functional foods a conceptual

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Functional foods: a conceptualdefinition

Maurice Doyon Laval University, Quebec City, Canada, and

JoAnne Labrecque HEC Montreal, Montreal, Canada

Abstract

Purpose – To draw the frontiers of the functional food universe, to identify concepts that should beincluded in a broadly accepted functional food definition and to propose a definition.

Design/methodology/approach – Based on a review of the literature and the Delphi techniquewith a group of North American and European experts.

Findings – Four concepts were identified: the nature of food, health benefits, functions and regularconsumption. Two dimensions, physiological effects and functional intensity, were developed to definethe frontiers of the functional food universe and a definition is suggested.

Practical implications – A large number of definitions as well as great variations withindefinitions make it difficult to provide industry partners with robust information on market trendsand market potential, or to appropriately protect consumers through legislation. This paper shouldcontribute to the debate surrounding the type of food that should be considered a functional food andsurrounding the lack of a common definition for functional foods.

Originality/value – This paper is the first one, to our knowledge, that attempts to conceptuallydefine the frontiers of the functional food universe and to provide a definition of functional food whichis not sensitive to cultural differences, can accommodate temporal variations and rely on previousknowledge (definition) as well as experts’ opinions.

Keywords Food products, Nutrition

Paper type Conceptual paper

IntroductionIn the early twentieth century, nutrition science was preoccupied with preventingdeficiencies and supporting body growth. Following World War II, although nutrientsufficiency and basic nutritional adequacy remained important, the economic growthenjoyed by numerouscountries fostered a more hedonistic approach to food consumption,with a focus on preferences and aversions (Arai, 2002). This led, in the last third of thecentury, to the recognition by nutritionists that consumption of some food componentscould have a negative impact on health, if they were consumed in sufficient quantities(Ashwell, 2003).

Today, the focus of nutritional science is shifting toward the concept of optimalnutrition, the objective of which is to optimise the daily diet in terms of nutrientsand non-nutrients, as well as other food properties that favour the maintenance

The current issue and full text archive of this journal is available at

www.emeraldinsight.com/0007-070X.htm

The authors would like to acknowledge the financial support of Le Fonds quebecois de larecherche sur la nature et les technologies as well as the work of Virginie Simard, Ste phaneLangevin and Denise Bweli, graduate and undergraduate students in the department of Agricultural Economics and Consumer Science at Laval University.

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British Food JournalVol. 110 No. 11, 2008

pp. 1133-1149q Emerald Group Publishing Limited

0007-070XDOI 10.1108/00070700810918036



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 conditionsthrough diet. Similarly, Milner (2002) draws on various sources to conclude that inNorth America, consumers believe that modifying their diet and using supplements are

the two most important options available to reduce health care costs and improvepersonal health. This recent nutritional shift is greatly motivated by demographicchanges, specifically the aging of the population in most developed countries, thehigher life expectancy and the desire for an improved quality of life. Moreover,an increase in life-style related diseases, combined with constantly rising health carecosts, have stimulated research to identify or produce food with functions that canimprove 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 theconcept of functional food has emerged.

The development of functional foods appears to be a long-term trend with importantmarket potential. According to Fitzpatrick (2003), the market for functional foods isexpanding by 7-10 per cent per year. Market size estimates vary widely, from$11 billion to $155 billion annually, depending on the definition (Weststrate et al., 2002).In this emerging market, information flows generated by research are needed tosupport private investment, consumption decisions and government regulation(Thomassin and Cloutier, 2001). Unfortunately, great variations between variousdefinitions make it difficult to provide industry partners with robust information onmarket trends and market potential, or to appropriately protect consumers throughlegislation. The lack of a commonly accepted definition for functional foods has beenasserted by numerous authors (Veeman, 2002; Falk, 2004; Government of Canada,2004; European Food Information Council, 2005). To make matters morecomplex, concepts such as nutraceuticals and natural health products are oftenassociated with functional foods, creating confusion between those product classes

(Veeman, 2002).While the literature includes numerous studies of market potential and thelegislative and technological perspectives for functional foods, to our knowledge nostudy has specifically attempted to define functional foods, with the exception of Roberfroid (2000). A better understanding of the various concepts and principles thatshould be considered while defining functional foods could increase uniformitybetween definitions and help the interpretation of information flows.

