As a move to protect its citizens from potentially damaging side-effects, hundreds of over-the-counter herbal medications have been banned as new European Union regulations come into force. From now on, only herbal medications that are licensed, well established, or prescribed by a registered herbal practitioner are allowed to be sold.
Herbal remedy makers and practitioners fear this rule could bankrupt them. According to studies carried out in the United Kingdom, approximately one quarter of its adult population has bought and used OTC herbal remedies at least once over the last 24 months, mostly from pharmacies and health food shops.
The new rules cover St. John’s Wort, valerian, Indian medications and traditional Chinese ones.
A herbal remedy is a medicine prepared from plants and generally includes most of the traditional remedies for diseases used worldwide. Most of us regard herbal remedies as OTC (over-the-counter) supplements. However, the majority of OTC and prescription medications are based on ingredients that originally originate from plants, such as digoxin and aspirin. Some herbal medications have been demonstrated to be effective against some conditions and illnesses. Experts say herbal remedies should be treated as carefully as prescription medications – patients should be careful about dosage, misuse and interactions with other drugs.
The new regulations came about after growing concern among health care professionals about how some remedies clash with conventional drugs, as well as the damaging effects a number of them can have when taken on their own.
Ginkgo and ginseng can interfere with blood-thinning drugs, while St. John’s Wort can undermine the effects of oral contraceptive medications.
Until this new rule came into force, standards with unlicensed herbal remedies were patchy, ranging from adulterated products, medications with the wrong herb in them, to others with weak information about safe usage. Details regarding side-effects and contra-indications would appear in some brands and not in others with identical ingredients. If one brand has a warning while another does not, there is a risk consumers might buy the one with no warning, thinking it is safer.
Herbal medications must now be evaluated and approved by the MHRA (Medicine and Healthcare products Regulatory Agency) before going on the market. Makers will have to present proof about their safety and efficacy, unless the medication has been in use for a long time.
The MHRA has issued several alerts over the last couple of years regarding possible side-effects and adverse events associated with some herbal remedies.
A traditional medicine needs to have been in use for at least 15 years in the European Union and 30 years globally.
Approvals will only apply for minor conditions, such as some aches, pains, sleeping problems, coughs, and colds.
Products which are currently on shelves and displayed for sale are exempt, until their expiry date.
As the licensing process can cost from between £80,000 to £120,000 ($125,000 to $190,000), many herbal remedies were lost. The British Herbal Medicine Association said that over 50 herbs, including the so-called natural Viagra horny goat weed, hawthorn berry (for angina pain) and wild yam will no longer be on sale in health food outlets.
UK Health Secretary, Andrew Lansley issued a written statement explaining that the authorities wanted to ensure continuing access to unlicensed herbal remedies through a statutory register for practitioners “to meet individual needs”.
Before today, herbal remedies were covered by the 1968 Medicines Act, which came into force when very few were available.
The MHRA says it has received 211 applications for registration. So far, 105 registrations have been granted.
On its web site, the MHRA writes:
“The THR certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.
Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.”
Written by Christian Nordqvist