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With the recent proposal by the EU Commission for a Directive on so-called 'traditional herbal products', it would seem that it is no longer possible for companies producing herbal products to simply put them in the marketplace. For years now, many herbal products have been marketed as cognitive enhancers or herbal antidepressants with little or no evidence to substantiate the claims except that they 'have been used traditionally for centuries'. The new EU Directive insists that any herbal products be treated as the medicines they claim to be, rather than seeking the protection of national food laws. Therefore, new and existing herbal compounds will be required to prove 'qualitative, efficacious and safe' results in structured clinical trials. The main disadvantage of the new law, which will have a major adverse impact on the trade of herbal remedies, is that products which cannot claim 30 years of established use will have to seek market authorisation as medicinal products. In this sense, the new Directive's ostensible intention to minimise cost burdens on small and medium-sized producers will also have the unpleasant effect of deleting several little-known herbal products from the EU market altogether.
Whilst many see the requirements as daunting prospects in terms of the financial implications, manpower required and time taken to organise, run and publish clinical trials, we must surely welcome this Directive as an opportunity to prove long-established claims for certain herbal compounds and oust those which are marketed merely to make a quick sale. |
