STC Number - 220

Proposed regulations for piper methysticum (kava-kava)

Maintained by: European Union; United Kingdom
Raised by: Fiji
Supported by:
First date raised: June 2005 G/SPS/R/37/Rev.1, paras. 72-73
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: G/SPS/N/GBR/4
Products covered: 09 Coffee, tea, mate and spices; 0904 Pepper of the genus Piper; dried or crushed or ground fruits of the genus Capsicum or of the genus Pimenta.
Primary subject keyword: Food safety
Keywords: Food safety; Human health
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

At the June 2005 meeting, Fiji expressed concerns regarding the UK notification of emergency measures on kava-kava, as kava-kava was one of Fiji's few tradable crops of economic significance. Fiji's concerns were related to the request of the UK Commission on Safety of Medicines (CSM) to prohibit kava-kava use in unlicensed medicinal products on the grounds that the CSM had sufficient evidence to conclude that kava-kava was associated with rare cases of liver toxicity. According to an in-depth investigation of kava-kava products conducted by a German consulting firm in 2003, the efficacy and safety of kava-kava had been proven by 20 clinical trials including more than 10,000 patients and supported by post-marketing experience in Europe, the United States and other areas. Health authorities such as the US Food and Drug Administration agreed that kava-kava was a safe drug. Findings also showed that should the toxicity exist, it would occur in an extremely low number of patients, far below the incident rate observed with other freely available drugs. Out of 450 million kava-kava pills exported all over the word between 1990 and 2000, only three cases of liver problems had been linked to the pills. The Fiji kava-kava council was currently drafting a legislative text including, inter alia, standards, certification and labelling to ensure consistency and quality of supply. Fiji requested the European Communities to provide any new evidence that supported the claim that the consumption of products containing kava-kava was associated with liver damage.
The European Communities recalled that the regulation banning kava-kava had come into force in England and Scotland in 2003 following reports of rare but serious risks to public health and a review of evidence by independent experts in 2002. Similar regulations for Northern Ireland had been planned at the time but only notified on 14 June 2005. A similar notification for Wales was also due to be issued soon. The Food Standards Agency of the United Kingdom had recently requested new evidence on kava-kava in order to review its position.