Germany, Palisi, and the Kava Act of 2002
Kava extract preparations have a history of over 130 years of medicinal use in europe. An estimated 450 million doses were consumed between 1991-2001. Prior to the year 2000, there was no known risk of any clinical significance, and kava was considered exceptionally safe [1]. In June 2002 BfArM (German Drug Regulatory Board) issued direction to completely remove all kava-containing, and kavain-containing drugs from the market. This direction cited “Undesirable effects on the liver” including acute toxic hepatitis, liver failure, and cases of transplantation [2]. Mold, pesticides and other contaminants were thought to have contributed to this situation [3], however at the time a swap had been made in kava variety. A change was made from beverage grade kavas, to non-beverage grade, also known as “Palisi”. These strains were used due to their high kavalactone contents and higher biomass as well as faster maturation times. The first harvests of this variety of kava for extraction by European drug companies coincides with the beginning occurrence of liver injury case reports in 1999-2000 in Switzerland [4].
Hold on a minute, does that mean kava is unsafe?
No, first of all because this pertains to kava extracts, and second because Vanuatu took action about the issue by creating and enacting the “Kava Act of 2002”. This document set rules that prevents the causal export of non-noble or non-beverage grade kavas [5]. This, combined with the German ban itself, put the proverbial breaks on the sale and export of these kavas to be extracted with solvents that were not suitable for daily drinking. Due to these and other efforts, in 2014 a German court ruled that banning kava was inappropriate, and the harms were best attributed to lack of product quality control, not inherent harm associated with appropriately sourced and manufactured products. Currently, in Germany, the law stands that kava can only be used under a prescriber’s direction, and not for self-care or recreational use, however it is not explicitly banned [6].
It’s obvious something happened which caused these severe reactions in the late 90s early 2000s, however it seems that the actions taken have reduced or eliminated the mass instances of acute liver injury, as evidenced by the lack of reports pertaining to it. The industry has matured and the knowledge of proper kava varieties and product quality has been disseminated from regulators and exporters all the way to the consumer level.
[1] Kuchta, Kenny, Marie Hladikova, Michael Thomsen, Adolf Nahrstedt, and Mathias Schmidt. 2021. “Kava (Piper Methysticum) Extract for the Treatment of Nervous Anxiety, Tension and Restlessness.” Drug Research 71 (2): 83–93.
(https://doi.org/10.1055/a-1268-7135.)
[2] BfArM. 2002. “Kava Removal.”
http://lrd.spc.int/ahp-publications/doc_download/578-gr-cis-bfarm-kava-removal.)
[3] Teschke, Rolf, Samuel X. Qiu, and Vincent Lebot. 2011. “Herbal Hepatotoxicity by Kava: Update on Pipermethystine, Flavokavain B, and Mould Hepatotoxins as Primarily Assumed Culprits.” Digestive and Liver Disease: Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 43 (9): 676–81.
(https://doi.org/10.1016/j.dld.2011.01.018.)
[4] Thomsen, Michael, and Mathias Schmidt. 2021. “Health Policy versus Kava (Piper Methysticum): Anxiolytic Efficacy May Be Instrumental in Restoring the Reputation of a Major South Pacific Crop.” Journal of Ethnopharmacology 268 (March): 113582.
(https://doi.org/10.1016/j.jep.2020.113582.)
[5] Vanuatu. 2002. “Kava Act 2002.” 7. Republic Of Vanuatu.
(https://biosecurity.gov.vu/images/Export/kava-act-2002.pdf.)
[6] White, C. Michael. 2018. “The Pharmacology, Pharmacokinetics, Efficacy, and Adverse Events Associated With Kava.” Journal of Clinical Pharmacology 58 (11): 1396–1405.
(https://doi.org/10.1002/jcph.1263.)
