Publication Date:
2016
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an overall discussion of the short regulatory history of medical foods, we cover the agencys recently released revised draft guidance and other regulatory requirements for medical foods, including the applicable Current Good Manufacturing Practices and import/export requirements, as well as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.
Iris type:
2.1 Contributo in volume (Capitolo o Saggio)
Keywords:
Distinctive nutritional requirements; FDA enforcement action; Import/export guidance; Manufacturing practices; Medical food; US food and drug administration
List of contributors:
Bragazzi, N. L.; Martini, M.; Saporita, T. C.; Nucci, D.; Gianfredi, V.; Maddalo, F.; Di Capua, A.; Tovani, F.; Marensi, L.
Book title:
Developing New Functional Food and Nutraceutical Products