IOM Proposes Framework for Evaluating Health Claims

Panel says FDA should evaluate food, supplements with same rigor it uses for drugs, devices
By Beth Gilbert
HealthDay Reporter

WEDNESDAY, May 12 (HealthDay News) -- The U.S. Food and Drug Administration should evaluate claims of foods' and nutritional supplements' health benefits with the same rigor it uses in evaluating approvals of medicines and medical technology, according to a new report from the Institute of Medicine (IOM).

An IOM committee has proposed a novel framework the FDA could use to consistently and transparently evaluate the validity of the scientific benchmarks companies use to back up the health and safety claims they make for their products. The three-part framework involves validating whether a biomarker can be accurately measured, ensuring that the biomarker is linked with a clinical outcome measure of concern, and confirming whether it is appropriate for intended use.

In addition, the report suggests that Congress provide the FDA with increased authority to require additional studies of drugs and devices after approval if their approval was based on studies using biomarkers as surrogate clinical outcomes. It also says the agency should have the authority to conduct studies on consumers' understanding of food and supplement health claims, and require that manufacturers make changes if their claims are not clear enough.

"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case," John R. Ball, M.D., committee chair, and executive vice president of the American Society for Clinical Pathology in Chicago, said in a statement.

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