How herbalism is regulated

Herbal medicines are licensed on the basis that the remedy has been in ‘longstanding use’

Money has sullied conventional medicine, whereas herbal medicine is pure and untainted by the horror of currency, goes one conventional argument. And it’s true that herbs will rarely make someone rich. But it’s not wholly non-commercial: there’s an ivy-growing industry in Ireland and we export it to be used in or as a herbal cough remedy.

We also export nettles. Indeed, Enterprise Ireland are currently invested in a project exploring the viability of growing herbs for export in the European herbal medicine market. You'll find many of these in Holland and Barrett. And Aoife Kelly, founder of Irish start-up ION Herbal Tonics, is an entrepreneur selling herbal blends which will be available in Lloyds Pharmacies from May.

Herbal remedies have required a licence since 2005. When regulation was introduced, the market for herbal medicines declined in Ireland, as some of the companies didn't seek a licence due to the relatively peripheral nature of the Irish market, explains Helen Sheridan, professor of pharmacology in Trinity College Dublin.

Herbal medicines are licensed and registered solely on the basis that the remedy has been in “longstanding use” (actually, this is just 30 years), and not upon data generated by clinical trials.


But anyone can become a herbalist and the profession is self-regulated. Herbalists usually give people a blend of herbs in a tea or tincture.

The Health Products Regulation Authority (formerly the Irish Medicines Board) says that all herbal medicines are considered as medicinal products and some are only available on prescription, and that it will take action against herbal medicinal products which are not authorised or registered.

“Many herbs have medicinal properties and it is important that the taking of such herbs be overseen by a trained physician,” they advise.

Herbalists are divided on the issue of regulation. Herbal remedies can contain up to nine herbs. But, increasingly, pharmaceutical firms have to take account of the fact that a patient might be taking up to five medications at the same time and that their drug might negatively interact with one of these.

Someone might go to their doctor and be afraid to tell them if they are taking supplements or using alternative or complementary ways of looking after themselves rather than the medical fix-it model, says Dr Dilis Clare, a GP and herbalist based in Galway. “The doctors pooh-pooh it and say that the herbs, at best, do nothing and that, at worst, they are dangerous. They are trained to be this dismissive. I was trained to be this dismissive.”

Making a blend specific to a patient's needs is a long-established practice, but it has its fierce critics. Most prominent among these is Edzard Ernst, who received training in acupuncture, homeopathy, herbalism and massage therapies before going on become a prominent sceptic. He went on to become the world's first professor of complementary medicine but was effectively forced into early retirement from Exeter University when he criticised Prince Charles for his promotion of alternative therapies and accused him of being a "snake-oil salesman".

In 2007, he published a study which was found that individualised herbalism, where patients are given a herbal blend, did not work. He said there was no scientific evidence for most herbal remedies and that consumers are being misled. He highlights how individualised herbalism has a higher risk of adverse side-effects, herb-drug interactions and contamination.

Ernst is slightly less critical of herbalism – where there are active ingredients – than he is of homeopathy, where there are not, and points to clinical signs showing effects for hawthorn and St John’s Wort.

Unsurprisingly, Clare isn’t convinced by Ernst’s findings. She is critical of the study’s design and says that his research showed that all the IBS patients on the trial experienced benefit and points out that talk therapy also forms a part of the benefit of herbs. And she says she’s not surprised that there isn’t enough evidence for the benefits of herbs, when in 2005 US government funding for all complementary and alternative medicine was $124 million (€112 million), compared to $20 billion (€18 billion)for new drug research.

“When you give me less than 1 per cent of the research, I can give you less than 1 per cent of the evidence,” she says.

She points to four research reports showing benefit from a herb called boswellia. “In the context of minimal if any safety concerns why not suggest people try it to see if it helps them before over-relying on non-steroidal anti-inflammatories (ibuprofen is one) with sometimes fatal consequences.”

A 1998 article in the American Journal of Medicine estimates they cause 16,500 fatalities in the US every year.