Health food stores in the UK, including the largest chains, have resumed kava (Piper methysticum) sales despite a self-imposed withdrawal agreed last December by manufacturers and the Medicines Control Agency (MCA).
The NBTY-owned Holland and Barrett chain, which has about 450 stores in the UK and Ireland, cited unacceptable delays by the Committee on the Safety of Medicines (CSM), which advises the MCA to hand down a verdict on kava's safety.
It also noted that, like many countries, kava stayed on store shelves in Germany, the origin of the first reported adverse events on kava in November, 2001. "Like Germany, the UK has in place procedures to facilitate a withdrawal in the case of a genuine safety issue. If this were the case, the CSM would have immediately recommended the withdrawal of kava," a Holland and Barrett spokesperson said.
She highlighted the uncertainty of the adverse event reports, which may be confounded by other drug and alcohol use, as well as the Food and Drug Administration's refusal to propose a US ban.
In defence of its position, the MCA said, "Where there is a major threat to public health, we are in a position to, and do, take immediate regulatory action. Where the evidence is less clear and does not justify an emergency prohibition order, we cannot require immediate withdrawal of unlicensed herbal remedies containing a particular ingredient." It noted that any regulatory ban on kava would first need to pass through a public consultation period.
The chairman of the Health Food Manufacturers Association, Penny Viner, said her association would advise its members to ignore the agreement if the MCA did not promptly deliver its findings.
Simon Mills, chairman of the British Herbal Medicine Association, called the health food retailers' action a threat to the industry's desire to self-regulate. "An excellent opportunity for the industry to prove that it can hold to a voluntary code risks being lost," he asserted. "We should have been sticking together on this one. Now other herbs might be vulnerable."