Our chapter explores the US Food and Drug Administrations (USFDAs) 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an overall discussion of the short regulatory history of medical foods, we cover the agencys recently released revised draft guidance and other regulatory requirements for medical foods, including the applicable Current Good Manufacturing Practices and import/export requirements, as well as FDAs enforcement actions to date.

Nutraceutical and functional food regulations in the European Union

Gianfredi V.;
2016-01-01

Abstract

Our chapter explores the US Food and Drug Administrations (USFDAs) 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an overall discussion of the short regulatory history of medical foods, we cover the agencys recently released revised draft guidance and other regulatory requirements for medical foods, including the applicable Current Good Manufacturing Practices and import/export requirements, as well as FDAs enforcement actions to date.
2016
Distinctive nutritional requirements
FDA enforcement action
Import/export guidance
Manufacturing practices
Medical food
US food and drug administration
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/105102
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