Food Law News - UK - 2005

FSA Consultation Letter, 17 February 2005

NOVEL FOODS - Consultation on the Kava-kava in Food (England) Regulations 2002

In January 2003, the Government prohibited Kava-kava in foods following reports world-wide of idiosyncratic liver damage (hepatotoxicity) associated with the consumption of the herbal ingredient Kava-kava. At present, on the basis of the existing evidence and independent expert advice the FSA is proposing that the prohibition should continue. However, the FSA will review this position carefully in light of all responses received to this consultation.

This consultation document invites you to submit to the FSA, any new evidence which you wish to be considered to assess whether the prohibition of Kava-kava in foods set out in the Kava-kava in Food ( England ) Regulations 2002 remains justified and proportionate.

Responses are required by 11 May 2005 .

Detail of Consultation

Previous action on Kava-kava

In 2002, the Food Standards Agency's independent expert advisors took the view that Kava-kava posed a rare but serious risk to public health. On the basis of the Agency's advice, Ministers prohibited the sale and importation of Kava-kava for use in foods, through The Kava-kava in Food ( England ) Regulations 2002. The Regulations came into force on 13 January 2003 . Similar action was taken in relation to unlicensed herbal remedies.

At the time the prohibition came into force the FSA stated its commitment to review the prohibition at any time if significant new data supporting the safe use of Kava-kava comes to light. The current consultation is taking place to fulfil an additional commitment made by Ministers, to review the available evidence relating to the safety of Kava-kava two years after the prohibition had been in place, to assess whether the prohibition remains justified and proportionate. A similar consultation is being undertaken for Kava-kava in unlicensed herbal products by the MHRA (Medicines and Healthcare Products Regulatory Agency).

The risk to consumer health

The FSA and MHRA have become aware of additional cases of liver toxicity, possibly associated with the use of Kava-kava containing products, since they first consulted on proposals to prohibit Kava-kava in foods in July 2002. The FSA and MHRA are now aware of 84 cases of liver hepatotoxicity, possibly associated with the use of Kava-kava containing products. Nine patients have suffered irreversible liver failure and received a liver transplant. Overall, six patients have now died, including one who had received a transplant. The new cases do not provide any new data to suggest that Kava-kava could be used safely.

The mechanism of toxicity remains unknown and there are no clear predictors, of toxicity, such as dosage or type of preparation, making the onset of damage unpredictable. In addition, no specific risk factors have been identified which may allow the safe use of Kava-kava under restricted conditions such as limiting the duration of treatment or its use in specific patient groups.

Review of evidence

The FSA will consider carefully any relevant evidence that is submitted to assess whether the prohibitions in The Kava-kava in Food ( England ) Regulations 2002 remain proportionate and justified.

The MHRA have received a number of representations made by interested parties since the introduction of the prohibition in 2003. These have been given careful and detailed consideration. The MHRA concluded that the evidence presented on these occasions did not add to existing understanding and that the risk assessment that Kava-kava posed a rare but serious risk to public health has remained unchanged. The Agency will consider all evidence submitted during the consultation exercise. However, stakeholders intending to provide evidence as part of this consultation exercise may wish to focus their attention on any significant new evidence.

A particular issue identified during the initial consideration of the liver toxicity associated with Kava-kava was the unpredictable nature of the associated adverse reactions. As such, 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 any review of the existing risk assessment for Kava-kava.

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