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Functional foods: a conceptual denition

Maurice Doyon
Laval University, Quebec City, Canada, and

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JoAnne Labrecque
HEC Montreal, Montreal, Canada
Abstract
Purpose To draw the frontiers of the functional food universe, to identify concepts that should be included in a broadly accepted functional food denition and to propose a denition. Design/methodology/approach Based on a review of the literature and the Delphi technique with a group of North American and European experts. Findings Four concepts were identied: the nature of food, health benets, functions and regular consumption. Two dimensions, physiological effects and functional intensity, were developed to dene the frontiers of the functional food universe and a denition is suggested. Practical implications A large number of denitions as well as great variations within denitions make it difcult to provide industry partners with robust information on market trends and market potential, or to appropriately protect consumers through legislation. This paper should contribute to the debate surrounding the type of food that should be considered a functional food and surrounding the lack of a common denition for functional foods. Originality/value This paper is the rst one, to our knowledge, that attempts to conceptually dene the frontiers of the functional food universe and to provide a denition of functional food which is not sensitive to cultural differences, can accommodate temporal variations and rely on previous knowledge (denition) as well as experts opinions. Keywords Food products, Nutrition Paper type Conceptual paper

Introduction In the early twentieth century, nutrition science was preoccupied with preventing deciencies and supporting body growth. Following World War II, although nutrient sufciency and basic nutritional adequacy remained important, the economic growth enjoyed by numerous countries fostered a more hedonistic approach to food consumption, with a focus on preferences and aversions (Arai, 2002). This led, in the last third of the century, to the recognition by nutritionists that consumption of some food components could have a negative impact on health, if they were consumed in sufcient quantities (Ashwell, 2003). Today, the focus of nutritional science is shifting toward the concept of optimal nutrition, the objective of which is to optimise the daily diet in terms of nutrients and non-nutrients, as well as other food properties that favour the maintenance
be cois de la The authors would like to acknowledge the nancial support of Le Fonds que phane recherche sur la nature et les technologies as well as the work of Virginie Simard, Ste Langevin and Denise Bweli, graduate and undergraduate students in the department of Agricultural Economics and Consumer Science at Laval University.
British Food Journal Vol. 110 No. 11, 2008 pp. 1133-1149 q Emerald Group Publishing Limited 0007-070X DOI 10.1108/00070700810918036

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of health (Ashwell, 2003). For instance, according to the Food Marketing Institute (2004), 65 per cent of grocery shoppers tried to manage or treat health conditions through diet. Similarly, Milner (2002) draws on various sources to conclude that in North America, consumers believe that modifying their diet and using supplements are the two most important options available to reduce health care costs and improve personal health. This recent nutritional shift is greatly motivated by demographic changes, specically the aging of the population in most developed countries, the higher life expectancy and the desire for an improved quality of life. Moreover, an increase in life-style related diseases, combined with constantly rising health care costs, have stimulated research to identify or produce food with functions that can improve health and well-being, and reduce the risk or delay the onset of major diseases (Arai, 2002; European Food Information Council, 2005). It is in this context that the concept of functional food has emerged. The development of functional foods appears to be a long-term trend with important market potential. According to Fitzpatrick (2003), the market for functional foods is expanding by 7-10 per cent per year. Market size estimates vary widely, from $11 billion to $155 billion annually, depending on the denition (Weststrate et al., 2002). In this emerging market, information ows generated by research are needed to support private investment, consumption decisions and government regulation (Thomassin and Cloutier, 2001). Unfortunately, great variations between various denitions make it difcult to provide industry partners with robust information on market trends and market potential, or to appropriately protect consumers through legislation. The lack of a commonly accepted denition for functional foods has been asserted by numerous authors (Veeman, 2002; Falk, 2004; Government of Canada, 2004; European Food Information Council, 2005). To make matters more complex, concepts such as nutraceuticals and natural health products are often associated with functional foods, creating confusion between those product classes (Veeman, 2002). While the literature includes numerous studies of market potential and the legislative and technological perspectives for functional foods, to our knowledge no study has specically attempted to dene functional foods, with the exception of Roberfroid (2000). A better understanding of the various concepts and principles that should be considered while dening functional foods could increase uniformity between denitions and help the interpretation of information ows. Objectives and methodology The objectives of this study are: . To identify key concepts found in various denitions of functional foods. . To identify and develop principles that would allow drawing the frontiers of the functional food universe. . To propose a working denition of functional food that accounts for cultural and temporal dimensions. To attain these objectives, the following methodological steps are taken: (1) Refer to the literature and the opinions of experts to identify key concepts of functional food[1].

