REPORT ON FUNCTIONAL FOODS

REPORT ON FUNCTIONAL FOODS



















Food Quality and Standards Service (AGNS)
Food and Agriculture Organization of the United Nations (FAO)
November, 2007

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Report on Functional Foods, November 2007




















This report was prepared for Food Quality and Standards Service (AGNS), Food and Agriculture
Organization of the United Nations (FAO) by Muriel Subirade, Professeure, Département des sciences
des aliments et de nutrition, Université Laval, Québec, Canada.

The views expressed in this publication are those of the author(s) and do not necessarily reflect the
views of the Food and Agriculture Organization of the United Nations (FAO). The designations
employed and the presentation of material in this information product do not imply the expression of
any opinion whatsoever on the part of FAO concerning the legal or development status of any country,
territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.




For further information, please contact:
Food Quality and Standards Service
Nutrition and Consumer Protection Division
Food and Agriculture Organization of the United Nations
Viale delle Terme di Caracalla
00153, Rome, Italy
Fax: (+39) 06 57054593
E-Mail: food-quality@fao.org
Web site: www.fao.org/ag/agn/index_en.stm

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Report on Functional Foods, November 2007


TABLE OF CONTENTS

I – INTRODUCTION








3

II – CURRENT FUNCTIONAL FOODS SITUATION




3

2.1. Terminology and definition

2.2. Market

2.3. Markers drivers
• Scientific investigations
• Socio-economics trends

III – REVIEW OF EXISTING NATIONAL, REGIONAL AND INTERNATIONAL
REGULATORY SYSTEMS GOVERNING THE PRODUCTION AND DISTRIBUTION OF
FUNCTIONAL FOODS








5

3.1. Europe

3.2. USA

3.3. Canada

3.4. Japan

3.5. Other asian countries

3.6. Codex Alimentarius

Conclusion

IV – RECENT SCIENTIFIC DEVELOPMENTS




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4.1. Disease/ target functions

4.2. Scientific controversies

Conclusion

V - SOME CRITERIA FOR THE DEVELOPMENT OF GUIDELINES FOR THE
ASSESSMENT OF FUNCTIONAL FOODS





17

VI- SOME RECOMMENDATIONS






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VII – REFERENCES








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Report on Functional Foods, November 2007


I
INTRODUCTION

The role of dietary active compounds in human nutrition is one of the most important areas of
concern and investigation in the field of nutritional science. The findings of investigations on
this subject have wide-ranging implications for consumers, health-care providers and nutrition
educators as well as food producers, processors and distributors. New evidence concerning
the benefits and risks associated with particular aspects of dietary compounds is constantly
emerging in both the scientific literature and the popular media. At times, controversies about
these findings emerge. Sifting through all the claims and counterclaims, incomplete and
incompatible studies, and biases and competing interests for the elements of truth and a
prudent course of action is a challenge. However, such discrimination is essential because
changing views about the effects of dietary compounds can profoundly influence the
consumption of various foods and, ultimately, health and nutritional status, agricultural
production, food processing technologies, food marketing practices and nutrition education.

The present report has the following principal objectives:

• To present current functional food situation;

• To examine the latest global and regional regulatory developments for health,
nutrients or other functional claims relating to foods;

• To review and analyze scientific and technical literature related to functional foods
and their role in improving nutrition;

• To establish key criteria for elaborating guidelines for the assessment of functional
foods;

• To propose some recommendations on functional foods.


II
CURRENT FUNCTIONAL FOOD SITUATION

2.1
TERMINOLOGY AND DEFINITIONS
The term “Functional Foods” was first introduced in Japan in the mid-1980s and refers to
processed foods containing ingredients that aid specific body functions, in addition to being
nutritious. Currently, there is no universally accepted term for functional foods. A variety of
terms have appeared world-wide such as nutraceuticals, medifoods, vitafoods and the more
traditional dietary supplements and fortified foods. However, the term Functional foods has
become the predominant one even though several organizations have attempted to
differentiate this emerging food category. Health Canada, for instance, defines a functional
food as “similar in appearance to a conventional food, consumed as part of the usual diet, with
demonstrated physiological benefits, and/or to reduce the risk of chronic disease beyond basic
nutritional functions” and a nutraceutical as “a product isolated or purified from foods that is
generally sold in medicinal forms not usually associated with foods (Health Canada website:
http://hc-sc.gc.ca). In Korea, functional foods are defined as dietary supplement whose
purpose is to supplement the normal diet and have to be marketed in measured doses, such as
in pill, tablets (Kim et al, 2006).

