- Download the Guidance (PDF: 170KB)
- Federal Register Notice
- Constituent Update: FDA Issues Final Guidance on Frequently Asked Questions About Medical Foods
- More Medical Foods Guidance Documents & Regulatory Information
How to Comment
The comment period opens May 13, 2016.
Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2013-D-0880.
Contains Nonbinding Recommendations
This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods.
The responses to these FAQs address common questions about the definition of and regulations for medical foods.
This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.”
This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in agency guidances means that something is suggested or recommended, but not required.
This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.