Most of the claims on health benefits of foods and nutritional supplements are 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. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, a new report by the Institute of Medicine, offers a way the agency can consistently and rigorously conduct such assessments.
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