Yes. FDA generally considers IEMs to be diseases or conditions that a medical food
could be used to manage. IEMs include inherited biochemical disorders in which a
specific enzyme defect interferes with the normal metabolism of protein, fat, or
carbohydrate. As a result of diminished or absent enzyme activity in these disorders,
certain compounds accumulate in the body to toxic levels, and levels of other
compounds that the body normally makes may become deficient (Ref. 1). Without
appropriate and accessible management, these metabolic disturbances can lead to a
host of medical and developmental consequences ranging from intellectual disability
to severe cognitive impairment and even death (Ref. 1). Management may include
one or a combination of the following: drug therapy, modification of the normal diet,
or use of a medical food.6
Some of these disorders can be managed with modification of the normal diet alone
(e.g., reduction of galactose and lactose for galactosemia). However, others cannot
be managed solely with diet modification. For these IEMs, a medical food is required
in addition to a specific dietary modification in order to obtain adequate levels of
essential nutrients (e.g., essential amino acids, essential fatty acids) that are restricted
by modifying the normal diet. Medical foods become indispensable for individuals
with these IEMs in order to meet the daily requirements of essential nutrients and to
limit the metabolic disturbances associated with the particular IEM
