1.

INTRODUCTION

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 1


Functional Foods
Nutraceuticals
Functional Ingredients
Supplements
Foods for special dietary use
Medical foods

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 2


Having a special activity, A food that is more than
purpose or task. a source of nutrition.
Designed to be practical Additional health
and useful. benefits linked to
consumption of that
food.

Prevention and/or
treatment of disease.
Provide energy and
Improved well-being.
nutrients for the bodys
growth, maintenance and
repair.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 3

 Criteria for functional
Birth place of Functional foods:
Foods 1980s. Have a defined physiological
Functional foods in the effect/function.
category of Foods for Be in the form of food.
Specified Health Use (FOSHU). Consumed as part of a
normal daily diet.
Food products fortified with
special constituents that Research to support claims:
possess advantageous Effectiveness in clinical
physiological effects. studies.
Safety in clinical and non-
Processed foods containing
clinical studies.
ingredients to aid specific
Determination of
bodily functions in addition to
active/effective components.
providing nutrition.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738
Martirosyan DM and Singh J. A new definition of functional food by FFC: what makes a new definition unique? Functional Foods in Health and Disease. 2015; 5(6):209-223. 4
S Lopez-Varela et al. Functional Foods and the Immune System: A Review.
 Functional Food Science in
No formal legal definition for Europe (FUFOSE) consensus
functional food. proposed working
Generally, functional foods definition (late 1990s):
are foods (not pills or A food that beneficially
supplements) consumed as affects one or more target
part of the normal diet, and functions in the body beyond
contain biologically active adequate nutritional effects
in a way that is relevant to
components which offer the either an improved state of
potential of enhanced health health and well-being and/or
or reduced risk of disease.(*) reduction of disease.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 5

(*)European Food Information Counsel (EUFIC). Functional Foods. http://www.eufic.org/article/en/expid/basics-functional-foods/ Accessed 7/20/2016
 Help to improve health, treat,
Foods similar in appearance to, manage and/or reduce the risk
or may be, a conventional food, of chronic disease.
that is consumed as part of the Cancer, atherosclerosis, diabetes,
usual diet, and is demonstrated osteoporosis, etc.
to have physiological benefits Foods developed by means of:
and/or reduce the risk of Micronutrient fortification.
chronic disease beyond basic Bioactive ingredients addition.
nutritional functions. Bioactive components
enhancement
Genetic engineering.
Plant breeding.
Processing.
Special animal feeding.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 6

Agriculture and Agri-Food Canada. Functional Foods and Natural Health Products.
http://www.agr.gc.ca/eng/industry-markets-and-trade/statistics-and-market-information/by-product-sector/functional-foods-and-natural-health-products/?id=1170856376710
 Health presence/level of
substance and disease risk
No legal definition for reduction; no claims to diagnose,
functional food. cure, mitigate, or treat disease.
Reviewed and evaluated by FDA
Evidence-based review system before use.
for the scientific evaluation of Low fat diets rich in fiber-
health claims. containing grain products, fruits,
and vegetables may reduce the risk
Claims allowed: of some types of cancer, a disease
Nutrient content level of a associated with many factors.
substance in the food but no Structure/function
reference to health. presence/level of substance; no
This product contains 5 g of reference to a disease. Not
soluble fiber per serving. reviewed or authorized by FDA
prior to market.
Fiber maintains bowel regularity.

IFT.Functional Foods Policy and Regulatory Developments. Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 7
http://www.ift.org/knowledge-center/focus-areas/food-health-and-nutrition/functional-foods/functional-foods-policy-and-regulatory-developments.aspx
 Depending on the Difficulties with the lack of
presentation of the formal definition:
functional food, it can be Other terms used
regulated as a conventional interchangeably to mean
food, a dietary supplement, functional foods.
a food for special dietary Nutraceuticals, designer
use, a medical food, or a foods, dietary supplements,
drug. fortified foods, medical foods,
foods for special dietary use.
Distinctions are often made
by the food manufacturer.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 8

Martirosyan DM and Singh J. A new definition of functional food by FFC: what makes a new definition unique? Functional Foods in Health and Disease. 2015; 5(6):209-223.
CFR - Code of Federal Regulations Title 21 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.76
 All food is essentially
functional at some level as it
provides energy and nutrients
Whole foods along with needed to sustain life.
fortified, enriched, or However, there is growing
enhanced foods that have a evidence that some food
potentially beneficial effect components, not considered
on health when consumed nutrients in the traditional
as part of a varied diet on a sense, may provide positive
regular basis at effective health benefits. Foods
levels based on significant containing these food
standards of evidence. components are
called functional foods.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 9
Academy of Nutrition and Dietetics. (2013) Position Paper. Journal of the Academy of Nutrition and Dietetics.


