BONN, Germany—Germany is set to reclassify kava (Piper methysticum) as a prescription-only drug following a recommendation by the country's top government health agency to the German Health Ministry.
A German Federal Institute for Drugs and Medical Devices (BfArM) spokesperson said the herb's new status will take effect July 1 if the Ministry approves the recommendation. This was likely, he added.
The move follows ongoing speculation about kava's safety. BfArM issued an alert last year highlighting cases of liver toxicity that may have been related to kava consumption. The alert precipitated the withdrawal of the product in many European countries.
These cases, plus other evidence, are being scrutinised by health authorities in Europe as well as North America, Australia, New Zealand and parts of Asia. Verdicts on the herb's legality and usage in these regions are expected later this year.
These verdicts are likely to be influenced by the German position, said Maurice Hanssen, director of the UK-based Council for Responsible Nutrition. "The Germans look as if they are taking the precautionary principle to extreme ends," he said. "It seems like a knee-jerk reaction and it may well start a domino effect throughout Europe and maybe the rest of the world."
Hanssen said he was concerned all kava products would be forced behind pharmacy counters when the evidence implies it is only kava extracts that are potentially hazardous.
Berndt Kunz, director of the Organisation for German Health Food Stores, agreed. "Maybe the best situation is for lower-dose products to be freely available while higher-dose extracts should be available by prescription."
Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, said he is confident the move will not have a major effect on kava's status in the US because it is classified as a dietary supplement there, not a drug, and hence freely available.