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Written question asked by Lord Clement-Jones (Liberal Democrat), in the House of Lords. It was answered by Lord Hunt of Kings Heath (Labour) on Monday, 5 March 2007.


Health: Food Supplements and Herbal Remedies

Question
When and for what reasons it was made illegal to offer melatonin for sale in the United Kingdom; and what assessment they have made of (a). the implications for public health of this decision; and (b) the legality of the continued marketing of products containing melatonin for sale to United Kingdom consumers by mail order from the Channel Islands; and
Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) has referred nine complaints to the Guernsey authorities and seven to the Jersey authorities since 1 January 2005. The MHRA received feedback from the Guernsey authorities on three cases. In two cases there were no offences under Guernsey law and in the third case the company was not actually based in Guernsey. The MHRA received feedback on three cases from the Jersey authorities. In all three cases the companies were not actually based in Jersey. A prohibition order on the sale, supply and importation of kava kava in unlicensed medicines, other than for external use, came into force on 13 January 2003. The order was made following advice from the Committee on Safety of Medicines and the Medicines Commission (the independent advisory committees advising the Secretary of State) that kava kava poses a rare but serious risk of liver toxicity. Similar action was taken in relation to kava kava in foods. The Guernsey authorities have investigated the supply of kava kava by a company apparently based on that island. The investigation showed that the product was not actually being distributed from Guernsey but from Cyprus. A complaint has been referred to the authorities in Cyprus. There are no special legislative restrictions on the sale or supply of the hormone melatonin. Unless it is being supplied as an unlicensed medicine in accordance with the relevant statutory controls, a medicinal product containing melatonin requires a marketing authorisation before it may be lawfully sold or supplied. The status of melatonin under medicines legislation was first considered in 1989. The MHRA is unaware of any implication for public health by the classification of melatonin as a medicinal product. The MHRA refers complaints about the sale and supply of melatonin from the Channel Islands to the relevant regulatory authority. The MHRA considers that the claims made for beres drops bring the product within the definition of a medicinal product. No assessment of the accuracy of those claims has been made as no application for a marketing authorisation has been received. Although the product was being sold by a Guernsey-based company, the MHRA took action to prevent advertising by a United Kingdom publication. There are no specific powers in the medicines legislation administered by the MHRA or in the Postal Services Act 2000 to control direct-mail advertising from the Channel Islands. The legislation administered by the MHRA does not apply to the Channel Islands. Advertisements issued from the islands would be the responsibility of the relevant authorities within those islands. The legislation administered by the MHRA does not apply to the Channel Islands. The islands have their own legislative Assemblies and are responsible for the regulation of activities relating to medicinal products that take place from those islands; therefore, any suspected illegal activity is referred to the relevant authority in the Channel Islands for investigation.


Secondary information

Type
Written question
Reference
2148; 690 c9-10WA
Session
2006-07
Subjects
Complaints Advertising Channel Islands Dietary supplements Direct marketing Health Drugs Labelling Powers Misrepresentation Marketing Regulation Medicines and Healthcare products Regulatory Agency Melatonin
Link
View this Written question on www.publications.parliament.uk