Medical foods, what are they?

Last month, Ginger, one of my patients, asked me, "What do you think about the medicine Metanx®?”I asked her, “Is it a supplement?” "No," she answered. “It’s a type of medicine. You need a prescription for it. It’s supposed to help 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 a vitamin or food supplement. Instead, it's regarded as a medical food.Medical foods are products designed to address diseases that create a nutritional deficiency that cannot be fixed by eating a regular diet. When a normal diet is not enough to treat a nutritional disorder, the Food and Drug Administration (FDA) created a particular category for compounds that could help medical foods.Medical foods were originally unique formulas designed for infants with certain metabolic and genetic diseases. Some babies need particular nutrients added to their formula. In contrast, other babies can’t safely consume certain dietary substances, so unique infant formulas were designed.
For example, babies born with phenylketonuria cannot safely process phenylalanine. To help those with phenylketonuria avoid accidentally ingesting phenylalanine, the FDA requires any foods containing it to have a warning added to the list of ingredients.
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, a medical food must be designed to be taken as a pill or liquid by mouth or in a tube feeding as a treatment for a medical condition with distinct dietary needs.
Finally, although medical foods are intended to be used by patients supervised by a medical provider, medical foods don'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. Still, in recent years other products have crept in under this category, attracted by the lack of oversight by the FDA.
The FDA has regulations that cover medications and food supplements designed to protect consumers from harmful products.
Prescription and non-prescription (over the counter) medicines must show the FDA that they are safe and effective before they get permission to market a new product.
Food supplements must list two disclaimers on their labels: "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.” Manufacturers of food supplements can use statements describing how the product supports specific organs or body functions.
Medical foods are different. They may seem “official” because they are often sold only by prescription and are marketed as a treatment for a specific disease state. They are actually LESS trustworthy than medications and food supplements because they don’t even have to be registered with the FDA.
One example of medical food is L-methylfolate, nearly identical to folic acid and marketed as Metanx® and Cerefolin NAC. Metanx® is a one-ingredient product targeting diabetics with neuropathy. Cerefolin NAC® is sold for memory loss and combines L-methylfolate with vitamin B12 and N-acetylcysteine.
Limbrel® contains flavonoids with antioxidant properties and is marketed for osteoarthritis to improve joint movement and mobility. However, no clear evidence exists that osteoarthritis is associated with any specific nutritional deficiency.
Axona® is marketed as a 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 prove to anyone that it works.

5 Key Facts About
Medical Foods:
1.They correct a nutritional deficiency. They address conditions that cannot be fixed by eating a regular diet.
2. Most have no proven benefits. There is little evidence that single-agent vitamin/nutritional supplements can improve dementia and diabetic neuropathy. However, eating whole foods like spinach, broccoli, and other fruits and vegetables has been shown to be helpful.
3.  They don’t have to prove they work.  Medical foods can be marketed for a particular disease but don’t have to prove that they’re safe or effective.
4.  Their use should be supervised. Although they don’t require a prescription, medical foods are intended to be used under a doctor’s supervision.
5.  They are expensive. Many medical foods cost $60 or more per month. The manufacturer then advises you to use them for 4-6 months before expecting any noticeable benefit.

Dr. Louise Achey, Doctor of Pharmacy, is a 43-year veteran of pharmacology and the author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Get clear answers to your medication questions at her website and blog, TheMedicationInsider.com. ©2022 Louise Achey