Food In The Market Place
Evolution of Health Care
 2000 BC-Here, eat this root
 1000 AD- That root is heathen. Here, say this
prayer
 1850 AD-That prayer is superstition. Here drink
this potion.
 1940 AD – That potion is snake oil. Here
swallow this pill
 1985 AD-That pill is ineffective. Here, take this
antibiotic.
 2000 Ad – That antibiotic doesn’t work anymore,
Here, eat this root.
Functional Foods-Definition
‘Foods which provide a
health benefit beyond basic
nutrition’.
International Food Information Council
Functional Foods-Definition
‘Those foods in which concentrations
of one or more ingredients have been
manipulated on modified to
enhance their contribution to a
healthful diet’.
 Institute of Medicine of the National Academy of
Sciences
Functional Foods
Unmodified whole foods like fruits and
vegetables
Modified foods including fortified foods
including those that have been fortified
with nutrients or enhanced with
phytochemicals or botanicals.
Functional Foods
The functional food industry in the U.S.
was valued at $20.2 billion in 2002 or
4% of the total food industry.
The market is expected to increase at
an AAGR (average annual growth rate)
of 13.3%, bringing the market value to
$37.7 billion by 2007.
Functional Foods
Factors affecting growth of functional
foods:
an aging population
self-efficacy or autonomy in health care
increased healthcare costs
advancing evidence (research) that diet
can regulate disease progression
changes in food regulation
Scientific Research
Strong Evidence
Substantial scientific agreement relationship of
a diet-disease relationship
Supported by Clinical Trials
Examples:
Fortified Margarines – Sterols and Stanols
Psyllum – soluble fiber
Soy
Whole oat products
Fatty Fish, n-3 fatty acids
Scientific Research
Moderate Evidence
Scientific evidence supporting dietdisease relationship is not conclusive
Examples:
Catechins in green tea – reduce risks of
certain types of cancers
Lycopene in tomato products – reduce
prostate cancer
Probiotics in dairy products – support GI
health
Scientific Research
Low Evidence
Some scientific evidence suggest a
relations ship but is limited or not
conclusive
Examples
Garlic – reduction of total and LDL
cholesterol
Lutein in spinach, kale, collard greens –
reduction of macular degeneration
Thy food shall be thy
remedy
Hippocrates, 2000 years ago
ific.org : Questions and Answers About
Functional Foods
Functional
Component
Source
Potential health
benefit
Lutein
Green vegies
Healthy vision
Omega 3 fatty
acids
Salmon, fatty fish
May reduce risk of
cardiovascular disease
and improve mental,
visual functions
Anthocyanidins
Berries, red grapes Bolster antioxidant
defenses
Qualified Health Claims
Qualifying language is included as part of
the claim to indicate that evidence
supporting the claim is limited.
http://www.cfsan.fda.gov/~dms/qhcsum.html
Dietary Supplements
The Dietary Supplement Health Education
Act (DSHEA - 1994) exempts dietary
supplements from the strict approval
required for food additives.
Permits dietary structure/function claims
with out FDA approval.
Structure Function Claim
Statements which claim a benefit related
to a nutrient deficiency disease (like
vitamin C and scurvy) as long as the claim
tells you how widespread the disease is in
the US.
Manufacturers of dietary supplements
which make structure/function claims on
the label must notify FDA no later than 30
days after marketing the supplement.
Structure Function Claim
May also describe the role of a nutrient or
dietary ingredient affecting a structure or
function in humans, such as “calcium
builds bones” or “fiber maintains bowel
regularity”.
Dietary Supplements
Label must contain disclaimer
 “This statement has not been evaluated
by FDA. This product is not intended to
diagnose, treat, cure or prevent any
disease”.
Advertising
Advertising is regulated by FTC
More lenient standards for advertising
claims about diet-disease relationship than
FDA for food labeling
Health Claims
Fish and meats must meet criteria for ‘extra
lean’
Extra lean: less than 5 g fat, 2 g saturated
fat and 95 mg cholesterol per 100 grams.
Authorized Health Claims - NLEA
(1990)
Well established relationship between
the a food, food component, dietary
ingredient or dietary supplement and
risk of a disease.
Authorized Health Claims - NLEA (1990)
Calcium – Osteoporosis
Sodium – Hypertension
Dietary fat – cancer
Saturated fat & cholesterol –
Coronary Heart Disease (CHD)
Fiber containing grain products,
fruits & vegetables – cancers
Authorized Health Claims - NLEA (1990)
Fruits, vegetables and grains products
which contain fiber, particular soluble
fiber - CHD
Fruits and vegetables – cancer
Folate – neural tube birth defects
Sugar alcohols – dental caries
Foods that contain fiber from whole
grains - CHD
Authorized Health Claims - NLEA (1990)
Foods that contain fiber from Psyllium
– CHD
Soy Protein – CHD
Plant Sterol/Stanol esters - CHD
Labeling Requirements
Claim
Nutrient amount allowed
Low Fat
≤ 3 gms
Low Saturated
Fat
Reduced Calorie
≤1 gm
Cholesterol Free
<2 mg
Lean meat
<10g fat, 4.5g SF 95 mg Chol
Extra Lean Meat
<5g fat, 2 gSF 95mg Chol
≤25% of Cal of original
The Food and Drug Administration
Modernization Act of 1997 (FDAMA)
Allows manufactures to use claims if
those claims are based on current,
published, and scientific statements
make by authoritative government
agencies such as NIH, CDC or NAS.
Manufacturers must notify FDA 120
days prior to using the claim.
The Food and Drug Administration
Modernization Act of 1997 (FDAMA)
Potassium – blood pressure and stroke
Whole grains – heart disease and
cancer
Qualified Health Claims - 2002
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 for a disease or health
related condition.
Manufactures can petition for a claim,
which the FDA publicly files within 45
days.
Qualified Health Claims
Petitioners need to demonstrate that
the “weight of scientific evidence”
supports the claim.
Qualifying language is included as part
of the claim to indicate that evidence
supporting the claim is limited.
Folic acid, B6, B12 – Vascular
disease
“As part of a well-balanced diet that is
low in saturated fat and cholesterol,
folic acid, Vitamin B6 and B12 may
reduce the risk of vascular disease”
“FDA evaluated this claim and found
that diets low in saturated fat and
cholesterol reduce the risk of heart
disease, the evidence to support this
claim in inconclusive.
Walnuts and Heart Disease
“Supportive but not conclusive
research shows that eating 1.5 ounces
per day of walnuts as part of a diet low
in saturated fat and cholesterol may
reduce the risk of heart disease”