Manufacturers’ claims can be confusing and misleading. Do antioxidants in pomegranate juice really ward off cancer? Is it true that some cereals reduce one’s risk for heart disease? Will a drug that increases bone density decrease risk of bone fracture? Some benefits claimed by manufacturers may be accurate, but different statements are subject to different regulations and guidelines, so people can have difficulty knowing which statements to trust. One step towards dispelling confusion and improving accuracy in food and drug labeling is to improve the use of scientific evidence in the evaluation of claims. 

In September 2008, the Food and Drug Administration (FDA) charged the Institute of Medicine (IOM) to recommend strategies that the FDA and other organizations can use to qualify biomarkers and surrogate endpoints—laboratory measurements such as cholesterol levels that are used to identify health benefits in advance of true outcomes such as a reduction in incidence of heart disease. Biomarkers and surrogate endpoints are used by food and drug manufacturers to show the benefits of their products, and by public health officials to demonstrate the utility of disease prevention strategies.

The IOM’s Committee on the Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease will provide recommendations regarding how best to evaluate the scientific evidence that regulators use to approve manufacturer claims using health biomarkers, or indicators of one’s state of health. In particular, the committee will focus on how to evaluate claims related to risk biomarkers, such as high levels of LDL cholesterol or blood pressure, that are used as “surrogate endpoints”—measurements that are presumed to reliably predict the likelihood of diagnosis of or death from a chronic disease like heart disease.

Through this study, the committee will provide standards for the evaluation of biomarkers and surrogate endpoints used by manufacturers, public health officials and other groups to justify health-related statements or actions.