A Unique FDA Category

A medical food (MF) is prescribed by a medical physician for a patient with special medical nutritional needs, in order to manage a disease or health condition, through dietary or nutritional means and when the patient is under the physician's ongoing care. MFs are not meant to be used by the general public, or by normal healthy adults, and may not be available in stores or supermarkets. MFs are not those foods included within a healthy diet intended to decrease the risk of disease, such as reduced-fat foods or low-sodium foods, nor are they weight loss products*.

Also note that in this simple explanation below, from the FDA's regulation, the Agency states explicitly that "for the dietary management of disease" must be printed on the label. See reference 1 below. The FDA's Compliance Program Guidance Manual recognizes four major categories of medical foods: 1. nutritionally complete products; 2. nutritionally incomplete formulas; 3. oral rehydration products; and 4. formulas for metabolic disorders (FDA, 1999). Indeed, a wide range of MFs are used for medical management of various conditions, such as prevention of loss of body mass, to provide proper nutrition for special population groups, and to prevent, control, and/or alleviate acute, genetic, and chronic diseases. As such, osteoarthritis qualifies as a chronic disease with a metabolic basis. In addition, the nutritional requirements of individuals with osteoarthritis change as a result of age, poor diet, oral health and gastrointestinal function, all of which can result in the need for special nutrients to manage or to balance the metabolic aspects of the disease. MFs were designated to meet this need. They are a unique regulatory class with certain special requirements.

*Medical Foods, from Office of Special Nutritionals, May 1997