The UK's National Association of Health Stores (NAHS) will hear this week if it has a case against the Medicines Control Agency (MCA) and the Food Standards Agency (FSA) to overturn the ban on the herbal remedy kava-kava.
The ban was issued in late December last year, after months of speculation that kava-kava, taken to treat stress and anxiety, caused damage to the liver. The MCA had issued a voluntary withdrawal of kava products the previous year and the herb has been banned since January 2003 in the UK in both food and supplements. It is also banned in Canada and a number of European countries including Germany.
However the NAHS, which has around 400 members, claims that there is not enough evidence to justify such a ban, and moreover that the MCA action was unlawful.
The association argues that the ban is both a discriminatory restriction on free trade in the European Community and also infringes human rights law as it removes public choice to purchase food products.
At the time of issuing the ban, the MCA said it had clearevidence linking kava with rare cases of liver toxicity, including 70 worldwide reports of adverse liver reactions. In four of these cases the patients died and in seven cases the patients required liver transplants. There have been four reports of liver toxicity in the UK thought to be due to consumption of the herb, although NAHS argues that only one of these led to hospitalisation for treatment of jaundice.
It also accuses the MCA of failing to thorougly review the available evidence, excluding in particular two reviews by the respected Cochrane Collaboration showing the herb to be safe and effective.
"This ban is unlawful, irrational, scientifically and morally bankrupt, procedurally defective and may even be in breach of the European Convention on Human Rights," said NAHS director Ralph Pike.
The association is also accusing the Food Standards Agency, which has banned kava in food products, of failing to consider less restrictive alternatives. The FSA did not take account of different levels of strength of the herb, and the normal conditions of use of kava-kava as a food, argues the NAHS.
"If the MCA had acted in a proportionate manner and asked for improved label information, as they recently did with St John's wort, that would be more than adequate to ensure protection for consumers from a herbal remedy that has been used for thousands of years," said Pike.
He added that NAHS has used much of its funding to mount the current campaign. The group has had little support from outside the independent retail sector, Pike told NutraIngredients.com.