The Food and Drug Administration (“FDA”) is enforcing its draft medical foods guidance. As previously reported here, FDA published a draft medical food guidance last month that severely restricts the type of products that qualify as medical foods. The draft guidance states that a food is a “medical food” only if:
– It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube.
– It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has 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;
– It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
– It is intended to be used under medical supervision; and
– It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
To illustrate the effect of these requirements, FDA explained that medical foods cannot be used to manage diseases like diabetes and conditions such as pregnancy because modification of the normal diet alone is sufficient to manage them. FDA also clarified that medical foods are not required to be available by prescription and that use of the symbol “Rx only” symbol or NDC numbers misbrands medical foods.
According to the draft guidance, FDA distributed it “for comment purposes only,” and the agency requested that comments be submitted no later than October 15, 2013. Nonetheless, FDA is currently enforcing its tenets. For example, on August 13, 2013, FDA issued a warning letter to Metagenic’s Inc. on the grounds that its products were misbranded because their labeling was false or misleading in that they were labeled as medical foods but did not meet the definition of a medical food. FDA reasoned that the products were not medical foods because they were intended to support diseases or conditions that do not have distinct requirements for certain nutrients, e.g., chronic fatigue syndrome, fibromyalgia, leaky gut syndrome, metabolic syndrome, cardiovascular disease, inflammatory bowel disease, eczema, rhinitis, allergy-responsive asthma, and peripheral artery disease. FDA also concluded that such products were drugs based upon therapeutic claims, e.g., “[A] medical food formulated to nutritionally support the management of conditions associated with metabolic syndrome and cardiovascular diseases including hypercholesterolemia, hypertriglyceridemia, and hypertension.”
This warning letter and the existence of the new draft guidance indicate that medical food enforcement has become a priority for FDA. Medical food companies are not safe just because the new medical food guidance is only a draft.