Objectives and methodologyThe objectives of this study are:

. To identify key concepts found in various definitions of functional foods.

.

To identify and develop principles that would allow drawing the frontiers of thefunctional food universe.

. To propose a working definition of functional food that accounts for cultural andtemporal 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].

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(2) Based on the literature and legislative texts from various countries, to identifyand develop principles that would allow to draw the frontiers of the functionalfood universe.

(3) Based on information gathered in Steps 1 and 2, to initiate a consultation of agroup of North American and European experts through the Delphi method inview of developing a working definition of functional food that accounts forcultural and temporal dimensions[2].

(4) Detail and illustrate the various components of the suggested definition.

The Delphi method, which is the principaltool used in this paper, consists of a structuredprocess for collecting and distilling knowledge from a group of experts through a seriesof questionnaires interspersed with controlled opinions and feedback (Adler and Ziglio,1996). The method allows discussion between experts without permitting socialinteractive behaviour, such as follow the leader, as might happen during a face to facegroup 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 technologyand other fields, as well as to deal systematically with complex tasks. This iterativetechnique could be summarized by the following four points:

(1) structuring the information flow;

(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 thepredictive nature required for a stable definition in the relatively new and fast growing

field of functional foods and the complexity of the problem and the geographical distancethat separates the identified experts in this study. The selected experts were first providedwith background material (Steps 1 and 2) and an open-ended questionnaire. A draftdefinition was provided in the second round with feedback and more questions, mostlyregarding litigious points among experts. After four rounds, near consensus (andsaturation) was reach on the working definition presented in this paper.

Review of definitionsA large number of definitions exist worldwide for functional foods[3]. Some definitionssuggest that any food, if marketed with the appropriate positioning, is a functional food(Riemersma, 1996; Hollingsworth, 1999). Others maintain that only fortified, enriched, orenhanced foods with a component having a health benefit beyond basic nutrition can be

considered (Center for Science in the Public Interest, 1999; Kleinschmidt, 2003). Somedefinitions indicate that if a health claim can be made, a food is functional (Iowa, 2000;Weststrate et al., 2002). While some definitions are quite simple: “Foods or foodcomponents that may have health benefits that reduce the risk of specific diseasesor otherhealth 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 beneficiallyone or more target functions in the body, beyond adequate nutritional effects, in a way that isrelevant 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 cannormally be expected to be consumed in the diet: it is not a pill or a capsule, but part of thenormal food pattern (Diplock et al., 1999).

After reviewing over a hundred definitions, twenty-six were selected on the basis of their representation of the various types of existing definitions for functional foods.The selected definitions are found in Table I. Then, among the selected definitions, fourkey concepts were identified:

(1) Health benefits. The concept of health benefits appears to be central to mostdefinition as illustrated by its mention in the twenty-six definitions selected.However, only two definitions indicate that the health benefits should beproven, without specifying the type of proof required. The health benefits foundin the definitions, when specified, could be classified as enhancing targetfunction or as reducing the risk of specific diseases.

(2) The nature of the food. The nature of the food also appears to be an importantconcept. Although most definitions use the word food, almost a third (8/26) specify

that a functional food should be or should look like a traditional food. Somedefinitions stipulate that the food must have been fortified, enriched or had aningredient added, while others mention the removal of allergens or of componentsconsidered detrimental to the health if over consumed (e.g. salt, sugar). More thanhalf the definitions (15/26) refer to the nature of the food concept.

(3) Level of function. All foods have some nutritional functions. However, accordingto more than half the definitions selected (13/26), what makes a food functionalare benefits beyond its basic nutritional functions. To stress the importance of this concept, Roberfroid (2002) advises that food be viewed through itsfunction(s) rather than as a product or through its physical attributes.

