The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered eternally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." The agency advises that it considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food.
Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision and intended for the specific dietary management of a disease or condition. The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: the product must be a food for oral or tube feeding; the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and the product must be intended to be used under medical supervision. Medical foods are exempt from the labeling requirements for nutrient content claims and health claims. Many other food labeling and regulations do apply to medical foods, including Current Good Manufacturing Practices, Food Allergen Labeling and Consumer Protection Act of 2004.
The attorneys of Rick Ruz, PLLC provide its clients with advice on all aspects of the regulations pertaining to medical food products. To obtain additional information regarding how our firm can help your business navigate through the complex regulatory maze pertaining to medical food products, please contact our firm to arrange a consultation.