FDA Issues Draft Guidance for Medical Foods

WASHINGTONThe U.S. Food and Drug Administration (FDA) today issued a revised Draft Guidance (Second Edition) for FAQs about Medical Foods and has opened the comment period until Oct. 15, 2013 for industry or the public to weigh in on the document.

The 60-day comment period after the date of publication is scheduled prior to FDA work on the final version. the Draft Guidance (Second Edition) is not yet available on the FDA's Web site. While guidance documents from FDA provide insight into FDA's likely application of the laws and regulations, they guidance is not itself law, but FDA interpretation of the law.

FDA issued the first edition of this guidance in May 2007. The draft guidance provides responses to additional questions regarding the definition, labeling and availability of medical foods and updates to some of the existing responses.

Medical foods are defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) as foods formulated to be consumed or administered orally or enterally under the supervision of a physician. Medical foods are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. FDA criteria to clarify the statutory definition of a medical food is in FDA regulations at 21 CFR 101.9(j)(8). FDA lists exemptions in the FAQs.

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 ah physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition like diabetes, for example.

FDA invites interested persons to submit comments by October 15, 2013. To submit comments electronically visit: http://www.regulations.gov. FDA has several issues open for comments at this time, including FSMA.