WASHINGTON, D.C. (May 13, 2010) -- A review released by the Institute of Medicine (IOM) an independent, nonprofit organization that works outside of the U.S. government, recommends that the Food and Drug Administration (FDA) "use the same degree of scientific rigor" for evaluating health benefit claims on foods and dietary supplements that it uses when evaluating drugs and medical devices. If implemented, foods and dietary supplements would be subjected to the analytical validation, qualification and utilization analysis as pharmaceuticals and medical devices.
The IOM committee's report, "Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease," examined biomarkers, described as characteristics that indicate biological processes. Biomarkers are often used by scientists and health professionals to obtain information about a person's health status or response to interventions. The report comes at a time where several major food manufacturers have come under scrutiny after putting unsubstantiated or incorrect health claims on their products, for example cereals that claimed to lower cholesterol or boost the immune system.
The Natural Products Association (NPA) analyzed the report and issued the following comment:
The IOM committee seems to have veered off course of their target. While the work on the biomarkers is of value, it seems unwise for the committee to present such broad statements regarding regulatory authority of the FDA on food claims, which is neither their expertise nor within the committee's scope to review the regulatory authority of the agency beyond the viability of using biomarkers. Despite the IOM committee's views on the Dietary Supplement and Health Education Act, or DSHEA, the act has not "hobbled" the FDA, but instead has actually provided the FDA with new enforcement authority over dietary supplements not previously available to the agency.