(2) Based on the literature and legislative texts from various countries, to identify and develop principles that would allow to draw the frontiers of the functional food universe. (3) Based on information gathered in Steps 1 and 2, to initiate a consultation of a group of North American and European experts through the Delphi method in view of developing a working denition of functional food that accounts for cultural and temporal dimensions[2]. (4) Detail and illustrate the various components of the suggested denition. The Delphi method, which is the principal tool used in this paper, consists of a structured process for collecting and distilling knowledge from a group of experts through a series of questionnaires interspersed with controlled opinions and feedback (Adler and Ziglio, 1996). The method allows discussion between experts without permitting social interactive behaviour, such as follow the leader, as might happen during a face to face group discussion with the result of tainted opinion forming (Wissema, 1982). The Delphi method was developed in the 1960s by a team of researchers led by Dalkey and Helmer, at the RAND Corporation. The method is widely used to generate forecasts in technology and other elds, as well as to deal systematically with complex tasks. This iterative technique could be summarized by the following four points: (1) structuring the information ow; (2) feedback to the participants; (3) iteration stops when a consensus or saturation is reached; and (4) anonymity for the participants. The Delphi technique is especially appropriate for the purpose of this paper given the predictive nature required for a stable denition in the relatively new and fast growing eld of functional foods and the complexity of the problem and the geographical distance that separates the identied experts in this study. The selected experts were rst provided with background material (Steps 1 and 2) and an open-ended questionnaire. A draft denition was provided in the second round with feedback and more questions, mostly regarding litigious points among experts. After four rounds, near consensus (and saturation) was reach on the working denition presented in this paper. Review of denitions A large number of denitions exist worldwide for functional foods[3]. Some denitions suggest that any food, if marketed with the appropriate positioning, is a functional food (Riemersma, 1996; Hollingsworth, 1999). Others maintain that only fortied, enriched, or enhanced foods with a component having a health benet beyond basic nutrition can be considered (Center for Science in the Public Interest, 1999; Kleinschmidt, 2003). Some denitions indicate that if a health claim can be made, a food is functional (Iowa, 2000; Weststrate et al., 2002). While some denitions are quite simple: Foods or food components that may have health benets that reduce the risk of specic diseases or other health concerns (National Institute of Nutrition, 2000), others are much more complex:
A food can be regarded as functional if it is satisfactorily demonstrated to affect benecially one or more target functions in the body, beyond adequate nutritional effects, in a way that is relevant to either improved state of health and well-being and/or reduction of risk of disease.

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A functional food must remain food and it must demonstrate its effects in amounts that can normally be expected to be consumed in the diet: it is not a pill or a capsule, but part of the normal food pattern (Diplock et al., 1999).

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After reviewing over a hundred denitions, twenty-six were selected on the basis of their representation of the various types of existing denitions for functional foods. The selected denitions are found in Table I. Then, among the selected denitions, four key concepts were identied: (1) Health benets. The concept of health benets appears to be central to most denition as illustrated by its mention in the twenty-six denitions selected. However, only two denitions indicate that the health benets should be proven, without specifying the type of proof required. The health benets found in the denitions, when specied, could be classied as enhancing target function or as reducing the risk of specic diseases. (2) The nature of the food. The nature of the food also appears to be an important concept. Although most denitions use the word food, almost a third (8/26) specify that a functional food should be or should look like a traditional food. Some denitions stipulate that the food must have been fortied, enriched or had an ingredient added, while others mention the removal of allergens or of components considered detrimental to the health if over consumed (e.g. salt, sugar). More than half the denitions (15/26) refer to the nature of the food concept. (3) Level of function. All foods have some nutritional functions. However, according to more than half the denitions selected (13/26), what makes a food functional are benets beyond its basic nutritional functions. To stress the importance of this concept, Roberfroid (2002) advises that food be viewed through its function(s) rather than as a product or through its physical attributes. (4) Consumption pattern. The last concept identied is the pattern of consumption which was found in nine of the denitions selected. This concept states that a functional food must be part of a normal diet or t a normal consumption pattern in a specic geographic and/or cultural context. Therefore, a food that is functional in one country may not necessarily be considered functional in another. Table I indicates that 4 of the 26 denitions selected contain the four concepts previously identied. The four denitions are #2 (Health Canada, 2006), #7 ( Jansen and Krijger, 2003), #23 (Diplock et al., 1999) and #25 (Lajolo, 2002). A closer look at the four denitions shows differences in their use of the concepts. These differences will in turn be used as a starting point to identify and develop the principles necessary to draw the frontier of functional food. More specically, denitions #2 and #23 include in their health benets the reduction of health risks as well as enhancing functions. On the other hand, denitions #7 and #25 refer to additional health benets without being more specic. Still on health benets issue, denition #25 does not mention any type of proofs for health benets. Denition #7 suggests that health benets can be claimed, while denition #23 talks of benets that are satisfactorily demonstrated. Only denition #2 mentions that health benets should be proven, but does not specify the type of proofs. Important variations on the nature of the food are found between the four denitions as well. They all mention that a functional food is a food or that it could be

