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Functional Foods : Opportunities and Challenges

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While food has long been used to improve health, our knowledge of the relationship between food compo- nents and health is now being used to improve food. Strictly speaking, all food is functional, in that it provides energy and nutrients necessary for survival. But the term “functional food” in use today conveys health benefits that extend far beyond mere survival. Food and nutrition science has moved from identifying and correcting nutritional deficiencies to designing foods that promote optimal health and reduce the risk of disease.
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Functional Foods:
Opportunities and Challenges
While food has long been used to improve health,
non-profit society for food science and technology, convened
a panel of internationally renowned experts to review the
our knowledge of the relationship between food compo-
science related to functional foods and the regulatory
nents and health is now being used to improve food.
environment for developing and marketing such products.
This IFT Expert Report contains insight from the
Strictly speaking, all food is functional, in that it
extensive deliberations of this multidisciplinary panel. As
provides energy and nutrients necessary for survival.
such, it joins two previous IFT Expert Reports—Emerging
Microbiological Food Safety Issues: Implications for Control
But the term “functional food” in use today conveys
in the 21st Century and Biotechnology and Foods—and an
health benefits that extend far beyond mere survival.
authoritative report, Managing Food Safety: Use of Perfor-
mance Standards and Other Criteria in Food Inspection
Food and nutrition science has moved from identifying
Systems. The IFT Office of Science, Communications, and
and correcting nutritional deficiencies to designing
Government Relations coordinated the development of these
foods that promote optimal health and reduce the
publications as part of its mission to promote regulatory
policies that are based on sound science.
risk of disease.
This Expert Report provides a comprehensive review
The costly and complex process of translating these
of functional foods that emphasizes the importance of
scientific advances and nutritional innovations into
functional foods, summarizes the applicable U.S. laws
consumer products is not without pitfalls. Sound science
and regulations, and presents scientifically based guidance
must underlie the development, marketing and regulation
for demonstrating both safety and efficacy. The report
of these new functional foods to protect and inform
recommends approaches for improving the regulatory
consumers. Regulatory policies must ensure the safety
framework to better address evolving science and food
and efficacy of products and the accuracy of their
composition. In addition, the report identifies potential
marketing claims.
incentives to expand the availability of new products
To advance the scientific perspective on these issues, the
and facilitate consumer understanding of the benefits of
Institute of Food Technologists (IFT), the 26,000-member
functional foods.
Founded in 1939, the Institute of Food Technologists is an international not-for-profit scientific society
with 26,000 members working in food science, technology, and related professions in the food indus-
try, academia, and government. As the society for food science and technology, IFT brings sounds
science to the public discussion of food issues.

IFT Expert Report Panelists
IFT is deeply grateful to the Expert Report panelists for the time and effort that each of them expended on this project,
bringing their expertise and insight into the state-of-the-science on the numerous topics addressed in the report. Panelists
traveled to Chicago to participate in full-day meetings and devoted considerable additional time to drafting the report, participat-
ing in conference calls to discuss drafts, and reviewing the drafts. IFT sincerely appreciates these experts’ invaluable dedication
to furthering the understanding of the opportunities and challenges posed by functional food development.
The participants on the Expert Panel were chosen based on their scientific, medical, and legal expertise. Their contributions
represent their individual scientific perspective and do not represent the perspective of their employer.
Panel Chair
Fergus Clydesdale, Ph.D.
Distinguished Professor and Department Head
Dept. of Food Science
University of Massachusetts, Amherst
Panel Members
Wayne R. Bidlack, Ph.D.
Mark L. Dreher, Ph.D.
Dean, College of Agriculture
Vice President, Research and Development
California State Polytechnic University, Pomona
McNeil Nutritionals, LLC, a Johnson & Johnson company
New Brunswick, NJ
Diane F. Birt, Ph.D.
Distinguished Professor, Dept. of Food Science
John W. Erdman Jr., Ph.D.
and Human Nutrition
Professor, Dept. of Food Science and Human Nutrition
Director, Iowa Center for Research on Botanical
University of Illinois, Urbana
Dietary Supplements
Iowa State University, Ames
Nancy Fogg-Johnson, Ph.D.
