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Food Fortification in
Public Health Policy
TH Tulchinsky MD MPH
Braun SPH
2 Nov 2004
Essential Considerations
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Public health and medical responsibility
Food industry and regulators involved
Create demand - enriched foods, behavior changes
Monitor compliance and ID rates
National council on nutrition - academic and
professional organizations and public reps
Long term program
Regulatory, monitoring and laboratory support
Public Health Nutrition Strategies
• Food based strategy
– Socio economic factors
– Food supply/costs
• Supplementation for target groups
– Women and children
– Elderly
• Fortification of basic foods
• Surveillance and monitoring
• Education
– Public
– Professional
18-19th Century Breakthroughs
• Lind and scurvy 1747
• Lemon juice in Royal Navy, 1796
• Davy isolates sodium, potassium, calcium,
magnesium, sulphur, boron, 1807
• Chatin shows iodine prevents goiter, 1850
• Takaki and beriberi, Japanese Navy, 1885
• Eijkman publishes cause of beriberi, 1897
Vital Amines
• 1900, nutrition - calories, fats, carbohydrates
proteins
• 1912, Funk defines vital amines
• Rickets, scurvy, goiter, beriberi common in
industrial countries
• Pellagra “epidemic” in southern US
• 1914, Goldberger of USPHS investigates pellagra
• 1922, McCollum and vitamin D in cod liver oil
Key Landmarks
• Morton’s iodized salt, 1924
• Louisiana - mandates vit B fortification of
flour, 1928
• US federal mandate - enrichment of flour with
vitamins B and iron, 1941
• UK and colonies same during WWII
Preventing Goiter and Iodine
Deficiency Disorders
• 1917, high % US draftees rejected - goiter
• 1922-27, goiter rates fall from 39% to 9% by
statewide prevention programs
• 1924, Morton’s Iodized Salt (N America)
• 1979, Iodization mandatory in Canada
• 1980s, WHO - universal iodization of salt
• Many countries achieved iodization
Percent
Iodine Fortification of Salt in the U.S.:
Trend in Goiter Prevalence in Michigan
Year
WHO Monograph Series N. 44
Pellagra: The 4 Ds
• Diarrhea, dermatitis, dementia, death
• Thought to be of infectious origin
• Common in prisons, mental institutions,
sharecroppers in southern US
• Curable by dietary change (Goldberger)
• 1929, niacin found as essential factor
• 1906-1940, 3 million cases and 100,000 deaths
attributed to pellagra
Figure 2
Rickets
• 1921, rickets affects 75% of children in New
York City schools
• Cod liver oil commonly used (middle class)
• 1940s, US fortifies milk with vitamin D
dramatically reduces rickets incidence
• Canada fortifies milk 1940s, then refortifies
resulting in increase in rickets in 1960s
Low Cost Solutions to Eliminate
Micronutrient Malnutrition
U
.S
.Dollars
Annual Per Capita Cost of Interventions
Iron
Suppl.
Iron Fort.
Source: World Bank, 1994
Iodine
Suppl.
Iodine
Fort.
Vit A
Suppl.
Vit A
Fort.
Relative Cost Effectiveness of Micronutrient
Interventions
Productivity Gained per US$ Expended
$
$
$
$
$
$
$
$
$
$
$
.
$
.
Fe Suppl. Fe Suppl.
(Wom.)
(Preg.
Wom.)
Source: UNICEF/UNU/WHO/MI, 1999
$
.
.
.
.
Iodine
Fort.
Vit. A
Fort.
Fe Fort.
Vit. A
Suppl.
