What to Know About Medical Foods ?

 What is a medical food product?

I am starting this journey to “understanding medical food product” with a most commonly asked question. Well, we have already discussed the basic meaning of medical food above. Now, let’s just listen to what Orphan Drug Act by the U.S. Food and Drug Administration (FDA) has to say. As per the act “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”.

If we break it down, medical food has three prime characteristics:

It involves such foods that meet distinctive nutritional requirements of an illness which can’t be met by dietary supplements. For example, Lunglaid is a medical food that is given to patients suffering from chronic asthma.

It should be consumed/administered orally under the supervision of a physician.

It is intended for the specific dietary management of a disease or condition. For example, type 2 diabetes mellitus or Alzheimer’s disease.

What are medical food examples?

Some of the examples of medical foods are:

• Lipisorb
• Nepro
• Oxepa
• Perative
• Renax
• Suplena
• Folgard Rx
• Foltx
• Phlexy-10
• Strovite Forte

Access Blog of Medical Foods Market @ https://gvrencompass.wordpress.com/2021/05/10/medical-food-food-for-special-dietary-use/

Which companies deal in medical food?

Some of the medical food companies are:

• Danone
• Nestle Nutrition
• Abbott Nutrition
• Targeted Medical Pharma, Inc.
• Primus Pharmaceuticals, Inc.
• Mead Johnson & Company, LLC.
• Medtrition, Inc.
• Fresenius Kabi AG

Difference between dietary supplements and medical foods

The major difference between dietary supplements and medical foods is that while dietary supplements don’t make a specific claim to completely cure the disease, medical foods do. For instance, in the case of Alzheimer’s disease, a dietary supplement would say something like “used to increase the dopamine levels” while medical food will claim to be “used for the treatment for Alzheimer’s disease”.

Does FDA regulate medical food?

No. As medical food is not a drug, hence, it is not regulated by FDA.

Are medical foods covered by insurance?

Insurance coverage for medical foods is highly variable depending upon the state to state. Hence, some patients receive very good coverage while others receive poor to no coverage. Moreover, there are no federal laws as of now that can make medical food coverage mandatory. Some of the private insurers will only give coverage to medical food if it’s demonstrated to provide 50% of total energy needs.

Furthermore, usually, a physician’s prescription is not required to buy medical foods (it should not be monitored under the guidance of a physician), however, a physician must write an order and specifically state that the following medical food or formula required for the treatment has to be covered under the health insurance policy. The problem doesn’t stop here. Even if the medical food is covered, it is usually treated as “tier-2” or “tier-3” drugs and involves a lot of costs. But gladly, many states have passed legislation and controlled the amount of costs to be involved in it.

What are the rules for labeling medical foods?

Medical foods are exempted from the labeling requirements for nutrients content claims or health claims under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343(r)(5)(A)). Just like other food, a medical food that contains false or misleading claims would be considered misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).