Chapter 21 - Medical foods and US regulations

Abstract

Our chapter explores the US Food and Drug Administration’s (USFDA’s) regulation of medical foods, a growing industry that lies between pharmaceutical drugs and food. In addition to an overall discussion of the short regulatory history of medical foods, we cover the agency’s recently released revised draft guidance and other regulatory requirements for medical foods, including the applicable current good manufacturing practices and import/export requirements, as well as FDA’s enforcement actions to date.