German scientist and kava expert Dr. Mathias Schmidt has expressed concerns about potential renewed opposition to kava from Germany’s Federal Institute for Drugs and Medical Devices (BfArM), despite a recent court ruling that lifted previous restrictions on the substance.
BfArM initially banned kava in 2002, citing links to liver damage, a move that significantly impacted the Pacific kava export industry during the late 1990s and early 2000s. This ban led to widespread refusals across the European Union to allow kava into their markets.
Dr. Schmidt revealed in an interview that BfArM has the option to appeal the court’s ruling, which they exercised on July 23 by taking the case to the upper administrative court. He noted that the court’s decision on whether to accept this appeal could determine the future of kava regulation in Germany. Should the court reject the appeal, the ruling would be finalized, compelling BfArM to reassess its stance on the substance. However, Dr. Schmidt cautioned that the agency is likely to seek other valid reasons to maintain its opposition to kava.
The legal dispute over kava has dragged on for over 20 years, with 12 pharmaceutical companies challenging BfArM’s restrictive policies. The case has been reviewed by the Administrative Court of Cologne multiple times, encountering significant resistance from BfArM, which has faced accusations of unfairly altering regulations to prevent kava’s market entry.
Dr. Schmidt indicated that the recent court ruling does not imply that kava is now freely available in Europe, and the legal challenges may continue for several years. If BfArM’s appeal is accepted, a hearing could be a long way off, potentially taking another three to four years before any progress is made, as the court has numerous other priorities to address.
Dr. Schmidt is now advocating for high-level governmental intervention in the ongoing case.