LOS ANGELES, Aug. 12, 2024, representing the interests of kava producers, advocates, scientists and consumers around the world, welcomes a landmark decision by the German court on 18 June 2024, removing arguments for long-standing restrictions imposed by BfArM (the Federal Institute for Drugs and Medical Devices) on the marketing of kava as a pharmaceutical in Germany. This decision marks the end of over two decades of impediments that had prevented kava's reintroduction into the German market.
BfArM, Europe's largest drug approval authority, had maintained barriers to kava based on outdated and contested scientific grounds, effectively stalling meaningful discussions and consumer access. Recent developments have vindicated long-standing objections raised by kava advocates, highlighting discrepancies in BfArM's handling of kava extracts and the unjust use of "tudei" kava varieties in their assessments.
"The court's decision to overturn BfArM's objections is a clear recognition of insubstantial evidence backing their arguments," said Matthew Lowe, Executive Director of the Kava Coalition. "Germany, and other European countries, should remove illegitimate barriers to kava and make it legal, regulated, and safe for consumers."
The recent pivot marks a significant milestone for kava legalization in Germany after a long journey. Documented original cases from Switzerland, upon which BfArM based its decisions, were attributed to an acetonic extract. Similarly, a detailed analysis of the data available for the ethanolic extracts did not conclude on risks. BfArM had been informed from the start that the quality of the plant material used in the acetonic extract was different from that used in the ethanolic extracts. It is now confirmed that a so-called "tudei" kava form, not regularly consumed in the kava-producing countries of the South Pacific due to its prolonged hangover effects, was used in the manufacture of the acetonic extract.
"The basis for BfArM's decision should not have been used," stated German scientist Mathias Schmidt. "The evidence clearly shows that the 'tudei' kava type is not representative of the traditional kava consumed in the South Pacific, and it is inappropriate to base safety assessments on this variety."
On Wednesday, 25 July, BfArM filed its appeal against the ruling of the Administrative Court of Cologne to the Upper Administrative Court of Münster. Until a decision on the appeal is taken, the marketing authorizations for the kava products remain suspended.
"We are confident the court will drop the appeal and the marketing authorizations will be automatically reinstated to the 2019 status," said Schmidt. "We applied for a swift treatment of the appeal. It is in the hands of the Upper Administrative Court now."
Experience from the past 24 years vindicates the actions taken by kava advocates, as the court's intervention removes a major barrier that had prevented kava's reintroduction in Germany. The unsuitability of the argument for the refusal of post-marketing authorization is now obvious. Today, the Kava Coalition calls on German authorities to restore kava to the marketplace.
"Marketing authorization would be great news for kava, whose name has finally been cleared after over 20 years of having its reputation tarnished for no scientific reason," said Vanuatu Deputy Prime Minister The Honorable Matai Seremaiah. "We trust that other European Union countries will also follow the same path and re-legalize kava, opening new horizons for our farmers."
From the early 2000's until the present day, kava advocates in Germany continually called for the courts to intervene. These advocates challenged BfArM's objections, including a new 2019 drug safety protocol and marketing objections, leading to the court's decision to remove BfArM's barriers.
The court in 2015 and 2024 decided on a positive benefit-to-risk ratio in the indication "nervous anxiety, stress and restlessness", as confirmed by the monograph of the German advisory Commission E in 1990. In 2018, the court had ruled that warning labels are to be accepted, but the court did not talk about the indication and the efficacy. Even though BfArM had paved the way for a change in indication (that was then used against kava) in 2016 by having the HMPC write an Assessment Report on the lack of efficacy against generalized anxiety disorder (GAD), they only used this in official decisions in 2019. Now, in 2024, the issue was for the first time discussed in court.
"Now that BfArM's arguments prohibiting kava have been dismissed, the next step is for the German government to lead the way in restoring a regulated but consumer-accessible kava market in Germany. With a foothold in Germany, it is all but certain that other European restrictions on kava will begin to fall," said Lowe.
About the Kava Coalition
Kava Coalition(KC) is a global alliance of kava consumers, experts, and industry leaders committed to advancing kava education, advocacy, and choice. Through educational initiatives and community engagement, KC promotes awareness and appreciation for kava's traditional practices and cultural significance. Simultaneously, KC advocates for modern regulation that reflects current scientific knowledge, ensuring consumer safety and product integrity.
Media Contact
Byron Johnson
bjohnson@kavacoalition.org
+1 202-680-8129
