Many herbal medicines banned under EU directives

By Dr. Ananya Mandal, MDMay 1 2011

According to the new EU rules that came into force over the weekend, hundreds of herbal remedies are now banned. The laws are aimed at protecting consumers from potentially damaging “traditional” medicines.

Under the new rules herbal medicines will now have to be registered. Products must meet safety, quality and manufacturing standards, and come with information outlining possible side-effects. Herbal practitioners and manufacturers say they fear the new rules could force them out of business.

The studies were conducted for the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2009 showed that 26% of adults in the UK had taken some herbal medicine or other in the last two years, mostly bought over the counter in health food shops and pharmacies. Commonest agents include echinacea, which is used against colds, St John's wort, used for depression and anxiety, and valerian, which is claimed to ease insomnia.

The MHRA believes that this directive would promote a more cautious approach to the use of herbal medicines after a study found that 58% of respondents believed these products were safe because they are “natural”. In fact, herbal remedies can have harmful side-effects. For example ginkgo and ginseng are known to interfere with the blood-thinning drug warfarin and St John's Wort can stop the contraceptive pill working. In February the MHRA issued a warning about the herbal weight loss product Honeysuckle Flower (Flos Lonicerae) (Herbal Xenicol) Natural Weight Loss Formula, after tests showed it contained more than twice the prescribed dose of a banned substance.

To date, the industry has been covered by the 1968 Medicines Act, drawn up when only a handful of herbal remedies were available and the number of herbal practitioners was very small. Going forwards manufacturers will have to prove their products have been made to strict standards and contain a consistent and clearly marked dose. Remedies already on sale will be allowed to stay on the shelves until their expiry date.

MHRA revealed that there had been 211 applications for approval of herbal remedies so far, with 105 granted and the rest still under consideration. At least 50 herbs, including horny goat weed (so-called natural Viagra), hawthorn berry, used for angina pain, and wild yam will no longer be stocked in health food shops, says the British Herbal Medicine Association. Approved remedies will come with a logo marked THR. The licensing process costs between £80,000 and £120,000.

Some of the most commonly used products were saved after the Health Secretary Andrew Lansley approved a plan for the Health Professions Council to establish a register of practitioners supplying unlicensed herbal medicines. Mr Lansley, in a written statement, said the Government wanted to ensure continuing access to unlicensed herbal medicines via a statutory register for practitioners “to meet individual patient needs”. Acupuncture falls outside the EU directive and so remains unaffected.

Professor George Lewith, professor of health research at Southampton University, said, “Evidence for the efficacy of herbal medicines is growing; they may offer cheap, safe and effective approaches for many common complaints.”