Food Fortification in Public Health Policy

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Food Fortification in Public Health Policy

• TH Tulchinsky MD MPH
• Braun SPH
• 2 Nov 2004

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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

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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

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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

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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

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Key Landmarks

• Mortons 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

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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, Mortons Iodized Salt (N America)
• 1979, Iodization mandatory in Canada
• 1980s, WHO - universal iodization of salt
• Many countries achieved iodization

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

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Figure 2                                       
                                            
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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

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Low Cost Solutions to Eliminate Micronutrient
Malnutrition
Annual Per Capita Cost of Interventions
Source World Bank, 1994
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Relative Cost Effectiveness of Micronutrient
Interventions
Source UNICEF/UNU/WHO/MI, 1999
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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

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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

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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)

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• 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

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Trends in Prevalence of Anemia in Low-income
U.S. Children, 12-17 Months Old
Hgb lt10.3 g/dL Yip et al., JAMA, 1987
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• Preschool children
• School age children
• and adolescents
• Non-pregnant women
• Pregnant women
• Adult men

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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)
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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

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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

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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

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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, Alzheimers Disease
• Nutrition and cancer
• Nutrition and cardiovascular disease
• Nutrition and diabetes
• Nutrition in disease management

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Folic Acid and NTDs

• Pre pregnancy folic acid supplements prevent
  neural tube defects, 1980s
• Supplements to women in age of fertility achieves
  lt1/3 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

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Table Return to top. Figure
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Global prevention of all folic acid-preventable
spina bifida and anencephaly by 2010. Oakley GP.
Community Genet. 2002 Sep5(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.

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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. 1331961S-1968S, 2003.
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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
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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 NTDs depends on an urgent and
  effective campaign to close this prevention gap.

• Pediatrics104,
• August 1999 325-7

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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. NEJM.
3467476-483, 2003
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Folic Acid and Heart Disease

• High homocysteine levels associated with excess
  CHD, birth defects, Alzheimers 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

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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

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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 May61(2)231-41
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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
• Manufacturers and regulatory agency attitudes

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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

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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 gt500 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 Jun62S44-8
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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 lt 0.001) reached in
  the 20th month after fortification started.

Am J Med Genet. 2003 Dec 1123A123-128
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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

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DMFT in Europe
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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

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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