See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/222777021

Functional food development: concept to reality

Article  in  Trends in Food Science & Technology · July 2007

DOI: 10.1016/j.tifs.2007.03.008

CITATIONS READS

144 8,334

2 authors, including:

Peter JH Jones
Nutritional Fundamentals for Health Inc
599 PUBLICATIONS   26,113 CITATIONS   

SEE PROFILE

Some of the authors of this publication are also working on these related projects:

fixed point theory View project

SUSTAINABLE ALCOHOLYSIS OF SOYBEAN OIL IN SUPERCRITICAL CARBON DIOXIDE AND ANALYSIS OF THE STRUCTURED LIPIDS WITH NUCLEAR MAGNETIC RESONANCE
SPECTROSCOPY View project

All content following this page was uploaded by Peter JH Jones on 30 November 2018.

The user has requested enhancement of the downloaded file.

 Trends in Food Science & Technology 18 (2007) 387e390
Functional food
development:
concept to reality
Peter J. Jonesa,* and
Stephanie Jewb
a
Richardson Centre for Functional Foods and
Nutraceuticals, 196 Innovation Drive, Smartpark,
University of Manitoba, Winnipeg, Manitoba R3T 6C5,
Canada (Tel.: D1 204 474 8883; fax: D1 204 474
7552; e-mail: peter_jones@umanitoba.ca)
b interests lie more in profit rather than sound science. Seem-
School of Dietetics and Human Nutrition, Faculty of
Agricultural and Environmental Sciences, McGill
University, 21,111 Lakeshore Road, Ste-Anne-de-
Bellevue, Quebec H9X 3V9, Canada
Functional food development involves several distinct stages
from concept to successful market implementation. The objec-
tive of the present review is to define processes involved at
each of these stages commencing with translation of an essen-
tial concept into an acceptable, marketable prototype. Such
prototypes then require assessment for efficacy and safety
through animal and human proof-of-concept testing. Publica-
tion of efficacy and safety data enhance the credibility for
functional food products which translates into improved con-
sumer awareness, which also forms the basis for regulatory
approval and health claim development. Consumer accep-
tance and provision of health claims result in improved market
penetration of functional food entities, which in itself spurs
initiatives for creation of new products in the same cycle.
Introduction
Functional food development has enjoyed heightened in-
terest by commercial, academic and governmental sectors
over the past decade. Food products with health claims
attesting to functional capacity to promote health which
extends beyond provision of essential nutrients are eagerly
accepted by consumers and likely results in decreased
* Corresponding author.
0924-2244/$ - see front matter Ó 2007 Elsevier Ltd. All rights reserved.
doi:10.1016/j.tifs.2007.03.008
Viewpoint
morbidity and mortality, and increased quality of life in
the general population. However, despite numerous impor-
tant advances in functional food development, the reputa-
tion of the field has been tarnished on account of at least
two reasons. First, inconsistent data have resulted in overt
inconsistencies regarding the impact of certain food ingredi-
ents on health indices. Examples of inconsistencies include
the controversy for vitamin E (Miller et al., 2005) and beta
carotene (Patrick, 2000; Pryor, Stahl, & Rock, 2000). The
absence of unequivocal evidence supporting dietedisease
relationships has posed a challenge for the public to place
their faith in nutritional messages. Second, the potential
for financial gain has resulted in many unsupported claims
for nutritional ingredients by commercial enterprises whose
ingly this is the case with the policosanol trials (Berthold,
Unverdorben, Degenhardt, Bulitta, & Gouni-Berthold,
2006; Varady, Wang, & Jones, 2003). Indeed, industry spon-
sored trials are generally not ranked highly by consumers.
For these reasons, nutritional sciences have suffered a cred-
ibility gap over past decades. Despite these drawbacks,
several substantial dietedisease links have been forged
over the past 50 years in nutritional science which have
been important in the introduction of functional foods to
the commercial market. The potential negative role of satu-
rated fat in the diet was likely one of the original discoveries
in the 1950s (Hu & Willett, 2002). More recently the evolu-
tion of concepts surrounding dietary fibre (Erkkila &
Lichtenstein, 2006) and plant sterols (Katan et al., 2003)
in relation to disease prevention reflects examples of the
positive aspects of nutritional sciences and functional foods
which have contributed to the wellness and longevity pro-
longation of populations. Although knowledge of the scien-
tific underpinnings to the dietedisease link is critical for
health promotion, the process of improving nutrition in-
