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June 1, 2004
By: Sean Moloughney
Editor, Nutraceuticals World
On April 1st, in Berlin, Germany, a delegation from the Pacific, headed by the Fiji High Commissioner to the U.K. and the Samoan Ambassador to Germany and High Commissioner to the U.K., met with German Deputy Health Minister Dr. Klaus Theo Schroeder for talks regarding the kava ban. Together with scientists, practitioners and representatives of the International Kava Executive Council (IKEC), the delegation discussed the requirements that will have to be met in order for kava to be made available again for patients suffering from stress, restlessness and mild degrees of anxiety. In the constructive discussions, it was agreed that further research activities would focus on the safety of kava first, before discussing its efficacy. While in Germany the question of efficacy is a major part of the debate, this is of less importance in other countries where it was not available through a doctor’s prescription and where the decisions to withdraw the products from the market were based on safety alone. As a result, the participants made a commitment to re-evaluate the safety of kava within the next six months. Deputy Health Minister Dr. Schroeder, therefore, called on representatives of the German Health Ministry, the IKEC and independent experts in the field of pharmacology and toxicology to come together to determine the appropriate design for the generation of new data. The results of the toxicological research being proposed may also contribute to the kava safety evaluations in other countries where it is currently prohibited or under debate. This was concluded in a meeting of the delegation with the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), which took place on April 2nd in London, U.K. In these talks, the MHRA expressed considerable interest in the German approach to creating new data, and advised that the agency welcomed a dialogue on this issue and will consider the results of all new research. These talks are only one part of a broad program of action organized by IKEC on behalf of the kava-producing Pacific Islands States that are currently suffering from drastic socioeconomic consequences of the kava ban; the Pacific Islands States lost about 20% of their gross national product (GNP) almost overnight as a result of the ban. (For more information, see this month’s Eurotrends column on page 24.)
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