German Court Ruling ReversesKava Ban; German Regulatory Authority Appeals Decision

摘要

Almost 12 years after the German drug regulatory authority, the Federal Institute for Drugs and Medical Devices (Bundesinsitut fiir Arzneimittel und Medizinprodukte, BfArM), issued an immediate withdrawal of marketing authorizations for products containing extracts of kava {Piper methysticum.) Piperaceae) root and/or rhizome,1 the case has been reviewed by a German administrative court in Cologne. According to the court's ruling on June 11, 2014, there was no justification for the German government'sban of kava medicinal products. The court ruled that based on the available data, the benefit-risk (also referred to as risk-benefit) ratio of kava medicinal products was confirmed as positive and must be considered positive.2 As a consequence, German kava products have been formally restored to their market status of June 2002.