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Keywords:

  • dietary supplements;
  • generally recognized as safe (GRAS);
  • medical foods;
  • nutritional management

Medical foods are a specific category of therapeutic agents created under the Orphan Drug Act of 1988, which separated medical foods from drugs for regulatory purposes. Products in this category share the requirements that they are intended for the nutritional management of a specific disease, are used under the guidance of a physician, and contain ingredients that are generally recognized as safe (GRAS). An example of medical foods are formulations intended to manage patients with inborn errors in amino acid metabolism. Newer medical foods are designed to manage hyperhomo-cysteinemia, pancreatic exocrine insufficiency, inflammatory conditions, cancer cachexia, and other diseases