Kava-kava (Hansard, 29 October 2002)

§ Ms Blears

Following initial advice from the Committee on Safety of Medicines in December 2001 as to public health risk associated with medicines containing Kava-kava, a voluntary agreement between the Medicines Control Agency (MCA) and the herbal sector to withdraw from sale medicinal products containing Kava-kava took effect at the beginning of 2002. In July the Committee on Safety of Medicines (CSM) gave further advice, that there was evidence that in rare cases Kava-kava was associated with hepatotoxicity, which may be serious in nature. The CSM made the provisional recommendation that use of the plant should be prohibited in unlicensed medicines. The Government considered that advice and asked the Medicines Control Agency to consult on proposals to prohibit the sale, supply or importation of unlicensed 743W medicinal products consisting of, or containing, Kava-kava except those for external use only. The proposals were set out in consultation letter MIX 286.

The consultation period has now ended and the Government have requested further advice on this issue, taking account of the responses to consultation, from the independent advisory committee, the Committee on Safety of Medicines. In addition, in accordance with the statutory procedure under section 62 of the Medicines Act 1968, the consultation responses have been referred to the Medicines Commission, who will report their findings and conclusions to Ministers. The Government will make an announcement once it has considered this advice and the Commission's report.

During the consultation period around 50 responses were received, with a majority of those commenting supporting the proposal. A number of the responses from the herbal sector advocated alternative options, in particular the continued availability of Kava-kava with voluntary inclusion of warning information for the purchaser or the continued availability of Kava but subject to restrictions, for example as to strength.

Over 20 representative organisations in the herbal sector or individual companies have at various stages notified the MCA of their participation in the voluntary agreement. In the period preceding the CSM's further advice in July, the MCA was aware that one company had withdrawn from the agreement on the basis of its view that there was insufficient evidence of risk to the public from Kava-kava to justify the withdrawal of the product, although it subsequently resumed participation. The current position is that the MCA is not aware of any relevant representative groups or organisations that have advised their members not to participate in the agreement. However, the national association of health stores notified the MCA at the end of July of their position that it was a matter for individual shops to check with their insurance companies to establish whether cover would remain in force.

The MCA has received a wide range of oral or written representations and views from the herbal sector relating to the voluntary agreement. The main points made by various parties have included: support for the agreement pending a decision on the future regulatory status of Kava-kava; disagreement or doubt that the strength of evidence of risk justified the agreement or its continuation; requests for an early decision about any regulatory action in order to resolve the position; and concerns over whether all parties were implementing or abiding by the agreement.

As herbal remedies may be supplied under section 12 of the Medicines Act 1968 without a marketing authorisation or any other form of notification to the MCA, a comprehensive record of Kava-kava products on the United Kingdom's market is not available. The MCA therefore requested information from the herbal sector about unlicensed remedies containing Kava-kava which had been on the market prior to the voluntary agreement. The information provided was insufficiently comprehensive to enable a detailed comparison with products on the German market. However, products listed by the herbal sector included ones similar to those 744W sold in Germany, such as standardised extracts providing a daily dose of between 120 and 210 mg of kavalactones.

In relation to the position on food, since December 2001 the Food Standards Agency (FSA) has been advising against consumption of foods containing Kava-kava and encouraging industry to voluntarily withdraw these products from the market. In July 2002, acting on the advice of the chairman of the committee on toxicity of chemicals in food, consumer products and the environment (COT), the FSA initiated a consultation on proposals which would prohibit the use and import of Kava-kava in foods. The consultation period has now ended and the FSA is considering the responses. Around 30 written responses have been received from a range of interested parties with roughly equal numbers supporting and opposing the proposals.

My right hon. Friend the Secretary of State for Health has had no discussions with the FSA on this matter. The FSA has no additional information to that outlined above on compliance with the voluntary withdrawal. The FSA does not hold information on the range of food products containing Kava-kava available on the German market.