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However, functional foods are generally considered as those foods which are intended to be
consumed as part of the normal diet and that contain biologically active components which
offer the potential of enhanced health or reduced risk of disease. Examples of functional foods
include foods that contain specific minerals, vitamins, fatty acids or dietary fibre, foods with
added biologically active substances such as phytochemicals or other antioxidants and
probiotics that have live beneficial. According to this definition, unmodified whole foods such
as fruits and vegetables represent the simplest form of a functional food. For example,
broccoli, carrots, or tomatoes would be considered functional foods because they are rich in
such physiologically active components as sulforaphane, beta carotene, and lycopene,
respectively.

Point 1: Functional foods should be clearly defined

2.2
MARKET
There is clearly a difference between the Western perspective on functional foods and the
Eastern perspective. In the West, functional foods are viewed as a revolution and represent a
fast growing segment of the food industry. In the Orient, in contrast, functional foods have
been a part of the culture for centuries. In Traditional Chinese Medicine, foods that have
medicinal effects have been documented since at least 1000 BC. From ancient times, the
Chinese have believed that foods have both preventive and therapeutic effects and are an
integral part of health, a view that is now being increasingly recognized around the world
(Shi, 2005).
The world market for functional foods and beverages is highly dynamic. According to an
Euromitor survey, Japan is the world's largest market at US$11.7 billion, then US is the
second one market with around US$10.5 billion while the European market is less developed
with an estimated market of US$7.5, the “big four” European markets being UK (US$2.6
billion), Germany (US$2.4 billion), France (US$1.4 billion), and Italy (US$1.2 billion) (Bech-
Larsen & Scholderer, 2007).
As a result, developing countries - such as Brazil, Peru, Kenya- have started to emerge as
active ingredients exporters to cater to the increasing demand in the developed countries
(Williams et al., 2006). Moreover, demand for functional foods within the developing
countries is growing, presenting a lucrative opportunity to develop domestic markets. For
instance, India, with its strong tradition of eating healthy foods, ranks among the top ten
nations in buying functional foods and the market size is expected to nearly double in the next
five years (Ismail, 2006). In Brazil, the sector is relatively young, but grows rapidly, sales
value is projected to reach US$1.9 billion by 2009. In China, the total functional foods market
is approximately US$6 billion per year, which is expected to double by 2010.
Even though detailed information on the size of functional food market is relatively sparse
depending on how the category is defined, one thing that all studies seem to agree on is that
functional markets grow steadily each year, with annual growth rate estimates varying
between 8% and 14%. This trend is likely to continue as changing population demographics
(e.g. an ageing population) and the effects of lifestyle diseases create greater demand for food
products targeting health and wellness.

2.3
MARKET DRIVERS

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Countries are currently faced with a number of major health challenges arising from an ageing
population and an increase in lifestyle diseases. Current research suggests that functional
foods can make a positive contribution to addressing those challenges. Behind functional food
research and development, the key drivers are the food industry, consumers and governments.

o
Scientific investigations
According to the traditional concept of nutrition, the primary role of the diet is to provide
adequate quantities of nutrients to meet metabolic requirments and maintain optimal
health. However epidemiological, experimental and clinical studies have shown that
certains types of food and specific food components can affect a variety of body functions
and provide health benefits (Takachi et al. 2007; Nöthlings et al. 2007; Kuriyama et al.
2006, Arnoldi et coll., 2004; Remacle et al, 2004; Wildman et coll, 2006, Watson et al.
and others). Based on scientific data it is now accepted that diet can have beneficial
physiological effects, beyond well-known nutritional effects, by modulating specific target
function in the body. Therefore, diet not only helps to achieve optimal development and
health, but it may promote better health and play an important role in disease prevention
by reducing the risk of certain chronic diseases.

