Kava in Germany: from love to divorce
The genesis of a certain scandal
If you have searched for information about Kava Kava on the internet, you have certainly come across the opinion that Kava is harmful to the liver, i.e. that Methystine Pepper is hepatotoxic. Let’s take a closer look at the origins of this – unfortunately – rather strongly spread assessment and the current state of research on the subject.
Although the opinion on Kava’s hepatotoxicity has a global impact, it has its most serious consequences in Europe. It also has its – nomen omen – roots here: is directly linked to an unclear decision by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM), announced in 2002 and banning the sale of medicinal products containing Kava. The ban was lifted by a federal court in 2014, but de facto it is still in force. How? Let’s find out!
Kava Kava in Germany
In Germany, Kava Kava was quite widely used in the practice of relieving anxiety symptoms for about 100 years – mainly in the form of ethanol extracts. It even became a commercial product: it is estimated that up to 70 million daily doses of Kava were consumed in Germany . Until 1998, there was no documented case of liver toxicity. 
Until suddenly in the early 2000s, there were reports of cases of severe liver damage and the BfArM decided to withdraw Kava extracts from the market. The decision was questioned even within the BfArM itself. As thorough expert reports showed, almost all reports of hepatotoxicity were seriously lacking. 
The case was taken up by the German Federal Administrative Court with a ruling in 2014. The ruling stated that the claim of Kava’s hepatotoxicity in the reported cases was a gross misrepresentation of Kava’s possible effects. The case was serious in that the reported cases were alleged to have led to deaths. The Federal Court ruled that Kava was unlikely to have caused the reported deaths and that the liver damage caused by Kava was so rare that it could be overlooked. The ban was “unlawful and inappropriate” and was lifted. 
Safety of Kava according to German researchers
Two studies and their summaries are worth citing in this context.
Is the alkaloid pipermethystine connected with the claimed liver toxicity of Kava products?
– M Lechtenberg, B Quandt, M Schmidt, A Nahrstedt
Publisched: Pharmazie, 2008 Jan. [SOURCE]
The pyridone alkaloid pipermethystine has been considered to be responsible for alleged hepatoxicity of Kava products. Investigation of a series of retain samples of finished products from the German market and self-produced extracts from root and stem material of Piper methysticum clearly showed that pipermethystine (1) is absent from all root and retain samples and extracts, with a limit of quantification of 45 ppm. As a positive control, leaves of P. methysticum showed an amount of 0.2% of 1. Thus, if there is any hepatotoxicity, compound 1 should not be the responsible constituent in the case reports with ethanolic extracts produced in Germany.
German Kava Ban Lifted by Court: The Alleged Hepatotoxicity of Kava (Piper methysticum) as a Case of Ill-Defined Herbal Drug Identity, Lacking Quality Control, and Misguided Regulatory Politics
– K. Kuchta, M. Schmidt, A. Nahrstedt
Publisched: Planta Med 2015; 81(18): 1647-1653 [SOURCE]
Kava, the rhizome and roots of Piper methysticum, are one of the most important social pillars of Melanesian societies. They have been used for more than 1000 years in social gatherings for the preparation of beverages with relaxing effects. During the colonial period, extract preparations found their way into Western medicinal systems, with experience especially concerning the treatment of situational anxiety dating back more than 100 years. It therefore came as a surprise when the safety of kava was suddenly questioned based on the observation of a series of case reports of liver toxicity in 1999 and 2000. These case reports ultimately led to a ban of kava products in Europe – a ban that has been contested because of the poor evidence of risks related to kava. Only recently, two German administrative courts decided that the decision of the regulatory authority to ban kava as a measure to ensure consumer safety was inappropriate and even associated with an increased risk due to the higher risk inherent to the therapeutic alternatives. This ruling can be considered as final for at least the German market, as no further appeal has been pursued by the regulatory authorities. However, in order to prevent further misunderstandings, especially in other markets, the current situation calls for a comprehensive presentation of the cardinal facts and misconceptions concerning kava and related drug quality issues.
German Kava blockade: the twisted logic of the ban
However, the expert reports and the court judgment have not ended the de facto blockade of Kava on the German market. Although the BfArM no longer insists on the claim of Kava’s hepatotoxicity, it… now claims that Kava has no efficacy in the treatment of anxiety. As an ingredient in medication, it shows no benefit, so it was classified as a risk. And so the ban was upheld.
