the Stakeholder Panel on Dietary Supplements

German Kava Regulations ▪ German Federal Institute of Drugs and Medical Devices (BfArM) made the decision to withdraw all drug registrations for all products containing kava on 14 June 2002 (previously approved for treatment of situational anxiety). ▪ Kava was officially judged as potentially dangerous and its efficacy was denied. The Society for Medicinal Plant Research neither accepted the official conclusions drawn from the presentation of fragmentary safety data, nor a negative benefit-risk-ratio (DOI: 10.1055/s-2003-45140). ▪ June of 2014, a German court ruled the “ban” illegal (data did not support alleged hepatotoxicity, and ban unjustified merely based on the perception of an inconclusive efficacy). Ruling confirmed (and finalized) 25 February 2015. ▪ The impact of ban on island economies was substantial.

Kava Regulations ▪ 25 March 2002 US FDA advised consumers of the potential risk of severe liver injury associated with the use of kava- containing dietary supplements. Urged consumers and their health care professionals to report any cases of liver and other injuries that may be related to the use of kava-containing dietary supplements. ▪ “FDA will continue to investigate the relationship, if any, between the use of DSs containing kava and liver injury.” ▪ NIH: Kava Kava in Generalized Anxiety: A Double-Blind Trial ▪ This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of Generalized Anxiety Disorder ▪ This study was to last 10 weeks with 16 participants randomly assigned to receive kava, venlafaxine (Effexor), or placebo for 8 weeks, then undergo a 1-week tapering of medication followed by an additional week of observation. ▪ This study has been terminated. European reports of liver toxicity from kava meant that the study had to stop.