On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods.  The draft guidance, “Frequently Asked Questions About Medical Foods; Second Edition,” amends and expands upon the original draft guidance published in 2007 by incorporating 15 new questions and answers. Specifically, the FDA addresses medical food labeling, physician supervision, and the scope of permissible diseases or conditions that medical foods may be labeled or marketed to manage.  You can access Venable LLP’s full client alert on the subject here.

As defined, medical foods are formulated to be consumed and administered for the dietary management of a disease or condition possessing distinctive nutritional requirements.  Significantly, physician supervision is required.  In accordance with the 2007 draft guidance and several recent Warning Letters, the revised draft guidance advises that it considers the statutory definition to “narrowly constrain” this category of food.  Products that qualify as medical foods are exempt from nutrition labeling requirements and those for health and nutrient content claims.   Accordingly, medical foods may bear claims regarding the management of disease or meeting the distinctive nutritional requirements of disease patients.

Below is a list of the pivotal aspects of the 2013 draft guidance.

  • Qualifying Disease or Condition.  Medical foods cannot be labeled or marketed for a disease or condition that can be managed solely by a normal diet alone.   Accordingly, FDA does not consider Diabetes Mellitus Types 1 and 2, pregnancy, and classical nutrient deficiency diseases, like scurvy or pellagra, to be diseases/conditions for which a medical food could be labeled and marketed.   The draft guidance also provides a non-exclusive list of specific Inborn Errors of Metabolism (IEMs) that medical foods can be used to manage.
  • Physician Supervision.  Though no written or oral prescription is necessary for medical foods, FDA expects that the patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food.  In short, there must be “active and ongoing” supervision.
  • Labeling.   “Rx only” statements and/or National Drug Code (NDC) numbers are prohibited.  Permissible language includes: “must be used under the supervision of a physician.”

While the revised draft guidance is no doubt intended to shed light on the FDA’s regulation of medical food, some of the FDA’s answers are likely to engender fervent industry commentary.  Pursuant to the Federal Register Notice, all comments on the draft guidance should be submitted by October 15, 2013 to ensure consideration by the FDA before it begins work on the final version.