Increase in Enforcement Actions against Medical Foods; FDA Sends Two Warning Letters

January 29, 2014

By Riëtte van Laack

On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics.  Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.”  FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.

Why is this worth a blog post, you ask?  To our knowledge, these are the first two Warning Letters in which FDA asserts yet another requirement for medical foods.  Under FDA’s “narrow 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.”  Although the Agency mentioned this requirement in the 2007 guidance and the draft 2013 guidance (see our previous post here), so far, the Agency had not mentioned this limitation in Warning Letters.  More important, the Agency has not provided any authority for adding this requirement.