U.K. Issues Kava Ban 37774U.K. Issues Kava Ban 37774
January 6, 2003
U.K. Issues Kava Ban
LONDON--The United Kingdom's Medicines Control Agency (MCA) (www.mca.gov.uk)announced an order prohibiting the supply of medicinal products containing kavawill be laid before parliament today and will come into force on Jan. 13, 2003.In addition, the country's Food Standards Agency (FSA) released parallellegislation to ensure that kava is no longer used in food products.
MCA's order follows a year-long investigation that began in December 2001,when the agency released a kava advisory that initiated a voluntary withdrawalof kava-containing products in the region's herbal sector. MCA consulted on aproposal that would prohibit unlicensed kava products until Sept. 27, 2001,during which time MCA also considered public comments. Following the publicconsultation, the Committee on Safety of Medicines (CSM) and the MedicinesCommission both concluded there is clear evidence linking kava with rare casesof liver toxicity. MCA noted 70 worldwide reports of adverse liver reactions,four of which involved death and seven of which involved liver transplants.Because the agencies could not determine what factors led to increased risk ofliver toxicity, CSM and the Medicines Commission were not reassured that therisk of adverse events would be reduced with label warnings.
"Given the expert advice from the CSM and Medicines Commission followingthe recent public consultation, it is clear that this ban is necessary,"said Professor Alasdair Breckenridge, chairman of CSM. "The issuessurrounding today's [Dec. 23] decision have been very carefully considered. Aprohibition on safety grounds can be reviewed at any time if new evidenceemerges and the MCA will be undertaking a specific review in two years time toassess whether this ban remains justified."
As for the future of kava in the United States, FDA reported it currentlystands by its consumer advisory for kava, which was released on March 25, 2002,and has no further plans to change the U.S. sales status of the herb. The agencyis continuing to monitor adverse event reporting and scientific research inregard to kava, according to an agency spokesperson, and should an additionalconsumer advisory become necessary, the agency will issue a public notice.
"I don't think this ban in Great Britain will be well publicized in theUnited States," said Tony Young, general counsel for the American HerbalProducts Association and partner at Washington's Piper Rudnick LLP. "FDA issimply looking at the data and information they have and the information that'scoming in. ... [T]he British have rendered a decision, but it's based on theinformation that everyone is already aware of. ... So, I think FDA's positionwill probably be that Great Britain has their law, we have our laws, and they'vetaken action under their law, which is different from ours."
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