Article by Mary Sano, Ph.D.
The notion of using food to treat or prevent disease dates to ancient times of more than 5,000 years ago in Indian traditions and can be traced through the writings of Hippocrates, the father of Western medicine. The interest remains strong, with evidence that more than a third of adults in the U.S. are using some form of alternative treatments for health problems.
Medical Foods are a modern example of products intended for the specific dietary management of a disease or condition that has distinctive nutritional requirements. In 1988, Medical Foods were regulated by the FDA as part of the Orphan Drug Act. Unlike FDA-approved drugs, which undergo testing in patients to assure they are effective, these products submit health claims to the FDA based on a theory of how the food works. The manufacturer does not have to prove that there is a benefit in patients, however the food must be made of ingredients that are “generally regarded as safe” (GRAS), and the food must be prepared under “good manufacturing practice.”
There are two medical foods that are currently targeted toward Alzheimer disease (AD). One, Axona, became available as a prescription supplement in 2009, claiming to target the nutritional needs of people with AD. Specifically, it has been proposed that AD hinders the brain’s ability to break down glucose, and
Axona may provide an alternative source of glucose that the brain can use for energy.