Take Cautious Look at Medical Foods Designed for Alzheimer's
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.
Furthermore, because medical foods are not required to go through clinical trials or get FDA approval, the association cautions that the efficacy of these products is not clear. “Unlike PKU (phenylketonuria, one type of inherited error of metabolism), no clear role for medical foods exists at this time for Alzheimer’s disease, as Alzheimer’s does not have ‘distinctive nutritional requirements, based on recognized scientific principles,’” the association’s position statement reads. “Current evidence does not document the efficacy of a medical food that substitutes for or supplements a balanced diet.” The association also warns that possible side effects – including how medical foods would interact with drugs taken for Alzheimer’s and other conditions – have not been identified.
The association also cautions consumers to check with insurers to determine if medical foods are covered in their plans. “Because medical foods are not drugs, insurance coverage may vary considerably,” the association stated. “A decision to purchase products that may not be effective and may not be covered by insurance should be made carefully.”
So if you are interested in trying medical foods, be sure to check with your doctor (and insurer) first.
Sources for This Sharepost:
Alzheimer’s Association. (2011). Medical foods.
U.S. Food and Drug Administration. (2009). Medical foods.
Wang, S.S. (2012). ‘Medical foods’ and supplements for brain health advance. Wall Street Journal.