State of The Kava Ban in Germany

Where do we stand at the moment with Germany and their ban?

As you probably know, the "global" prohibition of kava was instigated by the German regulatory body, The Federal Institute for Drugs and Medical Devices, commonly known as "BfArM" [1]. This measure met resistance even within the organization itself [2]. Originally, the ban was founded on reports of liver toxicity, but subsequent expert analysis revealed that the majority of these reports lacked crucial details [3]. It is essential to note that ethanolic extracts of kava roots and rhizomes have been utilized in Germany for over a century without any documented cases of liver toxicity until 1998 [4]. Post-2004 reports have indicated a favorable safety profile for kava extracts [5]. Nevertheless, BfArM has opted to repeat its stance by claiming that kava is ineffective in treating anxiety, thereby negating its "benefit" when weighing the "benefit to risk" ratio [6]. This decision arbitrarily placed kava in the "risk" category solely because of legislation and not based on reality or any factual risks associated with kava.

You heard that right. It has now been confirmed that Germany no longer perceives kava to be hepatotoxic (liver-damaging) because of the lack of adequate evidence supporting such a claim. This raises the question of why the ban on kava is still in place. The Federal Institute for Drugs and Medical Devices (BfArM) has asserted that the double-blinded, placebo-controlled clinical trials conducted in the 1990s are no longer in accordance with current standards, which were implemented AFTER the clinical studies on kava extracts were conducted. Given kava’s excellent safety profile, it should have been exempted from the current regulations, and the courts contended that "the authority cannot retract its decision merely because therapeutic guidelines may have changed at some later date." According to Kuchta et al, the situation could have been remedied by conducting a new clinical trial; however, BfArM declined to authorize any such study, citing spurious "safety concerns," effectively delaying the authorization indefinitely. It is important to emphasize that the denial of efficacy did not relate to kava and its pharmacological effects. Rather, it was only linked to specific herbal medicinal products on the market. BfArM is now treating kava extract preparations as entirely unknown entities with no available data, disregarding years of successful clinical trials, while simultaneously asserting that kava is ineffective in treating anxiety by ignoring both past and present research [6].

Really makes you think of the countries that followed Germany’s lead and removed kava-containing products from their shelves. Currently, as it would stand, their reasoning for this ban has been overturned in German courts; hence, there is now no legal backing to any of these bans and liver warnings, including the one we see here in the United States.

In summary, the prohibition of kava was founded entirely on unfounded conjecture, lacking any factual basis. In response to this, the German regulatory agency, BfArM, has chosen to discredit the safety and efficacy studies conducted in the 1990s, opting to view kava as a novel compound. In doing so, they have completely disregarded the thousands of years of safe kava consumption, while simultaneously maintaining the belief that kava is not effective in alleviating anxiety, despite empirical evidence and scientific research to the contrary.  

Germany, and more specifically BfArM, please reconsider. First you told us kava was safe, then it was dangerous. Now you’re saying it’s not dangerous and that it just doesn’t “work”? I am sure you can see how consumers and professionals alike are likely beginning to not take your word as the gold standard.

[1] BfArM. 2002. “Kava Removal From The European Market.” https://paperpile.com/app/p/bbd8e112-e58b-0900-820b-70cf426b817b

[2] Various. 2002. “Statement on Kava-Kava by the Members of the Commission E at the BfArM.” https://web.archive.org/web/20030901220234/http:/www.spc.int/cis/documents/Rebuttal_by_CommE_702.pdf.

[3] 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.

[4] Lewin L.ÜberPiper methysticum(Kawa-Kawa). Berl Klin Wschr 1886;1: 7–10

[5] Sorrentino, L., A. Capasso, and M. Schmidt. 2006. “Safety of Ethanolic Kava Extract: Results of a Study of Chronic Toxicity in Rats.” Phytomedicine: International Journal of Phytotherapy and Phytopharmacology 13 (8): 542–49. https://doi.org/10.1016/j.phymed.2006.01.006.

[6] Kuchta, Kenny, Mathias Schmidt, and Adolf Nahrstedt. 2015. “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.” Planta Medica 81 (18): 1647–53. https://doi.org/10.1055/s-0035-1558295.