Iron Deficiency
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•
•
•
•
Commonest MND
Affects survival, health and productivity
Affects women in age of fertility
Affects pregnancy and newborn
Affects growth and cognitive
development of infants and children
• Interaction with vitamin C deficiency
Global Burden of Iron Deficiency
WHO Region Anemic or Iron
Deficient
Africa
America
Europe
E. Mediterranean
S.E. Asia
Western Pacific
•Source WHO
206
94
27
149
616
1058
Prevalence of
Anemia in
Pregnancy
52
60
18
50
74
40
Benefits of Preventing
Iron Deficiency
 Benefits to children
Improved behavioral and cognitive
development
Improved child survival (where severe anemia
is common)
 Benefits to adolescents
Improved cognitive performance
Better iron stores for later pregnancies
(females)
Benefits to Pregnant Women and Their
Infants
Decreased low birth weight and perinatal mortality
Decreased maternal mortality and obstetrical
complications (where severe anemia is common)
Benefits to all Individuals
Improved fitness and work capacity
Improved cognition
Increased immunity
Lower morbidity from infectious disease
Trends in Prevalence of Anemia* in Low-income
U.S. Children, 12-17 Months Old
Program Enrollment
Percent
Follow-up
*Hgb <10.3 g/dL
Yip et al., JAMA, 1987
Birth Year
 Preschool children
 School age
children
and adolescents
 Non-pregnant
women
 Pregnant women
 Adult men
Prevalence of iron deficiency* by income and
race/ethnicity, U.S., 1-4 year olds, 1988-94
<=
>
white
% poverty
% poverty
*Based on serum ferritin model
NHANES III (Ogden et al., 1998)
black
MexicanAmerican
US Federal Policy
• USDA extension programs
• 1921-29, US Maternal and Infancy Act - state
health departments employ nutritionists
• 1930s, relief/commodity distribution
• 1941, enriched wheat flour with iron, vit B
• 1941, US establishes RDAs
• Food stamps, WIC, school lunch programs
• National nutrition surveys
Canada 1979
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National nutrition survey 1971
Geographic, social and ethnic deficiencies
Process of consultation
1979 federal regulations, mandatory
Vitamin A and D in all milk products
Iodine in salt
Vitamins B and iron in flour
Epidemiologic Revolution
1960s-1980s
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Risk factors for chronic disease
Health field concept
Health for All
Declining mortality from stroke and CHD, trauma
Advances in drugs and diagnostics
Control of infectious diseases
Rapid increase in costs of care: health system reform
Nutrition Interactions
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Iodine Deficiency – psychomotor retardation
Iron Def Anemia and infectious diseases
Iron promotes growth and development
Vitamin A and infectious diseases e.g. measles
Vitamin A promotes growth
Folic acid prevents birth defects
Folic acid with CVD, Alzheimer’s Disease
Nutrition and cancer
Nutrition and cardiovascular disease
Nutrition and diabetes
Nutrition in disease management
Folic Acid and NTDs
• Pre pregnancy folic acid supplements prevent
neural tube defects, 1980s
• Supplements to women in age of fertility
achieves <1/3 coverage, 1990s (US)
• FDA mandates fortification of “enriched”
flour, from 1998
• Canada and UK also mandate folic acid
fortification of flour
• New paradigm in public health
Return to top.
Figure
Global prevention of all folic acid-preventable spina
bifida and anencephaly by 2010. Oakley GP.
Community Genet. 2002 Sep;5(1):70-7.
Spina bifida and anencephaly are pandemic, affecting 225,000 children •
a year.
Need commitment to global prevention of all folic acid-preventable •
spina bifida and anencephaly (FA-P SBA) by 2010.
Folic acid fortification of centrally processed foods, such as wheat and •
corn flour, could immediately prevent all of these birth defects for
much of the world's population.
Fortification programs also help adults by increasing serum folate •
concentration, eradicating folate deficiency anemia, provide human
genome stability and reduce homocysteine serum levels.
Probably prevent heart attacks and strokes, and may prevent colon •
cancer and Alzheimer's disease.
Folic Acid Supplements and Fortification Affect
the Risk for Neural Tube Defects, Vascular
Disease and Cancer: Evolving Science.
