Consumers across Europe will be denied the right to use the majority of herbal remedies currently available in health food stores and on the Internet when a new European law is fully implemented on 1st May 2011, according to data published today by the Alliance for Natural Health International (ANH-Intl).
ANH-Intl has collated and released a list of the 79 herbal products registered for use in the UK by its medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The list, which is based on data taken from the MHRA’s website, shows that only 34 plant species are included out of a total of more than 1000 that are commonly used as medicinal herbs. The ban applies to any herbal product that is not registered by 1st May, and is a result of the full implementation of the EU Traditional Herbal Medicinal Products Directive (THMPD).
Non-European herbal products will be hardest hit: so far, not a single herbal remedy used in the two biggest traditions, Ayurveda (from India) and traditional Chinese medicine (TCM), has been approved.
Nutritional supplements that include any non-approved medicinal herbs will also be banned.
Robert Verkerk PhD, Executive and Scientific Director of ANH-Intl, said, “We believe consumers have the right to see which products have so far been registered, what they have in them, what their intended uses are and who has registered them. We have therefore collated the data into a single list while also releasing other lists that show the extensive range of Indian, Chinese, Tibetan and even western herbs that will be subject to the ban.”
The new legislation claims to put consumer safety first making it mandatory to indicate possible side effects and interactions with other drugs on the labelling of approved herbal products. But health-conscious consumers are likely to be surprised to find a wide complement (over 100) of additive ‘nasties’ in most (but not all) of the registered products. These include the detergent sodium lauryl sulphate, the controversial sweeteners aspartame and sodium cyclamate, artificial preservatives, such as E215, E217 and E219, and various polymers, such as butylated methacrylate copolymer, polyvinylpyrrolidone and polyvinyl alcohol (PVA). The latter is recognised by government authorities to cause cancer in laboratory animals.
Other key findings are:
Twenty-seven of the 79 registrations are for just two herbs, Valerian (15) and Echinacea (12).
Around one-third of UK registrations are from pharmaceutical companies whose core interests lie with conventional drugs rather than herbal products.
The 79 registered herbal products are licensed to just 26 companies, mainly of UK, German or Swiss origin.
Not one of the licensees is a supplier of Chinese or Indian (Ayurvedic) herbal products, these being the two most well-established herbal traditions in the world.
Eighty percent of registrations are for products containing single herbs, rather than herbal combinations, which are common to the non-European herbal traditions.
Only eight of the registrations (10%) are for products containing whole plant material; the majority of the remainder are alcoholic extracts stabilised in a chemical base, including various combinations of over 100 excipients.
Smaller traditional herbal providers are notable by their absence.
Herbs that are popular with consumers that are among the thousands to be banned in May, unless registrations are granted within the coming 75 days, include:
Western herb examples
Herbal combinations for premenstrual tension using Red Clover and Chasteberry.
Hawthorn for cardiovascular health.
Meadowsweet for arthritic inflammation.
Ayurvedic herb examples
Bibitaki one of the three key ingredients in Triphala, among Ayurveda’s most widely used herbal products (for digestive health).
Ashwagandha (sometimes referred to as Indian Ginseng) that is an ‘adaptogen’ used to balance the body.
Arjuna for heart and circulatory health.
Chinese herb examples
Baikal skullcap used as an anti-inflammatory.
Chinese foxglove (Rehmannia) as an immunosuppressant for those with autoimmune diseases.
Chinese goldthread (Coptis) used for detoxification.
Amazonian herb examples
Cat’s claw as an anti-inflammatory.
Pau d’Arco to help strengthen the immune system.
Graviola used as an anti-inflammatory, especially with cancer patients.
One possible explanation given by ANH-Intl for the lack of licences granted to smaller traditional herbal companies on the THMP list is the “obstacle course” that they face in what is a very expensive, complicated and time-consuming registration process not suited to complex herbal combinations. Estimates for the registration range from £80,000 to well over £150,000 per product. Many in the natural products industry believe the costs are prohibitive and effectively result in selective discrimination.
Verkerk says: “We are planning to initiate judicial review proceedings of the EU Directive, starting in the High Court in London. We hope then to get a reference to the European Court of Justice. We are challenging on the grounds that the law is disproportionate, non-transparent and discriminatory, especially to the non-European traditions. We have already raised about £60,000 of our £90,000 target to fund legal fees for this initial phase.
“A major flaw in the legalisation is that, unlike pharmaceuticals, herbal products are made from biological sources, and as such do not react in the same way that conventional pharmaceuticals do in a laboratory environment. Trying to push these ancient traditions into a European straitjacket based around synthetic drug manufacture is like to trying to push a square peg into a round hole.”
For further information please contact:
Adam Smith, science & communications officer, or Sophie Middleton, campaign administrator, European office of ANH-Intl, tel: +44 (0)1306 646 600, email: [email protected]
About the Alliance for Natural Health International (ANH-Intl)
Alliance for Natural Health International is an internationally active non-governmental organisation working towards protecting and promoting safe and natural approaches to healthcare. ANH-Intl campaigns across a wide range of fields, including for freedom of choice and the use of micronutrients and herbal products in healthcare. It also operates campaigns that aim to restrict mass fluoridation of water supplies and the use of genetically modified foods.
Through its work particularly in Europe and the USA, the ANH works to accomplish its mission through its unique application of ‘good science’ and ‘good law’. The organisation was founded in 2002 by Dr Robert Verkerk, an internationally acclaimed expert in sustainability, who continues his leadership.
The ANH brought a case against the European directive on food supplements in 2003, which was successfully referred to the European Court of Justice in early 2004. The ruling in 2005 provided significant clarification to areas of EU law affecting food supplements that were previously non-transparent.
About the Traditional Herbal Medicinal Products Directive (THMPD)
For further information about the EU directive on traditional herbal medicines (THMPD) and concerns over its implementation, please download the ANH briefing paper.