A manufacturer of a product purported to be a medical food has been hit with a Warning Letter from the US Food and Drug Administration (FDA), which says the product's claims that it is able to treat certain stages of Alzheimer's disease are unfounded.
Under the Orphan Drug Act of 1984, medical foods are defined as "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."
Key in that definition are four points:
- The food must be consumed orally.
- It must be specifically formulated (as opposed to a naturally occurring product).
- The food must be used under medical supervision.
- The food must be intended to manage/treat a specific disease or condition.
Medical foods are not products intended to be consumed as part of an overall diet intended to reduce the risk of disease, such as eating a diet high in vegetables and fruits to help reduce the risk or effects of diabetes or obesity.
In August 2013, FDA released a new draft guidance document, Frequently Asked Questions About Medical Foods, Second Edition, which adds a fifth definitional component on the definition of "medical supervision." Per the guidance document, a medical food is "intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food."
Notably, medical foods are also not prescribed. Per FDA, an "Rx Only" statement would cause the food to be misbranded under Section 403(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
A Recent Warning Letter
Warning Letters from FDA citing medical food issues are relatively uncommon, with the agency issuing just 12 letters since 2011, and just three between 2011 and the end of 2013. In FDA's most recent letter to MetaGenics, the agency alleged that the company failed to meet the statutory definition of medical food under 21 CFR 101.9(j).
In particular, FDA said it was not aware of evidence that the diseases the company's products claimed to treat were treatable through the use of specific nutrients, thus causing the product to run afoul of the statutory requirements.
Latest Warning Letter: Same Story, Different Company
FDA's latest Warning Letter to Colorado-based Accera, Inc, is quite similar to the MetaGenics letter, citing similar problems for a different disease. Accera's product, Axona, is marketed on the company's website as a medical food indicated for the management of "metabolic processes associated with mild to moderate Alzheimer's disease," FDA wrote.
As with MetaGenics, FDA said Accera had failed to substantiate that Alzheimer's has distinct dietary or nutritional requirements [21 CFR 101.9(j)(8)(ii). "There are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer's disease," FDA wrote. "Thus, this product is not a medical food… [and] the product is misbranded."
As the product is not a medical food, FDA said the product is thus by default an unapproved new drug, and listed allegedly violative claims found on the company's website.
Accera was given 15 working days in which to respond to FDA's Warning Letter.
Warning Letter to Accera