Substances [that]
Any modified food or provide essential
food ingredient that may nutrients often beyond
provide a health benefit quantities necessary for
beyond the traditional normal maintenance,
nutrients it contains. growth, and
development, and/or
other biologically active
components that impart
health benefits or
desirable physiological
effects.

Martirosyan DM and Singh J. A new definition of functional food by FFC. 2015. http://functionalfoodscenter.net/files/105582267.pdf

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 10



Natural or processed foods

that contain known or
unknown biologically-active
compounds; which, in
defined, effective non-toxic
amounts, provide a clinically
proven and documented
health benefit for the
prevention, management, or
treatment of chronic
disease.

Martirosyan DM and Singh J. A new definition of functional food by FFC. 2015. http://functionalfoodscenter.net/files/105582267.pdf
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 11
 Compounds naturally present
in plant, animal or microbial
food sources and responsible
for the desired
health/wellness benefits
associated with consumption
of specific foods.
Demonstrated to have a
physiological benefit and/or
provide protection against
chronic disease.
Present usually in small
amounts and act synergistically
to benefit health.
May be isolated or purified from
their natural sources.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 12
http://californiaagriculture.ucanr.edu/landingpage.cfm?article=ca.v065n03p141&fulltext=yes
 Foods containing Consumed as part of a
bioactive components regular and varied diet
with research- and provide health
demonstrated benefits beyond basic
physiological benefits to
help to improve health, nutritional functions.
and treat, manage
and/or reduce the risk of
chronic disease.
Cancer, atherosclerosis,
diabetes, osteoporosis,
etc.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 13

 From a practical point of A food with
view, a functional food added/replaced/removed/
can be: modified components
A natural, unmodified Processing (physical,
food chemical, enzymatic),
biotechnology.
A food with enhanced
A combination of any of
components special
growing conditions, these.
breeding or
biotechnology.
A food with modified
compound bioavailability.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 14

Howlett, J. Functional Foods: From science to health and claims. 2008. ILSI Europe.
 Nutraceutical = Nutrition + Any substance that may be
Pharmaceutical considered a food or part of a
food and provides medical or
Any food or parts of a food
health benefits, including the
that provide medical or health prevention or treatment of
benefits, including the disease. Such products may
prevention and treatment of range from isolated nutrients,
diseases. De Felice (1989) dietary supplements and diets,
to genetically engineered
designer foods, herbal products
and processed foods such as
cereals, soups and beverages.
De Felice (1994)

Stephen De Felice, M.D.,1989, Foundation for Innovation in Medicine, USA

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 15
 A nutraceutical is a
product isolated or
purified from foods that
is generally sold in
medicinal forms not
usually associated with
food. A nutraceutical is
demonstrated to have a
physiological benefit or
provide protection
against chronic disease.
(Bureau of Nutritional Sciences, Food Directorate of Health
Canada)

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 16

http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/nutra-funct_foods-nutra-fonct_aliment-eng.php
 Both may supplement the not intended
diet by increasing the daily to replace conventional food
intake of a specific nutrient. or become the sole item of a
Pill, capsule, tablet, powder meal.
or liquid form.
Cannot claim to cure, treat or
Vitamins, minerals, prevent disease.
botanicals, amino acids,
protein concentrates, - may replace a
extracts, enzymes. conventional food or be the
sole item of a meal when in
Not evaluated or reviewed food form.
by the FDA for safety and
effectiveness before being Prevention/treatment of
sold. disease/disorder additional
health benefits.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 17
US Dietary Supplement Health and Education Act (DSHEA), 1994
 The term "nutraceutical" USFDA regulates
is not recognized by the Any food or food-related
FDA, but it is often used item (food or drink and/or its
to describe products such components) as foods.
as dietary supplements, Nutraceuticals as dietary
functional foods, and supplements.
medical foods.
Functional ingredients as
food additives.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 18

