Health product claims face scrutiny

The alternative medicine industry will face tighter control soon, when two enforcement officers are appointed by the Irish Medicines…

The alternative medicine industry will face tighter control soon, when two enforcement officers are appointed by the Irish Medicines Board, which regulates the sale of medicines.

The IMB is hosting a meeting for the pharmaceutical industry today, at which it will introduce its new Guide to a Definition of a Medical Product.

The chief executive of the IMB, Dr Frank Hallinan, said strong action would be taken against any company marketing a product which claimed to have medicinal benefits but did not have a product authorisation from the board.

In 1996, the IMB replaced the National Drugs Advisory Board, which was funded by the Department of Health. The IMB is funded by the pharmaceutical industry, through fees for product authorisation and clinical trials. In 1997, the last year for which figures are available, its fee income was £5.08 million.

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The IMB is the licensing authority for the preparation, manufacturing, importation, distribution and sale of medicinal products for both human and veterinary use. It also advises the minister.

Dr Hallinan said the public was now faced with a wide range of products which claimed to have medicinal benefits, many of which had no product authorisation from the IMB. "These may include certain vitamins, amino acids, herbals and slimming products." He said any product which claimed to cure, alleviate or prevent disease would be considered as medicinal products. Examples of wording this might entail were "cures, heals, treats, helps with, calms and helps maintain normal water balance".

Asked if this might cover a very wide range of products, including some foods, he said: "We're interested in strong medicinal claims."

The guidelines are aimed at food products that contain added substances like vitamins, minerals, amino acids and herbal ingredients; vitamins, especially when the calculated daily intake exceeds the recommended daily dose, greatly enhanced amounts of amino acids and herbal medicines, which contain known pharmacological properties.

One product brought to the board's attention was a range called "SKIN-CAP", available through mail-order and believed to contain clobetasol propionate, a highly potent corticosteroid, which should be supplied only on prescription. It was marketed to treat psoriasis, red angry skin or scalp and other skin conditions.

There were moves to have more flexible authorisation for homeopathic medicines - and there was concern that some people were claiming medicines were homeopathic when they were not.

The IMB had no role in regulating professions like herbalists, its pharmaceutical director, Dr Mike Morris, explained, or in what a doctor prescribed. Its focus is on wholesalers and marketers of medicines, rather than on those who sell them.

Those who breach its regulations on marketing medicines will face heavy penalties, including fines and imprisonment. The board will appoint an enforcement officer and an assistant enforcement officer soon. These will be funded by the Department of Health.