Principal
Bruce R. Bistrian, M.D., Ph.D.
Life Sciences Alliance/Technology and Business
Professor of Medicine
Ventures, Inc.
Harvard Medical School, Boston, MA
Villanova, PA
Joseph F. Borzelleca, Ph.D.
Loren Israelsen, J.D.
Professor Emeritus, Dept. of Pharmacology and Toxicology
President
Medical College of Virginia/Virginia Commonwealth
LDI Group, Inc.
University, Richmond
Salt Lake City, UT
Roger A. Clemens, Dr.PH
Marge Leahy, Ph.D.
Director, Laboratory for Analytical Research and
Senior Manager of Health and Nutrition
Services in Complementary Therapeutics
Ocean Spray Cranberries, Inc.
Associate Director, Regulatory Science
Lakeville/Middleboro, MA
Adjunct Professor, Dept. of Molecular Pharmacology
and Toxicology
Gilbert A. Leveille, Ph.D.
University of Southern California School of Pharmacy,
Senior Consultant, Cargill, Inc.
Los Angeles
Wayzata, MN
2
Institute of Food Technologists

Diane B. McColl, Esq.
John E. Vanderveen, Ph.D.
Hyman, Phelps, and McNamara
Scientist Emeritus
Washington, DC
Center for Food Safety and Nutrition, Food and Drug
Administration, San Antonio, TX
Stephen H. McNamara, Esq.
Hyman, Phelps, and McNamara
Washington, DC
IFT Committee on Science, Communications,
Kenneth C. Mercurio
and Government Liaison Representatives
Director of Regulatory and Nutrition
Nestlé USA, Inc., Glendale, CA
Mary K. Schmidl, Ph.D.
John A. Milner, Ph.D.
Principal, National Food & Nutrition Consultants
Chief, Nutrition Science Research Group
Adjunct Assistant Professor, Dept. of Food Science
Division of Cancer Prevention
and Nutrition
National Cancer Institute, National Institutes of Health
University of Minnesota, St. Paul
Rockville, MD
Mark Uebersax, Ph.D.
Shridhar K. Sathe, Ph.D.
Chairperson and Professor, Dept. of Food Science
Professor, Dept. of Nutrition, Food, and Exercise Sciences
and Human Nutrition
Florida State University, Tallahassee
Michigan State University, East Lansing
Editorial Staff
Jennifer MacAulay, M.Ed., R.D.
Staff Scientist
Institute of Food Technologists
Washington, DC
Barbara Petersen, Ph.D.
Practice Director and Principal Scientist
Exponent, Inc.
Washington, DC
Fred Shank, Ph.D.
Vice President, Office of Science, Communications, and
Government Relations
Institute of Food Technologists
Washington, DC
Expert Report
3

Table of Contents
Definitions ...................................................................... 6
Scientific Standards for Evaluating a Proposed Claim .......... 24
Functional Foods ......................................................... 6
Significant Scientific Agreement .................................. 24
Nutrients .................................................................... 6
Weight of the Scientific Evidence ................................. 25
Introduction .................................................................... 7
Competent and Reliable Scientific Evidence ................... 26
Unlocking the Secrets of Functional Food Components ..... 7
Limitations of Current Policies ......................................... 27
Shifting the Paradigm for Health and Wellness ................ 8
Wording Claims to Avoid Drug Classification ............... 27
The Traditional Paradigm ......................................... 8
Defining Nutritive Value ............................................. 27
A New Paradigm ..................................................... 8
Case Study: Stanol and Sterol Esters and
Coronary Heart Disease ......................................... 28
Tailoring Diets for Special Needs ................................... 9
Case Study: Cranberries and Urinary Tract Health ..... 28
Encouraging the Development of Functional Foods .......... 9
Defining Differences in Qualified Health Claims ............. 28
The Intersection of Food and Genes .................................. 11
Process for Bringing Functional Foods to Market ............... 30
New Disciplines ......................................................... 11
Step 1: Identify Relationship Between Food
Nutrigenomics ...................................................... 11
Component and Health Benefit .................................... 30
Proteomics ........................................................... 11
Step 2: Demonstrate Efficacy and Determine
Metabolomics ....................................................... 11
Intake Level Necessary to Achieve Desired Effect ........... 31
Future Developments ................................................. 11
Identifying Bioactive Components ........................... 31
Current U.S. Legal Standards for Health-Related Claims ...... 15
Assessing Stability and Bioavailability of
Bioactive Substances in Food Matrices ..................... 31
Terminology ............................................................. 15
Physical Form .................................................... 31
Threshold Problem: Need to Avoid Drug Status ............. 15
Chemical Form .................................................. 31
