The U.S. Food and Drug Administration published a final guidance to provide more information about the definition and labeling of medical foods. According to the FDA, 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.”
The resource, “Frequently Asked Questions About Medical Foods: Second Edition,” finalizes the August 2013 draft guidance about medical foods, provides responses to additional questions about the definition and labeling of medical foods, identifies the types of diseases and conditions medical foods might manage, and updates prior responses from the first edition.
Constituents 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.
