An article published in the UK Independent on Dec. 30, 2010, reports: ‘From 1 May 2011, traditional herbal medicinal products must be licensed or prescribed by a registered herbal practitioner to comply with an EU directive passed in 2004.’
The reason given for the directive is a purportedly ‘rising concern over adverse effects caused by herbal medicines.’ The fact that this reason is given for the regulations reflects not only issues with herb safety but also the herbal community’s inability to unilaterally effectively address these concerns. Bickering factions among individual herbalists and herbal organizations have crippled their ability to self-regulate, resulting in regulations imposed by governmental agencies.
While the new law requires registration and licensing of individual herbal products and does not directly regulate the practice of herbal medicine, it will certainly affect herbalists in the EU. In most European countries, herbs are dispensed by medical doctors or individuals licensed in particular healing professions like Traditional Chinese Medicine and so forth. But if one is not a registered herbal practitioner — for which no registry has yet been created — one will no longer be able to dispense the hundreds of still-unlicensed herbal products. (For a bit of perspective, here is a World Health Organization listing of how EU countries regulated herbal medicines compiled in 2005.)
Under the new law, the EU has basically succumbed to the dispensing of herbs by medical doctors. However, even with the more extensive training in herbal medicine that German medical doctors evidently receive, it is questionable that they are skilled in the finer aspects of herbal prescribing that is an essential part of the art of traditional herbal systems throughout the world.
What finer aspects are these, you may ask? It’s the difference between deciding to prescribe an herb such as willow bark as an alternative to acetaminophen for a headache or choosing to prescribe an herbal compound that addresses both the headache as well as its underlying cause.
Failure to address the underlying cause of disease results in the widespread use and abuse of stronger synthetic alternatives. In fact, as much as 80% of all drugs are either derived from herbs or synthetic compounds found in plants. The reason for the plethora of drug side effects is precisely because of their concentration and the focus being largely directed to muffling symptoms rather than promoting rejuvenation and cure.
Because people have become aware of these undesirable side effects and dangerous risks, they have come to rely on herbs. In fact, the main reason people turn to herbs, supplements and alternative healing methods is because of well-founded fears regarding the adverse reactions to drugs and some medical interventions.
The herbal product regulations in the EU require that companies selling undergo similar licensing requirements as pharmaceutical drugs. Considering that there are literally thousands of medicinal herbs throughout the world with which people have had a long history of safe use, and that there are infinite combinations of herbal formulas that oftentimes make for more effective products, it is both impractical and unrealistic that a company should invest millions of dollars to license each of their herbs and herbal formulas. This is not to mention the inevitable prohibitive ultimate cost to consumers for these products. I agree with the critics of the move to ban herbs in the EU when they say that this is indeed ‘disproportionate and discriminatory.’
To restrict the sale of such common herbs as cascara sagrada, an herbal laxative; skullcap, an herbal sedative; and ashwagandha, a whole body tonic that increases health and libido which are only a few of the 100s of herbs that will be banned from sale starting in May shows flagrant disregard to the public’s reliance on these and other safe herbal products and discourages people from finding alternatives to the high cost of conventional medical care.
What about the United States?
Attitudes similar to the ones that led to the restriction of herbs in the EU, namely that the herbal and nutritional supplement industry is dangerously unregulated, are also present in the United States. Upon closer examination one may discover that the industry in the U.S. is subject to unannounced inspections by the FDA leveling severe fines on herbal companies who fail to follow stringent GMP (Good Manufacturing Practice) guidelines established both by the herbal industry itself along with the FDA. Recognizing the regulatory difficulties involved, the United States enacted what may be one of the most popular legislations in US history, the Dietary Supplement Health and Education Act of 1994 (DSHEA). This established the regulation of herbs and supplements in a separate class from drugs.
But if they don’t stand united and agree on a method of self-regulation, U.S. herbalists may find themselves in the same kind of quandary that those in the E.U. face today.
The American Herbalists Guild is the single herbal organization that has come closest to creating standards for professional clinical herbal practice in the United States. For over 20 years it has done much good for the profession, but one of the problems it has consistently encountered is attempting to appeal to and represent all the individual and sometimes quirky styles of herbalism that exist in the U.S. Nevertheless, it has a five-person peer review admissions board whose objective is to screen for and accept only professional applicants who meet the rigorous standards set forth by the AHG for its members.
At the AHG’s inception, a number of respected herbalists were granted professional membership based on their prior experience. Recognizing the need for such an organization, most of these herbalists responded to the call, and thus the AHG has grown over the course of its 22 years in existence. Some, however, saw the formation of the AHG as a threat to herbal medicine and an herbalists’ “civil war” ensued. The AHG had no intention of limiting the practice of herbal medicine but to establish professional standards of practice for its members and by so doing advance the profession of medical herbalism in America.
Several years ago, foreseeing possible developments restricting herbal medicine as is now occurring in the E.U., some of the members of the AHG tried to create a “Traditional Medicines Category” to protect our access to important medicinal herbs just in case such restrictions would be implemented in the U.S. When this endeavor was met by stiff opposition from “olde garde” herbalists, some members of the AHG felt that the project needed to be abandoned and so it was. Without such a protected category in place these herbs may one day be banned not only from the public but also from practitioners.
In view of the course taken by the E.U. and the highly restrictive climate of these times, herbalists in the United States should really consider this a wake-up call. What can we do to prevent the same from happening to us?
It is difficult at this point to not descend into the typical ‘˜us against them’ polemic but when apparently discriminatory repressive measures are taken against herbal medicines based on a very small number of reported incidents while far greater concerns regarding adverse drug reactions exist worldwide, it is impossible to not refer to the following statistics in order to frame a context for discussion.
An oft-cited statistic comes from a 1995 study based on the United States alone that describes an average 106,000 deaths per year from adverse drug reactions at a cost of $12 billion. Further, when combined with all other iatrogenic causes (caused by drugs and medical treatment) of injuries and deaths, the total rises to 16.4 million people who are affected with costs modestly estimated to be well over $300 billion a year.
In comparison with these statistics, the percentage of deaths and injuries from herbs and natural medicines is minuscule. The Natural Health Federation (NHF) reports that ‘There was not even one death caused by a dietary supplement in 2008, according to the most recent information collected by the U.S. National Poison Data System.’ This was based on polls of 61 poison centers who provide coast-to-coast data for the U.S. National Poison Data System, which is then reviewed by 29 medical and clinical toxicologists.
While there are no immediate signs that such regulations will extend to the United States, there is reason for concern that with the heightened atmosphere toward increased regulation generally, it could become a concern for those who rely on herbal supplements in the United States.
Therefore I urge that that we stand in solidarity with our European counterparts by signing the petition to stop the European Traditional Herbal Medicinal Products Directive: http://www.gopetition.com/petition/39757.html
To learn more about how to challenge the new law go to: