Remember the European kava ban and the effect it had on the kava industry in the years that followed? It’s worth looking at the risk-benefit of kava to consider whether that ban was fair.
The German government’s ban, finally reversed in June 2014 after 12 years, imposed an immediate withdrawal of marketing authorizations for products containing extracts of kava.
We argued all through that this ban made no sense, pointing out that we (and many people we know) had been taking kava for decades without any ill effects; and, going back further, Fijians had been drinking kava for centuries without problems. Quite the reverse in fact: kava is not only considered very safe, but has significant health benefits.
While the German authorities eventually came to the conclusion that there was no justification for the ban, some interesting statistics illustrate the risk-benefit of kava and the absurdity of the ban in the first place…
Kava dose numbers
An article on the HerbalEGram website, written by a prominent German herbal medicine researcher who was involved in the German court case on kava, says the following:
“By 2001, the overall retail sales of medicinal products containing kava had reached approximately 10% of that of benzodiazepines (conventional pharmaceutical anti-anxiety drugs), with a total of 450 million daily doses sold between 1991 and 2000, and no significant risks were observed. It therefore came as a surprise when, in 1999 and 2000, there were case reports of potential liver toxicity associated with ingestion of kava products, which then led to a so-called graduated plan procedure with the aim of examining risks and benefits of kava-containing preparations.”
That’s worth repeating: “450 million daily doses sold between 1991 and 2000, and no significant risks were observed.”
Which medicines out there could claim the same?
Risks and benefits of kava
Normally when the safety of pharmaceutical products is considered, there is an assessment of the risk-benefit. This was clearly not done in the case of the kava ban imposed in 2002:
“Benefit-risk assessments address not only the risk but also the efficacy of a pharmaceutical agent: when a benefit to the patient’s health is demonstrated, a risk may be deemed acceptable. This part of the equation led to misunderstandings on the international level with respect to kava.”
If the German government had considered the risk-benefit of kava around the world, then surely the above statistics would have prevented a ban?
Though there were, no doubt, complex regulatory issues at play, the 12-year ban had knock on effects around the world: kava farmers in Fiji, Vanuatu, Tonga, Samoa and elsewhere in the South Pacific rely heavily on exports for their livelihood.
The author of the above article believes that the German government did not examine the universal risk-benefit of kava, but only the few “specific medicinal products with German marketing authorizations”.
It was later proposed that these products may not have contained pure kava root/stem (the leaves contain toxins) or the preparation of the kava in these products may have released toxins not found in traditional preparations.
The court agreed and ended up ruling that the risk of liver toxicity from kava was considered “rare” or “very rare”. It also recognised its important role in relieving anxiety and stress.
We may not be able to draw a line under this issue yet, as the reversal of the ban has been appealed in Germany; but hopefully the relevant authorities start looking at the worldwide numbers as they consider the risk-benefit of kava in future.