(4) Consumption pattern. The last concept identified is the pattern of consumption

which was found in nine of the definitions selected. This concept states that afunctionalfoodmust be part of a normal diet or fit a normal consumption patternina specific geographic and/or cultural context.Therefore, a food that is functional inone country may not necessarily be considered functional in another.

Table I indicates that 4 of the 26 definitions selected contain the four conceptspreviously identified. The four definitions are #2 (Health Canada, 2006), #7 ( Jansenand Krijger, 2003), #23 (Diplock et al., 1999) and #25 (Lajolo, 2002). A closer look at thefour definitions shows differences in their use of the concepts. These differences will inturn be used as a starting point to identify and develop the principles necessary todraw the frontier of functional food.

More specifically, definitions #2 and #23 include in their health benefits the

reduction of health risks as well as enhancing functions. On the other hand, definitions#7 and #25 refer to additional health benefits without being more specific. Still onhealth benefits issue, definition #25 does not mention any type of proofs for healthbenefits. Definition #7 suggests that health benefits can be claimed, while definition#23 talks of benefits that are satisfactorily demonstrated. Only definition #2 mentionsthat health benefits should be proven, but does not specify the type of proofs.

Important variations on the nature of the food are found between the fourdefinitions as well. They all mention that a functional food is a food or that it could be

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C r i t e r i o n

A u t h o r s

D e fi n i t i o n

N a t u r e

F u n c t i o n

R e g u l a r

c o n s u m p t i o n

H e a l t h

b e n e fi t

# 7

J a n s e n a n d K r i j g e r ( 2 0 0 3 )

“ F o o d s t u f f s m o s t l y s i m i l a r i n a p p e a r a n c e t o c o n v e n t i o n a l f o

o d s

t h a t fi t d a i l y i n t h e d i e t a n d c o n s u m p t i o n p a t t e r n b u t t h a t , i n

a d d i t i o n t o t h e i r b a s i c n u t r i t i o n a l v a l u e , c o n t a i n s p e c i fi c

a d d i t i v e s o r p r o p e r t i e

s a c h i e v e d b y p r o c e s s i n g o r o t h e r w i s e

f o r

w h i c h a p h y s i o l o g i c a

l / h e a l t h b e n e fi t b e y o n d b a s i c n u t r i t i o n i s

c l a i m e d ”

X

X

X

X

# 8

N a t i o n a l I n s t i t u t e

o f

N u t r i t i o n ( 2 0 0 0 )

“ F o o d s o r f o o d c o m p o n e n t s t h a t m a y h a v e h e a l t h b e n e fi t s t h a t

r e d u c e t h e r i s k o f s p e c i fi c d i s e a s e s o r o t h e r h e a l t h c o n c e r n s ”

X

X

# 9

C e n t e r f o r S c i e n c e

i n t h e

P u b l i c I n t e r e s t ( 1 9 9 9 )

“ F o o d s w i t h a d d e d i n

g r e d i e n t s t h a t c l a i m t o p r o v i d e a h e a l t h

b e n e fi t t o c o n s u m e r s

b e y o n d t h e b e n e fi t s p r o v i d e d b y o r d i n

a r y

f o o d s t h e m s e l v e s ”

X

X

X

# 1 0

A d e l a j a a n d S c h i l l i n g ( 1 9 9 9 )

“ M o d i fi e d f o o d s o r f o o d i n g r e d i e n t s t h a t p r o v i d e h e a l t h b e n e fi t s

b e y o n d t h e i r t r a d i t i o n a l n u t r i e n t s ”

X

X

X

# 1 1

H a s l e r ( 2 0 0 0 )

“ F o o d s t h a t , b y v i r t u e o f p h y s i o l o g i c a l l y a c t i v e c o m p o n e n t

s ,

p r o v i d e b e n e fi t s b e y o

n d b a s i c n u t r i t i o n a n d m a y p r e v e n t

d i s e a s e o r p r o m o t e h e a l t h ”

X

X

# 1 2

E g g N u t r i t i o n C e n

t e r ( 2 0 0 4 )