• Folic acid supplements reduce the risk of NTDs and may be
associated with reduced risk for vascular disease and cancer.
• Observational and controlled intervention studies support
public health policies related to folic acid and NTDs.
• Educational to promote daily intake of FA supplements by
women of reproductive age did not increase supplement use.
• Food fortification appears to be associated with a reduction in
neural tube defects in the United States and Canada
• Potential for FA supplements to reduce the incidence, severity
of vascular disease and cancer is focus of major research
including intervention studies .
Bailey LB et al.
J. Nutr. 133:1961S-1968S, 2003.
Food Fortification Cuts Cases of Spina
Bifida in Canada
Fortification of food with folic acid dramatically reduces the
incidence of spina bifida and other NTDs, without masking
vitamin B-12 deficiency in elderly people..
Canadian study in Newfoundland, an area with historically high
rates of neural tube defects showed 78% reduction after
fortification. .
In 1998 fortification of white flour, pasta, and cornmeal with
folic acid was imposed in Canada to increase the intake of
folic acid of all women of childbearing age. .
NTD rates fell from 4.36/1000 births before fortification to 0.96
in 1000 births after fortification.
BMJ Oct 2004
American Academy of Pediatrics
Committee on Genetics
• The AAP endorses the US Public Health Service
recommendation that all women capable of becoming
pregnant consume 400 µg of folic acid daily to prevent neural
tube defects (NTDs).
• Studies show periconceptional folic acid supplementation
prevents 50% or more of NTDs e.g. spina bifida, anencephaly.
• Implementation of these recommendations is essential for the
primary prevention of these serious, disabling birth defects.
• Because fewer than 1 in 3 women consume amount of folic
acid recommended by the USPHS, the AAP notes prevention
of NTDs depends on an urgent and effective campaign to
close this prevention gap.
Pediatrics;104,•
August 1999; 325-7•
Plasma Homocysteine as a Risk Factor for
Dementia and Alzheimer's Disease.
• Elevated plasma homocysteine levels associated with poor cognition,
dementia. A total of 1092 subjects without dementia (667 women and 425
men (mean age, 76 years) from the Framingham Study study sample.
• Examined the relation of the plasma total homocysteine level measured at
base line and eight years earlier.
• Over period of eight years, dementia developed in 111 subjects, including
83 with Alzheimer's disease.
• Multivariable-adjusted RR of dementia was 1.4 (CI 1.1 to 1.9) for each
increase of 1 SD in the homocysteine value at base line or eight years
earlier.
• The RR of Alzheimer's disease was 1.8 (CI-1.3 to 2.5) per increase of 1 SD
at base line and 1.6 (CI 1.2- 2.1) per increase of 1 SD eight years before
base line. With a plasma homocysteine level greater than 14 µmol per liter,
the risk of Alzheimer's disease nearly doubled.
• Increased plasma homocysteine level is a strong, independent risk factor
for the development of dementia and Alzheimer's disease .
Seshadri S, Beiser A, Selhub J, et al.
Folic Acid and Heart Disease
• High homocysteine levels associated with
excess CHD, birth defects, Alzheimer’s
Disease
• Folic acid reduces high homocysteine
• Flour fortification effective in raising FA levels
in population
• Clinical trials of folic acid and CHD underway
• New paradigm in public health nutrition
Osteoporosis
• Aging of the population
• Vit D production in skin seasonal
• Sun varies by season and latitude even in
sunny countries
• Fortification of calcium popularized
• Vitamin D lacking in raw milk
• Calcium, vitamin D, fluoride co-factors
• Fortifying milk products with Vit D needed
Fortification strategies to meet
micronutrient needs
Food fortification played important role in the nutritional
health, well-being of populations in industrial countries.
From early 20th C, fortification targeted specific conditions:
goitre with iodized salt; rickets with vitamin D-fortified milk;
beriberi, pellagra and anaemia with B-vitamins and Feenriched cereals.
