THE CHALLENGE OF REGULATING HEALTH CLAIMS AND FOOD FORTIFICATION

The Food and Drug Administration has several options that will assist the Public Health Service in implementing its September 1992 recommend ation that all women of childbearing age consume 0.4 mg of folic acid daily to reduce their risk of having a pregnancy affected with a neura l tube defect. The FDA can authorize the use of a health claim on labe ls and in the labeling of foods that characterizes the relationship be tween a nutrient and a health-related condition. Fortification of cere al-grain products with folic acid is a second option that has the pote ntial for reaching most women of childbearing age without requiring th em to change their food selection patterns. Consideration of these opt ions has been intertwined with rapid developments in the scientific da tabase that is the foundation of the health claim, by conflicting opin ions regarding the effectiveness for women in the target population of FDA's proposed level of cereal-grain fortification, by lack of system atic safety data regarding the impact of fortification on persons in t he general population and by changes in the regulatory environment in which the agency acts.