Defining the Regulatory Framework and Clinical Utility of Medical Foods
Medical foods are a category of nutritional products formulated for oral or enteral administration and intended for the dietary management of a disease or condition for which distinctive nutritional requirements, established by medical evaluation, are unable to be met by modifications to the normal diet alone.
These products are regulated differently than conventional foods or dietary supplements, requiring supervision by a healthcare professional and specific labeling that identifies the disease or condition for which they are intended, reflecting their specialized role in supporting patients with complex metabolic or physiological deficits.
The defining characteristic of a medical food is that it must address a specific, established **"distinctive nutritional requirement."** A common example is the use of specialized formulas for patients with inherited metabolic disorders, such as phenylketonuria ($\text{PKU}$), where the body cannot process a standard amino acid. These medical foods provide all essential nutrients while restricting or replacing the specific problematic compound. Another key area of application is in the management of chronic conditions like Alzheimer's disease or pressure ulcers, where specific combinations of fatty acids, vitamins, and other micronutrients are formulated to address documented deficiencies or support specific physiological functions impacted by the disease. It is important to note that, under regulatory definitions, medical foods are not intended to treat a disease, but rather to provide the specific nutritional support required for its management. Their composition is based on recognized scientific and medical