Health Claims ........................................................... 15
Effects of the Total Diet ...................................... 32
Claims Based on Authoritative Statements ................ 16
Effects of Food Processing ................................. 32
Qualified Health Claims .............................................. 16
Environmental Factors ....................................... 33
Nutrient Content Claims ............................................. 18
Demonstrating Efficacy .......................................... 33
Statements of Nutritional Support for
Dietary Supplements .................................................. 19
Biological Endpoints and Biomarkers ............... 33
Definition of Disease ............................................. 20
Criteria for Evaluating Efficacy ........................ 34
Claims Relating to Signs or Symptoms of Disease ...... 20
Case Study: Efficacy of Omega-3 Fatty Acids ... 35
Claims Concerning Conditions Associated with
Case Study: Efficacy of Soy Protein ................... 38
Natural States ....................................................... 20
Case Study: Efficacy of Stanols/Sterols ............. 40
Structure/Function Claims Included in the
Case Study: Efficacy of Cranberry .................... 42
OTC Drug Review ................................................. 20
Estimating Dietary Intake ....................................... 42
Citations to Publications that Refer to Disease .......... 21
Step 3: Demonstrate Safety of the Functional
Structure/Function Claims for Conventional Foods ........ 21
Component at Efficacious Levels .................................. 43
Claims About Special Dietary Uses .............................. 23
Safety Assessments for GRAS Ingredients and
General Freedom to Use Statements That Are Not
Food Additives ...................................................... 43
‘False Or Misleading In Any Particular’ ........................ 23
Guidelines for Safety Assessments ............................ 43
4
Institute of Food Technologists

Use of Epidemiological Data ................................... 44
Nutrigenomics and Function of Bioactive Components .... 49
Allergen Management ............................................ 44
Policies Regarding Ethics, Regulatory, and Legal
Implications of Nutrigenomics and Molecular
Step 4: Develop a Suitable Food Vehicle for
Nutrition Research ..................................................... 50
Bioactive Ingredients .................................................. 44
Expanded Incentives for Health and
Step 5: Demonstrate Scientific Sufficiency of
Nutrition Research ..................................................... 50
Evidence for Efficacy .................................................. 45
Independent Peer Review ........................................ 45
Conclusions .................................................................. 51
Regulatory Approval When Necessary ...................... 45
References .................................................................... 52
Step 6: Communicate Product Benefits to Consumers ..... 46
Appendix A: Food Consumption Databases ....................... 60
Step 7: Conduct In-market Surveillance to
Folate Fortification Decision: Range of Dietary
Confirm Efficacy and Safety ........................................ 46
Intakes and Associated Issues ...................................... 61
Goals of an IMS Program ....................................... 47
Appendix B: Additional Examples of the Effects of
Role of Research ............................................................ 48
Functional Components of Foods ..................................... 63
Types of Research Needed .......................................... 48
Appendix C: Food Composition Databases ........................ 65
Nutrients and Bioactive Substances .......................... 48
Historical Perspective ................................................. 65
New and Existing Biomarkers .................................. 48
Adequacy of the Data ................................................ 65
Food Vehicles for Bioactive Ingredients ..................... 49
Appendix D: Safety Testing for Substances Without
Food Composition and Dietary Intake Databases ....... 49
Prior History of Safe Use ................................................. 66
List of Tables
Table 1. Examples of Functional Food Components Currently Marketed ................................................................................... 8
Table 2. Terminology and Disciplines Pertinent to Applications of Genetic Research to Nutrition and Health ............................... 12
Table 3. Gene Expression Processes Leading to Protein Formation and Selected Nutrient Regulators in the Process ....................... 13
Table 4. Examples of Nutrient Involvement in Gene Expression and Potential Phenotypic Results ................................................ 13
