"Medical Foods" are specifically formulated to meet unique nutrient needs that result from a specific disease or condition.

For example, insomnia is associated with serotonin deficiency. Medical foods have now been developed that are designed to promote increased synthesis of serotonin.

Some other conditions with unique nutrient needs that may be managed with medical foods:

Þ Obesity
Þ Sleep Apnea
Þ Depression
Þ Athersclerosis
Þ Erectile Dysfunction
Þ Female Sexual Dysfunction
Þ Autonomic Imbalance

Medical foods are intended for use only under medical supervision.

Medical foods add value to a patient’s treatment program.

Medical foods are intended for patients receiving active and ongoing medical supervision.

2. Medical Foods must be intended to meet distinctive nutritional requirements of a disease or condition. Under statutory definition found at 21 U.S.C. §360E(b)(3), distinctive nutritional requirements must be based on recognized scientific principles and established by medical evaluation (Id. at 60667-8).

3. Medical foods must be formulated to be consumed or administered eternally under the supervision of a physician. FDA interpreted "under the supervision of a physician" to mean that the patient is "receiving active and ongoing medical supervision in a health care facility or as an outpatient." Thus medical foods in the agency’s view require ongoing physician oversight because they are intended to meet the medical need for a particular nutrient or combination of nutrients to meet distinctive nutritional requirements. By contrast, the agency sees foods simply recommended as part of an overall diet designed to reduce the risk of disease or a medical condition, lose or maintain weight, or to ensure the consumption of a healthy diet as "special dietary use" foods (Id. at 60668).

4. The term "specific dietary management" in the statutory definition of medical foods provides evidence in FDA’s view that congress intended these foods to be an integral part of the clinic treatment of patients (Id.).

II. Current Regulatory Status

Despite the concerns stated by the FDA in 1996, the agency has not followed the ANPR with any other rulemaking initiatives and does not appear to have plans to further address its concerns by regulation in the near future. Indeed, our discussions with Robert J. Moore, the agency official in the Center for Food Safety and Applied Nutrition ("CFSAN") named as the medical food contact in the ANPR, reflect that enforcement action against medical foods is a low enforcement priority for the agency.