The Pharmaceutical Journal
Vol 271 No 7257 p37
12 July 2003

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The Food Supplements (England) Regulations 2003 (more)
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No need to remove supplements from sale yet, Society advises

Community pharmacies do not need to withdraw any vitamin or mineral supplement products from sale at present, the Royal Pharmaceutical Society is advising. Regulations currently being discussed in Parliament will not take effect until 1 August 2005.

Two pieces of European legislation, when transposed into British law, will impinge on the sale of complementary medicines. European Directive 2002/46/EC on food supplements will be put into effect in England in 2005 through the Food Supplements (England) Regulations 2003. The European Commission is also discussing a proposed directive on regulating traditional herbal medicines.

Two major concerns have been expressed about the food supplement regulations. The first is that some ingredients of food supplements sold in the United Kingdom are omitted from the approved list of vitamins and minerals in the directive. These include boron, cobalt, nickel, silicon, tin and vanadium.

The second is that the permitted levels allowed in the directive are based on nutritional need and not (as in the UK) on safety considerations. Both issues are being addressed by the Food Standards Agency which regulates food supplements not sold as medicines. The herbal medicinal products directive would require products not currently sold as medicines to be licensed by the Medicines and Healthcare products Regulatory Agency and manufactured to good manufacturing practice standards. Products would not have to demonstrate efficacy. Instead, the products would need to have a documented record of traditional use over 30 years.

The Society's complementary and alternative medicines working group is continuing to monitor the situation and will provide further information as it arises.

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