Table 5. Standardized Qualifying Language for Qualified Health Claims ................................................................................. 17
Table 6. Biomarkers for Well Being and Disease Risk Reduction ............................................................................................. 34
Table 7. Case Study: Omega-3 Fatty Acids and Coronary Heart Disease ................................................................................. 36
Table 8. Case Study: Soy Protein and Coronary Heart Disease .............................................................................................. 38
Table 9. Case Study: Stanol/Sterol Esters and Coronary Heart Disease ................................................................................... 40
List of Figures
Fig. 1. Benefits and Risks of Foods vs. Drugs ........................................................................................................................ 9
Fig. 2. Role of Functional Foods in Health Care Continuum .................................................................................................... 9
Fig. 3. Projected Increase in Number of Elderly Individuals ................................................................................................... 10
Fig. 4. Examples of Permissible Structure/Function Claims ................................................................................................... 21
Fig. 5. Seven Steps for Bringing Functional Foods to Market ................................................................................................ 30
Expert Report
5

Definitions
The first step in a comprehensive review of functional foods is to define what exactly is included. Similarly, any
discussion of bioactive food components must first begin by defining the term “nutrients.”
Functional Foods
The Expert Panel, for purposes of this report, defines “functional foods” as foods and food components that
provide a health benefit beyond basic nutrition (for the intended population). Examples may include conventional
foods; fortified, enriched or enhanced foods; and dietary supplements. These substances provide essential nutrients
often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically
active components that impart health benefits or desirable physiological effects.
Nutrients
For purposes of this Expert Report, nutrients are defined as traditional vitamins, minerals, essential fatty acids
for which recommended intakes have been established and other components that include phytonutrients or
bioactives present in foods for which a physical or physiological effect has been scientifically documented or for
which a substantial body of evidence exists for a plausible mechanism, but for which a recommended intake and
function have not been definitively established.
6
Institute of Food Technologists

Introduction
The combination of consumer desires, advances in
the past 200 years, but the impact of diet on health is much
broader than basic nutrition. A growing body of evidence
food technology, and new evidence-based science linking
documents positive health benefits from food components
diet to disease and disease prevention has created an
not considered nutrients in the traditional definition.
Scientific advances have allowed researchers to better
unprecedented opportunity to address public health
characterize the biological basis of disease states, under-
issues through diet and lifestyle. Widespread interest in
stand the metabolism of food at the cellular level, and
identify the role of bioactive components in food and assess
select foods that might promote health has resulted in
their impact on metabolic processes. New powerful analyti-
the use of the term “functional foods.” Although most
cal tools can enable scientists to unlock the biological
functions of vast numbers of food components and their
foods can be considered “functional,” in the context of
role in disease prevention and health promotion.
this report the term is reserved for foods and food
Functional foods can take many forms. Some may be
conventional foods with bioactive components that can now
components that have been demonstrated to provide
be identified and linked to positive health outcomes. Some
specific health benefits beyond basic nutrition (see
may be fortified or enhanced foods, specifically created to
reduce disease risk for a certain group of people. Consumers
definition on page 6). The term functional food is thus
can already select from a wide spectrum of foods that
arbitrary, but it is nonetheless useful since it will convey
contain functional components either inherently (e.g., soy
protein, cranberries) or via fortification (e.g., folate-fortified
to the consumer both the unique characteristics of the
foods). Health benefits may result from increasing the
food and the associated health benefits.
consumption of substances already part of an individual’s
The members of the Institute of Food Technologists
diet or from adding new substances to an individual’s diet.
