§ Mr. BurstowTo ask the Secretary of State for Health if he plans to review the sale of kava. [64281]
§ Mr. LammyFollowing the emergence of safety concerns in Europe, the issue of liver toxicity in relation to the use of medicinal products containing the herbal ingredient kava-kava was reviewed by the committee on safety of medicines (CSM) in December 2001. The herbal sector voluntarily withdrew stocks of products containing Kava-kava while the safety concerns were under investigation. In the light of further data that has since become available the CSM has recently given a provisional opinion that the possible therapeutic benefits of medicinal products containing kava-kava can not be considered to outweigh the safety risks and that consideration should be given to appropriate regulatory action.
The Medicines Control Agency (MCA) is currently aware of 68 cases worldwide of liver problems suspected to be associated with kava-kava. These include cases of liver failure resulting in six liver transplants and three deaths. There have been three reports of liver toxicity in the United Kingdom suspected to be due to consumption of kava-kava.
Following the committee's advice, the MCA will be consulting on proposals to make an Order under Section 62 of the Medicines Act 1968, prohibiting the sale, supply or importation of unlicensed medicines containing kava-kava. Regulatory action is in progress in relation to licensed medicines containing kava-kava.
1431WThe Food Standards Agency (FSA) has also considered the CSM's assessment as kava-kava may be used as an ingredient in some foods. In parallel with the MCA, the FSA will consult on legislation banning food products containing kava-kava.
Pending the outcome of consultation and any regulatory action which may follow, the MCA and the FSA have indicated to the relevant sectors that they would welcome continuing support for the voluntary withdrawal of kava-kava products in the interests of public safety.