by Mala Coomar
The German “kava ban” was notorious within the world of kava and, from afar, could be interpreted by the international community as meaning that kava is dangerous. Critically, it also could be seen as setting a precedent that the increasing popularity and accessibility of kava outside the Pacific Islands should be responded to with regulation and restriction.
Upon taking a closer look at that former “ban”, it can be seen that the policy was neither truly a ban nor was it referring at all to the kava plant or the traditional kava beverage. What was commonly understood as a ban was actually a marketing authorization withdrawal. And what was commonly understood as “kava” overall was actually herbal medicinal products prepared with or containing kava extracts. In any case, the so-called kava ban was overturned in 2014 when—upon a closer and more thorough investigation—it was determined that the ban was illegal.
Outside of the Pacific Islands, kava has been utilized for purposes beyond the traditional and ceremonially/socially important kava beverage made from kava root and water. During the colonial period, kava extract preparations found their way into medicinal systems in Europe where kava extract preparations were available as a registered drug marketed and prescribed for the treatment of situational anxiety.
During the 1990s, kava products were used as registered drugs for the treatment of anxiety problems in Europe, especially in Germany and Switzerland. Their interactions with alcohol, barbiturates, and psychopharmacological agents were clearly indicated and, in 2001, there was an estimated annual use of over approximately 70 million daily doses in Germany and 100 million daily doses in Europe. Based on this specific usage, kava belonged to a group of the most commonly used herbal products worldwide and for a long time was regarded as safe when used as directed. Kava products’ effectiveness was well proven in “many properly performed placebo-controlled double-blind studies and the positive effects on mental health problems, especially anxiety [were] well documented.”
On November 8, 2001, the German Federal Institute of Drugs and Medical Devices (BfArM)—the German equivalent of the FDA—issued a letter to all manufactures of herbal medicinal products containing kava manufactured and marketed in Germany. The letter disclosed the BfArM’s intention to possibly withdraw the market authorization of these products. Their basis for the withdrawal was 26 cases of liver-toxic effects allegedly connected to herbal medicines containing kava. At the time, however, those cases were not published and the data was not available for review. Companies did not have much time to respond to the letter and lamented that “[t]he withdrawal of the marketing authorization would only be reasonable when it is assumed that kava has no benefit and the side effects are so severe that the benefit-risk-ratio is infinitely negative.”
Nevertheless in 2002, the German government began to implement its so-called ban on kava. Internationally, the ban was perceived as a decision to protect the consumer from the potential adverse effects of kava. However, it is important to highlight that the ban did not refer to the kava plant or traditional kava beverage per se but the herbal medicinal preparations of kava extracts available from certain German dispensaries with a medical prescription.
It is also important to highlight that the “ban” was actually “a withdrawal of marketing authorizations of medicinal products containing kava extracts.” In Germany, kava was never legal for personal or recreational use and was rather primarily used for medicinal purposes—kava was only available at certain dispensaries through a medical prescription. When the “ban” began, this meant that all permits for dispensing kava were withdrawn and all “affected medications” containing kava preparations were recalled. The consequences of this ban were widespread not only affecting the economics of Pacific Islands who produced kava plants but also affecting Europe where the ban suddenly “deprived physicians of an effective and comparatively safe medication ‘creating a therapeutic gap nobody wished for.’”
The reasoning for this was that Germany’s Federal Institute for Drugs and Medical Devices (BfArM)—the German equivalent of the FDA—found that “justified suspicion exists that these medications when used as indicated can have harmful effects, and that these effects, are in excess of the justifiable norm as based on medical science known today.”
Immediately after this policy was implemented, it was faced with resistance even from within the organization that ordered it. Commission E within the BfArM took issue with withdrawal of the license for medicinal products containing Kava and released a collective response disagreeing with the policy’s position. In their statement, the members of the commission—all of whom were experts in the field of phytopharmaceuticals—expressed their astonishment at the ban saying that they “consider that their scientific competence has been disregarded and that their function has been called into question.” Their statement goes on to say that “[i]n contrast to the BfArM, the members of the Commission E are convinced by the available scientific data on the efficacy of Kava-kava and assess the risk/benefit ratio and the therapeutic advantages for the patients as positive” and “[u]nlike the BfArM, the members of the Commission E are of the opinion that there was no imminent danger which justified such a measure.” The members closed their statement by reiterating their disagreement with the ban and closed with the recommendation that medical prescription status for medical products containing kava be reinstated.
The ban was faced with much resistance for the next 13 years. One comprehensive report on the German kava ban found that it was a case of ill-defined herbal drug identity, a lack of quality control, and misguided regulatory policies.
Marketing authorization holders submitted extensive documentation detailing that the ban was inappropriate. This was complemented by visits from several representatives from kava producing countries in the Pacific Islands who aimed to clarify the safety of kava and inappropriateness of the ban. In the end, the former marketing authorization holders filed a lawsuit against the BfArM at the administrative court of Cologne. All data and arguments surrounding the ban thus once again needed to be thoroughly examined.
It was found that a “[a] detailed analysis of the original documentations of the reports presented by BfArM as a justification for the ban clearly demonstrated that the assessment by BfArM was not performed properly. Several cases were reported as duplicates, but still counted as individual cases, thereby inflating the number of reported cases of liver damages.” They went on to report that the assessment was made through an ad hoc approach and “would have likely produced different results if applied by different assessors, which was the case with kava when the assessments of the very same cases by BfArM, the European Medicines Agency, and independent scientists were compared.” In other words, the exact same cases that were assessed and used by the BfArM to rationalize the kava ban were assessed by different evaluators and produced different conclusions than that of the BfArM. For instance, the BfArM’s evidence for supporting a ban on kava comprised of 26 cases allegedly connected to liver damage. However one pharmaceutical consultant company found only three could actually be linked to the ingestion of a product containing kava.
A case report in itself is not proof of causality and many reports could “be much more easily explained by known adverse effects of documented co-medications or alcohol abuse rather than by potential hepatotoxic effects of the kava preparations themselves.” Some institutions pointed out that “even under the assumption of a very real risk for the patient, a drug must not be removed from the market if all possible replacements for it carry (or might potentially carry) an even higher risk.” In the context of treating anxiety, benzodiazepines are potential clinical alternatives to herbal medicinal preparations of kava and can have much more severe side effects than that of herbal medicinal preparations of kava.
After a thorough investigation, the court had ruled that the BfArM “had not conclusively proven the causal relationship between kava preparations and the alleged liver damage.” Consequently, in June 2014, the German courts finally ruled that the “ban” of kava products was illegal and restored the German marketing authorizations to the same status they had in 2002.
The former German kava ban was an instance where a supposedly legitimate and trustworthy body conducted a shoddy investigation resulting in the implementation of a policy that was ultimately found illegal.
The hasty actions of the German government in 2002 were especially harmful because of the impact they had on the medical community in Germany where herbal medicinal products containing kava were appreciated as a safer alternative to more harmful pharmaceuticals.
The former ban also likely had a negative effect on the perceptions and regulations surrounding kava at large in the international community. The former ban arguably set a precedent that other countries likely took into consideration when deciding how to treat and classify kava.
Germany eventually listened to the resistance, revisited their investigation, and ultimately withdrew their former ban. Hopefully this sets a new precedent when it comes to kava where governments and regulating authorities take extra care when it comes to their own investigations surrounding the regulation of kava.
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