volves further aspects that reach into domains of regulatory
and commercial interests. Indeed, for science-based nutri-
tional knowledge to morph into improved population health
requires a series of steps which culminate in a functional
food developed to help enhance public health. The purpose
of this article is to explore the process of translation of nu-
tritional concepts into improved population health through
this series of successive stages. The specific aim of this re-
view is to explore the fundamental mechanisms through
which evidence-based research can promote the develop-
ment of foods and nutritional products which confer health
388 P.J. Jones, S. Jew / Trends in Food Science & Technology 18 (2007) 387e390
benefits. By dissecting the components that underpin this
dynamic science supporting the growth of the functional
foods and nutraceuticals industry, a better sense can be
obtained of how various stakeholders work together syner-
gistically to improve public health and wellness.
The cycle of innovation
Concept testing
The process through which innovation in nutritional
science occurs develops through intersecting alliances of
various stakeholders as depicted in Fig. 1. Involved are
research, industry, regulatory and consumer sector interests.
Although the process of initiation of the cycle depicted
in Fig. 1 can commence at any point, the most likely facet
of the cycle to finally drive the remaining sequence is the
creation of an idea of a novel dietedisease concept.
Clearly, far more concepts emerge that fail to complete
the innovation cycle than do, however, a logical nutri-
tionehealth concept exists as a central defining feature of
the process. More often than not, such concepts originate
from academic research performed in industrial or univer-
sity laboratories. Occasionally, such concepts are derived
de novo, however, more likely they arise from amassed ev-
idence. Industry often initiates this part of the cycle; indeed
these concepts are often spurned from previous similar suc-
cesses. Innovative concepts may also emerge from aca-
demic researchers; however, although cognizant of the
science, academic researchers are often not aware of the
myriad of issues which come into play in translating
dietedisease concepts into marketable food products. How-
ever, with the maturation of academic based offices of
research services university researchers are become more
fully aware of issues of concern in working with industry.
Indeed, teams of academics working with business interests
provide the grounds for a sharing of views on what would
make an optimal concept product to take forward through
the successive elements of the innovation cycle. Such alli-
ances are increasingly being realized as food companies
work ever more closely with academics through the forma-
tion of scientific advisory boards.
Concept Generation
(Theory)
Novel ideas
Industry Product
Growth Development
Market (Reality)
penetration Prototype
evolution
Consumer Efficacy & Safety
Buy-In Cell, animal,
Perception and human studies
interest
Media + Health
Evidence
Activity Claims
Substantiates effects
Regulatory
review Publication
Peer-reviewed
Fig. 1. Functional foods and health promotion: cycle of success.
Product development
Following generation of a novel dietedisease concept,
the next natural stage in the innovation cycle is to develop
a real-world test product that embraces that concept. For in-
stance, production of a probiotic enriched yogurt, a cheese
enriched with omega 3 fats or a spread containing plant ste-
rols reflects translation of dietedisease concepts into func-
tional commercial products. Often rendering of the concept
into a marketable, acceptable product represents a consider-
able challenge. In many instances substantial hurdles sur-
round proper matrixing, formulation, as well as ensuring
that the product possesses acceptable hedonic qualities.
Foods which incorporate entities with the fewest taste,
mouth-feel, stability or intestinal side effect attributes will
hold the greatest possibility of seeing a concept translated
into a successful product.
Omega 3 fatty acids (FA) have garnered substantial com-
mercial interest due to their potential heart healthy proper-
ties (Breslow, 2006). The worldwide market for omega
3 fatty acid ingredients was valued at more than US$700
million in 2005 (Turner, 2006). Omega 3 FA have been
added to commercial products including milk, cheese,
yogurt, bread and juice. However, a recent report by Frost
and Sullivan show that omega 3 FA are stilled viewed
negatively by the food industry with some of the major con-
cerns being that omega 3 FA may be sensitive to oxidative
damage as well as possessing adverse taste and smell
qualities (Seaton, 2006; Staff reporter, 2006). Fortunately,
technological advances such as microencapsulation have
made incorporation of omega 3 FA into food much easier
and acceptable (Whelan & Rust, 2006).
Plant sterols exist as another key player in the functional
foods market and have been shown to effectively lower
blood cholesterol levels (Plat & Mensink, 2005). Plant ste-
rols are found in several formats with the most popular be-
ing yogurts and spreads. In a recent report by Frost and
Sullivan, European markets for plant sterols were valued
at $184.6m in 2005, and are estimated to reach $395.2m
by 2012 (Daniells, 2006a). With plants sterols being so
widely used and possessing such a positive safety profile,
the National Cholesterol Education Program (2002) has
incorporated a recommendation of using 2 g/day of plant
sterols as a therapeutic lifestyle change to lower LDL
cholesterol levels.
Probiotics represent another category of functional com-
pounds which have seen an upward trend in consumer inter-
est for their potential benefits in disease conditions
including gut health, cancer and allergies (Reid, Jass,
Sebulsky, & McCormick, 2003). The probiotic market is
one of the fastest growing sectors in fresh dairy market
with a retail growth of about 12% (Daniells, 2006b).
Many probiotics products are yogurt based. Similar to is-
sues faced by omega 3 formulation, incorporating probiot-
ics into foods presents technological challenges. Main
concerns over addition of probiotics to foods include
what type or form of ingredient/probiotic should be
 P.J. Jones, S. Jew / Trends in Food Science & Technology 18 (2007) 387e390
selected, how much must be added to have a beneficial ef-
fect, and whether supplementation changes sensory proper-
ties (Champagne, Gardner, & Roy, 2005).
Efficacy/safety and evidence
Expression of a nutritionehealth concept through devel-
opment of a product needs to be followed by verification
that the product will mirror the original concept through
the testing of biological efficacy. Although it is possible
to assume that biological action and safety of a given can-
didate product can be supported adequately by the preexist-
ing body of evidence, more often it is required that efficacy
and perhaps safety assessment of individual test matrices be
undertaken. Reasons for the need to test specific matrices of
bioactive ingredients are several. Placing a bioactive com-
ponent into a particular food matrix may affect its efficacy.
As an example, it has been demonstrated that plant sterol
efficacy differs across various matrices. Clifton et al.
(2004) studied plant sterol enriched milk, bread, cereal
and yogurt and discovered that although LDL cholesterol
was lowered by all four food types, the milk matrix was al-
most three times more effective than in bread or cereal.
Failure to properly disperse the bioactive principle within
the food delivery system is another potential reason for re-
duced efficacy. This has been demonstrated in earlier low
fat formatting of plant sterols into juice (Jones, Vanstone,
Raeini-Sarjaz, & St-Onge, 2003). Moreover, failure to
achieve a threshold dosage may limit the biological efficacy
of the bioactive material of interest. This is seen especially
with probiotics where Champagne et al. (2005) noted that
the survival of probiotic bacteria during passage through
acidic conditions of the stomach exists as a major concern
to manufacturers. Thus, for various reasons it is vital to
confirm the efficacy of any product developed on a theoret-
ical dietedisease concept.
Efficacy assessment is an essential element of establish-
ing the credibility of functional food entities and can be
performed using in vitro or in vivo systems. Cell systems
provide basic biological information regarding nutriente
biochemical process interactions. However, to assess
biological activity on a whole body physiological basis,
use of animal or human systems is preferable. Animal sys-
tems enable a high degree of control of diet, environment
and genetics, although, many instances exist where animal
models fail to adequately mimic the normal physiological
responses of humans. Numerous differences exist in lipid
metabolism among various species which should be consid-
ered when assessing the relevance in humans of research
findings from various animal models (Bergen & Mersmann,
2005). As such, properly conducted human trials are more
desirable than those in animals. Confirmation of efficacy,
particularly in a human system, also provides a strong basis
on which to argue allowing a health claim for that specific
product.
Demonstration of clinical efficacy for a functional food
product represents a critical point of the innovation cycle,
389
as at this stage the credibility gap narrows for both the
dietedisease concept, as well as the product claim itself.