“ F o o d s t h a t , i n a d d i t i o n t o s u p p l y i n g k n o w n n u t r i e n t s , c a n

p r o v i d e o t h e r h e a l t h b e n e fi t s a s w e l l ”

X

X

# 1 3

D e F e l i c e ( 2 0 0 7 )

“ A n y s u b s t a n c e s t h a t i s a f o o d o r p a r t o f a f o o d t h a t p r o v i d e s

m e d i c a l a n d / o r h e a l t h

b e n e fi t s , i n c l u d i n g t h e p r e v e n t i o n a n

d

t r e a t m e n t o f d i s e a s e ”

X

X

# 1 4

R o b e r f r o i d ( 2 0 0 2 )

“ A f o o d c o m p o n e n t ( b e i n g a n u t r i e n t o r n o t ) w h i c h a f f e c t s

o n e

o r a l i m i t e d n u m b e r o

f f u n c t i o n ( s ) i n t h e b o d y i n a t a r g e t e d w a y

s o a s t o h a v e p o s i t i v e e f f e c t s t h a t m a y j u s t i f y h e a l t h c l a i m

s ”

X

X

( c o n t i n u e d )

Table I.

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C r i t e r i o n

A u t h o r s

D e fi n i t i o n

N a t u r e

F u n c t i o n

R e g u l a r


H e a l t h

b e n e fi t

# 1 5

G e n e r a l A c c o u n t i n

g O f fi c e ,

U S A ( 2 0 0 0 )

“ F u n c t i o n a l f o o d s a r e

p r o d u c t s f o r m u l a t e d w i t h n a t u r a l l y

o c c u r r i n g c h e m i c a l s ( o r c o m b i n a t i o n o f c h e m i c a l s ) – f o u n d

i n

m a n y f r u i t s , v e g e t a b l e s , g r a i n s , h e r b s a n d s p i c e s – t o p r o v i d e a

h e a l t h b e n e fi t , l o w e r

t h e r i s k o f c e r t a i n d i s e a s e s , o r a f f e c t a

p a r t i c u l a r b o d y p r o c e s s . T h e y g o b e y o n d c o r r e c t i n g d i s e a s

e s

s u c h a s p e l l a g r a a n d s c u r v y , c a u s e d b y n u t r i t i o n a l d e fi c i e n c i e s .

F u n c t i o n a l f o o d s a r e

a k i n t o n o v e l m a c r o i n g r e d i e n t s i n t h a t

t h e i r f o r m u l a t i o n i s i n t e n d e d t o p r o v i d e a h e a l t h b e n e fi t t o

c o n s u m e r s . H o w e v e r , f u n c t i o n a l f o o d s a r e d e s i g n e d t o l o w e r

t h e

r i s k o f s p e c i fi c d i s e a s e s s u c h a s l u n g c a n c e r b y r e m o v i n g

c e r t a i n i n g r e d i e n t s , b

y a d d i n g o r c o m b i n i n g i n g r e d i e n t s n o

t

n o r m a l l y f o u n d i n a f o o d p r o d u c t , o r b y c o n c e n t r a t i n g

s u b s t a n c e s i n h i g h e r

t h a n u s u a l q u a n t i t i e s . ”

X

X

X

# 1 6

I o w a S t a t e U n i v e r s i t y ( 2 0 0 0 )

“ F o o d s t h a t h a v e b e e

n l i n k e d t o h e a l t h b e n e fi t s ”

X

# 1 7

K l e i n s c h m i d t ( 2 0 0 3 )

“ A w h o l e f o o d ( a s o p

p o s e d t o p i l l s , p o w d e r s , o r s u p p l e m e n

t s )

t h a t i s f o r t i fi e d , e n r i c h

e d , o r e n h a n c e d w i t h a c o m p o n e n t h a v

i n g

a h e a l t h b e n e fi t b e y o n d b a s i c n u t r i t i o n ”

X

X

X

# 1 8

W e s t s t r a t e e t a l . ( 2

0 0 2 )