Authors X

Denition

Nature

Criterion Regular Function consumption Health benet X

#1

CSIRO Human Nutrition (2004)

#2 X X

Health Canada (2006)

#3 X

FOSHU, Japan (1991) cited in Anon. (2003)

#4

European food information council cited in Anon. (2003)

X X X

X X

#5

National Academy of Sciences, USA cited in Anon. (2003)

#6

Institute of Food Technologists, USA cited in Anon. (2003)

Foods that may be eaten regularly as part of a normal diet, that have been designed specically to provide a physiological or medical benet by regulating body functions to protect against or retard the progression of diseases such as coronary heart disease, cancer, hypertension, diabetes and osteoporosis A functional food is a conventional food or a food similar in appearance to a conventional food, it is part of a regular diet and has proven health-related benets and (or) reduces the risk of specic chronic diseases above its basic nutritional functions Foods which are, based on the knowledge between foods or food components and health, expected to have certain health benets, and have been licensed to bear a label claiming that a person using them for specied health use may expect to obtain the health use through the consumption thereof Functional foods serves naturally primarily the supply of nutrients, but additionally they offer a special advantage for the health Foods that encompass potentially healthful products, including any modied food or food ingredient that may provide a health benet beyond the traditional nutrients it contains A conventional food with nutrient-content claims, pre-approved health claims, an authoritative statement such as the Food and Drug Administration Modernization Act, and structure-function claims with disclaimer or structure-function claims without disclaimer X

(continued )

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Table I. Denitions of functional foods from the literature

#7 X

#8

#9

#10

#11

#12

#13

#14

Table I. Denition X Nature Criterion Regular Function consumption X Health benet X X X X X X X X X X X X X X X X X Foodstuffs mostly similar in appearance to conventional foods that t daily in the diet and consumption pattern but that, in addition to their basic nutritional value, contain specic additives or properties achieved by processing or otherwise for which a physiological/health benet beyond basic nutrition is claimed Foods or food components that may have health benets that reduce the risk of specic diseases or other health concerns Foods with added ingredients that claim to provide a health benet to consumers beyond the benets provided by ordinary foods themselves Modied foods or food ingredients that provide health benets beyond their traditional nutrients Foods that, by virtue of physiologically active components, provide benets beyond basic nutrition and may prevent disease or promote health Foods that, in addition to supplying known nutrients, can provide other health benets as well Any substances that is a food or part of a food that provides medical and/or health benets, including the prevention and treatment of disease A food component (being a nutrient or not) which affects one or a limited number of function(s) in the body in a targeted way so as to have positive effects that may justify health claims (continued )

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Authors

Jansen and Krijger (2003)

National Institute of Nutrition (2000) Center for Science in the Public Interest (1999)

Adelaja and Schilling (1999)

Hasler (2000)

Egg Nutrition Center (2004)

DeFelice (2007)

Roberfroid (2002)

Authors X X X

Denition

Nature

Criterion Regular Function consumption Health benet

#15

General Accounting Ofce, USA (2000)

#16 #17

Iowa State University (2000) Kleinschmidt (2003)

X X

#18 #19

Weststrate et al. (2002) IFIC Foundation (2006)

