U.K. Issues Kava Ban

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 kava will be laid before parliament today and will come into force on Jan. 13, 2003. In addition, the country's Food Standards Agency (FSA) released parallel legislation 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 withdrawal of kava-containing products in the region's herbal sector. MCA consulted on a proposal that would prohibit unlicensed kava products until Sept. 27, 2001, during which time MCA also considered public comments. Following the public consultation, the Committee on Safety of Medicines (CSM) and the Medicines Commission both concluded there is clear evidence linking kava with rare cases of 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 of liver toxicity, CSM and the Medicines Commission were not reassured that the risk of adverse events would be reduced with label warnings.

"Given the expert advice from the CSM and Medicines Commission following the recent public consultation, it is clear that this ban is necessary," said Professor Alasdair Breckenridge, chairman of CSM. "The issues surrounding today's [Dec. 23] decision have been very carefully considered. A prohibition on safety grounds can be reviewed at any time if new evidence emerges and the MCA will be undertaking a specific review in two years time to assess whether this ban remains justified."

As for the future of kava in the United States, FDA reported it currently stands 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 agency is continuing to monitor adverse event reporting and scientific research in regard to kava, according to an agency spokesperson, and should an additional consumer advisory become necessary, the agency will issue a public notice.

"I don't think this ban in Great Britain will be well publicized in the United States," said Tony Young, general counsel for the American Herbal Products Association and partner at Washington's Piper Rudnick LLP. "FDA is simply looking at the data and information they have and the information that's coming in. ... [T]he British have rendered a decision, but it's based on the information that everyone is already aware of. ... So, I think FDA's position will probably be that Great Britain has their law, we have our laws, and they've taken action under their law, which is different from ours."

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