1. Folic Acid Food Fortification Elizabeth A. Yetley, Ph.D. Center for Food Safety & Applied Nutrition Food and Drug Administration

2. U.S. Folic Acid Fortification  folate-responsive NTDs by  folate intakes of women of child-bearing age Mandated folic acid addition to “enriched” cereal grain products Allowed fortification of breakfast cereals up to 100% DV (400 µg/serving) No limits on dietary supplements Effective 1996

3. Fortification Characteristics Ubiquitous in food supply Passive for consumer Exposures: lifetime & cumulative Balance: Safe intake for all consumers Improve intakes of target consumers Uncertainty surrounded every decision

4. Ubiquitous in Food Supply Orange juice McDonald’s hamburger Pastas Breakfast cereals & bars Cookies, cakes

5. Daily Folate Intakes Folate (mcg/day) Food, Supplements, Fortified Food Age in Years 1-3 MF4-10 MF11-18 M 19-50 M 51+ M11-18 F 19-50 F51+ F

6. Total Folate Intake Percent Total Folate (mcg DFEs) Females 19+ Yrs

7. Nutrient: Function/Risk

8. 400 – 800 mcg??? 1000 - ????? Mcg???

9. Post-fortification Monitoring? Assume: underestimate intakes; therefore underestimate effectiveness and safety Biomarkers of folate status Changing incidence of NTDs

10. Dietary Intakes Unreliable predictors of clinical status Underestimate calorie intakes Underestimate food content Analytical methods Labeling practices Overestimate requirements Consumer responsiveness varies

11. Intakes as predictors of status?

12. Changes in Folate Status

13. Bottom Line Advantages of national fortification: Passive exposure Disadvantages of national fortification: Passive exposure Balancing act – competing issues of safety and effectiveness

14. Summary Uncertainties Effective intakes Safety Ubiquitous in food supply Significant increases in folate status