Have you heard of medical foods? I hadn’t until I read a story in this morning’s Wall Street Journal, which reports that big food companies such as Nestle SA and Group Danone SA are starting to produce these types of foods to market to people with Alzheimer’s disease.
So what exactly are medical foods? According to the U.S. Food and Drug Administration (FDA), a medical food 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 Wall Street Journal warns that regulatory standards differ tremendously for drugs, supplements and medical foods. These differences are:
- Prescription drugs must be approved by the FDA to be used for a specific medical situation. These drugs must go through rigorous trials to demonstrate that they are safe before reaching the marketplace. Furthermore, adverse events while taking these drugs must be reported to the FDA.
- Medical foods are formulated to provide specific nutritional elements related to a disease that cannot be found in a modified diet. These foods are not allowed to advertise that they can treat the disease. Furthermore, they do not need to go through rigorous trials or to be approved before being available in the marketplace. Producers do not need to report adverse reactions to the FDA, although they must comply with the agency’s guidelines for manufacturing foods.
- Dietary supplements (which are also known as “nutraceuticals”) cannot claim to treat a disease, although producers can claim that the supplements help maintain health. These supplements do not need FDA approval before being marketed, but if adverse effects do emerge, they must be reported. The makers also must comply with the agency’s guidelines for manufacturing.
At this early stage, many are encouraging a cautious approach to medical foods. The Alzheimer’s Association has put out a statement concerning medical foods that, in part, reads: “The Association is aware of several products containing dietary supplements or agents naturally produced by the body that claim to beneficially affect Alzheimer’s. These products, as well as associated claims, have not been reviewed by the FDA. The manufacturers of some of these products intend to market them as ‘medical foods.’ This is a subject of concern as the Association strives to fulfill its mission of providing the public with scientifically accurate information about treatment for Alzheimer’s.”
The association notes that medical foods were originally developed to assist individuals who had inherited errors of metabolism that made it difficult or impossible to get the correct nutrients. However, these errors of metabolism rarely happen.