Related Experiment Video
Updated: Aug 5, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
Published on: May 10, 2016
The challenge of regulating health claims and food fortification
1Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, USA.
Abstract:
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 folic acid daily 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.
Related Concept Videos
Drug Regulation
Taste Buds and Receptors
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Sources of Food Contamination
Investigation of Disease Outbreaks

