Medical Foods: Personalized Nutrition
Both medical science and nutrition science tell us that up to 70% of all chronic diseases in the U.S. are fundamentally the result of nutrition deficiencies or imbalances. Perhaps such nutrition-based etiologies are an amalgam of personal genetics and American lifestyle. And while a full analysis of that possibility is yet to be undertaken, the Personalized Lifestyle Medicine Institute will foster sufficient inter-disciplinary discussion to reach insightful conclusions on that question.
Indeed, the concept of nutritional requirements for the body not being met is at the heart of the legal definition of a medical food, an increasingly important category of FDA-regulated medical products. A medical food stands roughly between a dietary supplement and a prescription drug—in terms of both use within a patient’s protocol and positioning under FDA regulatory law. Usually sold Rx only, a medical food is intended for the dietary management of a specific disease or condition that is characterized by some sort of nutritional or metabolic imbalance.
The statutory definition, under the amendments to the Orphan Drug Act (1988), is:
The term ”medical food” means a food which is formulated to be consumed or administered enterally [ingested or through a feeding tube] 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. 21 U.S.C. sec. 360ee(b) (3)
Some examples of diseases that are amenable to dietary management via medical foods are: Phenylketonuria (PKU), kidney dysfunction, osteoporosis, heart disease, and IBS. One chronic disease that is growing in epidemic proportions in the U.S., and which, is in my view, a prime candidate for new well-researched and beneficial medical foods, is diabetes. I would like to focus the remainder of this blog on that disease, especially since in the past few years there have been many promising products—both foods and dietary supplements—making express and implied diabetes claims.
Many of these claims push valid structure/function statements, such as “Supports healthy blood sugar levels” or “Promotes normalizing of glucose levels,” to impermissible marketing statements such as “Nutritional support for diabetics” or “Controls your insulin use.” The supplement products making the two latter claims really want to be Medical Foods in their next life. And they do have an important and beneficial role to play in disease management and nutritional control.
In turn, the FDA has responded to these express and implied disease claims above with Warning Letters to the makers and marketers of “diabetic” teas and “Diabetes Support” supplements. The good news is that many of these ingredients and formulas are, as I have indicated, potentials for a different category of product: an effective and legal medical food (“MF”).
However, we are not talking about doing a simple “relabeling” of a supplement bottle to add the claim “For the dietary management of diabetes.” And the term “retailoring” of a supplement to a medical food does not do justice to the required and detailed process of MF research and development—both scientifically and legally. For example, unlike for the dietary ingredients of supplements, all MF ingredients must be either FDA-approved food additives or GRAS (Generally Recognized As Safe).
Nonetheless, there are potential medical foods products that are legally and scientifically valid—and not just for diabetes, but for many other chronic diseases as well. Yes, some large companies such as Abbott are already key players in this market sector, but there is room for many smaller innovators that are in the process of developing quite promising ingredients and formulas for new medical foods.
Thus, it should be possible for the healthcare practitioner of the near future to manage diseases—nutritionally—with medical foods, rather than to exclusively treat them with drugs. Accordingly, the patient of the near future (especially elderly ones) could then avoid ingesting a plethora of prescription pharmaceuticals (with a consequent cacophony of drug interactions), and then be compelled to take yet other Rx and OTC drugs to treat the side effects of the first line medications! Instead, I envision a healthcare world in which many people stay productive and vital well beyond the early AARP years– by taking several dietary supplements and a few select medical foods, and zero Rx drugs!
Note: For more information on medical foods, from an FDA perspective, please see my longer article Medical foods boom along with Baby Boomers, originally published in Functional Ingredients (Feb./March 2010), and posted on newhope360.com, at this link: