FDA recently announced the availability of guidance for industry titled, "Frequently Asked Questions About Medical Foods; Second Edition." A medical food is a food formulated to be consumed or administered under the supervision of a physician and that is intended "for the specific dietary management of a disease or condition" for which distinctive nutritional requirements are established by medical evaluation. FDA published earlier versions of the guidance in May 1997 and May 2007. The second edition of the guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some prior responses. For instance, FDA clarifies that medical foods that bear a false or misleading claim would be considered misbranded under section 403(a)(1) of the Food, Drug, and Cosmetic Act. In addition, FDA updates its response regarding diabetes, stating that there are no distinctive nutritional requirements associated with the management of diabetes mellitus ("DM") but nutritional recommendations established for persons to manage it. FDA still maintains that DM can be managed by a modification of the diet alone, and hence medical foods cannot be marketed for the treatment of diabetes.
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