Medical Foods to comply with CFR and be intended for those seriously ill or requiring the product.

On Dec 26, 2013 the FDA issues two Warning Letters regarding medical foods.  The FDA alleges the associated products are misbranded as medical foods because there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for Polycystic Ovarian Syndrome (PCOS).  It has been reported these are the first two Warning Letters where FDA asserts another requirement for medical foods.  Under FDA’s interpretation, medical foods must not only meet all the requirements of FDA’s regulation, 21 C.F.R. 101.9(j)(8), they also must be intended for “the patient who is seriously ill or who require use of the product as a major component of a disease or condition’s specific dietary management.”  This requirement is within Agency guidance from 2007 and draft guidance of 2013, but this was the first indication of it included in a Warning Letter.