o
Socio-economics trends
Many countries around the world have an ageing population due to reduced birth rates and
greater life expectancy. As people are living longer, the older population is growing
exponentially throughout the world. For instance, the Canada’s National Statistical
Agency reports that the proportion of the Canadian population aged over 60 is today 13 %
and will increase over the next 20 years to reach around 25% of the total population in
2030. With lengthened years comes increased threat of chronic diseases and from a socio-
economical viewpoint, countries are facing financial difficulties in medical care costs due
to the increase in chronic diseases and the expansion of life spans. As an example, health
expenditures in Canada are approximately $100 billion annually, increasing yearly by 7%.
Health expenditures of seniors represent 42% of total health costs. These expenditures will
increase with life expectancy. A recent report estimates a saving of 20% per year to health
care expenditures through functional foods (Holub, 2002). Thus, governments are aware
of the economic potential of these products as part of public health prevention strategies.
Moreover, a vast majority of people has a positive image of healthy food and agrees that
food and nutrition have a positive impact on long-term and current health (Landstrom et
al. 2007). The observed growth in this market is driven largely by consumers' aim for a
healthier lifestyle through a dietary approach.
The growth of the functional foods sector not only represents significant benefits to the
health sector but also offers opportunities for processing and manufacturing companies.
Manufacturers and their search for added-value, higher margin products provided key
impetus for the growth of functional products. However, the potential for financial gain
resulted in many unsupported claims for functional ingredients by commercial enterprises
whose interests lie more in profit rather than sound science (Jones & Jew, 2007). As a
result, the functional foods field has been tarnished and suffers a credibility gap.

III
REVIEW EXISTING NATIONAL, REGIONAL AND INTERNATIONAL REGULATORY
SYSTEMS GOVERNING THE PRODUCTION AND DISTRIBUTION OF FUNCTIONAL FOODS

A growing number of foods now carry nutrition and health claims and companies have been
using health-related claims for years. The proliferation of claims on a variety of food products

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and dietary supplements has created an environment of confusion and distrust among health
professionals and consumers. Thus to harmonize the provision of this type of information,
many countries worldwide have recently introduced a regulation on the use of nutrition and
health claims for foods. This section presents an overview of the functional foods regulatory
systems of Europe, USA, Canada, Australia, Japan and other asian countries as well as codex
alimentarius.
All of the information for this analysis was obtained from publicly available sources provided
by the respective regulatory authorities in each country. Moreover, very useful information on
worldwide health claims regulatory systems have been obtained from the Australian National
Centre of Excellence in Functional Foods1.

III.1 EUROPE
Historically, companies attempting to launch a functional food in Europe have faced a variety
of legislative frameworks regulating the approval of products, the kinds of nutrition
information required on labels, and the types of functional and health claims that were
allowed in connection with a product, often in a way that was highly inconsistent between EU
member states (Bech-Larsen & Scholderer, 2007; Butris, 2007; Kuhn, 2007; Madsen, 2007).
After a first attempt at harmonization, which technically prohibits all product-related
communications from attributing properties for prevention, treatment or cure of human
diseases to food (European Parliament & Council of Europe, 2001), the situation changed.
On July 2003, the European Commission proposed a harmonized regulation COM/2003/0424
on nutrition and health claims made on foods, including dietary supplements (Commission of
the European Communities, 2003). In December 2006, the regulation on the use of nutrition
and health claims for foods was adopted by the Council and Parliament of Europe (European
Parliament & Council of Europe, 20062).
For the purposes of this regulation, the following definitions have been proposed:
• “claim”: any message or representation, which is not mandatory under Community or
national Legislation, including pictorial, graphic or symbolic representation, in any
form, which states, suggests or implies that a food has particular characteristics;
• “nutrition claim”: means any claim which states, suggests or implies that a food has
particular beneficial nutritional properties due to: a) the energy (calorific value) it (i)
provides; (ii) provides at a reduced or increased rate; or (iii) does not provide; and/or
b) the nutrients or other substances it (i) contains; (ii) contains in reduced or increased
proportions; or (iii) does not contain;
• “health claim”: means any claim that states, suggests or implies that a relationship
exists between a food category, a food or one of its constituents and health;
• “reduction of disease risk claim”: means any health claim that states, suggests or
implies that the consumption of a food category, a food or one of its constituents
significantly reduces a risk factor in the development of a human disease
It can be noted that medicinal claims for foods – i.e. claim, which states or implies that a
product has the property of treating, preventing or curing human disease- are prohibited under
National and European Labelling Rules. In order to be permitted to make a medicinal claim, a
product must be classed as a medicine in accordance with the definition in the Directive

1 National Centre of Excellence in Functional Foods: http://www.nceff.com.au/resources/regulations.html
2 Regulation (EC) on nutrition and health claims made on foods No 1924/2006 published in the Official Journal
of the European Union 18.1.2007. Available at http://eur-
lex.europa.eu/LexUriServ/site/en/oj/2007/l_012/l_01220070118en00030018.pdf;

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2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use.

