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NPA Comments on IOM Biomarker Recommendation

NPA has analyzed a report released by the Institute of Medicine, which recommends FDA “use the same degree of scientific rigor” for evaluating health benefit claims on foods and dietary supplements that it uses when evaluating drugs.

The Natural Products Association (NPA), Washington, D.C., has analyzed a report released by the Institute of Medicine (IOM), which recommends 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.

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. Several major food manufacturers have come under scrutiny recently after putting unsubstantiated or incorrect health claims on their products.

According to NPA: “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 area of 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.”

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