FDA’s final medical foods guidance maintains restrictions on category

On May 12, 2016, the Food and Drug Administration (FDA) finalised its August 2013 draft guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition.” Although the draft guidance was issued nearly three years ago and was the subject of numerous comments from stakeholders, the final guidance reflects few changes and ignores the legal and science-based comments from the industry. In particular, it does not address critical research in nutritional science relevant to the role of specially formulated foods for a range of medical conditions.