Medical Food Draft Guidance – Has the FDA Bitten Off More than it Can Chew?

By Riëtte van Laack & Wes Siegner –

Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods – Second Edition.  As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect to medical foods that would eliminate medical foods as an FDA category for all but a very few products that, in FDA’s view, meet FDA’s criteria.  FDA’s attempt to limit medical foods to those products that meet “distinctive nutritional requirements” of a disease or condition that cannot be met by modification of the “normal diet,” combined with FDA’s inclusion of dietary supplements as part of the “normal diet,” is contrary to important public health interests as well as the First and Fifth Amendments to the United States Constitution.  It appears that FDA’s overreaching has finally united the medical food industry in opposition to agency policy, boding well for the future of medical foods and patient health.