The FDA definition of 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.”
Medical foods were defined back in 1988 with the FDA orphan drug act amendments. Medical foods are subject to the same safety regulation and labeling requirements of the food, drug and cosmetic act.
Examples of medical foods would be amino acids for the treatment of specific diseases like PKU or enteral tube feeds for those with malabsorption.
Another example of a medical food is UreaAide, a food taken orally, under the supervision of your doctor, meant to treat Hyponatremia ( low serum sodium) and is guideline based. We at KidneyAide are meticulous when it comes to the above FDA regulations and requirements. UreaAide is manufactured and stored in an FDA registered cGMP manufacturing facility and we use only high grade USP Urea. It is critical that you are getting the highest quality medical foods for safety and effectiveness. So as we say UreaAide is safe, effective and guideline based so you can rest assured your sodium is in proper balance naturally.