(IFT) recognize that the foods already on the market
As additional bioactive components are identified, the
represent a small fraction of the potential for functional
opportunities for developing functional foods will be broad
foods. Today’s science and technology can be used to
(O’Donnell, 2003). Foods that naturally provide a bioactive
provide many additional functional foods, and future
substance may be enhanced to increase the level present in
scientific and technological advances promise an even
the food (e.g., eggs with increased levels of omega-3 fatty
greater range of health benefits for consumers. Functional
acids). Alternately, foods that do not naturally contain a
foods can provide health benefits by reducing the risk of
substance can be fortified to provide consumers with a
chronic disease and enhancing the ability to manage
broader selection of food sources for a particular component
chronic disease, thus improving the quality of life. Func-
and its health benefit (e.g., calcium-fortified orange juice).
tional foods also can promote growth and development
Areas for research include better understanding the role
and enhance performance.
and optimal levels of traditional nutrients for specific
IFT prepared this Expert Report to provide a detailed,
segments of the population, as well as identifying bioactive
state-of-the-art review of the development of functional
substances present in foods and establishing optimal levels.
foods, including the products, the science, and the possibili-
Early nutrition research focused on the range of vitamin
ties. (The report discusses examples of functional foods,
and mineral intakes necessary to prevent frank deficiencies.
however it does not provide a comprehensive review of all
Now, researchers are investigating the optimum intake
functional foods.) The report also emphasizes the impor-
levels for traditional nutrients and the differences for various
tance of functional foods, provides scientifically based
subpopulations. Understanding the role of nutrients at the
guidance for demonstrating both safety and efficacy, and
molecular level will result in even more specific recom-
provides a comprehensive summary of the applicable
mended dietary allowances for different population sub-
U.S. laws and regulations. The report proposes solutions
groups. Similar research is needed to identify the role of
to current impediments to functional food development,
other bioactive food components, an area of research that
including limitations in the existing regulatory framework
is still in its infancy. Only recently, several government
and the need for appropriate incentives to expand the
agencies have begun developing a standard definition
availability of new products.
for “bioactive” food components (HHS/OS/OPHS, 2004).
Research has proven that food and isolated food compo-
Unlocking the Secrets of Functional Food Components
nents can reduce the risk of disease, from the effect of
Food technology and improved nutrition have played
vitamin A from eggs on blindness to the effect of zinc from
critical roles in the dramatic increase in life expectancy over
high-protein foods on the immune system. Some examples
Expert Report
7

of foods that may be considered functional foods include
deficiency diseases is a logical extension of traditional
calcium-fortified orange juice, phytosterol/stanol-fortified
nutritional interventions. Nonetheless, such an extension
spreads and juices, folate-enriched foods, soluble oat
requires changes in not only the foods themselves, but also
fiber, cranberry, and soy (see Table 1).
their regulation and marketing—truly a paradigm shift.
Research currently underway at academic, industry
Creating a scientifically valid distinction between food
and government facilities will reveal how a myriad of
and medicine has never been easy. Centuries ago, Hippo-
substances can be used as functional food components.
crates advised, “Let food be thy medicine and medicine
Although additional research is necessary to validate
be thy food.” Early nutrition research resulted in cures for
efficacy and establish appropriate dietary levels, research-
numerous widespread deficiency-based diseases. Recent
ers have identified functional food components that may
scientific advances have further blurred the line between
improve memory, reduce arthritis, reduce cardiovascular
food and medicine, as scientists identify bioactive food
disease and provide other benefits typically associated
components that can reduce the risk of chronic disease,
with drugs.
improve quality of life, and promote proper growth and
In addition, new technologies will provide opportu-
development.
nities to produce bioactive food components from
The Traditional Paradigm
nontraditional sources. For example, Abbadi et al.
(2004) developed transgenic plant oils enriched with
Traditional fortification of foods with vitamins and
very long chain polyunsaturated fatty acids. Other
minerals has been accepted by consumers and regulators,
research has produced stearidonic acid (a precursor
but consumers should recognize the clear distinction
for eicosapentaenoic acid) in canola seeds to provide
between the use and purpose of foods vs. drugs (see Fig. 1).
another source of omega-3 fatty acids in the diet
Food has traditionally been viewed as a means of
(James et al., 2003; Ursin, 2003).
providing normal growth and development. Regulatory
Emerging science requires that we broaden our frame
policies were established to replace nutrients lost during
of reference to take full advantage of these new discover-
processing and, in some cases, to prevent nutrient deficien-
ies. Foods may be developed to promote the expression
cies in the population. Federal policies have generally
of specific metabolites, reducing or preventing common
required that other diseases be treated and managed through
diseases that afflict consumers with a specific genotype.
the use of drugs.