X X X X X X X X

#20

Riemersma (1996)

#21

Hillian (1995) cited in Roberfroid (2002)

#22

Smith et al. cited in Roberfroid (2002)

Functional foods are products formulated with naturally occurring chemicals (or combination of chemicals) found in many fruits, vegetables, grains, herbs and spices to provide a health benet, lower the risk of certain diseases, or affect a particular body process. They go beyond correcting diseases such as pellagra and scurvy, caused by nutritional deciencies. Functional foods are akin to novel macro ingredients in that their formulation is intended to provide a health benet to consumers. However, functional foods are designed to lower the risk of specic diseases such as lung cancer by removing certain ingredients, by adding or combining ingredients not normally found in a food product, or by concentrating substances in higher than usual quantities. Foods that have been linked to health benets A whole food (as opposed to pills, powders, or supplements) that is fortied, enriched, or enhanced with a component having a health benet beyond basic nutrition Foods that make specic health claims Foods that may provide health benets beyond basic nutrition Foods or foods products marketed with the message of the benet to health Foods and drink products derived from naturally occurring substances consumed as part of the daily diet and possessing particular physiological benets when ingested Foods derived from naturally occurring substances, which can and should be consumed as part of the daily diet and which serves to regulate or otherwise affect a particular body process when ingested

(continued )

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Table I.

#23

#24

#25

#26

Table I. Denition X Nature Criterion Regular Function consumption X X Health benet X X X X X X X X X X A food can be regarded as functional if it is satisfactorily demonstrated to affect benecially one or more target functions in the body, beyond adequate nutritional effects, in a way that is relevant to either improved stage of health and well-being and/or reduction of risk of disease. A functional food must remain food and it must demonstrate its effects in amounts that can normally be expected to be consumed in the diet: it is not a pill or a capsule, but part of the normal food pattern Foods, that by virtue of physiologically active food components, provide health benets beyond basic nutrition A food that is a food and not a drug, that is part of a normal diet and that can produce benets beyond basic nutrition They are foods which can be part of our everyday diet but which have properties that provide an additional health benet

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Diplock et al. (1999)

International Life Sciences Institute cited in Milner (2002) Lajolo (2002)

Agriculture, Food and Rural Development, Alberta (2003)

conventional food. Denition #23 even species that it cannot be a pill or a capsule. On the other hand, denitions #2 and #7 indicate that it should at least look like a conventional food, which implies that it does not need to be a conventional food. Denition #7 describes a food that contains specic additives or properties achieved by processing or otherwise. The three other denitions do not specify if the food should have something added or removed. Differences in the pattern of consumption among the four denitions are more subtle. The four denitions make it clear that a functional food should be part of a regular or a normal diet. However, denition #7 is more restrictive with its daily diet and consumption pattern. Denition #23 refers, instead, to quantity normally expected to be consumed in the diet, while making references to the health effects. This implies that the benet should be present without having to consume abnormal quantity of a specic food. Functional food boundaries Using the differences identied above, we can frame questions that will enable us to draw the boundaries of functional food. One obvious question is if health benets should be proven and the type of proof that should be considered acceptable. It appears that some sort of health benet guarantee is essential to protect consumers and to insure the future of functional food. However, only one denition surveyed clearly states that the health benet should be proven. On the other hand, numerous denitions state that a functional food must have a health or a nutrient claim. Since claims are generally regulated, this somehow implies some sort of approval from a government agency and therefore some level of protection for consumers. Is a health claim a sufcient proof? The problem with health claim is the fact that they are a creation of regional regulation bodies. For instance, Canada only has ve health claims and its legislation is considered to be restrictive. By contrast, China has at least 24 health claims and some, notably for sexual potency, appear suspicious in terms of proven effects. Japan uses the notion of health claims and the FOSHU logo to dene its universe of functional food, but based on a legislative background that is unique. These illustrations demonstrate the problem of using health claims in a denition whose aim is to be global. To dene functional food using the health benet concept, one should not focus on the presence of health claims, but rather on the level of proofs required by government to use a health claim. The consultation of North American and European legislations on health claims indicates that, obviously, clinical proofs are a possibility. However, this implies clinical studies for, most likely, each specic product. Given the time and cost required, examinations of this sort would be too restrictive to be imposed too all functional foods. Generic proofs, which are based on knowledge from evidence in the scientic literature and/or on recommendations from recognized national or international public health agencies, are also considered for health claims and therefore should also be considered in a denition of functional food. Such proofs link a food characteristic (nutrient or non-nutrient) to a health benet. Thus, as long as the food fulls minimal compositional criteria, the benets should be considered proven. Evidence of benecial characteristics is a necessary, but not a sufcient criterion, for a functional food. If a proof is made that an innovative food product can cure a disease, is it a functional food? In contrast, if a proven harmful component of a food is removed or

