. /.WORLD TRADE
ORGANIZATIONG/TBT/N/GBR/3
21 August 2002
(02-4510)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED KINGDOM (UK)
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Industry and Trade
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Any unlicensed
medicinal product consisting or containing Piper methysticum  (known as Kava-Kava of
Combined Nomenclature heading 1211 90 98), other than a product for external use only.
5. Title, number of pages and language(s) of the notified document:   The Medicines for
Human Use (Kava-Kava) (Prohibition) Order 2002 (4 pages, in English)
6. Description of content:   Under Section 62 of the 1968 Medicines Act, the proposed Order
will prohibit the sale, supply or importation of any unlicensed medicinal product for internal
use which consists of or contains Piper methysticum  (known as Kava-kava) in the
United Kingdom, subject to the exceptions set out in article 2 of the draft order..
7. Objective and rationale, including the na ture of urgent problems where applicable:
Evidence has emerged that, in rare cases, members of the public consuming products
containing the plant Kava-kava may suffer liver damage. To date, 68 possible reports of
suspected liver toxicity, associated with the us e of Kava-kava, have been received by the
Medicines Control Agency (MCA), the regulatory authority responsible for medicines in the
UK. Out of these, six patients suffered irreversible liver failure and required a transplant.Three patients, including one of the transplant patients, died.
On 10 July 2002, the Committee on the Safety of Medicines (CSM) advised the MCA that
there was sufficient evidence that Kava-kava was associated with rare cases of
hepatotoxicity which may be serious in nature. The CSM considered a number of regulatory
options, and recommended that the use of the plant be prohibited in unlicensed herbal
remedies.
Ministers and the Medicines Control Agency have considered the safety concerns and the
advice from the CSM and are now proposing, in the interests of safety, to make an order
prohibiting the sale, supply or importation of unlicensed medicinal products consisting of or
containing Kava-kava. Ministers are now consulting on the proposal.G/TBT/N/GBR/3
Page 2
The United Kingdom’s Food Standards Agency has proposed that, for human health
reasons, the use of Kava-kava in food be prohibited. This intention is being notified under
the SPS Agreement. Mention is made here for transparency.
8. Relevant documents:   The Medicines for Human Use (Kava-kava) (Prohibition) Order 002
9. Proposed date of adoption:
Proposed date of entry into force:   The period for consultation in the UK ends on
27 September 2002.  If, after the comment period, the Secretary of State for Health and the
Northern Ireland Minister for Health, Social  Services and Public Safety consider the
proposed prohibition to be necessary to protect public health, the prohibition order will bemade as soon as possible.
10. Final date for comments:   2 October 2002
11. Texts available from:  National enquiry point [     ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
Andy Weller
Bay 310
International Trade Policy Unit (TP1A)
Department of Trade and Industry
Kingsgate House66-74 Victoria Street
London Sw1E 6SW
Tel: +44 (0)20 7215 4548
Fax: +44 (0)20 7215 4249Email: andy.weller@dti.gsi.gov.uk