`Irish Medicines Board proposes to get tough on illegal medicines," states a recent press release from the board. But it's not just talking about exotic new "quack" products with grandiose claims of magic cures. Garlic pills, evening primrose oil and vitamin C are also in the board's sights. Who would have believed that the cures our grannies told us about would one day be classed as "illegal" drugs?
While the health food sector across the EU awaits the outcome next month of deliberations by the European Commission on the harmonisation of health food products, the Irish Medicines Board (IMB) has published its own guidelines in advance. Harmonisation is required since each member state, at present, has different regulations regarding the manufacture and sale of herbal and vitamin supplements as well as homeopathic medicines.
Under the new IMB guidelines, issued in May, many health food stores and pharmacies are trading illegally by supplying eucalyptus oil and echinacea, since these products are not licensed under IMB regulations. Once enforcement of the guidelines begins, such products will be removed from point of sale and any shops selling them could be liable for prosecution, since all products which claim to cure, alleviate or prevent disease are considered by the IMB as medicinal products.
Any of the following words or statements appearing on the labels of your alternative therapies, mean that they are automatically categorised as medicines, and therefore need to be licensed by the IMB: "Cures, heals, treats, restores, prevents, clears, stops, protects, helps with, traditionally used for, strengthens the immune system, calms, helps maintain normal water balance". According to the European Court of Justice, this is the case even if the product is "generally considered as a foodstuff and even if it has no known therapeutic effect in the present state of scientific knowledge".
So where do these guidelines, both European and national, leave the Irish consumer, whose demands for alternative therapies have been steadily increasing over the past decade?
Brod Kearon of Natures Gold in Greystones, Co Wicklow is concerned both for his consumers and for the huge effect the new guidelines will have on his business. Working in the health food sector for more than 22 years, he is clear about the profile of his customers.
"People who buy their food supplements from us are usually well informed, have conducted their own research and are responsible for their own well-being. They are interested in the promotion of their own health, and do not necessarily see the GP as the first port of call. Vitamins account for over 50 per cent of my turnover, which indicates the level of public demand." But how can the public be assured that the products they are using are safe if they are not licensed according to the IMB regulations?
"The value of vitamins and minerals as food supplements has been scientifically established for many years," he responds, pointing to Dr Derek Shrimpton's research, published in 1995. "Dr Shrimpton's paper `Vitamins and Minerals, a Scientific Evaluation of the Range of Safety Levels' included a review of over 300 scientific papers on the subject. His findings have since formed the basis for industry policy both here and abroad, and were subsequently endorsed by Dr John Hathcock in a summary review published in the American Journal of Clinical Nutrition in 1997."
Safety levels, as opposed to recommended daily allowances, form the core of the difficulties between the Irish Medicines Board and the health food sector. Kearon is also a committee member of the Irish Health Food Store Association and points out that, while safety is paramount, this can easily be established through good manufacturing and laboratory practice. Quality control at laboratories ensures that any toxic ingredients are checked for and any impurities removed, without the need for expensive licensing procedures.
While the IMB guidelines call for the licensing of any product which can be regarded as a "medicine", the Irish Health Trade Association - representing the manufacturing and distribution side of health foods in the Republic - is dubious about the licensing of alternative therapies. According to its president, Martin Murray, it is practically impossible for these therapies and products to fit the current licensing blueprint.
"Alternative therapies do not always accord to the profile of pharmaceutical products," he says. "For example, a laboratory can take a drug and reproduce it exactly time after time. Natural products are like seasonal crops, with regional variations. Just like you get potatoes in Donegal which are different to those in Wexford, herbs will vary from time to time, and therefore cannot be reproduced exactly to fit the guidelines for licensing." While Murray is a licensed manufacturer operating within Ireland and abroad, he is concerned about the effects of these guidelines on the health food business and for the consumer.
"The IMB is rightly regarded as one of the most proficient regulators in Europe but, as with all government agencies, it is somewhat distant from consumer demands. We are delighted that the IMB is as concerned as we are for the safety of consumers, but we are looking for a sensible approach to these products. We would like a simplified registration procedure for food supplements, similar to that allowed for homeopathic medicines."
At present, there is no formal representation from the complementary medicine sector on the IMB. Appointment to the board is at the behest of the Minister for Health.
Murray estimates enforcement of the IMB guidelines will result in closures of many of the Republic's health food stores, as well as damage in the manufacturing sector. The total job losses could be up to 2,500, he says.
His own company, Newvistas Health Care, supplies a considerable amount of produce directly to nurses, who increasingly use herbal and homeopathic remedies as part of routine medical care. He points to the fact that companies operating in Ireland are unable to cope with the level of consumer and professional inquiry regarding health food products, indicating growing consumer demand and further markets down the road.
"Our discussions with the IMB are ongoing," he adds, "and we are hopeful it will take account of our representations on behalf of the industry and the consumer."
IMB spokesman Paul White says the board is simply restating the existing legal position in a "user-friendly" form. "The concerns of the IMB centre around three issues: safety, effectivity and quality of product. Our primary concern is to safeguard public health. We will be relying on the public to report any adverse effects or otherwise from products currently on sale, particularly as the enforcement side becomes more active."
It is understood the appointment of an enforcement officer and assistant is imminent. The IMB continues to be concerned about the availability of non-licensed health food products on the Internet and via mail order, but at present has no means to intervene in this market. This means well-informed consumers and health-care practitioners can still buy and use health food products without restriction.
The Irish Health Food Store Association and the Irish Health Trade Association plan to launch a consumer campaign in the near future. Consumers interested in more information on the campaign can call Gabrielle McAuley on 01-4518681
The IMB Guide to the Definition of a Medicinal Product can be downloaded from the Internet by visiting the IMB site on http://www/imb.ie