What Are Medical Foods?

Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. They were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments[1] and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. Medical foods are distinct from the broader category of foods for special dietary use and from traditional foods that bear a health claim. In order to be considered a medical food the product must, at a minimum:

• be a food for oral ingestion or tube feeding (nasogastric tube)
• be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements intended to be used under medical supervision.

Medical foods can be classified into the following categories:

• Nutritionally complete formulas
• Nutritionally incomplete formulas
• Formulas for metabolic disorders
• Oral rehydration products