FDA should apply the same rigor to evaluating the science behind health claims of foods and dietary supplements as it devotes to assessing medication and medical technology approvals, a new report from the Institute of Medicine (IOM) stated. The committee that wrote the report recommended developing a new framework the agency could use to consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products. Because it can be time-consuming and difficult to test products against actual clinical outcomes, IOM says companies often conduct studies measuring effects on biomarkers, which are used as biological yardsticks or substitutes for clinical outcomes.

According to IOM, FDA has been hampered in its ability to assess the proliferation of health claims made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food and medical communities to evaluate biomarkers as valid and appropriate measurements. The committee’s proposed three-part framework gives the agency a way to consistently and rigorously assess the selection and use of biomarkers across the food, device and drug areas. The proposed framework entails validating that a biomarker can be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use. The report also calls for Congress to enhance FDA’s abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging.

According to the Natural Products Association (NPA), Washington, D.C., scientists and health professionals often use biomarkers to obtain information about a person’s health status or response to interventions. Several major food manufacturers have recently come under scrutiny after putting unsubstantiated or incorrect health claims on their products.

After analyzing the IOM report, NPA offered this 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 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.”