“Medical foods,” by federal definition, are foods specifically formulated and processed for a sick patient to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. These foods can be consumed orally or through a feeding tube.
Medical foods do not require FDA pre-market approval. Manufacturers of such foods can make disease claims, which means they are exempt from the labeling requirement for health claims with its demand for random controlled trials. Medical foods do, however, have to follow current good manufacturing practices (cGMPs), facility registration, and other normal safety requirements. Our white paper on medical foods has more information.
Medical foods under threat
In 2013 the FDA issued an updated draft guidance on medical foods which drastically limits the number of medical conditions that medical foods can be used to manage. Outrageously, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (along with taking FDA-approved drugs, of course).
This is consistent with the usual FDA stance, which wants there to be as little competition as possible for approved drugs. By contrast, nearly all integrative physicians and even many conventional doctors would argue that diabetes requires very aggressive nutritional intervention, and medical foods can be a vital part of the treatment plan.
Just turn foods into drugs?
Under the new guidance, producers of medical foods will either have to reformulate their products to go through the drug approval process or else market them as dietary supplements (which would severely limit the claims their products could make, depriving practitioners and consumers of valuable health information).
By making the “buy-in” for the medical food industry affordable only to Big Pharma, small businesses and start-up innovators will be kicked out of the industry, drug companies will reap the rewards of yet another FDA-sponsored monopoly, and consumers will be left to deal with the ramifications of limited, more expensive options.
One provision requires companies to start the drug approval process even if a nutrient is to be studied only for its potential disease prevention or treatment. It doesn’t matter that the food or supplement won’t make any related health claims or be marketed as a drug! This means medical foods can’t even be studied without paying $2.3 billion for an NDI.
Another problem with the FDA’s guidance is that since medical foods are, by definition, administered under medical supervision, the patient’s physician is fully qualified to decide whether the medical food is required or not. The FDA doesn’t need to override doctors’ judgment and tell them what’s necessary for their patient!
ANH-USA urged American citizens to send letters to Congress and the FDA protesting these changes, and the FDA agreed to review the guidance—though the agency isn’t making any promises.