Nutraceuticals: Emphasis on Medical Foods. http://www.idscbiotechnetwork.com/white-papers/medical-foods-2013/
 Ingredients added to Benefits associated with
foods to enhance their their consumption:
functional properties. Health-promoting
Juice with calcium.
Disease-preventing
Plant sterol and stanol
esters (cholesterol-lowering
ingredients) added to
spreads.
Energy-boosting
Drinks with added B
vitamins or caffeine.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 19

 Foods that provide a Any item intended for
health benefit beyond use in the diagnosis, cure,
nutrition. mitigation, treatment or
Health claims may be prevention of disease.
made for certain foods/ Extensively tested for
food ingredients. safety and effectiveness in
Implied or explicit humans.
statement about the Benefits/risks evaluated by
relationship between a government scientists
food substance and a prior to approval.
disease or health-related Follow-up after approval
condition. and marketing.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 20

USFDA. How FDA Evaluates Regulated Products: Drugs. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm269834.htm
 Foods designed or
Made by increasing, adding or
manufactured to fit a specific removing components to
purpose that are similar in improve the foods functional
appearance to normal foods properties to promote health
and may be consumed and/or reduce the risk of
regularly as part of the usual disease
diet.
Lactose-free milk

Fortification, enrichment.
modified to provide a health
benefit. High-lactoferrin milk.
Fortified, enriched, enhanced, Canola oil.
altered.

High DHA omega-3 eggs.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 21

Rajasekaran, A. and Kalaivani, M. Designer foods and their benefits: A review. J.Food Sci.Technol. DOI 10.1007/s13197-012-0726-8 ftp://ftp.cordis.europa.eu/pub/fp7/kbbe/docs/funtional-foods_en.pdf
 Vitamin B3 (niacin)-enriched
flour to help prevent
pellagra.
Vitamin B1 (thiamin)-enriched
flour to help prevent
beriberi.
Vitamin D-fortified milk to
help prevent rickets.
Iodized salt to help prevent
goiter.
Vitamin C to help prevent
scurvy.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 22

 Designed specifically for
nutrition-related disorders.
Specific dietary management
of a disease or condition with
established distinctive
nutritional requirements.
Metabolic disorders

Formulated to be consumed
or given under a medical
professionals supervision to
ensure that the nutritional
requirements of the patient
are met.
http://www.idscbiotechnetwork.com/white-papers/medical-foods-2013/
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 23
 Foods formulated for special
dietary needs, but where the
nutrients required are the
same as those of regular The food may supply a
people. vitamin, mineral, or other
The foods may have different ingredient for use by humans
ingredients from the regular to supplement the diet by
food but no special nutrient increasing the total dietary
requirements. intake.
The food may be used as the
sole item of the diet (FDA,
2009).
Hypoallergenic foods such as
gluten-free foods and lactose-
free foods, and foods offered
for weight reduction.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 24

