UK kava kava ban upheld
products in the UK, following a review of the latest scientific
evidence weighing its reputed benefits for alleviating anxiety and
inducing sleep against the risk of liver toxicity.
Kava kava is a herb from the pepper family with a long history of use in the Pacific Islands, and more recently in Europe, the US and Australia as a herbal medicine and in foods such as tea, cereal products, smoothies and spirit drinks.
The UK's Food Standards Agency (FSA) and the Medicines and Healthcare products Regulatory Authority (MHRA) both dismissed the reinstatement of the UK kava kava market this week, even though some within the herbal products industry have maintained that grounds for the ban were unmerited.
The sale and import of kava kava containing foods and herbal medicine products was originally banned in the UK in early 2002, following data supplied to the MHRA the previous year by the Committee on Safety of Medicines' Expert Working Group (EWG) and the Medicines Commission, which agreed that, in rare cases, the use of unlicensed medicines containing kava kava could lead to liver damage.
The FSA subsequently reviewed this evidence and, after consulting with the Committee on Toxicology (COT), agreed that the risk also held true for food uses.
Both the Medicines for Human Use (kava kava) (Prohibition) Order 2002 and the Kava kava in Food Regulations 2002 came into effect on January 13 2003. The FSA insists that it was necessary to bring in laws banning kava kava, as it was "the only means by which we can adequately protect public health".
However at the time of the original ban Professor Edzard Ernst, chair of Complementary Medicine at Exeter University, said that it went too far. "Kava is proven to be effective in treating anxiety and, looking at the total risk, it is safer than synthetic drugs. If we are going to ban kava today, then we should have banned Valium twenty years ago."
Ralph Pike, director of the National Association of Health Stores, went so far as to say: "This ban is unlawful, irrational, scientifically and morally bankrupt, procedurally defective and may even be in breach of the European Convention on Human Rights."
The new communication on the subject is the result of consultations in fulfilment of pledges made by Ministers to review the available evidence after two years.
The FSA's COT looked at evidence submitted to the agency and reviews scientific literature at a meeting held in December 2005, and the MHRA's EWG at a meeting in October 2005, following three months of public consultation at the beginning of last year.
The COT reviewed human studies on urinary metabolites, case reports, clinical trails and epidemiological studies, as well as animal and in vitro studies and review articles.
"Members considered that the new data were not sufficient to demonstrate the safety of food products containing kava kava, particularly considering the severe nature of the hepatoxicity linked with kava kava consumption," it said in the meeting minutes.
Likewise the MHRA's EWG concluded from its review that the prohibition order on kava kava remained "justified and proportional".
A spokesperons for the MHRA told NutraIngredients.com that it took nine months to communicate the outcome of the EWG meeting to the public since the detailed report first had to be circulated around members of the group for comments. The FSA indicated that since its consultation was conducted in parallel to the MHRA's, it made sense to publish at the same time.
The FSA has said: "If any new evidence comes to light that suggests the ban is no longer necessary, the prohibition will be reviewed."
The UK is taking a more cautionary approach than Germany, where an outright prohibition on kava kava was lifted in May 2005. Products must now be registered in that country.
In Wales the ban was lifted in late 2002 due to enforcement difficulties. New regulations are anticipated but have yet to be introduced.
France, Ireland and Portugal have withdrawn kava kava from sale, to varying degrees. Canada and Australia advise against consumption while a risk assessment takes place, and the US and New Zealand have also initiated safety assessments, although products remain on sale for the meantime.
A background discussion paper circulated prior to the COT meeting is available online. http://www.food.gov.uk/multimedia/pdfs/TOX-2005-32-Kava-Kava.pdf.
MHRA has also published on its website reports on which it based its latest opinion.