Why the sudden change in approach? As Kava Kava expert Jimmy Price describes [SOURCE]
Well BfArM has decided that all of the doubled-blinded placebo controlled studies of the 1990s are now “not conforming to recent standards”. Those “recent standards” were enacted AFTER the clinical studies on kava extracts were performed. Kava, having shown an excellent safety profile, should have been grandfathered in and the courts argued that “The authority cannot withdraw its decision just because therapeutic guidelines may have changed at some later date”. According to Kuchta et al the entire issue could have been solved by running a new clinical trial, however BfArM would not authorize any such study due to its own false “safety concerns”, basically delaying the authorization into infinity. It’s important to underline that the denial of efficacy did NOT relate to kava and its pharmacological effects. This was only related to the specific herbal medicinal products on the market. BfArM is now treating kava extract preparations as completely unknown entities with no data whatsoever, ignoring the years of successful clinical trials, while at the same time saying it’s ineffective at treating anxiety by ignoring previous and even current research as well.
The result: the German blockade relies on studies it does not itself recognise and limits new analyses.
Kava's hepatotoxicity in drugs? Something to compare!
Although Kava Kava is not a drug, many people find it soothing – mentally as well as physically. It seems legitimate, therefore, to juxtapose reports of its hepatotoxicity with popular drugs throughout Europe. As researcher S Apo Aporosa describes in his article De-mythologising and re-branding of kava as the new ‘world drug’ of choice [SOURCE]
A comparison with Diazepam, a widely prescribed benzodiazepine that has similar effects to kava, is useful at this point. Schmidt et al. (2005), who investigated 83 kava toxicity reports that had been influential to initiating the Kava Ban in Europe, pointed out that: ‘only three cases could be attributed to kava with high probability’. Of these cases it was suspected that other factors were responsible for the negative reaction (Schmidt et al., 2005: 182). The study reported 12 ‘probable’ cases of liver failure would account for a kava toxicity rate ‘of 0.23 cases per 1 million daily doses’ (187). Schmidt and colleagues note that at the time of the European Kava Ban, diazepam toxicity rates accounted for 2.12 cases of per million daily doses (187). In another study, kava hepatotoxicity rates were compared with that of Paracetamol/Panadol. In that study, Rasmussen (2005) reported that these commonly prescribed over-the-counter pain medications accounted for ‘an estimated 458 deaths due to acute liver failure in the U.S. each year’, and summarized that kava was ‘dramatically’ safer than the popular readily available analgesic’s.
Kava in Europe and in the world
Kava’s German fascination and relationship of over a century ended in a surprisingly quick divorce. On top of that, not approved by the court.
For many Kava fans, a situation in which, after so many years, there are suddenly (from one year to the next) dozens of applications, falsely interpreted/classified, introducing an ‘unlawful and inappropriate’ ban – that, despite the verdicts, continues for another decade – is a bit too many coincidences at once.
The German policy towards Kava – astonishingly radical and at the same time full of internal contradictions – has cast a shadow over Kava’s reputation not only in Europe. Many European institutions have invoked German decisions in shaping their own approach to the status of Methistine Pepper. Fortunately, global attitudes towards drinking traditional Kava and its medicinal uses are slowly changing. In the US, kava bars are steadily growing in popularity, both in big cities and smaller centres. On the other side of the Pacific, Australia, the market for the commercial importation of Kava opened at the end of 2019, a long-awaited decision for the entire region. It will certainly translate into the worldwide popularisation of Kava.
On the other hand, scientists and doctors value the analgesic and anti-anxiety potential of Methistine Pepper so much that they are looking for ways to massify its cultivation with bacteria and yeast  – to use Kava in the production of medicines, among other things. The world is moving in the right direction!
 Edzard Ernst, MD, PhD, Dep. of Complementary Medicine, University of Exeter, UK – Second thoughts about kava, To the Editor, ©2002 by Excerpta Medica, Inc. – LINK
 State of The Kava Ban in Germany – Jimmy Price – LINK
 Coulter, David, Tamayo Carmen Sotheeswaran Subramaniam, Catherine Ulbricht, and World Health Organization. 2007. “Assessment of the Risk of Hepatotoxicity with Kava Products.pdf.” World Health Organization. https://apps.who.int/iris/handle/10665/43630.
 Compare: German court overturns kava ban – LINK
 Uncovering the riches of traditional global medicine – LINK