FDA Finalizes Guidance for Industry about Medical Foods

Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety requirements. This alert provides a brief background about the legal framework for medical foods and a high-level summary of the guidance, and highlights key differences between the draft guidance and final guidance.