Consumers might select functional foods and tailor their
A New Paradigm
diets to meet changing health goals and different require-
ments at different ages. Future benefits might include
A new self-care paradigm (adapted from Clydesdale,
functional foods for increased energy, mental alertness,
1998) recognizes that foods can provide health benefits that
and better sleep.
can co-exist with traditional medical approaches to disease
treatment. Science has clearly demonstrated additional
Shifting the Paradigm for Health and Wellness
dietary roles in reducing disease risk, and consumers have
A growing number of consumers perceive the ability
learned that food has a greater impact on health than
to control their health by improving their present health
previously known. At the same time, consumers recognize
and/or hedging against aging and future disease. These
problems with the current healthcare system, perceiving that
consumers create a demand for food products with
it is often expensive, time-constrained,
enhanced characteristics and associated health benefits.
and impersonal.
In one study, 93% of consumers believed certain foods
Functional foods fit into a continuum that ranges from
have health benefits that may reduce the risk of disease or
health maintenance/promotion to disease treatment (see
other health concerns. In addition, 85% expressed interest
Fig. 2). On one end of the continuum are public health
in learning more about the health benefits offered by
programs aimed at reducing disease risk in a large segment
functional foods (IFIC, 2002).
of the population through self-directed lifestyle changes.
Using foods to provide benefits beyond preventing
The other end of the continuum is individualized treatment
of disease by health care professionals
Table 1. Examples of Functional Food Components Currently Marketed
using drugs and other medical
interventions. Although the health
Functional Component
Health Benefits
U.S. Regulatory Status of Claims
professional involvement is low in
Soluble oat fiber
Coronary heart disease
FDA approved health claim
self-directed treatment relative to
individualized treatment, an important
Soy protein
Coronary heart disease
FDA approved health claim
educational component remains. New
Phytosterol/stanol esters
Coronary heart disease
FDA approved health claim
functional foods will continue to
(interim final rule)
expand the continuum, providing
Calcium
Osteoporosis
FDA approved health claim
additional options for consumers.
Folate-enriched foods
Neural tube defects
FDA approved health claim
There is a role for all aspects of
this paradigm in our health care
8
Institute of Food Technologists

Fig. 1.
Benefits and Risks of Foods vs. Drugs
nutritional status is a major issue for older citizens and that
at least four health conditions (under nutrition, cardiovascu-
Food and Food Components
Drugs
lar disease, diabetes, and osteoporosis) would benefit from
Energy/nutrition/necessary for life
Treatment of disease
nutritional intervention in either “preventative or treatment
modes.” Some functional foods are already available for
Life long use and benefits
Immediate effect
each of these purposes, but more are needed. Many elderly
All populations
Target population
individuals may benefit by expanding their use of functional
Safea
Benefit > risk
foods and supplements, particularly where new research can
guide their selection of those foods to meet specific needs.
Consumer selects
Health provider prescribes
It would be unreasonable to expect functional foods to
Adapted from Yetley, 1996.
address all of the elderly’s medical needs, but functional
a Safe when consumed as a food, but with a potential increase in risk as the component
foods can improve health and wellness, minimize costs,
levels increase. Safety evaluation will be conducted to identify the limits.
and provide consumers with greater control.
system. Functional foods should be integral components of
Encouraging the Development of Functional Foods
established public health programs to reduce the risk of
specific diseases (Clydesdale, 1998).
