Pressure against EU herb laws mount When the monstrosity of European laws gets in the way of healthcare traditions that are thousands of years old, it's no wonder that people get upset. Two of the biggest eastern traditions, the practice of which within the EU could be sabotaged by European laws as early as the middle of next year, are traditional Chinese medicine (TCM) and the traditions of Ayurveda and Unani from the Indian subcontinent. But being upset does nothing in itself to change these laws. We have come together with the Holland and Belgium based European Benefyt Foundation to do everything we can to protect these age-old healthcare cultures. Read all about our joint strategy in our press release issued today, which refers also to our position paper on the subject, co-authored by Rob Verkerk of ANH-Intl and Chris Dhaenens of Benefyt. Press Release 1st September 2010 PRESSURE AGAINST EU HERB LAWS MOUNT BRUSSELS, 1 Sep 10. The European Benefyt Foundation and the Alliance for Natural Health International (ANH-Intl) presented yesterday their united strategy to a range of stakeholders representing Chinese and Ayurvedic traditions of herbal medicines. The meeting was held in the Renaissance Hotel, Brussels. The proposed strategy aims in particular to address the grave regulatory situation facing thousands of products representing non-European herb-based healthcare traditions. It will also help to keep on the market products associated with minor European herbal traditions that are struggling to cope with the raft of EU laws affecting them. In April 2011, when the EU Traditional Herbal Medicinal Products Directive (THMPD) is fully implemented after a seven year transition phase, thousands of products distributed by specialist herbal suppliers will become increasingly difficult to sell. Medicines regulators in many Member States appear to be using the full implementation of the THMPD as a means of narrowing the scope of the food supplements regime, under which most of these products have to-date been sold. The long transition phase of the THMPD is meant to have provided stakeholders with the time required to ensure their products have been successfully registered under the simplified medicinal licensing scheme offered by the Directive. However, a range of eligibility and technical problems, along with prohibitive costs, have, so far, prevented any products from either the Chinese or Indian traditions from successfully being registered under the scheme. The core strategy of the two organisations has been detailed in a 10-page position paper authored by the heads of the respective organisations, namely Dr Robert Verkerk (ANH-Intl) and Chris Dhaenens (Benefyt). The paper was tabled at the stakeholders meeting and received broad support from the diverse range of attendees, some of which had travelled from as far away as India. The joint strategy was presented at the conference by lead author, Dr Verkerk. Commenting on it, he said, “While the herbal directive provides an additional framework that is amenable to some, predominantly European herbal products, it simply doesn’t work for the majority of complex, multi-herb products associated with these ancient non-European traditions.” The strategy involves three primary initiatives; improvement of the food supplements regime under which most Chinese and Indian herbal products have been sold up until now, the initiation of judicial review proceedings with the aim of gaining a reference to the European Court of Justice, and the development of an altogether new framework for such products. The former two approaches are regarded as essential to the short-term resolution of challenges facing many stakeholders as of mid-2011, while the latter focuses on facilitation of a new framework that is both accessible to the majority of stakeholders in the sector, whilst ensuring the safety of products through proportionate and scientifically-validated quality control measures. Verkerk added, “We have seen a big increase in classifications by national medicine regulators of herbs as novel foods or unlicensed medicines, and it is clear that regulators intend to narrow the scope of the food supplement regime for herbal products after April next year. On top of this, most claims for botanical food supplements will soon have to be removed given the anticipated negative opinions being issued by the European Food Safety Authority under Article 13 of the Nutrition and Health Claims Regulation. The herbal directive, which should provide a carve out for these products, acts disproportionately against non-European traditions, while also discriminating against those who want to use such products—that have after all stood the test of time—to manage their own health. It is therefore essential that judicial review proceedings are started in advance of the end of the transition period.” Speaking after the conference, Chris Dhaenens said, “The herbal directive as it currently stands is poorly thought through and is simply inaccessible to most players distributing high quality Chinese or Indian herbal products in Europe. Ironically, while the quality control measures are one of the biggest stumbling blocks for most stakeholders in the sector, they don’t guarantee that products are safe. Amongst our proposals, are revised quality control measures that are both cheaper and more effective than those offered by the existing directive. We are very happy to be collaborating closely with the ANH and are hopeful that a strong, more united effort will bring positive change.” The joint ANH/Benefyt position paper can be downloaded from the following link: ANH-Intl and Benefyt are calling on interested parties to contact either of the organisations for further information. They have stressed that adequate financial support will be crucial to the effective implementation of the joint strategy and have warned that inaction will result in the loss of thousands of products with consequent impacts both on public health and the small businesses in the sector. ENDS.
CONTACT For further information, please contact: ANH-Intl: Sophie Middleton (campaign administrator), tel +44(0)1306 646 600 or email info@anhinternational.org European Benefyt Foundation: Chris Dhaenens or Harrie Sandhövel, Tel +31 320 251 313 or email: info@benefyt.eu EDITOR’S NOTES ANH-Benefyt position paper Position paper title: Working collaboratively to maintain the supply of products associated with traditional systems of medicine in Europe from 2011 onwards About ANH International |
Wednesday, September 1, 2010
Can the Pressure Against EU Herb Laws Affect the US?
Wednesday, August 25, 2010
EU Food Supplement Clampdown Overrides Consumer Choice --- We, the People, Can't Allow This to Happen in the US
EU food-supplement clampdown overrides consumer choice
August 19, 2010
WASHINGTON, D.C., Aug. 19, 2010/ Troy Media/ –
In 2011, hundreds of food supplements and thousands of health-benefit claims concerning food supplements will be banished from the European market as each European Union member state enforces the EU Supplements Directive of 2002.
