Medical foods are not simply foods recommended by a physician. They are not supplements or medications, either. You don’t need a prescription for a medical food, but it must be consumed or administered under the supervision of a physician. The FDA does not approve or regulate medical foods, however it does define and enforce their labeling requirements. Products used for diabetes treatment or for pregnancy are not considered medical foods by the FDA, however a product used to treat ADHD is.
Confused yet? You’re in good company.
According to a 2017 article in the Food and Drug Law Journal written by Bruce P. Burnett, Ph.D., and Robert M. Levy, MD, “Medical foods are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing.”
At the same time, new research suggests that the medical food developed for the management of ADHD symptoms in children may improve mood and behavior, with few side effects. So it seems this is a natural, supplemental treatment for ADHD deserves a deeper look — and some clean, clear explanation.
What Is a Medical Food?
It’s quite easy to list all of the things a medical food is not (as we’ve done above). Considerably more difficult is the task of explaining what a medical food actually is. According to the U.S. Food and Drug Administration (FDA), it 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 terminology surrounding medical foods and dietary supplements (not to mention functional foods and nutraceuticals) is confusing. The bottom line is that medical foods are not actually “food.” Instead, they are prescribed applications created from natural, food-based elements. Their mechanism is the delivery of pharmaceutical-grade components to the body in an effort to restore balance and routine metabolic processes.
Medical foods contain highly-concentrated and purified natural ingredients designated as GRAS (Generally Recognized as Safe), a standard put forth by the FDA. Unlike dietary supplements, which are intended for the maintenance of otherwise normal healthy bodies and minds, medical foods are designed to provide nutrients and restore function for a specific condition or disorder.
How Do Medical Foods and Supplements Differ?
Since the passage of the The Dietary Supplement Health and Education Act of 1994, the FDA has published several key regulations on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. These supplements, which may be purchased over the counter and largely taken without medical supervision, are highly regulated to protect consumers.
The FDA does not regulate medical foods in the same way it does drugs or dietary supplements. Instead, it monitors medical food like any other food — any product that bears a false or misleading claim would be considered misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also publishes a compliance program guidance manual titled “Medical Foods Program – Import and Domestic” to aid FDA inspectors in assessing medical foods and their manufacturing processes/facilities, and in collecting samples in accordance with the FD&C Act.
The FDA also defines what constitutes a medical food; if a product meets the criteria below, it is exempt from nutritional labeling requirements.
- It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube, meaning a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine.
- It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has 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.
- It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation.
- It is intended to be used under medical supervision.
- 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.
According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), medical food labels must list all major food allergens — such as milk, egg, and peanuts — contained within the product.
There are medical foods available today formulated to treat hematological abnormalities like sickle cell anemia, nonhematologic genetic diseases like cystic fibrosis, and conditions of malabsorption like Crohn’s disease, ulcerative colitis, and gastroesophageal reflux disease. These take the form of a powdered formula, capsule, liquid formula, or emulsion.
Insurance Coverage for Medical Foods
Medical insurance does not typically cover the cost of medical food. Though a prescription is not needed to purchase a medical food, it may be required by your insurance provider to process coverage. Even when a physician issues a written order stating that a medical food is necessary for a patient’s successful treatment, the insurance provider may consider it a second- or third-tier drug, which means high out-of-pocket costs. For patients covered by Medicare Part D, non-FDA-approved therapies may not receive any pharmacy reimbursement at all. A three-month supply of Vayarin, for example, costs $159.99
Medical Food for ADHD: Vayarin
One medical food indicated for the management of ADHD is Vayarin, which is designed to control the lipid imbalances associated with ADHD. (Lipids are healthy fats like omega-3s that the brain loves; several studies demonstrate that patients with ADHD have lower levels of than do individuals without the disorder.) Vayarin contains phosphatidylserine-omega-3, enriched with EPA (eicosapentaenoic acid), which is a type of omega-3 fatty acid found in fish and shellfish. This omega-3 has been found to improve mood and behavior.
Research on PS-Omega3, the main lipid product made by VAYA Pharmaceuticals, suggests that it may reduce ADHD symptoms in children. According to a recent study, “Preliminary analysis suggests that this treatment may be especially effective in a subgroup of hyperactive-impulsive, emotionally and behaviorally-dysregulated ADHD children.”1
The research found no reported significant risk associated with taking Vayarin. Most children tolerate it well, though gastrointestinal discomfort is cited as an adverse side effect. One study shows that cost and patient objection to Vayarin’s taste are leading reasons for therapy failure.2
What Do ADHD Patients Say About Vayarin?
Patient feedback on the effectiveness of Vayarin is far from conclusive, in part because so few people have tried treating ADHD with medical foods. According to one ADDitude reader, “Vayarin has helped my son, who has ADHD with high-functioning autism. He is a lot more affectionate and less emotional when things don’t go his way. I haven’t noticed a difference with my ADHD-only son. (Vayarin) did help my daughter, too, but she doesn’t care for the taste.”
Yet, another parent had a very different experience: “I tried Vayarin with my two sons — two pills twice a day for three months, as directed… After three months, there were no noticeable effects whatsoever, so we stopped using it.”
Dr. Maria Zangara, a Naturopathic physician in New York and Connecticut, says, “Vayarin is not a magic bullet. You can’t put something into an empty barrel and expect it to work. The barrel needs to be filled with the right balance of ingredients — rest, diet, mindfulness, and exercise — for there to be positive change.”
A poor diet comprising fast food, additives, and preservatives has been linked to aggravated symptoms in those affected with ADHD.3 Sugar, furthermore, creates a perfect storm in an ADHD body and brain, exacerbating hyperactivity and worsening symptoms overall. The right recipe of nutrients, vitamins and minerals, and even herbs can make a difference for some patients.4
1 Magen A, et al. “The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children.” European Psychiatry. 2012 Jul;27(5):335-42. doi: 10.1016/j.eurpsy.2011.05.004.
2 Stephanie Nguyen, et al. “Efficacy of EPA Enriched Phosphatidylserine-Omega-3 (Vayarin) on Children with ADHD” American Academy of Neurology. 2015 April; vol. 82 no. P7.336. ISSN: 0028-3878Online ISSN: 1526-632X
3 Kim KM1, et al. “Associations between attention-deficit/hyperactivity disorder symptoms and dietary habits in elementary school children.” Appetite. 2018 Aug 1;127:274-279. doi: 10.1016/j.appet.2018.05.004.
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