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reduced, does that food become a functional food? The classication system of health claims, and more specically, the CODEX Alimentarius, the International Life Science Institute as well as the European consensus on health claims can help resolve the issue. In its health and nutritional claims project, the European Commission studied a scoring system that allocates positive or negative values to specic food components (Marmonnier and Costes, 2006). As an illustration, saturated fat, sodium and sugar are valued negatively while calcium, fruits and vegetable percentage are positively valued. We suggest that a similar approach should be used to dene functional food. This would eliminate the possibility that, for instance, a cranberry trans fat free donut highly charged in saturated fat and sugar is classied as a functional food. The experts we consulted, as well as instances such as the CODEX Alimentarius, distinguish between drugs and food. According to each, a food that could cure or heal a disease would be considered and treated as a drug, regulation wise. Thus, such food should not be part of the functional food universe. From this discussion it appears that one important boundary or dimension that denes the functional food universe is physiological effects. The upper bound of the physiological effect dimension would be food that cure or heal. It has also been established previously that a functional food should have benets beyond its basic nutritional functions. To better dene the boundaries of functional food, it is important to distinguish nutritional deciency from other physiological effect such as disease risk reduction. Thus, a food that improves nutritional equilibrium should not be considered, on that unique basis, a functional food. Another dimension of the functional food universe is functional intensity. Since all foods have some degree of functional intensity, a functional food must have a minimal degree of functional intensity. This functional intensity is measured through its physiological effects and its concentration of active components. The two dimensions used simultaneously should be sufcient to dene the universe of functional food, as illustrated by Figure 1. Figure 1 has two dimensions, physiological effects and functional intensity. Physiological effects could be positive or negative while functional intensity is positive. The dark portion of Figure 1 delimited on its lower right by minimal intensity, by drug-food on its upper portion and by the reduce risk physiological effect, does not exist or is undened. As mentioned previously, drug-food is outside the boundaries of functional food. The functional food universe is also delimited by foods that improve nutritional equilibrium such as enriched or improved foods. The functional food universe, which is a subset of health foods, is therefore comprised of foods that reduce risk of disease, enhance function and contribute to restore health, all of this with a minimal level of intensity. Therefore, an enriched or improved food would be a functional food only if its physiological effects are within the boundaries illustrated in Figure 1 (reduce risk-contribute to restore health). Contrary to denitions (such as Weststrate et al., 2002) found in the literature, the sole fact of improving nutritional equilibrium is not sufcient to qualify for functional foods. The frontiers of the functional food universe being drawn, the next step is to suggest a working denition. Based on the literature and following the completion of the Delphi technique we formulated the following denition:

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Figure 1. Frontiers of the functional food universe

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A functional food is, or appears similar to, a conventional food. It is part of a standard diet and is consumed on a regular basis, in normal quantities. It has proven health benets that reduce the risk of specic chronic diseases or benecially affect target functions beyond its basic nutritional functions.