As research provides clear evidence of relationships
Treatment and prevention of coronary heart disease
between dietary components and health benefits, the
(CHD) provides an example of this paradigm shift. In the
challenge has just begun. Scientific, regulatory, and
past, recommendations for treating hypercholesterolemia,
business frameworks must be in place to evaluate the data
one of the risk factors for CHD, included dietary and
for efficacy and safety, ensure effective regulatory over-
lifestyle interventions along with medication. The dietary
sight, communicate the findings to consumers, and provide
and lifestyle interventions included reducing intake of
incentives that encourage research and development of
saturated fat and cholesterol, quitting smoking, increasing
these novel food products.
regular physical activity, and maintaining a healthy body
This report recommends modifications to the existing
weight (NCEP, 1988, 1993). These recommendations, often
efficacy and safety evaluation process to ensure a sound
in conjunction with medication, have been effective
scientific underpinning for each proposed functional food,
strategies for managing heart disease.
while providing clear information to consumers. Corre-
The most recent clinical guidelines for treatment of
sponding improvements in the regulatory oversight of new
coronary heart disease include therapeutic dietary options
functional components also are proposed. These changes
for reducing low density lipoproteins (LDL) by consuming
must be implemented now to protect consumer confidence
specific foods, such as those that contain plant stanols/
in the safety of the food supply and to encourage the food
sterols, increasing intake of soluble fiber, and reducing
industry to invest in the development of new functional
intake of trans fatty acids (NCEP, 2001). Several food
foods. Science is moving rapidly; industry and government
components currently under study may provide additional
must also move rapidly to ensure that the results are
dietary options in the prevention and treatment of CHD.
translated into benefits for the consumer. The functional
Tailoring Diets for Special Needs
foods currently available represent only a fraction of the
potential opportunities for consumers to manage health
Functional foods can address many consumer needs
through diet.
within the new paradigm when used as part of a diet tailored
Traditional definitions and arbitrary distinctions between
to address the special health needs of a specific group of
food and medicine should not prevent consumer access to
consumers. In addition to those with needs because of
knowledge about the benefits of incorporating functional
chronic medical conditions, other groups with special needs
foods into their diets. Likewise, the framework for provid-
include women of childbearing
age, adolescent girls and boys,
athletes, military personnel, and
Fig. 2.
Role of Functional Foods in Health Care Continuum
the elderly.
Delivery
Foods
Fortified/Enhanced Foods
Supplements
Medical Foods
Drugs
For example, improving
Options
the health of the elderly in cost
Purpose of
effective and consumer-accept-
Reduction of Risk
Treatment of Disease
Therapy
able ways will become even
more urgent as the population
Health
Low
High
Professional
of individuals 65 years of age
Involvement
and over increases by approxi-
Individual
High
Low
mately 50% during the next
Participation
27 years (see Fig. 3).
The Institute of Medicine
Treatment
Low
High
Cost
(IOM, 2000) reported that poor
Expert Report
9

Fig. 3.
Projected Increase in Number of Elderly
the frameworks must be modified.
Individuals (AOA, 2002)
Developing a new functional food is an expensive
process. Food companies have traditionally funded research
Number of Persons 65+
8 0
for new food product formulations but for functional foods,
(number in millions)
7 0 .3
7 0
the stakes are higher—for both food companies and con-
6 0
5 3 .7
sumers. Government investment in basic and applied
5 0
3 9 .7
research will promote the development of functional foods,
4 0
3 5
3 1 .2
but additional incentives are needed to reward private
2 5 .7
3 0
1 6 .7
companies that pioneer new health claims. The research
2 0
9
required for a functional food to meet scientific standards
1 0
3 .1
4 .9
0
for efficacy and safety is a substantial investment, but
1 9 0 0 1 9 2 0 1 9 4 0 1 9 6 0 1 9 8 0 1 9 9 0 2 0 0 0 2 0 1 0 2 0 2 0 2 0 3 0
currently the return on that investment is not exclusive to
Ye a r (a s o f J u ly 1 )
the company that conducted the research and developed the
initial regulatory petition. As soon as the health claim is
ing strong regulatory oversight should not present unneces-
adequately documented, competing companies can use
sary barriers to the development and marketing of functional
the claim. Incentives, such as a period of exclusivity or tax
foods. Where existing terminology and regulatory frame-
incentives, would encourage food companies to pursue
works are inadequate to address the full scope of benefits
functional food development by ensuring a profitable
and opportunities for functional foods, the terminology and
return on successful products.