Clinical efficacy credibility is strengthened by the presence
of parallel studies with related products. Evidence also
needs to be provided by parallel studies conducted across
several jurisdictions and conducted in both academic and
private sector institutional laboratories. Indeed commercial
enterprises conduct extensive responsible and sound FF
research from a scientific point of view, both in their inde-
pendent labs and in collaboration with academics. Even
multiple clinical studies attesting to biological efficacy of
a functional ingredient have limited utility if all such stud-
ies emanate from a single source and other laboratories fail
to reproduce the same dietehealth marker relationship.
Publication
The optimal path for dissemination of biological efficacy
data is through publications in peer-reviewed journals, gener-
ally accepted as the most authoritative route of dissemination
of leading edge science. However, journals are increasingly
aware of the positive impact that published positive results
can have in terms of marketing of pharmaceutical or nutra-
ceutical ingredients, thus, have become more stringent and
restrictive over potential conflict of interest of authors.
Many journals now publish disclosure statements concerning
linkages of authors with the study funding sources. Journals
are also less willing to publish studies containing negative
findings which can result in obfuscation of overall distribu-
tion of the literature, favoring sometimes erroneously an
overly positive position for a given functional food ingredi-
ent. It is equally important that negative, as well as positive,
efficacy and safety results be disseminated through peer-re-
viewed publication in order to provide a balanced evaluation
of the true merits of that ingredient.
Health claims and regulatory review
The next stage of the innovation cycle involves commu-
nication of the health messages generated through active
research and regulatory review of a specific food product
to the general public. Regulatory review is required in order
to translate peer-reviewed published data supporting the ef-
ficacy and safety of a given bioactive product within a novel
food matrix or capsule into policy changes consistent with
approving products for sale of functional food products. Ei-
ther the supportive data can be used directly in promotional
material, or indirectly in securing a health claim. For health
claims to be approved through the regulatory review pro-
cess, functional food products must be thoroughly evalu-
ated for efficacy and safety through the stages of the
cycle of innovation defined in Fig. 1. Unfortunately in cer-
tain jurisdictions, restrictive health claim environments
have resulted in substantial challenges in terms of commu-
nication of food/health relationship to the general public.
Globally, regulatory systems vary widely with some coun-
tries such as Japan allowing over 500 functional foods
(Yamaguchi, 2005), while other countries such as Canada
 390 P.J. Jones, S. Jew / Trends in Food Science & Technology 18 (2007) 387e390
allow a much more limited number of health claims. Such
restrictions have been challenged successfully in courts of
law. As an example, the successful Pearson versus Shalala
landmark health claim lawsuit petitioned against the Food
and Drug Administration, which resulted in the present se-
ries of qualified health claims in the US.
Although the number of claims allowed varies widely
across jurisdictions, the process of regulatory review shares
some common features. Normally the benchmark of
successful regulatory review rests in provision of sound
peer-reviewed data, which are compared to a set of criteria
necessary for permission of any given claim. Normally,
a certain threshold of evidence is required during the course
of regulatory review to enable a claim to be made for a
specific or generic functional food category.
Industry growth
Securing specific messages on foods attesting to their
health benefits represents a vital part of the cycle of moving
a functional food from concept to a marketing success
story. Given that consumers are both interested and in-
formed about foods that confer health benefits beyond sim-
ply providing nutrients (Heller, 2006) the presence of an
informative, authoritative claim on a food will stimulate
the market share penetration of that product within its sec-
tor. Such an increase in market share will promote further
growth by leading to additional ‘‘concepts/theories’’ to be
elaborated and tested thus reinitiating the cycle. Ultimately
the successful development of any successful FF will stem
from a balance between the obstacles surrounding regula-
tion and available science versus the demands of the com-
mercial market.
Summary