Malla S., Hobbs J., Sogah EK. Assessing the Functional Foods and Natural Health Products Industry: A Comparative Overview and Literature Review.
April 2013. CAIRN Network. Canada.
 Milk-based, iron-
fortified formula for full-
term infants 0-12
months. It has complete
nutrition for any infant
for whom routine
formula is appropriate.
Contains MFGM and
Lactoferrin, largely
found in breast milk. Iron-fortified, lactose-free, galactose-free,
hypoallergenic infant formula designed for
newborns and infants who are allergic to
the intact proteins in cows milk and soy
formulas, as well as other foods. It contains
Enriched nutrition* for extensively hydrolyzed protein to avoid an
premature low birth immune system response by reducing the
weight infants. It is allergen exposure, and the probiotic LGG
typically used during the to help support the strength of the
first year of life for infants intestinal barrier and support digestive
from approximately 1800 health. Appropriate for infants with
grams in weight. galactosemia.
* Increased caloric density, When used as a milk substitute, the total
protein, and some vitamins calcium content of the diet should be
and minerals compared to assessed. As a sole source of diet is most
standard term formula to help
appropriately monitored by physicians and
support weight and growth in
babies born prematurely. nutritionists on a case-by-case basis, with
attention to developmental as well as
nutritional implications of such a dietary
regimen.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 25
https://www.meadjohnson.com/pediatrics/us-en/product-information/products
Nutraceuticals: Emphasis on Medical Foods Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 26
http://www.idscbiotechnetwork.com/white-papers/medical-foods-2013/
 Fiber-containing grain products,
fruits, vegetables and a reduced
risk of cancer
Fruits, vegetables and grains
products containing fiber, in
particular soluble fiber (pectins, Plant sterol/stanol esters and
gums and mucilages) and reduced risk of CHD
reduced risk of CHD
Calcium and vitamin D and
Fruits and vegetables and reduced risk of osteoporosis
reduced risk of certain cancers
Dietary saturated fat and
-glucan from oats and reduced cholesterol and increased risk
risk of CHD of CHD

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 27

 Products with health claims
must contain certain nutrients
within a specified range
At least 10% of DV for Vitamin A,
C, calcium, protein, fiber, or iron.
A product does not become
healthy just by adding
vitamins or other nutrients to
be able to make that health
claim.
Not to allow a health claim for
one nutrient when the
product is out of range for
other nutrients of concern.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 28
(USFDA, Nutrition Labelling and Education Act (NLEA),1990).
Sugar, Wheat Flour, Vegetable Oils (Canola, Palm, Palm Kernel Oil, Soybean Oil
And Partially Hydrogenated Cottonseed And Coconut Oil), Cocoa, Dextrose,
Polydextrose, Yellow Corn Flour, Corn Syrup, Baking Soda, Soy Lecithin, Salt,
Natural & Artificial Flavor, Monoglycerides, Vanilla Extract.
Vitamins & Minerals: Calcium Carbonate, Vitamin C (Asorbic Acid), Iron
Orthophosphate, Zinc Oxide, Copper Oxide, Manganese Gluconate, Iodine,
Chromium Chloride, Vitamin E (Tocopherol Acetate), Vitamin A (Palmitate),
Biotin, Vitamin B3 (Niacin), Vitamin B5 (Pantothenic Acid), Vitamin D3, Vitamin
K (Phytonadione), Vitamin B1 (Thiamine Mononitrate), Vitamin B6, Vitamin B2,
Vitamin B12, Folic Acid.
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 29

: plant, animal or
microbial. anticancer, antioxidant,

anti-inflammatory, anti-
garlic atherogenic, anti-
and onions as source of hyperlipidemic.
allyl sulfur compounds;
broccoli and cabbage as lipids, proteins,
a source of indoles; carbohydrates,
tomatoes as a source of phenolic compounds,
lycopene. isoprenoids.

Wildman, R. Nutraceuticals and Functional Foods, in Handbook of Nutraceuticals and Functional Foods
Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 30
 Awareness of link Possibility of reversing
between food and health or halting progress of
diet and chronic chronic diseases due to
disease. the potential health
Perception of greater
benefits of specific
benefit because health- foods and/or its
promoting biochemical components.
compounds present in a Improve quality of life
food. of the aging population.
Improve cognitive Minimize cost of health
functions. care.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 31

 Early development and Prevention/Treatment of
growth: mothers diet, diseases/disorders:
children and Obesity
adolescents. CVD
Health maintenance: Diabetes mellitus
immune function, Musculoskeletal disease
gastrointestinal health, Osteoporosis
mental health/function, Alzheimers disease
health and well-being,
physical performance.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 32

 Functional Component Health Benefits linked to the
prevention of these conditions

Soluble oat fiber Coronary heart disease

Soy protein Coronary heart disease
Phytosterol/stanol esters Coronary heart disease
Calcium Osteoporosis
Folate-enriched foods Neural tube defects

Food and Food Components Drugs

Energy/nutrition/necessary for life Treatment of disease
Life long use and benefits Immediate effect
All populations Target population
Safe (*) Benefit > risk
Consumer selects Health provider prescribes

