State of The Kava Ban in Germany
Where do we stand at the moment with Germany and their ban?
If you’ve been following along you will know that the “global” ban on kava began with the German regulators of The Federal Institute for Drugs and Medical Devices also known as “BfArM” [1]. This action was contested even from within its own organization [2]. Originally the ban was based on liver toxic adverse event reports, however after further expert analysis nearly all of the adverse reports were found to be lacking in very important ways [3]. It is most crucial to understand that ethanolic extracts of kava roots and rhizomes have been used for over 100 years in Germany without a single case report of liver toxicity until the year 1999 [4]. Reports after that time indicated a good safety profile from kava extracts [5]. Be that as it may, BfArM has now doubled down by instead saying now that kava lacks efficacy in regards to anxiety, which completely removes its “benefit” when considering “benefit to risk” ratio [6]. This action has placed kava automatically in the “risk” category solely due to legislation, and not based on reality, or any actual risks involved with kava at all.
You heard that right. Germany no longer considers kava to be hepatotoxic (liver damaging) due to the fact that there was not enough evidence to say so to begin with. That begs the question “then why on earth is it still banned?”. 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 [6].
Really makes you think of the countries which 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 at the 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.
To sum it all up, kava’s ban was based entirely on speculation with no real facts to support it. When faced with this, the German board BfArM has decided to delegitimize the safety and efficacy studies of the 90s and instead will approach kava as if it is an entirely new compound. They’re now completely ignoring the thousands of years of safe consumption, while also holding firm the stance of kava not being efficacious towards the relief of anxiety even though empirical evidence and scientific studies say otherwise.
Germany, and more specifically BfArM, please make up your mind. First you told us kava was safe, then it’s dangerous, now you’re saying it’s not dangerous and that it just doesn’t “work”? I’m 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.
