New report: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

IOM report releases May 12

Claims about the health benefits of foods and nutritional supplements have proliferated in recent years, most of them based on studies measuring ingredients' effects on biomarkers as substitutes for actual clinical outcomes.

The use of biomarkers is common in drug, device, and nutritional studies, but the U.S. Food and Drug Administration has been hampered in its ability to evaluate food health claims in part because it lacks a process accepted across the regulatory, food, and medical communities to assess the validity and appropriateness of these biological benchmarks.