FDA published the draft guidance on August 13, 2013, requesting that comments be submitted during the following 60 days. Soon after, the agency received requests to extend the 60-day period. However, the lapse of appropriations and cessation of many government operations from October 1 through October 16 prevented FDA from extending the comment period. Therefore, the agency is now reopening the comment period to allow interested parties additional time to review the draft guidance and submit comments.
Medical foods are formulated for the dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are specifically formulated for patients who have a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who have other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are intended to be consumed or administered under the supervision of a physician.
FDA issued the first edition of its guidance on medical foods in May 2007. This draft second edition contains updates that include newly developed responses to additional questions on the definition, labeling, and marketing of medical foods.
Interested parties may submit comments by December 16, 2013. Comments may be submitted electronically on www.regulations.gov using docket number FDA-2013-D-0880.