1. Food Fortification in Public Health Policy
TH Tulchinsky MD MPH
Braun SPH
2 Nov 2004

2. Essential Considerations
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

3. 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

4. 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

5. 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

6. 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

7. Preventing Goiter and Iodine Deficiency Disorders
1917, high % US draftees rejected - goiter
, 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

8. Iodine Fortification of Salt in the U. S
Iodine Fortification of Salt in the U.S.: Trend in Goiter Prevalence in Michigan
WHO Monograph Series N. 44

9. 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
, 3 million cases and 100,000 deaths attributed to pellagra

10. Figure 2                                                                                   

11. 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

12. Low Cost Solutions to Eliminate Micronutrient Malnutrition
Annual Per Capita Cost of Interventions
Source: World Bank, 1994

13. Relative Cost Effectiveness of Micronutrient Interventions
Source: UNICEF/UNU/WHO/MI, 1999

14. Iron Deficiency 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

15. Global Burden of Iron Deficiency
WHO Region
Anemic or Iron Deficient
Prevalence of Anemia in Pregnancy
Africa
America
Europe
E. Mediterranean
S.E. Asia
Western Pacific
206 94 27
149
616
1058 52 60 18 50 74 40
Source WHO

16. 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)

17. 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

18. Trends in Prevalence of Anemia. in Low-income U. S
Trends in Prevalence of Anemia* in Low-income U.S. Children, Months Old
*Hgb <10.3 g/dL
Yip et al., JAMA, 1987

19. Preschool children
School age children
and adolescents
Non-pregnant women
Pregnant women
Adult men

20. Prevalence of iron deficiency. by income and race/ethnicity, U. S
Prevalence of iron deficiency* by income and race/ethnicity, U.S., 1-4 year olds,
*Based on serum ferritin model
NHANES III (Ogden et al., 1998)

21. US Federal Policy USDA extension programs
, 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

22. Canada 1979 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

23. Epidemiologic Revolution 1960s-1980s
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

24. Nutrition Interactions
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

25. 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

26. Table Return to top. Figure

27. Global prevention of all folic acid-preventable spina bifida and anencephaly by Oakley GP. Community Genet 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.

28. 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,

29. 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

30. 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

31. Seshadri S, Beiser A, Selhub J, et al. NEJM. 346;7:476-483, 2003
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 ) 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. NEJM. 346;7: , 2003

33. 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

34. 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

35. 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 Fe-enriched 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 May;61(2):231-41

36. Problems with Fortification Policy
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

37. Progress 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

38. 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 pre-fortification period ( ) 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 Jun;62:S44-8;

39. 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
Chile, showed decrease of 31% during the Significance (P < 0.001) reached in the 20th month after fortification started.
Am J Med Genet Dec 1;123A:

40. 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

41. DMFT in Europe 040701 Decayed, missing or filled1 2 3 4 5 6 7
1970
1980
1990
2000
2010
Germany
Israel
Slovenia
United Kingdom
Decayed, missing or filled
teeth at age 12 (DMFT-12 index)

42. Conclusion 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

43. Referent Agencies 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