As Cropwatch looks further into the banning of kava-kava products, the less sense the situation makes – unless, say, parties representing the interests of pharmaceutical companies had unduly influenced the regulators, or that the regulators themselves had insufficient knowledge or data to make a scientifically robust decision. Keith-Reid (2002) has previously voiced the suspicions of Pacific kava growers about pharmaceutical companies who may want to block competition to protect their anti-depressant product sales.

Recently the following note was posted on a herbal products newsgroup by a third party, about PayPal blacklisting kava-kava sellers – it is hoped by reproducing it here also it may reach a wider audience:

"Recently Paypal decided to prohibit sales of kava. They based this on
the FDA's Alert List: http://www.cfsan.fda.gov/~dms/ds-warn.html The
`Awa Development Council is working to purge this list as it is not
based on scientific evidence, is speculative, and only serves as an
official blacklist. In fact, it is rejected by University of Hawai`i
researchers.

I have also advised Paypal of their unethical practice of withholding
transfer of earned funds to their respective kava business owners.
Goods have already been delivered to customers but Paypal refuses to
allow the business owners to receive their funds.

Until Paypal engages in honest, ethical business practices and
respects kava as a legitimate nutriceutical protected by DSHEA and
giving it full rights as all other goods & services sold, I cannot
recommend to anyone of doing business with Paypal.

Mahalo

Jonathan Yee.”

Current Legal Status of Kava-kava in Wales.

Cropwatch wrote to the Food Standards Authority (FSA) on 7^th April 2006 concerning the confusion over current legal status of Kava-kava in Wales, and within a fortnight received an informative reply from Phil Morgan, the Assistant Director FSA Wales. Cropwatch reproduces this reply here in the public interest.

“Thank you for your letter of 7^th April….seeking clarification as to the current legal status in Wales of Kava-kava food & medicinal products.

May I first begin by explaining that the use of kava-kava for medicinal products is not permitted by virtue of the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002. These regulations were made using powers contained in the Medicines Act 1968. These functions have not been transferred to the National Assembly for Wales, and the above order therefore applies jointly to England & Wales.

In so far as foods containing Kava-kava are concerned, the powers to inhibit the sale & marketing of these products have been devolved. In response to concerns by the Independent Committee on Toxicology that Kava-kava posed a rare but serious risk to public health (due to an association with abnormal liver toxicology) controls on sales of food products were introduced across the UK in 2002 (including the Kava-kava in Food (Wales) Regulations 2002). Unfortunately after the Regulations had been made it came to light that there had been a technical flaw in the making process. On advice from Council, Assembly Ministers accepted the Regulations should be revoked and remade. Accordingly the Regulations were formerly revoked in late 2003. However the equivalent Regulations in the remainder of the UK were unaffected by this decision and therefore remain in force.

The making of fresh regulations in respect of Wales have since been delayed for a variety of reasons, but particularly to allow a review of the evidence base relating to the safety of Kava-kava Medicines & Food Regulations in England to be concluded. These parallel reviews, including consultations with stakeholders, took place in 2005. At broadly the same time, FSA Wales undertook a consultation involving mainly Welsh stakeholders on proposals to introduce fresh regulations prohibiting the sale and importation of Kava-kava for use in foods in Wales. This consultation was supported by draft Regulatory Appraisal outlining a range of policy options.

Although the consultation was completed some months ago – and incidentally no responses were forthcoming from stakeholders – no further action has been possible while the FSA/MHRA review processes were in progress. These processes, which included consideration by the relevant scientific advisory bodies of any available new data, have now been concluded. COT members concluded that the new data were not sufficient to demonstrate the safety of food products containing Kava-kava, particularly with regard to the severe nature of liver toxicity associated with Kava-kava consumption. The MHRA’s Expert Working Group concluded that on the basis of the available evidence the prohibition of Kava-kava in unlicensed medicines remains proportionate & justified.

FSA Wales will therefore shortly be advising Assembly Ministers of the outcome of the above reviews, and reporting the results of the consultation last year with stakeholders in Wales. Ministers will then be able to come to a considered view on re-introducing prohibitions on the sale of Kava-kava food products in Wales.

Finally I can add to the best of my knowledge there are currently no Kava-kava food products on direct retail sale in Wales.”