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Explanation of the denition . The rst sentence A functional food is, or appears similar to, a conventional food implies that the food is not, for example, a pill. This sentence does not exclude the possibility that the food could be enriched or improved as long as the foods appearance is mentioned. . It is part of a standard diet and is consumed on a regular basis, in normal quantities. The denition allows for adaptation to cultural differences, including widely differing standards among culture and countries. The phrase, is consumed on a regular basis implies that such a food would not be consumed solely for therapeutic purposes and it reinforces the idea that it has to be part of a normal diet. The phrase, in normal quantities implies that the food must contain a certain level or concentration of a specied molecule (minimal intensity) to be benecial. . It has proven health benets As discussed previously, the proof of health benet could be direct or generic. This also means that a food component or nutrient is present in sufcient concentration for the food to be functional. Temporal variation is also implied, since a food that naturally contains molecule x would become a functional food when proven health benets are associated with that molecule. Thus, a food that is not functional today might be functional tomorrow, if health benets are found and proven. The use of the term health benets is not restrictive. It refers to physiological, psychological and biological advantages. . The phrase, that reduce the risk of specic chronic diseases or benecially affects target functions denes the universe of functional food in terms of the following physiological effects: risk reduction, enhance function and contribute to restore health. The last two physiological effects being summarized in the statement benecially affect target function . The term basic nutritional functions refers to the role of nutrients in growth, development and maintaining the organs and systems of the human body. Therefore, the basic functions of a food are to provide vitamins, minerals and energy derived from the proteins, carbohydrates and lipids required for the well-being of the human body[4]. Test of functional food frontiers and denition Figure 1 provides an illustrative conceptual framework to dene a functional food. Using the suggested denition, as well as Figure 1, an attempt is made to determine if a food is a functional food or not. Justications are given in each case. This procedure allows testing the concepts behind our suggested denition. All-bran cereals All-bran cereals are a good source of insoluble bres which have been scientically linked to a reduced rate of colon cancer. All-bran cereals have net positive physiological effects and meet all the conditions of the denition. Thus, all-bran cereals are a functional food.

An apple Although an apple a day might keep the doctor away, there are so far no proven health benets that reduce the risk of specic chronic diseases or benecially affect target functions, beyond its basic nutritional functions. This is a clear example of the fact that a healthy food is not necessarily a functional food. In Figure 1, apples would be located in the basic food sub-section of health foods. An apple, which after several studies, has shown that it can prevent some types of cancer This example illustrates the temporal dimension of our denition, as well as the reliance on the concept of physiological effect rather than on the food itself, as suggested by Roberfroid (2000). Thus, a food that was not a functional food can become one once there are sufcient proven health benets that either reduce the risk of specic chronic diseases or benecially affect target functions, assuming that the other conditions of the denition are met. A variant would be a new variety of apples, which, through biogenetics or selection, has a higher concentration of a nutrient that has proven health benets to reduce the risk of specic chronic diseases. Two per cent milk with added vitamin D Milk is a good source of calcium, and calcium has been proven to help reduce the risk of osteoporosis. One might ask whether calcium is beyond the basic nutritional functions of milk, since milk has always been a good source of calcium. However, assuming that the calcium in milk is both accessible and in sufcient concentration, and given that vitamin D, which helps calcium absorption, has been added; and relying on the physiological effects rather than the food, we must conclude that fortied milk is a functional food. Orange juice fortied with calcium This is a typical case of enriched food, which by itself is not a functional food as illustrated in Figure 1. However, calcium has been proven to help reduce the risk of osteoporosis, and if in sufcient concentration (beyond minimal intensity) its physiological effect would lift it to the functional food universe (Figure 1). Moreover, the addition of calcium causes the product (orange juice) to transcend its basic nutritional function. Since all the other conditions of the denition are met, it is a functional food. Omega-3 fatty acid enriched milk Omega-3 fatty acids have been proven to help control hypertension and lipid metabolism. Although naturally present in milk, Omega-3 fatty acids are not normally found in a sufcient concentration to deliver health benets that reduce the risk of specic chronic diseases or benecially affect target functions. Omega-3 milk can be produced by enriching milk with axseed oil or by changing dairy cattle rations so that milk production contains a higher proportion of Omega-3 fatty acids. Whichever process is used, whether industrial or natural, and assuming a minimal intensity level that insures the functionality, such milk (without accounting for calcium) becomes a functional food.

