Nearly every town in Ireland has one. Health food stores are a rapidly expanding business; everything from food supplements to flower essences are sold. But nobody is checking just what they have on their shelves, and a number of the products are sold without a licence. No one has ever been prosecuted. The Irish Pharmaceutical Union recently called for the introduction of more stringent regulations for the sale and distribution of complementary medicines.
There are a number of reputable companies, but according to the IPU's vice-president, Mr Brendan Quinn, regulations are unclear and unenforced. "I am a great believer in complementary medicine and it is the first thing that I think of when someone has already tried conventional medicine. But in some cases you could actually be putting people in danger instead of helping their condition. A particular product might have a recommended dosage of no more than 50mg. One sold in a health food shop with similar properties could be sold in doses of up to 400mg.
"Of course the accusation will be levelled that pharmacists only want to control the market - but what we really want is to control the professionalism of health care." Ironically, though, there are products for complementary medicine on sale in many pharmacies which technically breach existing regulations.
Andrew Cape, who runs Simple Simon health food store in Donegal, says health food shop owners would welcome a system of inspections and clear regulations. "In theory there is a regime in place, but in practice there is no system to implement it. It is all very fuzzy," says Mr Cape, chairman of the Irish Association of Health Food Stores, which has 50 members. Members must agree to abide by a code of ethics and are subject to a bi-annual inspection by the association. However, only about half of the health food stores in the State are members - and the others operate their own policies.
The Irish Medicines Board (IMB), which largely has responsibility in this area, is caught in the middle. Its job is to ensure that products sold as medicines are proven to be effective in independent tests - but there is a strong lobby which cries foul at attempts to regulate "things that have been used since the beginning of time". The difficulties are compounded by the fact that the Departments of Health, Finance, Enterprise and Employment, Health Boards and the Pharmaceutical Society of Ireland all have roles to play.
Dr John Kelly, chief executive officer of the IMB, described this as a "difficult, complex and emotive" area. The board does not have a force of inspectors to carry out inspections for health food shops. In some EU states where there is a more traditional history of use, the regulatory system is better. "We obviously would like an EU standard, but there is no considered view just yet."
Any product with levels above the recommended daily allowance (RDA) is considered a medicine, but according to Dr Kelly, there is a problem with the claims made for some products. "Some of these definitions are borderline. There is a difference between a claim for a product which states `we recommend this for insomnia' or `helps you to relax and promotes restful sleep'. If we see a claim that has crossed a barrier, we take that up and expect them to change it."
Andrew Cape of the Irish Association of Health Food Stores says his organisation is very wary of products which make unsupported claims. "This is one of the first things that needs to be tackled. We are not at all in favour of products which make claims such as `spend £49.99 and this product will cure your arthritis within a week'. He is also concerned about mail order products and products that are sold at parties through private agents. "They would certainly be operating contrary to our code of ethics."
If someone sells what are considered to be medicines without the proper licence they are operating against the law, says Dr Kelly, and liable to prosecution. But the enforcement of the law is unclear. The IMB, which replaced the National Drugs Advisory Board, is just two years old, and has not yet taken any such legal action. According to the Department of Health, no prosecutions have been taken.
However, the IMB does appear to be making some moves towards regulating the industry. The latest edition of the board's newsletter includes a reminder that "any product which contains substances having a pharmacological action or which makes medicinal claims is a medicine".
All medicines on sale in Ireland need to be authorised by the IMB and to carry a product authorisation number - but the IMB is concerned about breaches of regulations that include the sale of unauthorised products imported from abroad.
Other areas of concern are: the advertising and sale of products making claims for which an authorisation is required, including hair loss, obesity, allergies or treatment of infection or various skin conditions; herbal products making unauthorised medicinal claims; products containing vitamins which "are clearly in excess of the recommended daily allowance; homeopathic products making specific medicinal claims".
Some products which are supposed to be available on prescription only are being sold over the counter. A typical example is ginkyo biloba, a herbal remedy which is said to stimulate blood circulation and in turn improve poor memory.
The IMB is involved in a review of herbal products which is currently going on at European level. It is also reviewing the area of food supplements, and a registration system will shortly be in place for oral and topical homeopathic products, which will exclude the making of specific medicinal claims. "At present the situation is quite clear and those wishing to place products on the market and manufacturers, wholesalers and retailers must operate within the law," states the newsletter.
But the Irish Association of Health Product Manufacturers and Distributors, which represents eight Irish companies, would disagree - and believes that the situation is far from clear. Mr Jonathan Griffith, managing director of the Natural Medicine Company, describes the regulations as "highly ambiguous".
It appears that while these regulations are being developed at EU level the regulatory authorities have taken a "wait and see" attitude. "Our policy is to work with the Department of Health - unfortunately they do not see fit to see us as a significant industry to work with," says Mr Griffith.
He adds that members of the association who have complied with existing regulations are being discriminated against - while others are coming in, breaking the regulations "and giving everyone a bad name". In 1989 members withdrew certain products above the RDA and applied for product licences. However, little has happened since then. The government, he explains, has said that any food supplement containing nutrients above the recommended daily allowance is a medicine and requires a licence. "But we disagree with that policy. Our policy is that if a product is safe as a food it should be allowed to be sold as a food. "
A report into vitamins and minerals commonly found in food supplements was commissioned, he says, because of the long delays. For the first time it has set safe upper limits for daily supplements. "Up to now the only reference was recommended daily allowances, which were set in 1945 to make sure that American servicemen were not under-nourished. There needs to be change but we are getting no response."
