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  1. CFSAN Constituent Updates

FDA Issues Final Guidance on Frequently Asked Questions About Medical Foods

Constituent Update

May 12, 2016

The U.S. Food and Drug Administration has published a resource to give industry more information about the definition and labeling of medical foods.

The final guidance for industry “Frequently Asked Questions About Medical Foods: Second Edition,” represents FDA’s current thinking on medical foods. This second edition, which finalizes the August 2013 draft guidance, provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be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.

Medical foods are specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are not those foods simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.

Although this is a final guidance, you may submit electronic or written comments on the guidance at any time starting May 13, 2016. Submit electronic comments to http://www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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