Throughout 2013, the FDA issued several Warning Letters to manufacturers of medical foods, suggesting that the FDA’s final guidance may narrow its interpretation of the definition of “medical foods.” The details and implications of these Warning Letters are discussed in a Food Industry LawFlash from our FDA Practice.
It remains important for the medical food industry to monitor the status of the guidance and any continued enforcement efforts in order to determine whether the agency will be revise its interpretation of the medical food category or continue to enforce the more limiting criteria set forth in the nutritional labeling regulations.