A food product expressly prepared or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the complete or partial feeding of patients with limited, disturbed or impaired ability to take in, digest, absorb, metabolize or eliminate common foods or certain nutrients contained therein or metabolites, or with other nutritional needs determined by clinical conditions and whose dietary management cannot be accomplished solely by modification of the normal diet.