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Oreo type cookies low in fat and sugar A cookie low in fat or sugar is healthier than its regular version, and if consumed in reasonable quantities, not detrimental to health. If a scoring system was used, such cookie would have few negative points, but would not qualify for positive point. Therefore, total score would position this type of cookie in the negative physiological effect zone of Figure 1, or in the basic food zone. This type of food has no proper function and no health benets beyond its basic nutritional functions. Thus, it is not a functional food. Hypoallergenic peanuts There are no proven health benets at present that reduce the risk of specic chronic diseases or benecially affect target functions for peanuts. However, an increasing be coise des number of individuals have a deadly allergy to peanuts (Association que allergies alimentaires, 2005). Although the development of a hypoallergenic peanut would be welcome, it would not move peanuts on the physiological effects and functional intensity scale (Figure 1). Thus, this would not qualify as a functional food. Margarine with plant stanols esters Plant stanols esters inhibit intestinal absorption of LDL-cholesterol, and therefore lower the blood level of LDL-cholesterol A high level of LDL-cholesterol increases the risk of coronary heart disease, a major disease in industrialized countries. This product is near the limit of foods that cure or heal. In fact, this margarine reduces a risk factor (LDL-cholesterol) for a specic chronic disease. When consumed on a regular basis and in normal quantities (for a North American or European diet), the product is effective with virtually no risk of overdose (in opposition to drugs with dosage). This type of spread would be near the top right corner of the functional foods universe in Figure 1. Energy drinks Energy drinks claim to raise the levels of energy, concentration and alertness (enhance functions). These drinks are mostly made of water, sugar, caffeine and guarana. Caffeine has been proven to be a stimulant. However, in a scoring system, the presence of sugar, the interactive effect of caffeine and guarana and the potential dependence effect would generate negative points, which cancel out potential positive effects on the physiological effect scale (Figure 1). Moreover, to our knowledge, there exist no direct proofs regarding the energy drink claims (clinical trial) and the level of generic proofs is non-existent or thin, at current concentration level of caffeine and guarana. Therefore, energy drinks would not classify as a functional food according to our denition, although they are marketed as such. Conclusion To reach their full market potential, functional foods need to move from a blurred idea with many and sometimes conicting denitions to a sharply dened and quantiable concept. In contrast to marketing, where value added could only be perceived, the value added associated with functional foods must be real. To clarify and distinguish functional foods, four necessary and sufcient concepts were identied (nature of the food, health benets, function and consumption pattern) based on 26 denitions from the literature as well as based on the opinions of experts.

The frontiers of the functional food universe were dened using the concept of physiological effects and of functional intensity. It is important to incorporate and use a scoring system based on physiological effect (positive and negative). With regard to evidence of functionality, direct proofs (clinical trial) as well as generic proofs (based on a body of scientic evidence recognized internationally by credible authorities) are required. The following working denition was generated after an extensive literature review and consultation with a group of North American and European experts using the Delphi technique:
A functional food is, or appears similar to, a conventional food. It is part of a standard diet and is consumed on a regular basis, in normal quantities. It has proven health benets that reduce the risk of specic chronic diseases or benecially affect target functions beyond its basic nutritional functions.

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Further work should focus on clarifying and rening the frontier of the functional food universe, which would be the product of a detailed scoring system.
Notes 1. Experts consulted were nutritionists, physicians and food scientists afliated with universities, public and private research centers or government agencies in North America and Europe. 2. Eight North American and three European Experts have participated in the Delphi method. 3. A simple search on the internet with the keywords Functional food denition generates over 1 million entries. 4. It should be noted that the sentence Moreover, these benets disappear when its consumption is interrupted is not part of our nal denition. This question divided the experts through the early part of the process. However, in the end it was removed for the following reasons: it refers to a dosage effect; some effects can be long term; and it contradicts the concept of disease prevention. References Adelaja, A. and Schilling, B. (1999), Nutraceuticals: blurring the line between food and drugs in the twenty-rst century, Choices, Vol. 14 No. 4, p. 5. Adler, M. and Ziglio, E. (1996), Gazing into the Oracle, Jessica Kingsley Publishers, Bristol, PA. Anon. (2003), Functional foods project, agenda 2003, Federal Report, Canada, p. 72. Agriculture, Food and Rural Development (2003), Functional Foods, Agriculture, Food and Rural Development, Alberta, p. 2. Arai, S. (2002), Global view on functional foods: Asian perspectives, British Journal of Nutrition, Vol. 88, suppl. 2, pp. S139-43. Ashwell, M. (2003), ILSI Europe Concise Monograph on Concepts of Functional Foods, The International Life Sciences Institute, Washington, DC. be coise des allergies alimentaires (2005), General Annual Assembly Report, Association que be coise des allergies alimentaires. Association que CSIRO Human Nutrition (2004), Functional foods, CSIRO Human Nutrition, Australia, available at: //www.foodscience.csiro.au/functional-foods.htm (accessed May 2004).

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