According to the Food and Drug Administration’s (FDA) Orphan Drug Act, a “medical food” is one that is “formulated to be consumed or administered enterically under the supervision of a physician and [that] is intended for the specific dietary management of a disorder or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
According to the FDA, medical foods differ from other foods marketed with health claims in important ways: First, manufacturers formulate and process these foods; they are not naturally occurring foodstuffs. Second, these foods target use by seriously ill patients or those who require them as major components in managing a disease or a condition. Third, only patients under medical supervision can use these foods.
Even though medical foods are available by prescription only, they are not subject to the same regulatory requirements as drugs. They need not, for example, undergo premarket review or approval. They also do not face the same labeling requirements as other foods, and their labels can thus include health claims. Medical foods find use in the treatment of allergic conditions, diabetes, digestive diseases, chronic pain, and arthritis.
At least two medical foods on the market target people with arthritis. Primus Pharmaceuticals, Inc., markets Limbrel to people with osteoarthritis (OA). Limbrel contains flavanoids, colorful substances found naturally in fruits and vegetables that have demonstrated health benefits. According to Primus, Limbrel inhibits inflammatory processes that promote osteoarthrisis. Trepadone is available from several manufacturers. Used in the management of joint disorders involving pain and inflammation, it provides certain neurotransmitters, antioxidants, and other substances that moderate inflammation. It also contains glucosamine and chondroitin sulfate, substances that some researchers believe help maintain the healthy structure and function of joints. If you are considering the use of a medical food, be sure to discuss its pros and cons with your health-care team.