UK to hear new evidence on kava
banned herbal kava early next year, it revealed this week.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a ban on kava, taken to ease stress and anxiety, in early 2003, citing evidence of its toxic effects on the liver.
But it also said it would review any new data demonstrating the herbal's safety and Joerg Gruenwald, executive director of the International Kava Executive Council, is confident that significant new evidence will renew the debate on the herbal.
"We will definitely submit a lot of new data. There have been 50 new investigations and publications in the last two years and we will also have the results of two new toxicology trials by the end of the year," he said.
The additional toxicology tests look specifically at kava's effects on liver toxicity and were prompted by discussions with the German Health Ministry, regulators for Europe's biggest herbals market, where kava generated almost €100 million during 2001.
The results, likely to confirm the herbal's safety, according to Dr Gruenwald, could provide sufficient evidence for its return to other European markets.
"German requirements for herbal medicines tend to be much stricter than other countries like the UK or Netherlands. They have higher expectations of quality and efficacy. So we are pretty sure that if Germany accepts the new safety data, other countries will follow," Dr Gruenwald told NutraIngredients.com earlier this year.
"We are confident that we can at least describe which extract to use for a safe form of the herbal," he added.
It is thought that discrepancy in the varieties and parts of the plant used for extracts destined for Europe may have been responsible for some of the side effects. The kava industry, predominately located in the islands of Vanuatu, Fiji, Samoa and Tonga, is expected to increase optimization of products and quality if it gains new trade.
The growers say they have lost $200 million in raw material sales every year since the ban, said Gruenwald, and no other product has taken the place of kava in the months following the ban, although there is some overlap with St John's wort for depression.
The MHRA's 12-week public consultation process will be launched in January 2005, two years after the ban.
It claims that evidence submitted since the ban has not changed its initial assessment of kava's safety and it is therefore looking for new data before the product will be allowed back onto the market.
"Any new data permitting identification of the mechanism of toxicity, or data on any patient or product characteristics (such as dose) associated with increased risk would form an important part of the review of the existing risk assessment for kava," said the MHRA document.
The IKEC is also speaking with regulators in the Netherlands, France and Denmark, in an attempt to reverse the ban in these markets too.