(*) Safety evaluation needs to be conducted to identify the limits.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 33
IFT Expert Report: Functional Foods and Challenges
 Role of Functional Foods in Health Care Continuum
Foods > Fortified/Enhanced Foods > Supplements > Medical Foods > Drugs

Purpose of Reduction Treatment

Therapy of Risk of Disease

Health
Professional Low High
Involvement

Individual High Low

Participation

Treatment Low High

Cost

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 34

IFT Expert Report: Functional Foods and Challenges
 Properties and benefits of A food does not need to be
nutrients in foods. engineered to be functional.
Food systems are complex and Most conventional foods when
their beneficial compounds often prepared appropriately have
work together synergistic benefits beyond basic nutrition.
effect.
Balance and moderation
Risk of developing chronic more better
diseases and genetic factors natural safe
Contribution of diet to the quality
of an individuals life.

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 35

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 36
 IFT Expert Report. Functional Foods: Opportunities and Challenges. 2004.
http://www.ift.org/~/media/Knowledge%20Center/Science%20Reports/Expert%20Reports/Functional%20Foods/Functionalfo
ods_expertreport_full.pdf
Dietary Supplements. http://www.consumer.ftc.gov/articles/0261-dietary-supplements . November 2011. Accessed on 08-12-
2015.
Aluko, R. Functional Foods and Nutraceuticals, Food Science Text Series, Springer, 2012.
Cencic A and Chingwaru W. (2010). The Role of Functional Foods, Nutraceuticals, and Food Supplements in Intestinal
Health. Nutrients. 2010 Jun; 2(6): 611625. Published online 2010 Jun 1. doi: 10.3390/nu2060611
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3257668/pdf/nutrients-02-00611.pdf
Crowe KM, Francis C. Position of the Academy of Nutrition and Dietetics: Functional Foods. Journal of the Academy of
Nutrition and Dietetics. August 2013, Volume 113, Issue 8, Pages 10961103. DOI: http://dx.doi.org/10.1016/j.jand.2013.06.002
Howlett, J. Functional Foods: From science to health and claims. 2008. ILSI Europe.
Insel P, Ross D, McMahon K, Bernstein M. Nutrition. Fourth Ed. Jones and Bartlett Learning, 2013.
Martirosyan DM and Singh J. A new definition of functional food by FFC: what makes a new definition unique? Functional
Foods in Health and Disease. 2015; 5(6):209-223.
Rajasekaran, A. and Kalaivani, M. Designer foods and their benefits: A review. J.Food Sci.Technol. 2013. Feb;50(1):1-16. doi:
10.1007/s13197-012-0726-8
Wildman, R. Nutraceuticals and Functional Foods, in Handbook of Nutraceuticals and Functional Foods, 2007. CRC Press,
Boca Raton, FL.
American Cancer Society. Understanding the claims on dietary supplement labels.
http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/dietarysupplements/
dietary-supplements-reading-labels Last Revised: 03/31/2015. Accessed on 08-18-2015.
Agriculture and Agri-Food Canada. Functional Foods and Natural Health Products. Last modified 12-18-2015. Accessed on 7-
19-2016 http://www.agr.gc.ca/eng/industry-markets-and-trade/statistics-and-market-information/by-product-
sector/functional-foods-and-natural-health-products/?id=1170856376710
European Food Information Counsel (EUFIC). Functional Foods.Last updated 07/14/2016.
http://www.eufic.org/article/en/expid/basics-functional-foods/ Accessed 7/20/2016

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 37

 Crowe, K.M. and Francis, C. Position of the Academy of Nutrition and
Dietetics: Functional Foods. August 2013, Volume 113, Issue 8, Pages 1096
1103. DOI: http://dx.doi.org/10.1016/j.jand.2013.06.002
Lopez-Varela, S., Gonzalez-Gross, M., and Marcos, A. Functional Foods and
the Immune System: A Review. European Journal of Clinical Nutrition.
(2002) 56, Suppl. 3, S29-S33.
http://www.nature.com/ejcn/journal/v56/n3s/pdf/1601481a.pdf?origin=publi
cation_detail

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 38

Reference books

Dr. I.Echeverry, CHS, CAMS, KSU 2nd3738 39