Kava in Germany: the ban, the court case, and what followed

2023-02-24 · 5 min read

By the kava.fyi editorial team · Last updated: 24 February 2023

A hundred years of legal use

If you search for information about kava online, sooner or later you will run into the claim that the plant damages the liver. That view has a specific, historical source, and it is bound up above all with Germany. Before the ban, though, kava (Piper methysticum) had long been an established product there. Ethanol extracts of its root were used to ease anxiety symptoms for close to a hundred years, and according to estimates cited by the researcher Edzard Ernst of the University of Exeter, as many as 70 million daily doses of kava were taken in Germany alone each year. Up to 1999, not a single documented case of serious hepatotoxicity linked to these preparations had been recorded.

A sudden turn at the turn of the century

Around the turn of 1999 and 2000, reports of serious liver damage began reaching Germany's Federal Institute for Drugs and Medical Devices, known by its abbreviation BfArM, in several cases ending in death or a transplant. The institute reacted quickly: in 2002 it withdrew from the market all medicinal products containing kava extracts. The decision had wide repercussions, since Germany was at the time the largest European market for the plant, and other countries, including France and Switzerland, based their own restrictions directly on the German assessment.

The trouble is that once scientists began closely analysing the reported cases, the picture stopped being clear-cut. A team led by Lechtenberg, with Quandt, Schmidt and Nahrstedt, examined a series of products withdrawn from the German market, along with extracts they had prepared themselves from kava root and stem, for the presence of pipermethystine, an alkaloid to which the toxicity had been attributed. Results published in the journal Pharmazie in 2008 showed that pipermethystine was absent from all tested root and stem samples, at a detection limit of 45 parts per million. So whatever compound was responsible for the reported toxicity, it was certainly not this particular alkaloid, at least not in extracts produced in Germany from traditional raw material.

The administrative court's ruling

The case went to a German administrative court, which ruled in 2014. The court found that BfArM's decision to withdraw kava from the market had been, literally, unlawful and improper. In the court's assessment, the risk of liver damage from kava was rare enough to be disregarded, and the institute had not produced convincing evidence that kava, rather than other factors, was responsible for the reported cases. An analysis by Kenny Kuchta, Mathias Schmidt and Adolf Nahrstedt, published in 2015 in the journal Planta Medica, describes the case as an example of poorly defined herbal-material identity, a lack of quality control and flawed regulatory policy, rather than a genuine health hazard. It also notes that decades of prior clinical experience with kava in treating situational anxiety were largely ignored during the proceedings.

The ruling was not appealed, which makes it final, at least for the German market. Radio New Zealand, reporting on the ruling, quoted the researcher Vincent Lebot of Vanuatu, who stressed that the regulator's overreaction cost Pacific kava growers hundreds of millions of dollars, since further European Union countries followed the German ban.

The ban officially lifted, but the market still blocked

What happened next may be the most instructive part of this story. After the ruling, BfArM stopped claiming outright that kava was hepatotoxic, but began arguing instead that kava, as an ingredient in medicines, did not show sufficient efficacy in treating anxiety, and that without a demonstrated benefit, even a minimal risk stopped being justified. In practice, this meant that despite losing in court, kava medicines never fully returned to the German pharmaceutical market.

For comparison, it is worth citing figures raised by the researcher S. Apo Aporosa in an article published in 2019 in the journal Drug Science, Policy and Law. The author cites a 2005 analysis by Schmidt and colleagues, according to which, of the 83 reports on which the European ban was based, only three cases could be attributed to kava with high probability, corresponding to a toxicity rate of around 0.23 cases per million daily doses. By comparison, over the same period the toxicity rate for diazepam, a commonly prescribed benzodiazepine, was estimated at 2.12 cases per million daily doses, and paracetamol was linked in the United States at the time to around 458 deaths a year from acute liver failure.

Kava's status in Europe today

It is worth remembering that in the European Union, kava does not have formal novel-food status, which on its own makes it hard to sell legally as a food product in many member states. In Poland the situation is even clearer: kava (listed in the regulation as kava kava) appears on the list of substitute substances banned from being placed on the market as food, under a regulation of the Minister of Health. In Germany, despite BfArM's court defeat, kava effectively functions as a prescription-only product rather than something sold freely. If you want to know how kava's liver safety looks in light of more recent research, see the article kava and the liver, and if you are wondering about interactions with pharmaceuticals, also read kava and medicines. You can find more on the plant itself in the article on kavalactones.

The German story of kava shows how hard it is to reverse an opinion once it has taken hold, even when a court formally sides with the other party. At the same time, the global trend is moving in the opposite direction: in Australia, the market opened to commercial kava imports at the end of 2019, and in the United States the number of kava bars keeps steadily rising, in both major cities and smaller towns.

This story is also a good lesson in caution on both sides. On one hand, it shows how easily a single, insufficiently verified cluster of reports can shape regulation across many countries at once, even when later analysis undermines its foundations. On the other hand, that does not mean kava is free of risk under all conditions. Cases of liver damage, though rare, did genuinely occur, and researchers point out that they were usually accompanied by additional factors: overdosing, prolonged use, taking other medicines at the same time, or simply poor-quality raw material. That is an important distinction, especially when comparing the traditional way of preparing the drink, a water extract of the root, with the industrial ethanol or acetone extracts that dominated the German pharmaceutical market before 2002.