Food Fortification in Public Health Policy

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 • 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

8. 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 • 1906-1940, 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 • Source WHO

16. Benefits of PreventingIron 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. Children, 12-17 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., 1-4 year olds, 1988-94 *Based on serum ferritin model NHANES III (Ogden et al., 1998)

21. 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

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 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.

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 NTDsand may be associated with reduced risk for vascular diseaseand cancer. • Observational and controlledintervention studies support public health policies related to folic acid and NTDs. • Educational to promote daily intakeof FA supplements by women of reproductive age did not increase supplement use. • Food fortification appears to be associated with areduction in neural tube defects in the United States and Canada • Potential for FAsupplements to reduce the incidence, severity of vasculardisease and cancer is focus of major research includingintervention studies. Bailey LB et al. J. Nutr. 133:1961S-1968S, 2003.

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 PediatricsCommittee 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 NTDsdepends on an urgent and effective campaign to close this prevention gap. • Pediatrics;104, • August 1999; 325-7

31. 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 womenand 425 men (mean age, 76 years) from the Framingham Study study sample. • Examined the relation of the plasma totalhomocysteine level measured at base line and eightyears earlier. • Over period of eight years, dementiadeveloped in 111 subjects, including 83 withAlzheimer's disease. • Multivariable-adjusted RRof dementia was 1.4 (CI 1.1 to1.9) for each increase of 1 SD in the homocysteinevalue 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 eightyears before base line. With a plasma homocysteine level greaterthan 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 andAlzheimer's disease. Seshadri S, Beiser A, Selhub J, et al. NEJM. 346;7:476-483, 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. 2002 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 (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;

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 1999-2001. Chile, showed decrease of 31% during the 2000-2001. Significance (P < 0.001) reached in the 20th month after fortification started. Am J Med Genet. 2003 Dec 1;123A:123-128

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. 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 DMFT in Europe

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