorized on an

authoritative statement. These health claims are summarized on the FDA website (Food and

Drug Administration, 2009).

Qualified health claims are intended to provide information about diet disease

relationships when the scientific support has not reached the highest level of scientific evidence.

Currently, qualified health claims are allowed for six disease categories, including atopic

dermatitis risk, cancer risk, cardiovascular disease risk, cognitive function, diabetes, and

hypertension.

23
2.6 The future of functional foods

Extensive research is currently directed toward increasing our understanding of

“functional foods.” Academic, government and private research institutes around the globe are

devoting substantial efforts to identifying how functional foods and food ingredients might help

prevent chronic disease or optimize health, thereby reducing healthcare costs and improving the

quality of life for many consumers. An emerging discipline that will have a profound effect on

future functional foods research and development efforts is nutrigenomics, which investigates the

interaction between diet and development of diseases based on an individual’s genetic profile.

Interest in nutrigenomics was greatly augmented by the recent announcement that a rough draft

of the complete sequence of the human genome had become available. In February 2001, the

complete sequence of the human genome was announced by Ventor and colleagues (Arai, 2006).

This technological breakthrough could eventually make it feasible to tailor a diet for an

individual’s specific genetic profile. Nutrigenomics will have a profound effect on future disease

prevention efforts including the future of the functional foods industry. Another technology that

will greatly influence the future of functional foods is biotechnology. Recent examples of

biotechnology-derived crops which have tremendous potential to improve the health of millions

worldwide include golden rice and iron-enriched rice. These grains are genetically engineered to

provide enhanced levels of iron and β -carotene which could, in turn, help prevent iron deficiency

anemia and vitamin A deficiency–related blindness worldwide. In the future, other foods

enhanced with other nutritive or nonnutritive substances may even help to prevent chronic

diseases such as heart disease, osteoporosis or cancer. The acceptance of biotechnology by

consumers (currently a major issue in Europe) will be important if the potential of this powerful

methodology is to be realized (Arai, 2006).

24
3.0 CONCLUSION AND RECOMMENDATIONS

3.1 Conclusion

Today, functional foods represent a large-scale field of research and promotion in food

and nutritional sciences. The functional properties of many traditional foods are researched and

studied on a hand, and the development and discovery of new useful food products on the other

hand. Some examples of these foods are fruits, vegetables, whole grains, fortified foods and

drinks, and some nutritional supplements. Functional foods are used to reduce a proportion of

human diseases because they contain functional components that have properties such as

antimicrobial activity, antioxidant and anti-cancer. Rigorous studies of safety and efficacy must

be based on strong scientific evidence when studying any health benefits attributable to

functional foods. Interactions with other dietary components and potential adverse interactions

with pharmaceutical agents must be clearly imparted. It should be noted that functional foods are

not a magic wand to solve health problems, that is, consumers must be careful of the many

promoted or implied benefits of these foods, and that there is no coordinated regulation or

application of current regulations in the field of functional foods.

3.2 Recommendations

Based on the review above it is recommended that the challenges presented by functional

foods serve to highlight the quickly changing nature of the food supply. Regardless of these

changes, there is a continuing need to know the accurate composition of foods, both for nutrients

and nonnutrients, and for understanding the amount of these components in foods.

25
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