Up to 60 per cent of herbal food supplements and alternative medicinal treatments could be forced off shop shelves if the Irish Medicines Board proceeds with proposals to categorise them as medicines and demand that they be licensed, a new lobby group has warned.
If implemented, the cost of the licensing system could result in everyday food supplements such as garlic, evening primrose, fish oils and vitamin C tablets disappearing from the market, the lobby group Consumers for Health Choice (CHC) said yesterday.
The decision of the Irish Medicines Board to apply the same regulations to herbal food supplements and alternative medicinal products as it applies to mainstream pharmaceutical products has angered consumers and manufacturers of these products.
Manufacturers could be faced with licensing costs of between £500,000 and £2 million, according to the managing director of Wholefoods Wholesale, Mr Quentin Gargan. There were 150 health shops in Ireland, and the Medicines Board proposal would threaten up to 2,000 jobs, he said.
An Irish Medicines Board spokesman said its guide to a definition of a medicinal product, published in May, aimed to clarify the grey areas in the application of the law. Under the new guidelines, products will be deemed to be medicinal when their labelling or accompanying or associated literature makes any preventative, curative or remedial claim. Preparations would also be considered medicinal products when the recommended daily intake calculated with respect to any of the added vitamin or mineral constituents exceeded the maximum recommended daily dietary allowance for such constituents published by the Minister for Health, or if their content was otherwise sufficient to exert pharmacological or toxicological effects.
CHC believes that vitamin, mineral and herbal supplements should be regulated, but not using the same criteria as adopted for the regulation of medicines such as steroids and antibiotics.
Herbal products were difficult to regulate as no two samples were the same, according Ms Sue Croft of CHC UK, as the climate and temperature of the area in which they were grown might affect the concentration of the active ingredients. The Irish Medicines Board guidelines were based on EU directives and regulations from 1965 to 1998.
The guidelines were a threat to the right of all consumers to buy safe dietary supplements of their choice, Ms Croft said. The original directive was introduced in 1965, she said, and she questioned the timing of its implementation 34 years later.
The Green Party TD Mr Trevor Sargent said the agenda was being set by the pharmaceutical industry which claimed regulation was in the interests of people, when in reality they were trying to take control of the growing preventative medicine market.
The EU is currently preparing legislation to harmonise the differing regulations under which food supplements and alternative medicinal preparations are sold.