“ F o o d s t h a t m a k e s p e c i fi c h e a l t h c l a i m s ”

X

# 1 9

I F I C F o u n d a t i o n ( 2 0 0 6 )

“ F o o d s t h a t m a y p r o v i d e h e a l t h b e n e fi t s b e y o n d b a s i c

n u t r i t i o n ”

X

X

# 2 0

R i e m e r s m a ( 1 9 9 6 )

“ F o o d s o r f o o d s p r o d

u c t s m a r k e t e d w i t h t h e m e s s a g e o f t h

e

b e n e fi t t o h e a l t h ”

X

# 2 1

H i l l i a n ( 1 9 9 5 ) c i t e d

i n

R o b e r f r o i d ( 2 0 0 2 )

“ F o o d s a n d d r i n k p r o

d u c t s d e r i v e d f r o m n a t u r a l l y o c c u r r i n

g

s u b s t a n c e s c o n s u m e d

a s p a r t o f t h e d a i l y d i e t a n d p o s s e s s

i n g

p a r t i c u l a r p h y s i o l o g i c a l b e n e fi t s w h e n i n g e s t e d ”

X

X

X

# 2 2

S m i t h e t a l . c i t e d i n

R o b e r f r o i d ( 2 0 0 2 )

“ F o o d s d e r i v e d f r o m n a t u r a l l y o c c u r r i n g s u b s t a n c e s , w h i c h

c a n

a n d s h o u l d b e c o n s u m e d a s p a r t o f t h e d a i l y d i e t a n d w h i c h

s e r v e s t o r e g u l a t e o r o t h e r w i s e a f f e c t a p a r t i c u l a r b o d y p r o c e s s

w h e n i n g e s t e d ”

X

X

( c o n t i n u e d )

Table I.

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C r i t e r i o n

A u t h o r s

D e fi n i t i o n

N a t u r e

F u n c t i o n

R e g u l a r


H e a l t h

b e n e fi t

# 2 3

D i p l o c k e t a l . ( 1 9 9 9 )

“ A f o o d c a n b e r e g a r d e d a s f u n c t i o n a l i f i t i s s a t i s f a c t o r i l y

d e m o n s t r a t e d t o a f f e c

t b e n e fi c i a l l y o n e o r m o r e t a r g e t f u n c t i o n s

i n t h e b o d y , b e y o n d a d e q u a t e n u t r i t i o n a l e f f e c t s , i n a w a y t h a t

i s r e l e v a n t t o e i t h e r i m p r o v e d s t a g e o f h e a l t h a n d w e l l - b e i n g

a n d / o r r e d u c t i o n o f r i s k o f d i s e a s e . A f u n c t i o n a l f o o d m u s t

r e m a i n f o o d a n d i t m u s t d e m o n s t r a t e i t s e f f e c t s i n a m o u n t s t h a t

c a n n o r m a l l y b e e x p e

c t e d t o b e c o n s u m e d i n t h e d i e t : i t i s n

o t a

p i l l o r a c a p s u l e , b u t

p a r t o f t h e n o r m a l f o o d p a t t e r n ”

X

X

X

X

# 2 4

I n t e r n a t i o n a l L i f e S c i e n c e s

I n s t i t u t e c i t e d i n M

i l n e r ( 2 0 0 2 )

“ F o o d s , t h a t b y v i r t u e o f p h y s i o l o g i c a l l y a c t i v e f o o d

c o m p o n e n t s , p r o v i d e

h e a l t h b e n e fi t s b e y o n d b a s i c n u t r i t i o n ”

X

X

# 2 5

L a j o l o ( 2 0 0 2 )

“ A f o o d t h a t i s a f o o d a n d n o t a d r u g , t h a t i s p a r t o f a n o r

m a l

d i e t a n d t h a t c a n p r o

d u c e b e n e fi t s b e y o n d b a s i c n u t r i t i o n ”

X

X

X

X

# 2 6

A g r i c u l t u r e , F o o d

a n d R u r a l

D e v e l o p m e n t , A l b e r t a ( 2 0 0 3 )

“ T h e y a r e f o o d s w h i c h c a n b e p a r t o f o u r e v e r y d a y d i e t b u t

w h i c h h a v e p r o p e r t i e

s t h a t p r o v i d e a n a d d i t i o n a l h e a l t h

b e n e fi t ”

X

X

X

Table I.