The European Food Safety Authority (EFSA) is involved in implementing the new regulation
and has published a guidance to help companies who want to submit health claims for
authorization (EFSA, 2007). The assessment of a health claim by EFSA is the first step in the
authorization process. Only those claims which are scientifically substantiated will finally be
authorized for use. The EU PASSCLAIM project3 (Process for the Assessment of Scientific
Support for Claims on Foods) provides industry, academics, consumer groups and regulators
with the means to evaluate the scientific basis for health claims (Aggett et al. 2005). The final
approval of a health claim is the responsibility of the European Commission and Member
States, based on the scientific assessment expressed in the opinion of EFSA’s Panel. It is the
first time that a harmonized approach for authorizing health claims has been established
across EU Member States.

• European Agencies:
o
European Commission: http://ec.europa.eu. The European Commission represents and
upholds the interests of Europe as a whole. It is independent of national governments.
It drafts proposals for new European laws, which it presents to the European
Parliament and the Council. It manages the day-to-day business of implementing EU
policies and spending EU funds. The Commission also keeps an eye out to see that
everyone abides by the European treaties and laws. It can act against rule-breakers,
taking them to the Court of Justice if necessary
o
European Food Safety Authority (EFSA): http://www.efsa.europa.eu. The European
Food Safety Authority (EFSA) is an independent European agency funded by the EU
budget that operates separately from the European Commission, European Parliament
and EU Member States. A European Food Safety Authority ("the Authority") will
provide scientific advice and scientific and technical support in all areas impacting on
food safety. It constitutes an independent source of information on all matters in this
field and ensures that the general public is kept informed.
o
European Food Information Council (EUFIC): www.eufic.org. The European Food
Information Council (EUFIC) is a non-profit organization which provides science-
based information on food safety & quality and health & nutrition to the media, health
and nutrition professionals, educators and opinion leaders.
o
International Life Sciences Institute (ILSI): www.ilsi.org. The international Life
Sciences Institute (ILSI) is a non-profit, worldwide foundation that seeks to improve
the well-being of the general public through the advancement of science. Its goal is to
further the understanding of scientific issues relating to nutrition, food safety,
toxicology, risk assessment, and the environment by bringing together scientists from
academia, government, and industry.

III.2 USA

Currently, Food and Drug Administration (FDA) has neither a definition nor a specific
regulatory rubric for foods being marked as “functional foods”, they are regulated under the
same regulatory framework as other conventional foods under the authority of the Federal
Food Drug and Cosmetic Act4. There are three categories of claims that can be used on food:

3 PASSCLAIM Consensus on criteria. Available at http://europe.ilsi.org/NR/rdonlyres/693AF260-444C-4ABE-
B314-7176FBE78857/0/PASSCLAIMConsensusonCriteria.pdf
4 Claims that can be made on foods in USA are available at: http://www.cfsan.fda.gov/~dms/hclaims.html;

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• Health Claims - Health claims describe a relationship between a food substance and a
disease or health-related conditions. There are three sets of legislation by which FDA
exercises its oversight in determining which health claims may be used on a label or in
labeling for a food or dietary supplement:
o
NLEA Authorized Health Claims – Under the provisions of the Nutrition
Labeling and Education Act (NLEA) of 1990, the Dietary Supplement Act of
1992, and the Dietary Supplement Health and Education Act of 1994
(DSHEA), FDA may authorize a health claim for a food or dietary supplement
based on an extensive review of the scientific literature, generally as a result of
the submission of a health claim petition, using the significant agreement
standard to determine the nutrient/disease relationship is well established (Link
to
the
significant
scientific
agreement
standard:
http://www.cfsan.fda.gov/~dms/ssaguide.html); Example of NLEA Authorized
Health Claims: "diets high in calcium may reduce the risk of osteoporosis";
o
Health Claims Based on Authoritative Statements – Under the 1997 Food
and Drug Administration Modernization Act (FDAMA), a health claim may be
authorised for a food based on an authoritative statement of a scientific body of
the U.S. government or the National Academy of Sciences. FDA has prepared
a guide on how a firm can make use of authoritative statement-based health
claims on food (not currently available for dietary supplements) (link:
http://www.cfsan.fda.gov/~dms/hclmguid.html). Companies wishing to make
such a claim must submit a notification to the FDA which reviews whether the
notification includes the information necessary for the claim and notifies the
submitter by letter within 120 days if notification does not comply. Examples
of health claims based on authoritative statements may also be found at:
http://www.cfsan.fda.gov/~dms/flg-6c.html.
o
Qualified Health Claims – FDA's 2003 Consumer Health Information for
Better Nutrition Initiative provides for the use of qualified health claims when
there is emerging evidence for a relationship between a food, food component,
or dietary supplement and reduced risk of a disease or health-related condition.
In this case, the evidence is not well enough established to meet the significant
scientific agreement standard required for FDA to issue an authorizing
regulation. Both conventional foods and dietary supplements may use qualified
health claims. FDA uses its enforcement discretion for qualified health claims
after evaluating and ranking the quality and strength of the totality of the
scientific evidence. FDA has prepared a guide on interim procedures for
qualified health claims and on the ranking of the strength of evidence
supporting
a
qualified
claim,
available
at:
http://www.cfsan.fda.gov/~dms/hclmgui3.html. FDA information on qualified
health claims may be found at: http://www.cfsan.fda.gov/~dms/lab-qhc.html. A
summary of the qualified health claims authorized by FDA are available at:
http://www.cfsan.fda.gov/~dms/qhc-sum.html.
A new guidance for industry on the process for evaluating the scientific evidence for a health
claim is under evaluation (Food and Drug Administration, Draft guidance: Evidence-Based
Review System for the Scientific Evaluation of Health Claims: July 2007 CFSAN/Office of
Nutrition,
Labeling
and
Dietary
Supplements.
available
at
http://www.cfsan.fda.gov/~dms/hclmgui5.html#ftn1)


