FDA Issues Final Guidance on Frequently Asked Questions About Medical Foods

Today, FDA published a final guidance for industry “Frequently Asked Questions About Medical Foods: Second Edition.” The final guidance represents FDA’s current thinking on medical foods and provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance. Although this is a final guidance, you may submit electronic or written comments on the guidance beginning May 13, 2016. Comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or electronically at http://www.regulations.gov

For Additional Information:

Final Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition -http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm054048.htm

Constituent Update: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm500095.htm

Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network