FWD 2 HerbalGram: Kava Stakeholders Plan Regulatory Review and Market Return


Issue: 61 Page: 69-70

Kava Stakeholders Plan Regulatory Review and Market Return

by Joerg Gruenwald

HerbalGram. 200461:69-70 American Botanical Council


The roads of the Fiji islands of Taveuni are empty these days. A thriving economy based on the export of the traditional Pacific crop kava (Piper methysticum G. Forst., Piperaceae) collapsed in 2001 due to allegations in Europe that the plant extract caused liver toxicity.1 This shocked native island people as their ancestors had been drinking kava extracts for thousands of years for ceremonial and social purposes without such apparent effect. An explanation of this surprising turn of events was suggested at the recent meeting in Brussels, Belgium, of Pacific and European kava stakeholders.

The first-ever European-Pacific Kava Stakeholders meeting was held in Brussels on August 25 and 26, 2003, organized by the European Centre for the Development of Enterprise (CDE) and PRO€INVEST, both based in Brussels. The main objective of the meeting was to explore ways to re-establish the kava trade between the European Union (EU) member states and South Pacific countries. A major focus of discussion was the main findings of the study entitled "In-Depth Investigation of EU Member States Market Restrictions on Kava Products" (Phytopharm Report) presented by Phytopharm Consulting at the end of March 2003. The entire report can be downloaded from <www.analyze-realize.com/Publications/Kava.en.html>.2

The report was commissioned by the EU CDE, on behalf of some kava-producing countries in the South Pacific and the Pacific Island Forum Secretariat (PIFS), to critically evaluate whether or not the restrictions placed on kava by some European health authorities are justified. It included an independent expert report on the pharmacological and clinical documentation of kava (Phytopharm Report part IIA and B) and a detailed case analysis of all reported cases of hepatotoxic events (Phytopharm Report part IIA Annex 1). The findings presented in the Phytopharm Report clearly speak for the safety and efficacy of kava in the symptomatic treatment of anxiety and stress and, in most aspects, strongly supported the scientists’ charges that the kava ban was not justified based on the available scientific and medical evidence. Furthermore, the report criticized the German health authority (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM, the Federal Institute for Drugs and Medical Devices) for having ignored and misinterpreted important scientific data in its evaluation and for creating an obviously distorted image for kava.

The meeting brought together key participants from the Pacific Region and Europe, representing a cross section of stakeholders, namely European manufacturers, regulatory agencies, kava exporters, scientists and experts, and organizations such as the CDE, PRO€INVEST, PIFS, Commonwealth Secretariat (COMSEC), European Commission (EC), the World Health Organization (WHO), and the Technical Centre for Agricultural and Rural Cooperation ACP-EU (CTA). The meeting also reviewed alternative strategies that might be used to reintroduce kava into European markets, established a detailed action plan, and identified the possible roles and contribution of the different organizations and representatives in achieving these goals.

Kava Strategy: The Way Forward

The stakeholders acknowledged the significant economic, social and cultural damage done by the market recalls, restrictions, and bans. They noted that the negative publicity from the numerous kava bans, alerts, and market recalls had led to an adverse economic impact for the South Pacific kava industry predominantly located in Fiji, Samoa, Tonga, and Vanuatu. Since 2001 loss of local export earnings in the South Pacific was more than US$200 million, and many thousands of jobs in both the South Pacific and Europe. The ban especially affected the incomes of rural farmers and processors as well as foreign exchange, as exports are seriously adversely affected. The meeting further noted the loss of business for the European importers.

The participants also endorsed the findings of the Phytopharm Report, and agreed to use its scientific evidence, which clearly indicate that the bans, sales restrictions, and market recalls by the regulators in respective EU countries were unjustified (see Table 1). Such bans and restrictions also ignored the huge body of positive evidence on efficacy and safety of kava.

The stakeholders agreed to establish an International Kava Executive Committee (IKEC) comprising representatives of the stakeholders and organizations to address immediate and future issues relating to the management of kava as proposed in the strategy of the Phytopharm Report (see Figure 1).

Those present also adopted the proposed strategy in the Phytopharm Report presented in Figure 2 and the summarized and amended version of this strategy performed by the representative of the Pacific Islands Forum Secretariat.

As a matter of immediate priority, the stakeholders agreed to undertake the following actions:

1. Establish an International Kava Executive Committee (IKEC) of EU and Pacific members to implement the coordinated strategy for re-establishing the kava market in Europe, consisting of the following:

Pacific Islands Stakeholders

• Four Pacific Island countries:

— Josateki Nawalowalo (Fiji Kava Council);

— Eddi Wilson (Samoa Association of Manufacturers and Exporters);

— Toimoana Takataka (Tonga Kava Council);

— Frank King (Vanuatu Kava Exporters Association);

• Pacific Islands Forum Secretariat.

European Stakeholders

• Barbara Steinhoff (Bundesverband der Arzneimittelhersteller or German Medicines Manufacturers’ Association);

• Mathias Schmidt (Representative of the Kava Industry);

• Anthony Bush (European Federation of Health Product Manufacturers Associations);

• Carlo Sessa (Associazione Italiana fra Coltivatori, Raccoglitori, Trasformatori, Importatori, Esportatori, Grossisti e Rappresentanti di Case Estere di Piante Medicinali e Aromatiche or Italian Medicinal and Aromatic Plants Producer and Traders Association).

Executive Director

• Joerg Gruenwald (Phytopharm Consulting)

2. Request funding from CDE/PRO€INVEST for Phytopharm to become the active coordinator of the activities in Europe.

3. Take immediate steps in addressing the following:

• Provide German and other relevant authorities with the Phytopharm Report;

• Pacific members to request WHO for a re-evaluation of safety and efficacy of kava by an independent expert commission;

• CDE/PRO€INVEST to support the proposed strategy by providing technical assistance, and lobbying support to the IKEC.

4. Use the scientific evidence to dispel fears of harm from kava and kava-based products.

5. Encourage a plan of action to strengthen the kava industry in the Pacific with appropriate training programs and standards compliance.

6. Secure funding from International Donor Agencies to initiate various activities.

7. Circulate the Phytopharm Report as widely as possible, including those EU countries that have not banned kava, to use the report to prevent any future bans.

Finally, the stakeholders expressed their sincere appreciation to the CDE, PRO€INVEST, and PIFS for their effective roles in undertaking the study and organization of the meeting. The meeting also acknowledged the ongoing support of these organizations and others such as COMSEC, WHO, and the EU in addressing the problems associated with kava and kava products.

Joerg Gruenwald is president of Phytopharm Consulting, a specialized business consulting company for herbal medicine, dietary supplements, and functional foods. He is author of the international reference work for botanical medicines Physician Desk Reference for Herbal Medicines, co-editor of The Complete German Commission E Monographs, and editor in chief of Advances in Natural Therap. Dr. Gruenwald is the executive director of the International Kava Executive Committee. He can be reached at Phytopharm Consulting, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: <jgruenwald@phytopharm.org>; website: < www.analyze-realize.org>.

References:

1. Blumenthal M. Kava safety questioned due to case reports of liver toxicity. HerbalGram 2002;55:26-32.

2. Gruenwald J, Mueller C, Skrabal J. In-Depth Investigation of EU Member States Market Restrictions on Kava Products. Phytopharm Consulting, 2003. Accessed December 2, 2003 at URL: <www.analyze-realize.com/Publications/Kava.en.html>.