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• Nutrient Content Claims - The Nutrition Labelling and Education Act of 1990
(NLEA) permits the use of label claims that characterize the level of a nutrient in a
food (i.e., nutrient content claims) made in accordance with FDA's authorizing
regulations. Conditions for nutrient content claims are described in the FDA food
labelling guide (available at http://www.cfsan.fda.gov/~dms/flg-toc.html). Most
nutrient content claim regulations apply only to those nutrients or dietary substances
that have an established daily value (available at http://www.cfsan.fda.gov/~dms/flg-
7a.html). A summary of the rules for use of nutrient content claims can be found in
Chapter VI of The Food Labelling Guide: http://www.cfsan.fda.gov/~dms/flg-toc.html.
Examples of nutrient content claims can be found in Appendices A and B of The Food
Labelling
Guide:
http://www.cfsan.fda.gov/~dms/flg-6a.html
and
http://www.cfsan.fda.gov/~dms/flg-6b.html.

• Structure/Function Claims - Structure/function claims have historically appeared on
the labels of conventional foods and dietary supplements as well as drugs. However,
the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some
special regulatory procedures for such claims for dietary supplement labels.
Structure/function claims describe the role of a nutrient or dietary ingredient intended
to affect normal structure or function in humans, for example, "calcium builds strong
bones." In addition, they may characterize the means by which a nutrient or dietary
ingredient acts to maintain such structure or function, for example, "fiber maintains
bowel regularity," or "antioxidants maintain cell integrity," or they may describe
general well-being from consumption of a nutrient or dietary ingredient.
Structure/function claims may also describe a benefit related to a nutrient deficiency
disease (like vitamin C and scurvy), as long as the statement also tells how widespread
such a disease is in the United States. The manufacturer is responsible for ensuring the
accuracy and truthfulness of these claims; they are not pre-approved by FDA but must
be truthful and not misleading. If a dietary supplement label includes such a claim, it
must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must
also state that the dietary supplement product is not intended to "diagnose, treat, cure
or prevent any disease," because only a drug can legally make such a claim. Further
information regarding structure/function claims can be found in FDA's January 9,
2002
Structure/Function
Claims
Small
Entity
Compliance
Guide:
http://www.cfsan.fda.gov/~dms/sclmguid.html. Manufacturers of dietary supplements
that make structure/function claims on labels or in labelling must submit a notification
to FDA no later than 30 days after marketing the dietary supplement that includes the
text of the structure/function claim.

• Agencies:
o
The Food and Drug Administration (FDA) (http://www.fda.gov) - The
Food and Drug Administration (FDA) is responsible for ensuring that all
foods in the American food supply (other than meat products, poultry
products, and egg products that are regulated by the U.S. Department of
Agriculture) are safe, secure, sanitary, wholesome, and properly labelled;
o
The American Heart Association (AHA) – a national, voluntary health
agency in the USA whose mission is to reduce disability and death from
cardiovascular diseases and stroke;
o
The Institute of Medicine (IOM) – an independent, private, scientific advisor
serving Canada and the USA, providing unbiased, evidence-based, and
authoritative information and advice concerning health and science policy.

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