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Medical Foods-A Closer Look at the Menu: A Brief Review and Commentary
John S Markowitz1, Patrick C Gurley2, Bill J Gurley3
1Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics and Precision Medicine, University of Florida, Gainesville, FL, USA.
Abstract:
The notion of a medical food-a foodstuff that, by definition, must be obtained and used while under medical supervision, and regulated by the US Food and Drug Administration, is a source of considerable confusion to the lay public as well as many-if not most-in the health professions community. Such restrictions are more often associated with pharmaceutical agents or medical devices. Additionally, specific regulatory aspects of medical foods are overseen by the US Food and Drug Administration, and these specifics appear to overlap with other foods and dietary supplements in terms of requirements and allowances. Furthermore, these requirements and allowances have changed over time and are likely to continue to evolve via federal regulatory action, or the introduction of newer formulations that defy current categorization. The present review attempts to bring some clarity to the definition of medical foods, to parse out the differences from related products, and to review the terminology surrounding medical foods, other foods, and dietary supplements.l.
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