Recently, in the US, risk of pregnancy affected by NTDs with
folic acid-fortified cereals.
Enormous increase in fortification programs in developing
countries, in reducing vitamin A and I deficiencies, but less so
with Fe.
Food fortification can play an large role in prevention and
.control of micronutrient malnutrition.
Proc Nutr Soc. 2002 May;61(2):231-41
Problems with Fortification Policy
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Antagonism to North American initiatives
European resistance e.g. EU
Nutritionist focus on clinical approach
WHO ambivalence/opposition
“Green” attitudes
Medical attitudes and lack of interest
Resistance to “mandatory medication”
Individual choice vs. public good
Clinical vs. population approaches
Manufacturer’s and regulatory agency attitudes
Progress
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Decreased contamination and food-borne disease
Improved food handling methods - refrigeration
Improved nutritional value of foods and crops
Food fortification
Identifying essential micronutrients
Food-fortification programs eliminated rickets,
goiter, pellagra in the US, Canada
• Folic acid and other new disease relationships
• Micronutrients as functional food elements
• Genetically engineered foods
Folic acid fortification of wheat
flour: Chile.
Neural tube defects (open spina bifida, anencephaly, and encephalocele) represent
the first congenital malformations to be preventable through public health
measures such as supplementation and/or food fortification with folic acid.
In Chile, starting in January 2000, the Chilean Ministry of Health legislated to add
folic acid to wheat flour (2.2 mg/kg) to reduce the risk of NTDs.
This policy resulted in an estimated mean additional supply of 427 microg/d in
significant increases in serum folate and red cell folate of 3.8 and 2.4-fold,
respectively, in women of fertile age, one year after fortification.
The impact on the rate of NTDs is presently being studied in all births, both live
births and still births, with birth weight >500 g in the city of Santiago.
Preliminary results show a reduction of 40% in the rates on NTDs from the prefortification period (1999-2000) to post-fortification period (2001-June 2002).
Fortification of wheat flour with folic acid in Chile is effective in preventing
NTDs in Chile.
Nutr Rev. 2004 Jun;62:S44-8;
Changes in NTD prevalence rates after
folic acid fortification in South America
Several South American countries are fortifying
wheat flour with folic acid. Chile started in 2000
to add 2.2 mg/kg, providing 360 mcg daily per
capita.
Data from 361,374 births occurred in 43 South
American hospitals, in five countries, in 19992001.
Chile, showed decrease of 31% during the 20002001. Significance (P < 0.001) reached in the 20th
month after fortification started.
Am J Med Genet. 2003 Dec 1;123A:123-128
Recent Findings in Israel
Berry Committee recommends fortification 1986
Process of implementation slow
Anemia rates declining but still high
Iodine deficiency – Sack, Mates et
Folic acid low, homocysteine levels high, vit
B12 levels low (Kark)
Voluntary fortification
Mandatory fortification of flour, salt and milk products
– regulations in progress
DMFT in Europe
040701 Decayed, missing or filled
teeth at age 12 (DMFT-12 index)
7
6
5
4
Germany
Israel
Slovenia
United Kingdom
3
2
1
0
1970
1980
1990
2000
2010
Conclusion
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Nutrition a major public health issue
Fortification is one of the key PH inteventions
Affects MCH, infectious, non infectious disease
High priority – birth defects, IDA, IDD, CHD
Fortification has low sex appeal vs. clinical Rx or Px
Mandatory vs. voluntary – false dilemma
Requires concern, knowledge, conviction, advocacy,
persistence and leadership
• Population health perspective
• Public health role is to implement successful
inteterventions
Referent Agencies
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World Health Organization
UNICEF
Centers for Disease Control
American Academy of Pediatrics
American College Obstetrics and Gynecology
US Food and Drug Administration
Health Canada
March of Dimes
World Bank
Micronutrient International and other NGOs