In “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease” an Institute of Medicine (National Academy of Sciences) panel has recommended that FDA adopt a consistent scientific process and framework for biomarker evaluation across all regulated areas, including drugs, medical devices, biologics, foods, and dietary supplements. As evinced by recent articles in the food industry press this recommendation is creating concern in the food manufacturing sector and considerable alarm in the dietary supplement industry.

A PDF of the Report Brief (May 2010) is attached. The full report can be purchased at: