FDA Moves to Eliminate Medical Foods

There’s still a small window to make the FDA listen to reason. “Medical foods,” by the federal government’s definition, aren't simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient and are intended to meet specific nutritional requirements for the management of a disease or condition. The FDA has recently issued an updated draft guidance that drastically limits the number of conditions that medical foods can be used to manage. Under the new guidance, producers of medical foods will either have to reformulate their products to go through the drug approval process (which can cost billions of dollars) or 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 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.