Kava Coalition Celebrates Court Decision Setting the Stage for Kava Legalization in Germany
13 August 2024 - 12:00PM
UK Regulatory
Kava Coalition Celebrates Court Decision Setting the Stage for Kava
Legalization in Germany
LOS ANGELES, Aug. 12, 2024 (GLOBE NEWSWIRE) -- The Kava
Coalition, 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barriers to kava based on outdated and contested scientific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