Although the 1988 amendments to the Orphan Drug Act provided the statutory definition for medical foods presented above, no further regulatory information was provided. Thus, when the NLEA was passed in 1990, the statutory definition of a medical food was included and medical foods were exempted from the nutrition labeling, health claim, and nutrient content claim requirements given for most other foods. The final rule on a definition was promulgated by FDA in 1993. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food. The NLEA relates to health claims, nutrient content claims, and nutrition labeling.
Health claims require prior regulatory approval.
Thus, manufacturers obviously prefer marketing an item as a medical food. 1. be a food for oral or tube feeding. 2. be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements. 3. be intended to be used under medical supervision. Medical foods are foods that are specially formulated and processed, as opposed to naturally occurring foodstuffs used in their natural state.