Have you ever looked at a label and noticed the term medical food? Although medical foods have been around for decades, many healthcare professionals may not recognize this term, as it was not part of our standard medical training. In addition, the medical food category is one that is growing. As these therapeutic medical foods become more and more popular it is our responsibility as healthcare professionals to understand what they are, their significance, and how they compare to functional foods.
According to the U.S. Food and Drug Administration (FDA), a medical food is defined in the Orphan Drug Act as “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.” In other words, a medical food must be labeled for a specific medical disease or condition that has distinctive nutritional requirements. Inherent in this definition is the fact that medical foods are not meant for use by a healthy person and their use is intended to be under medical supervision. In addition to these requirements, all medical food ingredients must be considered Generally Recognized as Safe (GRAS), which provides a standard of safety through qualified expert evaluation, published research, and corroboration from other data sources. Medical foods therefore have undergone toxicology studies and multiple human clinical trials in order to prove efficacy and safety.
Although functional foods can be beneficial and easy for people to obtain and sustain, they do not require the same rigor in efficacy-based research and safety studies as do medical foods.
As integrative practitioners, we all recommend the use of food in its natural state to support specific conditions, and so you may be wondering, “What’s the big deal about a medical food?” A medical food is specifically formulated for ill patients who require the food as a major part of their treatment. In certain circumstances it may be best to recommend a food in its natural state, for example when offering lifestyle preventative counseling. Although constructing a therapeutic diet for patients is a vital part of most treatment protocols, this alone may not be enough for some people with a serious illnesses. Whenever a patient’s condition requires nutritional nourishment that extends beyond the capacity of their diet, the addition of a medical food with its additional macro and micronutrients, vitamins, and minerals may be indicated.
Another term commonly mentioned in the healthcare industry is “functional foods.” This is an industry term, as there is not a defined set of regulations specific to functional foods. So-called functional foods are regulated as a food. Functional foods are essentially foods fortified with vitamins, minerals, macro and micro nutrients (eg, vitamin D-fortified milk, probiotic-fortified yogurt). Although functional foods can be beneficial and easy for people to obtain and sustain,they do not require the same rigor in efficacy-based research and safety studies as do medical foods. In addition, functional foods cannot make specific substantiated condition and disease claims as can medical foods.
Medical foods can come in a variety of forms, such as powders, liquids, and even gum. Although medical foods can be used as an acute critical care therapy, such as enterally administered lifesaving nutrients during an inpatient visit, they are more commonly used to slow the advance of chronic conditions and diseases through long-term use in an outpatient setting. As medical food manufacturers continue to expand their offerings it is important for us to expand our knowledge of their potential in our practices.
* I would like to acknowledge the significant help of Christine Toomasi, ND, in researching and writing this article.
