FDA Issues Final Guidance for Medical Foods Largely Ignoring Comments

May 16, 2016

By Riëtte van Laack

FDA announced the availability of the Final Guidance for Medical Foods: “Frequently Asked Questions About Medical Foods; Second Edition.”

As we previously reported, in August 2013, FDA issued a draft guidance, updating the 2007 guidance for medical foods. In the 2013 draft guidance FDA made numerous statements that we believe were not in accordance with the law. Among other things, FDA specifically excluded foods for certain diseases, such as diabetes, from the medical food definition. The draft guidance generated many comments.

In the notice of availability published in the Federal Register, FDA asserts that it modified “the guidance where appropriate” and “made editorial changes to improve clarity.” Review of the Guidance shows that, overall, FDA largely ignored the comments and continues to narrowly interpret the definition of medical foods. This is disappointing but hardly surprising development.  

Possibly the most surprising change is FDA’s new rationale for exclusion of foods for diabetics from the medical food definition. In the 2013 draft guidance, FDA acknowledged that diabetes is associated with nutrient requirements but those requirements could be met by modification of the diet alone. Therefore, such products failed one of FDA’s regulatory requirements for medical foods. In the final guidance, FDA now asserts that there are no special nutrition requirements for patients with diabetes. Therefore, foods for diabetics fail one of the statutory requirements.

Since this is guidance and FDA does not need to explain its actions, we can only speculate as to FDA’s reasons for its persistence in misinterpreting the law.