PLI Therapy

Primary Locus Intervention

Questions and Answers


What is a "medical food"?

It is any food specifically formulated for oral administration to individuals who are under the supervision of a physician for the specific dietary and nutritional management of a disease or condition based on recognized scientific principles. However, the term "medical foods" does not pertain to all foods that are used under a doctor’s supervision. Instead, they are foods that are specially formulated and processed rather than being naturally occurring, and intended to provide unique or distinctive medical therapy that complements good diet, exercise and life style. As defined by Congress in the Orphan Drug Act and Amendments of 1988, a medical food is to be used only in patients receiving active and ongoing medical supervision including instructions on its use as it may change over time.

What criteria define “medical foods”?

In general, the minimal requirements for a product being designated as a “medical food” are that it must be a food for oral or tube feeding. It must be labeled for the dietary management of a specific medical disorder, disease, or condition such as GYNECA or muscle loss associated with aging for which there are distinctive nutritional requirements. Finally, even though it is not a drug, the product must be used under supervision by a health care professional.

Why must a medical food be used under a doctor’s supervision?

Because of therapeutic or chronic medical needs the treated individual has limited ability to absorb or metabolize certain essential nutrients from ordinary foodstuffs or has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. As a result, use of a medical food such as Sarcotropin requires professional oversight that includes among other things, instruction on when and how to take the product as the condition changes over time.

Are there any regulations governing the manufacture of medical foods?

Yes. Medical foods such as Sarcotropin must comply with all applicable guidelines within the Code of Federal Regulations including the Good Manufacturing Practices regulations, Registration of Food Facilities requirements and Emergency Permit Control regulations. Ingredients used in medical foods must be approved food additives or Generally Recognized as Safe (GRAS).