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Regulation of medical foods: toward a rational policy.

Medical foods are enterally administered formulas used as complete or supplemental nutrition support in the treatment of diseases and clinical disorders of hospitalized or incapacitated adult patients. Because clinical trials have failed to demonstrate a consistent benefit of these products on morbidity and mortality rates, it has been difficult to reach consensus on their primary role. Are medical foods components of supportive care or should they be considered pharmacologic treatment? To date, the US Congress has defined medical foods, but the Food and Drug Administration has not developed regulatory statutes for them beyond those designed to ensure the sanitary manufacture of all processed foods. Before effective regulations can be developed, medical foods need to be defined further in order to distinguish them from each other and from other classes of nutritional products such as parenteral nutrients or infant formulas. Because we believe that the role of medical foods is in supportive care rather than pharmacologic therapy, we argue that these products should be subject to regulations similar to those that apply to conventional foods.