Kava is a herbal preparation prepared from the rootstock of the plant Piper methysticum originating from the South Pacific Islands. Due to its remarkable calming and muscle relaxing effects, it is used in food supplements and herbal medicines worldwide. In 2002 its sale was prohibited in a number of countries after adverse effects were reported that were thought to be possibly related to the intake of kava products.
Kava has a long tradition of use in the South Pacific. For over 1000 years, a tranquilizing ritual beverage has been prepared from the rootstock of the plant. Based on its traditional use, and the sound scientific data documenting the safety and efficacy of kava preparations in numerous of pharmacological studies and clinical trials — kava is definitely one of the best documented herbal drugs on the market — kava preparations were marketed as approved drugs in numerous countries. Drug monographs have been published by expert committees on herbal medicinal products, such as the German Commission E and the European Scientific Cooperative on Phytotherapy (ESCOP), confirming that kava is a safe and effective herbal. Kava even was proposed to be listed in the main section of a proposed German “Positivliste” (= positive list) alongside the most popular synthetic drugs. This list was created by an independent expert committee, implemented by the German Health Ministry, and only “these drugs should be included that have a proven efficacy in the claimed indication, and conform to the criteria of evidence based medicine”.
After the occurrence of a few cases of severe hepatotoxicity, claimed to be possibly related to the intake of kava products, the German BfArM re-evaluated the benefit risk ratio of kava and banned kava preparations up to a homoeopathic dilution of D4. Most other health authorities in Europe followed the decision of the BfArM, or asked producers to voluntarily recall their products. From one moment to the next, a traditional drink from the pacific spontaneously mutated from a safe and effective drug into a highly dangerous substance.
A great number of specialists in the field of herbal medicine, pharmacology and toxicology, immediately went up in arms about this decision. They claim that case analysis by independent experts all revealed that the vast majority of the case reports can definitely not be related to the intake of kava and that the evaluation of the BfArM omitted many important facts, such as co-medication, alcohol and drug abuse or previous liver damage.
In March 2003, Phytopharm Consulting submitted an comprehensive report on the kava ban, raising further doubts about the reliability of the benefit risk evaluation of the BfArM and other health authorities. The report was commissioned by the EU-institution CDE (Center for Development of Enterprise), on behalf of the Pacific Islands Forum Secretariat (PIFS) and some kava producing countries in the South Pacific, to critically evaluate whether the restrictions placed on kava by some European health authorities are justified. Among other things, it included an expert report on the pharmacological and clinical documentation of kava and a detailed case analysis of the reported cases of hepatotoxic events. The findings presented in the Phytopharm report In Depth Investigation on EU Member States Market Restrictions on Kava Products clearly speak for the safety and efficacy of kava for the claimed indication and, in most aspects, confirmed the scientists regarding the kava ban as unjustified. Furthermore, the authors criticized the German health authority for having ignored and misinterpreted important scientific data in their evaluation and for giving kava an obviously distorted image.
Due to the findings presented in the Phytopharm report and the negative socio-economic impact in the developing kava producing countries of the South Pacific, caused by the ban of kava, the CDE together with PRO€INVEST organized the first International Kava Stakeholder Meeting in Brussels, in August 2003. There, the stakeholders decided to join forces in an international organization that should organize and co-ordinate all further actions and keep kava stakeholders and interested parties updated. In November 2003, the International Kava Executive Council (IKEC) was officially established.