Kava extract preparations have a history of over 130 years of medicinal use in europe. An estimated 450 million doses were consumed between 1991-2001. Prior to the year 2000, there was no known risk of any clinical significance, and kava was considered exceptionally safe [1]. In June 2002 BfArM (German Drug Regulatory Board) issued direction to completely remove all kava-containing, and kavain-containing drugs from the market. This direction cited “Undesirable effects on the liver” including acute toxic hepatitis, liver failure, and cases of transplantation [2]. Mold, pesticides and other contaminants were thought to have contributed to this situation [3], however at the time a swap had been made in kava variety. A change was made from beverage grade kavas, to non-beverage grade, also known as “Palisi”. These strains were used due to their high kavalactone contents and higher biomass as well as faster maturation times. The first harvests of this variety of kava for extraction by European drug companies coincides with the beginning occurrence of liver injury case reports in 1999-2000 in Switzerland [4].
Hold on a minute, does that mean kava is unsafe?
No, first of all because this pertains to kava extracts, and second because Vanuatu took action about the issue by creating and enacting the “Kava Act of 2002”. This document set rules that prevents the causal export of non-noble or non-beverage grade kavas [5]. This, combined with the German ban itself, put the proverbial breaks on the sale and export of these kavas to be extracted with solvents that were not suitable for daily drinking. Due to these and other efforts, in 2014 a German court ruled that banning kava was inappropriate, and the harms were best attributed to lack of product quality control, not inherent harm associated with appropriately sourced and manufactured products. Currently, in Germany, the law stands that kava can only be used under a prescriber’s direction, and not for self-care or recreational use, however it is not explicitly banned [6].
It’s obvious something happened which caused these severe reactions in the late 90s early 2000s, however it seems that the actions taken have reduced or eliminated the mass instances of acute liver injury, as evidenced by the lack of reports pertaining to it. The industry has matured and the knowledge of proper kava varieties and product quality has been disseminated from regulators and exporters all the way to the consumer level.
| Update from Dr. Schmidt |
|---|
| After speaking to Dr. Mathias Schmidt in regards to the legality of kava in Germany at present, it seems BfArM, through a number of new decisions are now attacking kava again at different regulatory angles. One approach was to simply use the same arguments as the ban in 2002. It's been contested in court, and they are currently waiting for the courts to convene because they've been out for Covid. Currently kava is not available as a prescription or otherwise. (M. Schmidt, personal communication, May 27, 2021) |
[1] Kuchta, Kenny, Marie Hladikova, Michael Thomsen, Adolf Nahrstedt, and Mathias Schmidt. 2021. “Kava (Piper Methysticum) Extract for the Treatment of Nervous Anxiety, Tension and Restlessness.” Drug Research 71 (2): 83–93.
(https://doi.org/10.1055/a-1268-7135.)
[2] BfArM. 2002. “Kava Removal.”
http://lrd.spc.int/ahp-publications/doc_download/578-gr-cis-bfarm-kava-removal.)
[3] Teschke, Rolf, Samuel X. Qiu, and Vincent Lebot. 2011. “Herbal Hepatotoxicity by Kava: Update on Pipermethystine, Flavokavain B, and Mould Hepatotoxins as Primarily Assumed Culprits.” Digestive and Liver Disease: Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 43 (9): 676–81.
(https://doi.org/10.1016/j.dld.2011.01.018.)
[4] Thomsen, Michael, and Mathias Schmidt. 2021. “Health Policy versus Kava (Piper Methysticum): Anxiolytic Efficacy May Be Instrumental in Restoring the Reputation of a Major South Pacific Crop.” Journal of Ethnopharmacology 268 (March): 113582.
(https://doi.org/10.1016/j.jep.2020.113582.)
[5] Vanuatu. 2002. “Kava Act 2002.” 7. Republic Of Vanuatu.
(https://biosecurity.gov.vu/images/Export/kava-act-2002.pdf.)
[6] White, C. Michael. 2018. “The Pharmacology, Pharmacokinetics, Efficacy, and Adverse Events Associated With Kava.” Journal of Clinical Pharmacology 58 (11): 1396–1405.
(https://doi.org/10.1002/jcph.1263.)
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