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conventional food. Definition #23 even specifies that it cannot be a pill or a capsule.On the other hand, definitions #2 and #7 indicate that it should at least look like aconventional food, which implies that it does not need to be a conventional food.Definition #7 describes a food that contains specific additives or properties achieved

by processing or otherwise. The three other definitions do not specify if the food shouldhave something added or removed.

Differences in the pattern of consumption among the four definitions are moresubtle. The four definitions make it clear that a functional food should be part of aregular or a normal diet. However, definition #7 is more restrictive with its “daily dietand consumption pattern”. Definition #23 refers, instead, to quantity normallyexpected to be consumed in the diet, while making references to the health effects.This implies that the benefit should be present without having to consume abnormalquantity of a specific food.

Functional food boundaries

Using the differences identified above, we can frame questions that will enable us todraw the boundaries of functional food. One obvious question is if health benefitsshould be proven and the type of proof that should be considered acceptable. It appearsthat some sort of health benefit guarantee is essential to protect consumers and toinsure the future of functional food. However, only one definition surveyed clearlystates that the health benefit should be proven. On the other hand, numerousdefinitions state that a functional food must have a health or a nutrient claim. Sinceclaims are generally regulated, this somehow implies some sort of approval from agovernment agency and therefore some level of protection for consumers.

Is a health claim a sufficient proof? The problem with health claim is the fact that theyare a creation of regional regulation bodies. For instance, Canada only has five healthclaims 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 define itsuniverse of functional food, but based on a legislative background that is unique. Theseillustrations demonstrate the problem of using health claims in a definition whose aim isto be global. To define functional food using the health benefit concept, one should notfocus on the presence of health claims, but rather on the level of proofs required bygovernment to use a health claim.

The consultation of North American and European legislations on health claimsindicates that, obviously, clinical proofs are a possibility. However, this implies clinicalstudies for, most likely, each specific 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 scientific literature

and/or on recommendations from recognized national or international public healthagencies, are also considered for health claims and therefore should also be consideredin a definition of functional food. Such proofs link a food characteristic (nutrient ornon-nutrient) to a health benefit. Thus, as long as the food fulfils minimal compositionalcriteria, the benefits should be considered proven.

Evidence of beneficial characteristics is a necessary, but not a sufficient criterion, fora functional food. If a proof is made that an innovative food product can cure a disease, isit 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 classification system of healthclaims, and more specifically, the CODEX Alimentarius, the International Life ScienceInstitute 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 specific food components(Marmonnier and Costes, 2006). As an illustration, saturated fat, sodium and sugar arevalued negatively while calcium, fruits and vegetable percentage are positively valued.We suggest that a similar approach should be used to define functional food. Thiswould eliminate the possibility that, for instance, a cranberry trans fat free donuthighly charged in saturated fat and sugar is classified 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 adisease 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

defines the functional food universe is physiological effects. The upper bound of thephysiological effect dimension would be food that cure or heal. It has also beenestablished previously that a functional food should have benefits beyond its basicnutritional functions. To better define the boundaries of functional food, it is importantto distinguish nutritional deficiency from other physiological effect such as disease riskreduction. 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 allfoods have some degree of functional intensity, a functional food must have a minimaldegree of functional intensity. This functional intensity is measured through itsphysiological effects and its concentration of “active” components. The two dimensionsused simultaneously should be sufficient to define 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, bydrug-food on its upper portion and by the reduce risk physiological effect, does notexist or is undefined. As mentioned previously, drug-food is outside the boundaries of functional food. The functional food universe is also delimited by foods that improvenutritional equilibrium such as enriched or improved foods. The functional fooduniverse, which is a subset of health foods, is therefore comprised of foods that reducerisk of disease, enhance function and contribute to restore health, all of this with aminimal level of intensity.

Therefore, an enriched or improved food would be a functional food only if itsphysiological effects are within the boundaries illustrated in Figure 1 (reducerisk-contribute to restore health). Contrary to definitions (such as Weststrate et al.,2002) found in the literature, the sole fact of improving nutritional equilibrium is notsufficient to qualify for functional foods.

The frontiers of the functional food universe being drawn, the next step is tosuggest a working definition. Based on the literature and following the completion of the Delphi technique we formulated the following definition:

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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 dietand is consumed on a regular basis, in normal quantities. It has proven health benefits thatreduce the risk of specific chronic diseases or beneficially affect target functions beyond itsbasic nutritional functions.

Explanation of the definition. The first 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 notexclude the possibility that the food could be enriched or improved as long as thefood’s appearance is mentioned.

. “It is part of a standard diet and is consumed on a regular basis, in normalquantities”. The definition allows for adaptation to cultural differences, includingwidely differing “standards” among culture and countries. The phrase, “isconsumedon a regular basis” implies that such a food would not be consumed solelyfor therapeutic purposes and it reinforces the idea that it has to be part of a normaldiet. The phrase, “in normal quantities” implies that the food must contain a certain

level or concentration of a specified molecule (minimal intensity) to be beneficial.. “It has proven health benefits” As discussed previously, the proof of health benefit

could be direct or generic. This also means that a food component or nutrient ispresent in sufficient concentration for the food to be functional. Temporalvariation is also implied, since a food that naturally contains molecule x wouldbecome a functional food when proven health benefits are associated with thatmolecule. Thus, a food that is not functional today might be functional tomorrow,if health benefits are found and proven. The use of the term “health benefits” is notrestrictive. It refers to physiological, psychological and biological advantages.

. The phrase, “that reduce the risk of specific chronic diseases or beneficiallyaffects target functions” defines the universe of functional food in terms of the

following physiological effects: risk reduction, enhance function and contributeto restore health. The last two physiological effects being summarized in thestatement “beneficially 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 andenergy derived from the proteins, carbohydrates and lipids required for thewell-being of the human body[4].

Test of functional food frontiers and definitionFigure 1 provides an illustrative conceptual framework to define a functional food.Using the suggested definition, as well as Figure 1, an attempt is made to determine if afood is a functional food or not. Justifications are given in each case. This procedureallows testing the concepts behind our suggested definition.

All-bran cerealsAll-bran cereals are a good source of insoluble fibres which have been scientificallylinked to a reduced rate of colon cancer. All-bran cereals have net positive physiologicaleffects and meet all the conditions of the definition. Thus, all-bran cereals are afunctional food.

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An appleAlthough an apple a day might keep the doctor away, there are so far no proven healthbenefits that reduce the risk of specific chronic diseases or beneficially affect targetfunctions, 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 locatedin 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 definition, as well as thereliance on the concept of physiological effect rather than on the food itself, assuggested by Roberfroid (2000). Thus, a food that was not a functional food canbecome one once there are sufficient proven health benefits that either reduce the riskof specific chronic diseases or beneficially affect target functions, assuming that theother conditions of the definition 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 benefits to reduce the risk of specific 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 functionsof milk, since milk has always been a good source of calcium. However, assuming thatthe calcium in milk is both accessible and in sufficient concentration, and given thatvitamin D, which helps calcium absorption, has been added; and relying on thephysiological effects rather than the food, we must conclude that fortified milk is afunctional food.

Orange juice fortified with calciumThis is a typical case of enriched food, which by itself is not a functional food asillustrated in Figure 1. However, calcium has been proven to help reduce the risk of osteoporosis, and if in sufficient concentration (beyond minimal intensity) it’sphysiological effect would lift it to the functional food universe (Figure 1). Moreover, theaddition of calcium causes the product (orange juice) to transcend its basic nutritionalfunction. Since all the other conditions of the definition are met, it is a functional food.

