What is a medical food

Several years ago, 85-year old Clarence asked me, "What do you think about the medicine Metanx®?”
"Is it a supplement?"
“No, you need a prescription for it. It helps nerve pain in diabetes.”
Metanx® contains L-methyl folate, a close cousin to folic acid. Although folic acid is considered a B vitamin, L-methyl folate is not classified as either a vitamin or food supplement. Instead, it's marketed as a medical food.
Medical foods are intended to address nutritional conditions that cannot be fixed by eating a healthy diet. 
Some people have metabolic diseases that require specialized nutrients to keep them symptom-free. The Food and Drug Administration (FDA) created a particular category for products that address specific nutritional deficiencies: medical foods.
The first medical foods were unique formulas designed for infants with certain metabolic genetic diseases. Some babies needed particular nutrients added to their formula, while others couldn’t safely consume certain dietary substances. Special foods were designed that provided key nutrients or didn’t contain any troublesome compounds. 
In recent years other products have crept in under this category, attracted by the lack of regulation required by the FDA. 
To be classified as a medical food by the FDA, a product must meet several criteria. First, it must be a specific formulation instead of in its natural state. Next, it must be designed to be taken either as a pill or liquid by mouth or in a tube feeding to treat a medical condition with distinct dietary needs. Finally, although it doesn't require a prescription, medical foods are intended to be used only under the supervision of a physician.
Manufacturers of prescription and non-prescription (over the counter) medicines must first show the FDA that their product is safe and effective before getting permission to market it. 
Food supplement manufacturers are allowed to use statements on their labels about how their product supports particular organs or body functions. The FDA requires the following disclaimer statements on the labeling of all supplements: "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.” 
Medical foods are very different. They seem more “official” or “trustworthy” because they are often sold only by prescription and marketed as a "natural" treatment for a specific disease state. 
The truth?
Products sold as medical foods are less trustworthy than medications or food supplements because they have even less oversight by the FDA.
Some examples of medical food products include Metanx® and Cerefolin NAC, which contain L-methyl folate, a close relative to folic acid. Metanx® is a one-ingredient product targeting diabetics with neuropathy. Cerefolin NAC® is marketed for memory loss and combines vitamin B12 and N-acetylcysteine with L-methyl folate. 
Axona® is promoted 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. Because Axona® is marketed as a medical food, its manufacturer isn't obligated to prove that it works. 
Limbrel® contains flavonoids with antioxidant properties and is marketed people with osteoarthritis to improve joint movement and mobility. There is no clear evidence that osteoarthritis is associated with any specific nutritional deficiency. In fact, the FDA received so many reports of Limbrel® causing problems like liver injury and pancreatitis that they asked the manufacturer Primus to stop making it.
Here Are 5 Key Facts About Medical Foods:
1.  They are intended to treat a nutritional disease. 
Medical foods are products designed to address diseases that create a nutritional deficiency that cannot be fixed by eating a healthy diet. 
2. They don't improve dementia or diabetic neuropathy.
There is very 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 have been shown to help. 
3. Medical foods have very little regulation. 
Medical foods are allowed to be marketed for a particular disease, yet don't have to show the FDA any proof that they are safe or effective. 
4. They must be used under the supervision of a doctor.
Medical foods do NOT require a prescription but are supposed to be used only under the supervision of a physician.
5.  Medical foods can be expensive. 
Most are sold through the internet. Most medical food products cost at least $60 per month, with the manufacturer advising you to try them for 4-6 months before expecting any noticeable benefit.
Dr. Louise Achey, Doctor of Pharmacy is a 40-year veteran of pharmacology and author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Check out her NEW website TheMedicationInsider.com for daily tips on how to take your medicine safely.
2020 Louise Achey

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