How to Explain Medical Foods to Your Patients
Today, there is growing enthusiasm around the subject of medical foods. “Medical food” is not just simply food recommended by doctors as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition. It is specially formulated and distinguished from the broader category of specially formulated food products (foods for special dietary use [FSDU]).
What is medical food?
Medical food products have three primary characteristics—meets distinctive nutritional requirements of a disease or condition that cannot be satisfied by a typical diet, administered/prescribed under medical supervision, and intended for the specific dietary management of a disease or condition (e.g., Alzheimer disease or type 2 diabetes mellitus). It is important to note that medical foods cannot prevent or cure illness; they are meant only to manage the course of a disease or condition, usually in an effort to avoid development or progression of a pre-existing disease or condition. The majority of medical foods are part of the life-long management of a disease or condition through dietary means.
Medical Foods over the years
Debuting in the late 1960s, Lofenalac was the first commercially developed of the medical foods. Prior to 1972, medical foods were primarily formulas designed for the unique nutritional needs of patients with inborn errors of metabolism (e.g., phenylketonuria [PKU] or maple syrup urine disease), which are usually rare genetic disorders. Today, medical foods have been developed for patients with macular degeneration (e.g., Lumega-Z™), malabsorption caused by inflammatory bowel disease (i.e., Crohn disease and ulcerative colitis), gastroesophageal reflux disease (GERD), chronic intestinal pseudo-obstruction, insomnia, attention deficit hyperactivity disorder (ADHD), and inherited diseases of amino and organic acids.
The difference between medical foods and dietary supplements and the role of the FDA
Medical food products often are confused with dietary supplements. Medical foods and dietary supplements have separate United States Food and Drug Administration (FDA) regulatory classifications. According to the FDA, “A dietary supplement is a product intended for ingestion that contains a ‘dietary ingredient’ intended to add further nutritional value to (supplement) the diet. A ‘dietary ingredient’ may be one, or any combination, of the following substances: a vitamin, a mineral, an herb, or other botanical.” The goal of dietary supplements is to augment wellness among healthy individuals.
In contrast, according to the FDA, “medical food” 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.” The FDA has written guidance documents on the topic of medical foods. But it should be made clear that medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs. In the guidance, the FDA indicates its definition is meant to “narrowly constrain” this category of food products and distinguishes medical foods from what it considers to be a broader category of specially formulated food products, FSDU.
The key difference between the two (dietary supplement vs. medical food) is that a medical food can make a medical claim such as this product can be ‘used for the treatment of Alzheimer disease,’ while the dietary supplement would say something like ‘supports healthy dopamine levels.’ Furthermore, medical foods require medical supervision, which is why manufacturers of medical foods require a product to be dispensed only upon a doctor’s request. One author put it best by saying, “Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation.”
In terms of drug-drug interactions, side effects, and safety, trustworthy research about medical foods is similar to that of dietary supplements. Manufacturers are not required to prove efficacy or safety before marketing medical foods or dietary supplements. Dietary supplements have strict labeling guidelines, while medical foods have virtually no labeling regulations. In contrast, packaging for medical foods is similar to prescription medications with package inserts, National Drug Code (NDC) numbers, and usually “Rx only” on the labels. Additionally, medical foods are tested for effectiveness in clinical trials and deemed safe by panels of experts before they are brought to the marketplace and consumers. All ingredients in a medical food must be on the FDA’s “Generally Recognized as Safe” list.
Who pays for medical foods?
Private health insurance coverage for medical foods is not uniform across all states. As a result, some patients end up receiving very good coverage, whereas others receive poor to no coverage. State legislation for coverage of medical foods is highly variable. For example, 33 out of 50 states have provisions related to private insurance coverage requirements for medical foods to treat disorders identified through newborn screening. No private insurance requirements were found in Alabama, District of Columbia, Georgia, Idaho, Illinois, Iowa, Kansas, Michigan, Mississippi, Nebraska, North Carolina, Ohio, Oklahoma, South Carolina, Virginia, West Virginia, Wisconsin, and Wyoming. Requirements range from mandates for private health insurers to provide medical food for one specified metabolic condition (e.g., PKU in Alaska and California) with those that require private health insurers to provide coverage for modified low protein foods (one form of prescribed solid modified foods) to treat any newborn screening disorder identified by the state program (e.g., Arizona). Typically, FDA approval for an agent translates into insurance reimbursement, which is a major problem since medical foods are not regulated by the FDA and therefore cannot receive approval. Therefore, patients/parents are required to work with their insurance carrier to educate them about the nature and necessity of the medical foods to have any hope of obtaining coverage and/or reimbursement.
How to best explain it to patients
Doctors who are practitioners of evidence-based medicine should keep in mind and emphasize the following to their patients when recommending and supervising medical foods:
- Medical foods are specially formulated and indicated for the management/treatment of your
- Medical foods require medical supervision, which is why you need to procure a doctor authorization code (DAC) that will be validated in order to receive the appropriate food (a “prescription” of sorts). In addition, you will be scheduled for a follow-up appointment.
- Medical foods are not dietary supplements or prescription medications.
- Medical foods are not regulated by the FDA, but are usually backed by scientifically credible evidence for their use.
- Medical foods are not always covered by health insurance.
Why would a medical food be best when combating eye-related problems?
Today, retinal disease is all too common and macular degeneration is the leading cause of vision loss/blindness in individuals over the age of 55. Researchers at Guardion Health Sciences offer Lumega-Z, the only vision-specific medical food created to replenish, restore, and maintain the macular pigment. Previous studies have shown that the depletion of the macular pigment increases the risk of developing eye diseases such as macular degeneration. Lumega-Z contains all three critical macular carotenoids (which comprise the macular pigment)—lutein, zeaxanthin, and meso-zeaxanthin—as well as a robust complex of 35 critical micronutrients with potent antioxidant activity. Humans can neither synthesize nor obtain enough of the three critical carotenoids in a normal diet to maintain the macular pigment, which is why supplementation with Lumega-Z can effectively replenish the protective macular pigment and has the potential to prevent or alter the course of a disease such as macular degeneration.