Functional food development is a multistage process that
requires input from commercial, academic and regulatory
interests, with a critical need to achieve acceptance by con-
sumers. It is only through these partners working coopera-
tively through the multiple elements of the continuum from
concept to successful marketing of functional foods that
this sector will see continued growth and sustainability.
References
Bergen, W. G., & Mersmann, H. J. (2005). Comparative aspects of lipid
metabolism: impact on contemporary research and use of animal
models. Journal of Nutrition, 135(11), 2499e2502.
Berthold, H. K., Unverdorben, S., Degenhardt, R., Bulitta, M., &
Gouni-Berthold, I. (2006). Effect of policosanol on lipid levels
among patients with hypercholesterolemia or combined hyper-
lipidemia: a randomized controlled trial. The Journal of the
American Medical Association, 295(19), 2262e2269.
Breslow, J. L. (2006). N-3 fatty acids and cardiovascular disease.
American Journal of Clinical Nutrition, 83(Suppl.), 1477Se1482S.
Champagne, C. P., Gardner, N. G., & Roy, D. (2005). Challenges in the
addition of probiotic cultures to foods. Critical Reviews in Food
Science and Nutrition, 45(1), 61e84.
View publication stats
Clifton, P. M., Noakes, M., Sullivan, D., Erichsen, N., Ross, D.,
Annison, G., et al. (2004). Cholesterol-lowering effects of plant
sterol esters differ in milk, yoghurt, bread and cereal. European
Journal of Clinical Nutrition, 58(3), 503e509.
Daniells, S. (2006a). Phytosterols market set to continue growth.
Available at www.nutraingredients.com/news/
printNewsBis.asp?id¼68068. Posted 31/05/2006.
Daniells, S. (2006b). Danone challenges Yoplait, Glanbia’s Essence
range. Available at www.nutraingredients.com/news/
ng.asp?id¼66964. Posted 10/04/2006.
Erkkila, A. T., & Lichtenstein, A. H. (2006). Fiber and cardiovascular
disease risk: how strong is the evidence? Journal of Cardiovascular
Nursing, 21(1), 3e8.
Heller, L. (2006). Health is global purchasing priority, finds AC
Nielsen. Available at www.nutraingredients-usa.com/news/
ng.asp?n¼69101-ac-nielsen-purchasing. Posted 12/07/2006.
Hu, F. B., & Willett, W. C. (2002). Optimal diets for prevention of
coronary heart disease. Journal of the American Medical Associa-
tion, 288(20), 2569e2578.
Jones, P. J. H., Vanstone, C. A., Raeini-Sarjaz, M., & St-Onge, M. P.
(2003). Phytosterols in low- and nonfat beverages as part of
a controlled diet fail to lower plasma lipid levels. Journal of Lipid
Research, 44(9), 1713e1719.
Katan, M. B., Grundy, S. M., Jones, P., Law, M., Miettinen, T., &
Paoletti, R., Stresa Workshop Participants. (2003). Efficacy and
safety of plant stanols and sterols in the management of blood
cholesterol levels. Mayo Clinic Proceedings, 78(8), 965e978.
Miller 3rd, E. R., Pastor-Barriuso, R., Dalal, D., Riemersma, R. A.,
Appel, L. J., & Guallar, E. (2005). Meta-analysis: high-dosage
vitamin E supplementation may increase all-cause mortality.
Annals of Internal Medicine, 142(1), 37e46.
National Cholesterol Education Program. (2002). Third report of the
National Cholesterol Education Program (NCEP) expert panel on
detection, evaluation, and treatment of high blood cholesterol in
adults (Adult Treatment Panel III). (pp. v14ev15). NIH Publication
No. 02e5215.
Patrick, L. (2000). Beta-carotene: the controversy continues. Alterna-
tive Medicine Review, 5(6), 530e545.
Plat, J., & Mensink, R. P. (2005). Plant stanol and sterol esters in
the control of blood cholesterol levels: mechanism and safety
aspects. The American Journal of Cardiology, 4(96(1A)),
15De22D.
Pryor, W. A., Stahl, W., & Rock, C. L. (2000). Beta carotene: from
biochemistry to clinical trials. Nutrition Reviews, 58(2 Pt 1),
39e53.
Reid, G., Jass, J., Sebulsky, M. T., & McCormick, J. K. (2003). Potential
uses of probiotics in clinical practice. Clinical Microbiology
Reviews, 16(4), 658e672.
Seaton, T. (2006). The omega 3 explosion. Available at www.
nutraceuticalsworld.com/articles/2006/03/the-omega-3-
explosion.php. Posted 03/2006.
Staff reporter (2006). Negativity remains over omega-3, says Frost.
Available at www.foodnavigator-usa.com/news/ng.asp?n¼65661-
frost-omega. Posted 02/07/2006.
Turner, J. (2006). Nothing ‘‘fishy’’ about omega-3s. Available at
www.foodproductdesign.com/articles/641application.html.
Posted 04/05/2006.
Varady, K. A., Wang, Y. W., & Jones, P. J. H. (2003). Role of polico-
sanols in the prevention and treatment of cardiovascular disease.
Nutrition Reviews, 61(11), 376e383.
Whelan, J., & Rust, C. (2006). Innovative dietary sources of N-3 fatty
acids. Annual Review of Nutrition, 26, 75e103.
Yamaguchi, P. (2005). Japan’s nutraceuticals today e CoQ10, GMP and
FOSHU update. Available at www.npicenter.com/anm/templates/
newsATemp.aspx?articleid¼14032&zoneid¼45. Posted 28/10/
2005.