Omega-3 fatty acid enriched milkOmega-3 fatty acids have been proven to help control hypertension and lipid

metabolism. Although naturally present in milk, Omega-3 fatty acids are not normallyfound in a sufficient concentration to deliver health benefits that reduce the risk of specific chronic diseases or beneficially affect target functions. Omega-3 milk can beproduced by enriching milk with flaxseed oil or by changing dairy cattle rations so thatmilk production contains a higher proportion of Omega-3 fatty acids. Whicheverprocess is used, whether industrial or natural, and assuming a minimal intensity levelthat insures the functionality, such milk (without accounting for calcium) becomes afunctional 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 inreasonable quantities, not detrimental to health. If a scoring system was used, suchcookie would have few negative points, but would not qualify for positive point.

Therefore, total score would position this type of cookie in the negative physiologicaleffect zone of Figure 1, or in the basic food zone. This type of food has no properfunction and no health benefits beyond its basic nutritional functions. Thus, it is not afunctional food.

Hypoallergenic peanutsThere are no proven health benefits at present that reduce the risk of specific chronicdiseases or beneficially affect target functions for peanuts. However, an increasingnumber of individuals have a deadly allergy to peanuts (Association quebecoise desallergies alimentaires, 2005). Although the development of a hypoallergenic peanutwould be welcome, it would not move peanuts on the physiological effects andfunctional intensity scale (Figure 1). Thus, this would not qualify as a functional food.

Margarine with plant stanols estersPlant stanols esters inhibit intestinal absorption of LDL-cholesterol, and thereforelower the blood level of LDL-cholesterol A high level of LDL-cholesterol increases therisk of coronary heart disease, a major disease in industrialized countries. This productis near the limit of foods that cure or heal. In fact, this margarine reduces a risk factor(LDL-cholesterol) for a specific chronic disease. When consumed on a regular basis andin normal quantities (for a North American or European diet), the product is effectivewith 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 drinksEnergy drinks claim to raise the levels of energy, concentration and alertness (enhancefunctions). 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 presenceof sugar, the interactive effect of caffeine and guarana and the potential dependenceeffect would generate negative points, which cancel out potential positive effects onthe physiological effect scale (Figure 1). Moreover, to our knowledge, there exist nodirect proofs regarding the energy drink claims (clinical trial) and the level of genericproofs 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 ourdefinition, although they are marketed as such.

ConclusionTo reach their full market potential, functional foods need to move from a blurred ideawith many and sometimes conflicting definitions to a sharply defined and quantifiableconcept. In contrast to marketing, where value added could only be perceived, the valueadded associated with functional foods must be real.

To clarify and distinguish functional foods, four necessary and sufficient conceptswere identified (nature of the food, health benefits, function and consumption pattern)based on 26 definitions from the literature as well as based on the opinions of experts.

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The frontiers of the functional food universe were defined using the concept of physiological effects and of functional intensity. It is important to incorporate and usea scoring system based on physiological effect (positive and negative). With regard toevidence of functionality, direct proofs (clinical trial) as well as generic proofs (based on

a body of scientific evidence recognized internationally by credible authorities) arerequired.

The following working definition was generated after an extensive literature reviewand consultation with a group of North American and European experts using theDelphi technique:

A functional food is, or appears similar to, a conventional food. It is part of a standard dietand is consumed on a regular basis, in normal quantities. It has proven health benefits thatreduce the risk of specific chronic diseases or beneficially affect target functions beyond itsbasic nutritional functions.

Further work should focus on clarifying and refining the frontier of the functional fooduniverse, which would be the product of a detailed scoring system.

Notes

1. Experts consulted were nutritionists, physicians and food scientists affiliated withuniversities, public and private research centers or government agencies in North Americaand 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 definition” generatesover 1 million entries.

4. It should be noted that the sentence “Moreover, these benefits disappear when itsconsumption is interrupted” is not part of our final definition. This question divided theexperts through the early part of the process. However, in the end it was removed for thefollowing reasons: it refers to a dosage effect; some effects can be long term; and itcontradicts the concept of disease prevention.

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Corresponding authorMaurice Doyon can be contacted at: [email protected]

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