Last year, Clarence, one of my patients asked me, “What do you think about the medicine Metanx®?”
“I’m not familiar with it. Is it a supplement?”
“No, you need a prescription for it. It helps nerve pain in diabetes.”
Metanx®, contains only one ingredient: L-methylfolate, a close cousin to folic acid. Although folic acid is considered a B vitamin, L-methylfolate is not classified as either a vitamin or food supplement. Instead, it’s considered a medical food.
Medical foods are products designed to address a disease that creates a nutritional deficiency that cannot be fixed by eating a normal diet. When something more is needed to address a nutritional disease than eating a normal diet, the Food and Drug Administration (FDA) created a special category for them: a medical food.
Medical foods started as special formulas designed for infants with certain metabolic genetic diseases. Some babies needed special nutrients added to their formula, while other babies couldn’t safely consume certain dietary substances, so their formula was designed without the troublesome nutrient. For example, if you are born with phenylketonuria, you cannot safely process phenylalanine. To help you avoid accidentally ingesting it, any foods containing phenylalanine are required to have a warning added to the list of ingredients to alert those with phenylketonuria to avoid consuming it.
To be classified as a medical food by the FDA, a product must meet several criteria. First, its nutrients must be in a specific formulation instead of their natural state. Next, it must be designed to be taken either as a pill or liquid by mouth or in a tube feeding as treatment for a medical condition that has distinct dietary needs. Finally, although it is intended to be used by patients getting ongoing treatment supervised by a medical provider, it doesn’t require a prescription.
Medical foods were originally specialized infant formulas for certain genetic diseases or for infants needing a ketogenic diet to prevent seizures, but in recent years other products have crept in under this category, attracted by the lack of regulation required by the FDA.
Prescription and non-prescription (over the counter) medicines must show the FDA that they are both safe and effective before they get permission to market a new product. Food supplements have to put disclaimers on their labels including, “This statement has not been evaluated by the Food and Drug Administration,” and “This product is not intended to diagnose, treat, cure, or prevent disease.” Food supplement manufacturers are allowed to use statements describing how the product supports certain organs or body functions.
Medical foods are very different. They seem more “official” or “trustworthy” because they are often sold only by prescription and they can be marketed as a treatment for a specific disease state. The truth is they are less trustworthy than medications or food supplements because they don’t have to be registered with the FDA.
Some examples of medical food products include Metanx® and Cerefolin NAC which contain L-methylfolate, which is similar to folic acid. Metanx® is a one-ingredient product targeting diabetics with neuropathy and Cerefolin NAC® is marketed for memory loss and combines vitamin B12 and N-acetylcysteine with L-methylfolate.
Limbrel® contains flavonoids with antioxidant properties and is marketed people with osteoarthritis to improve joint movement and mobility; however, there is no clear evidence that osteoarthritis is associated with any specific nutritional deficiency.
Axona® is marketed as memory booster for Alzheimer’s dementia. It contains ketone bodies which the manufacturer claims may function as an “alternative energy source” instead of glucose to improve brain functioning and memory. There isn’t any clear evidence to support this, but because it is marketed as a medical food, they don’t have to provide any proof to anyone that it works.
Here Are 5 Key Facts About Medical Foods:
- They are intended to address nutritional deficiencies.
Medical foods are supposed to treat diseases that create a nutritional deficiency that cannot be fixed by eating a normal diet.
- They don’t have to prove that they’re safe or effective.
Although medical foods are only allowed to be marketed for a particular disease, they don’t have to show any proof that they’re safe or effective when used to treat it.
- They don’t require a prescription, but require medical advice.
Medical foods can be purchased without a prescription but are supposed to be used only under the supervision of a physician.
- Eating your veggies may be a more effective alternative.
There is very little evidence to show that single-agent vitamin/nutritional supplements can improve dementia and diabetic neuropathy as well as eating whole foods like spinach, broccoli and other fruits and vegetables.
- They can be expensive.
Many medical food products cost $60 or more per month, with the manufacturer advising you try them for 4-6 months before expecting any noticeable benefit.