That administrative rule is one of the Western world’s most extensive experiments in centralized government planning. By order of the European Food Safety Authority, as confirmed by the European Commission, the nations of Europe will dutifully dispatch their health investigators and police to remove from the market hundreds of food supplements consumed for decades without serious complaint.
Companies forced to downsize or close
Those agents will force the downsizing or closure of a number of companies that have manufactured and distributed the banned products, particularly small to medium-size businesses. The agents will also censor health information in ways more sweeping (reaching health claims made in all 27 member states) than the dreaded English Licensing of the Press Act of 1662.
The food supplement market in Western Europe is estimated to have an annual value of approximately US$80 billion. About 40 per cent of the adult population of Europe use dietary supplements daily, varying in kind preferred and in level of interest by country. Increasingly, Europeans have come to associate above-recommended daily intake of certain vitamins and minerals with beneficial health effects, causing them to depend on access to those products as part of a personal health regimen.
Countries seriously affected
Certain countries in Europe already suffering from high unemployment rates, such as Spain (near 20 per cent), Ireland (13 per cent), Portugal (10 per cent) and Greece (9.2 per cent), stand to suffer the most from unemployment resulting from the EU crackdown on supplements and supplement claims.
The directive has empowered that bureaucratic scientific body - the Safety Authority - to stand between those who make and distribute food supplements and European consumers, and to dictate which products previously lawfully available may henceforth be allowed to reach consumers and what may henceforth be said about them. Its aim is to render uniform the entire European market, despite the great diversity in food-supplement preferences that exist among the peoples of Europe.
The system discriminates against small companies and new market entrants in favor of large companies and incumbent sellers because it presumes all products sold without incident to be unlawful unless proven – based on clinical trial evidence – to be safe and bioavailable. Proof, in the form of scientific dossiers, must establish to EFSA’s satisfaction that products intended for sale are safe and bioavailable. No claims may henceforth be made unless scientific dossiers establish to EFSA’s satisfaction that the claims are proven to a near conclusive degree. The dossiers are expensive, roughly[B1] US$500,000 or more per submission. At least 90 per cent of the companies in this market cannot afford to submit a dossier and so must either cease sales altogether or reduce product offerings to those that others succeed in getting approved.
EFSA, a draconian taskmaster
To date, EFSA has proven itself a draconian taskmaster. Of some 800 dossiers for food-supplement approval that have been submitted, almost 80 per cent haven’t been approved by the agency. Unless a food supplement is placed on EFSA’s list of approved supplement ingredients, it is unlawful to sell. That method reversed the prior burden of proof. Before the EU Supplements Directive, if a product was derived from food, it was presumed safe unless a government in Europe established the product to be adulterated (i.e., to be unsafe for human consumption). Since the EU Supplements Directive, every food supplement is presumed unsafe, regardless of its prior history of safe use, unless scientifically established to EFSA’s satisfaction to be safe and bioavailable.
Proof of safety and bioavailability has proven to be a catch-22 in EFSA’s Kafkaesque system of risk reviews. If a food supplement could be unsafe at some dose level (a truism for everything in nature, including water), then it is presumed unsafe at every dose level unless a dossier proves safety at a particular dose level. In addition, if a food supplement has an effect on the body (true for almost every food supplement and dependent on dose), then if that biological effect can be linked to some potential adverse event it becomes an impermissible dose. In the end, this system reduces dosages for food supplements to levels of inactivity, making them largely useless as aids to health, undermining entirely the market for these products by eliminating them except at dose levels that have no beneficial health benefits.
To date, EFSA has also been an effective censor. Of some 9,000 health-claim dossiers filed, EFSA has acted on only 1,080. EFSA says it will act in September on the remainder still on file. Its rulings have generally been negative, condemning nearly every claim for probiotic products, antioxidants, even omega-3 fatty acids. Claims not supported by proof to a near-conclusive degree are rejected.
Although almost no science, including nutrition science, is ever provable conclusively, EFSA condemns all nutrition science that accurately reflects the extent to which a nutrient may affect health on the illogical presumption that science is false unless conclusively proven true.
In the real world of science, information exists on a continuum between a bare hypothesis and a proposition that is proven, with most existing in the realm between the two, backed by credible evidence that links the nutrient to an effect on health and disease, albeit inconclusively.
EU fails to disclose information
Consumers depend on credible science that is inconclusive in making daily purchasing decisions. Indeed, they depend on inconclusive science to make critical, life-affecting decisions in the market – everything from which car to buy to what drug to take. Uniquely, the EU has chosen to keep from consumers all less-than-conclusive information about nutrients potential to cause illness or disease. In this way, the EU is dumbing down the European marketplace for food supplements, robbing Europeans of essential information on emerging science and the potential of certain nutrients to reduce disease and improve health.
Ironically, while EU officials contend that this experiment in centralized planning protects the health of Europeans, it may well harm their health. Science linking certain nutrients to disease risk reducing effects (such as omega-3 fatty acids and heart and brain health; antioxidants and reduction in the risk of certain kinds of cancer; selenium and reduction in certain kinds of cancer, among many others) may well prove true, yet in Europe, consumers will be denied that information in the market into the foreseeable future.
Consequently, those Europeans who would wish to bet on the provability of emerging science by exercising choice in the market will be denied the opportunity to make that bet by a paternalistic EU, an EU that thinks it knows better than the typical European what is in that European’s own self-interest. The result may well be a higher level of heart disease, senescence, Alzheimer’s, and cancer than would otherwise be the case. At a minimum, this new system reduces the sovereignty of EU member states and, most importantly, citizens of each EU member country, proving once again that a common market can also mean common enslavement.
Jonathan Emord can be reached at jonathan.emord@troymedia.com