The medical foods market has grown significantly in the last decade and with the market still nascent and not properly regulated, the global is estimated t $9-12 billion. I am not going to discuss the fundamentals of medical foods, but if you are interested, please refer to my recent article in Nutraceuticals World. In this blog I am going to highlight the new challenges faced by the industry with respect to FDA’s new draft guideline on medical foods.
 
Medical foods have now been developed for a range of diseases, from neurological disorders such as Alzheimer’s disease (e.g., Souvenaid by Nutricia) to general physiological disorders such as hypertension, viral infections and inflammation. Ailments such as food intolerance, insomnia or fatigue, are also treated by specific medical foods.
 
A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
 
New FDA Draft Guidance: New Challenges
FDA has recognized the gaps and recommended new guidance for a decade-old medical food definition. As per FDA, “Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick patients are not medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management.”
 
If we look at the draft critically, it seems medical foods are adjuncts of drug and other therapies. FDA clearly demonstrated the statutory definition as “It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.” Again the obvious question is whether such foods should be available by prescription. But FDA’s answer is “no.” Here the industries are concerned about how these foods should be used.
 
FDA’s guidance clarified that “a medical food is a food that is intended to be used under medical supervision and is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis…” As part of the overall treatment scenario, the consumer needs to visit doctors and get instruction from the physician on the use of specific foods related to ailments. There are a good number of medical foods currently marketed via OTC or supermarket channels. An example is Souvenaid for early Alzheimer’s patients, which was recently introduced by Nutricia in Australia. This issue should be addressed in final format.
 
The majority of U.S. medical food products, 51 of 82, on the market are for metabolic diseases. FDA’s new draft guidance specifically excluded diabetes as conditions for which a medical food could be labeled and marketed. FDA recommended: “Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by either type of DM (along with appropriate drug therapy if necessary). Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. Therefore, FDA generally would not consider a product labeled and marketed for DM to meet the regulatory criteria for a medical food.” Diabetes is more of a physician question, but it would be a big blow to the medical food industry.
 
Future
Despite stringent regulatory actions such as FDA’s new draft guidance and warning letter (e.g., warning to Realm labs and Metagenics for a few of their medical food products), awareness is growing significantly alongside the market. In spite of these challenges to the industry, consumers and patients are hungry for new evidence-based options. I believe this is the area where researcher and manufacturers can position their innovation with clinical support.
 
Dilip Ghosh, PhD, FACN, is director of nutriConnect, based in Sydney, Australia. He can be reached at [email protected].au; www.nutriconnect.com.au.

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The ideas and opinions expressed in this article are those of the author and do not necessarily reflect views held by Nutraceuticals World.