New EU rules ban many herbal remedies

Patients will lose access to herbal medicines from this weekend onwards as European regulations have come into force.

Under the new directive, traditional products must be licensed or prescribed by a registered herbal practitioner.

European Union has set May 1 is the deadline for the expiry of a seven-year transition period. This means herbal remedies need to be registered, meet safety and quality standards to remain in the market.

John Dalli, European Commissioner for Health and Consumer Policy stated, "Patients can now be confident about the traditional herbal medicinal products they buy in the EU.

"We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficiency."

Simplified procedure
Given the long history of herbal medicines use in the UK, the Herbal Directive has introduced a simplified procedure that permits traditional products to be registered without the safety tests and clinical trials that marketing of other medicinal products requires.

In accordance with the new directive only herbal remedies assessed by the Medicine and Healthcare products Regulatory Agency (MHRA) will be available for commercial use.

Additionally, the products must meet strict manufacturing standards and come with information about dosage and possible side-effects.

Moreover, it is imperative the traditional medicines provide evidence that it has been used safely for the past 30 years, particularly 15 years within the EU.

Also, herbal remedies will be granted sanction only for minor ailments like coughs and colds, muscular aches and pains, or sleep problems.

However, traditional products already in the market will be allowed to stay on the shelves until there expiration date.

Richard Woodfield of MHRS said, “This EU directive and the registration scheme puts consumers in the driving seat so they can identify that a product meets assured standards on safety, quality and information about safe use.”

Serious side effects
A survey carried out by MHRA in 2009 found that nearly 26 percent adults in the UK had used herbal medicines in the last two years. Most of them purchased them over the counter in health food shops and pharmacies.

The popular perception of the respondents was that herbal medicines were safe because they are "natural".

On the contrary, alternative medicines are known to have potentially serious side effects.

Studies have found John's Wort, a popular herbal remedy for mild depression, can interfere with the effects of birth control pills while traditional medicines like ginkgo and ginseng have a blood-thinning effect like the drug warfarin.

Black cohosh used by many menopausal women has been linked to liver damage and the weight loss pill called Herbal Flos Lonicerae (Herbal Xenicol) was found to contain more than twice the prescribed dose of a banned substance.

Pat O'Mahony, chief executive of the Irish Medicines Board, (IMB) said, "In recent years there has been a substantial rise in the use of herbal medicines and an increase in evidence and understanding that side-effects and interactions between herbal and other medicines can occur.

"The EU Directive was adopted to provide for a regulatory framework for these products to ensure consumer protection”.