Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has
a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary
foodstuffs or certain nutrients, or who has other special medically determined nutrient
requirements, the dietary management of which cannot be achieved by the
modification of the normal diet alone. While some diets may not supply the full
amount of nutrients necessary for women who are pregnant or planning to become
pregnant, generally the levels of micronutrients necessary for pregnancy can be
achieved by the modification of the normal diet alone. It is generally practicable for
women who are pregnant or planning to become pregnant to follow the IOM and
FDA recommendations for nutrient intake within a normal diet. Therefore, FDA
generally would not consider a product labeled and marketed for pregnancy to meet
the regulatory criteria for a medical food.
