QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Yetley, E. A. Articles by Rader, J. I. Search for Related Content PubMed Articles by Yetley, E. A. Articles by Rader, J. I.

The Challenge of Regulating Health Claims and Food Fortification¹

^* Office of Special Nutritionals Office of Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204

² To whom correspondence should be addressed: Office of Food Labeling, HFS-175, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204.

The Food and Drug Administration has several options that will assist the Public Health Service in implementing its September 1992 recommendation that all women of childbearing age consume 0.4 mg of folic acid dail to reduce their risk of having a pregnancy affected with a neural tube defect. The FDA can authorize the use of a health claim on labels and in the labeling of foods that characterizes the relationship between a nutrient and a health-related condition. Fortification of cereal-grain products with folic acid is a second option that has the potential for reaching most women of childbearing age without requiring them to change their food selection patterns. Consideration of these options has been intertwined with rapid developments in the scientific database that is the foundation of the health claim, by conflicting opinions regarding the effectiveness for women in the target population of FDA's proposed level of cereal-grain fortification, by lack of systematic safety data regarding the impact of fortification on persons in the general population and by changes in the regulatory environment in which the agency acts. J. Nutr. 126: 765S-772S, 1996.