10
Institute of Food Technologists

Document Outline
  • Table of Contents
    • Functional Foods
    • Nutrients
    • Introduction
    • Unlocking the Secrets of Functional Food Components 7
    • The Traditional Paradigm
    • A New Paradigm
    • Tailoring Diets for Special Needs
    • Encouraging the Development of Functional Foods
    • The Intersection of Food and Genes
    • New Disciplines
    • Nutrigenomics
    • Proteomics
    • Metabolomics
    • Future Developments
    • Current U.S. Legal Standards for Health-Related Claims
    • Terminology
    • Threshold Problem: Need to Avoid Drug Status
    • Health Claims
    • Claims Based on Authoritative Statements
    • Qualified Health Claims
    • Nutrient Content Claims
    • Statements of Nutritional Support for Dietary Supplements
    • Definition of Disease
    • Claims Relating to Signs or Symptoms of Disease
    • Claims Concerning Conditions Associated with Natural States
    • Structure/Function Claims Included in the OTC Drug Review
    • Citations to Publications that Refer to Disease
    • Structure/Function Claims for Conventional Foods
    • Claims About Special Dietary Uses
    • General Freedom to Use Statements That Are Not 'False Or Misleading In Any Particular'
    • Scientific Standards for Evaluating a Proposed Claim
    • Significant Scientific Agreement
    • Weight of the Scientific Evidence
    • Competent and Reliable Scientific Evidence
    • Limitations of Current Policies
    • Wording Claims to Avoid Drug Classification
    • Defining Nutritive Value
    • Case Study: Stanol and Sterol Esters and Coronary Heart Disease
    • Case Study: Cranberries and Urinary Tract Health
    • Defining Differences in Qualified Health Claims
    • Process for Bringing Functional Foods to Market
    • Step 1: Identify Relationship Between Food Component and Health Benefit
    • Step 2: Demonstrate Efficacy and Determine Intake Level Necessary to Achieve Desired Effect
    • Identifying Bioactive Components
    • Assessing Stability and Bioavailability of Bioactive Substances in Food Matrices
    • Physical Form
    • Chemical Form
    • Effects of the Total Diet
    • Effects of Food Processing
    • Environmental Factors
    • Demonstrating Efficacy
    • Biological Endpoints and Biomarkers
    • Criteria for Evaluating Efficacy
    • Case Study: Efficacy of Omega-3 Fatty Acids
    • Case Study: Efficacy of Soy Protein
    • Case Study: Efficacy of Stanols/Sterols
    • Case Study: Efficacy of Cranberry
    • Estimating Dietary Intake
    • Step 3: Demonstrate Safety of the Functional Component at Efficacious Levels
    • Safety Assessments for GRAS Ingredients and Food Additives
    • Guidelines for Safety Assessments
    • Use of Epidemiological Data
    • Allergen Management
    • Step 4: Develop a Suitable Food Vehicle for Bioactive Ingredients
    • Step 5: Demonstrate Scientific Sufficiency of Evidence for Efficacy
    • Independent Peer Review
    • Regulatory Approval When Necessary
    • Step 6: Communicate Product Benefits to Consumers
    • Step 7: Conduct In-market Surveillance to Confirm Efficacy and Safety
    • Goals of an IMS Program
    • Role of Research
    • Types of Research Needed
    • Nutrients and Bioactive Substances
    • New and Existing Biomarkers
    • Food Vehicles for Bioactive Ingredients
    • Food Composition and Dietary Intake Databases
    • Nutrigenomics and Function of Bioactive Components
    • Policies Regarding Ethics, Regulatory, and Legal Implications of Nutrigenomics and Molecular Nutrition Research
    • Expanded Incentives for Health and Nutrition Research
    • Conclusions
    • References
    • Appendix A: Food Consumption Databases
    • Folate Fortification Decision: Range of Dietary Intakes and Associated Issues
    • Appendix B: Additional Examples of the Effects of Functional Components of Foods
    • Appendix C: Food Composition Databases
    • Historical Perspective
    • Adequacy of the Data
    • Appendix D: Safety Testing for Substances Without Prior History of Safe Use

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