BACKGROUND
The Nova Scotia Herbalist Association has long had an inherent interest in the preservation and use of herbs for medicinal purposes. Through the years, beginning with the Second Advisory Committee, our members have made numerous representations to the federal government including written and verbal presentations, internet websites, and both private and public lobbying efforts.
We congratulate the government on progress made to date and wish to build on the many accomplishments already achieved through the efforts of dedicated cadres of expert advisory personnel.
Herbalists have long kept the medicinal use of herbal medicine alive; indeed, herbalists have preserved and protected herbal knowledge through the ages often against strong forces such as vested medical guilds and crippling governmental fiat. Despite it all, herbs are once again making a strong comeback in healthcare due to the rising swell of popular demand.
The Nova Scotia Herbalist Association is dismayed by the tendancy of this recent governmental effort to continue perpetuating the idea that one, big complementary system of medicine can properly address the needs of people who wish to use natural health products. Just as one political party is a dictatorship, or one religion is disdainfully monotheistic, or withholding the franchise from women is chauvinistic, so too is the tendancy of the medico model (allopathy) to usurp and integrate herb usage into their single, monopolistc construct. We are displeased with their Orwellian usage of such terms as preventative medicine, well-woman clinics, and especially, co-option of natural health products.
In this submission we will endeavor to communicate our points-of-view in a positive and constructive manner so that Alternative health, and its associated practicing herbalists, may be recognized as making up a paradigm of medicine separate and distinct from the allopathic medical model. Medicos using herbs within the allopathic model in no way represent herbalists using herbs within the Alternative health paradigm.
SUMMARY
· It is the position of the Nova Scotia Herbalist Association that herbs used toward medical purposes have long been proven, again and yet again, through the annuls of time. In the context of Canadian medical history herbs and associated therapies once thought to be totally disproved through layer after layer chemical-drug advancement, decade after decade, are now emerging as equally efficacious or superior to many accepted drug & surgery treatments. As herbalists we encourage and promulgate this view.
It is often the subject of debate among herbalists as to whether or not participation within the bureaucratic process results in a net positive or a negative influence upon the rightful role of herbalists in the application of healthcare. Always, superior economic entities or well-intentioned business/professional constructs emerge which skew the true nature and character of herbal medicine. Recent moves to "standardize" herbs, to codify the whens and hows of usage, or to restrict the whos of herbal medicine exemplify the results when powerful forces intervene in the name of herbalists ostensibly to reveal the true benefits of herbal products but, in actuality, are merely seeking to gain control over economic substances toward their own dubious ends.
· It is the position of the Nova Scotia Herbalist Association that herbs "...are different in nature from foods and pharmaceutical products" not by their physical characteristics but rather by how they are used. A screwdriver to housewife may be an excellent tool for opening cans of paint but in the hands of an electrician a screwdriver is a tool capable of vastly different constructive acts, none of which would be attained if 'tool' usage was regulated by housewives under a common system of practice.
Although the Office of Natural Health Products seems tacitly aware that usage of a botanical product helps to define it characteristically as a natural health product ("a substance or substances used as a traditional medicine...") it is our position that usage by a herbal practitioner is the gold standard in promoting a product into this category. Desiccated apple may be both a food and a natural health product if used for health building purposes by a herbal practitioner.
It is this usage by an Alternative-health practitioner which makes a product natural. And it is the usage of a botanical product by an Alternative herbalist practitioner which makes it a botanical. Otherwise, the product is simply a drug-like product used by an allopathic or complementary practitioner.
· It is the position of the Nova Scotia Herbalist Association that true understanding, control, regulation, and application of natural health products cannot be accomplished without the definition, establishment, and autonomous regulation of the Alternative health paradigm. Herbalists see themselves as being a component part of such a structure. It is unlikely that herbalists will integrate themselves into the existing allopathic structures or into a contained, complementary structure as the medical treatment approaches are diametrically different in objective and purpose; hence, formal recognition of a different paradigm is required.
Foremost in the collective mind of the Nova Scotia Herbalist Association is that herbs and time-honored herbal therapies be preserved for future generations. This is our legacy and our mission. Success in dealing with the complex issues of natural health products of traditional and botanical nature must be an acknowledged aspect of our histories and of our mission to preserve such practices for future generations, without the undue interference of those unsympathetic to the Alternative (natural health) paradigm.
Definition of Natural Health Products
The proposed definition of natural health products is very good but it is also fundamentally flawed.
The proposed definition of natural health products is excellent because:
1) it defines broadly the intended sphere of natural health products;
2) it defines their use (i.e.. promote health / treat or prevent disease); and
3) it incorporates practices (e.g.. homeopathy / traditional healing systems);
4) it allows for arbitrary inclusion of substances (e.g.. shark cartilage); and
5) it allows for arbitrary exclusion of substances including, redundantly, substances in the Controlled Drug and Substances Act.
The proposed definition of natural health products is also fundamentally flawed. The fundamental flaw is that decisions such as arbitrary inclusion or exclusion are being made by what is essentially a marketing board which has no moral or ethical imperative other than to design and maintain a safe and constricted trading category.
Natural health products are more than simply a list of items. They are 'natural health' because they reflect the holistic principles inherent in, and a component part of, the Alternative-health paradigm. The Alternative-health paradigm is built upon a belief system which incorporates holistic principles (e.g.. 2 + 2 >= 4). Holistic principles are not evidence-based or scientifically-determined. Science goes a long way toward explaining why holistic practices work but they do not determine them. Homeopathy assumes 'like cures like' and herbalism assumes 'you are what you eat.' They are basic tenets. They are not logical extensions of precise incremental science.
The solution to the problem is to create a parallel medical society, for example a Holistic Health Society, for the express purpose of representing natural health products and practices in Canada. Such a body can best deal with the day-by-day decisions and recommendations that are even now pressing heavily upon the Department of Health. It makes no sense to place non-holistically accredited individuals in control of natural products. Even though well-intentioned, there is simply no way that one paradigm can represent another. By way of analogy, even a well-intentioned Pope cannot expect to be a respected spiritual leader of those who follow an Islamic faith.
When an allopath uses Vitamin C therapy or lemon juice therapy it is because of definite double-blind, clinical studies which predict a reasonably confident result. However, a natural health practitioner may perform these therapies because of the belief that these therapies will work. Over time, only Alternative experts will be able to judge the efficacy of traditional treatments.
In elaboration, lets use the example of, here, a hypothetical therapy: the Freshly-Pitted Cherry treatment of high blood pressure.
The standard, evidence-based system of allopathic medicine demands an expensive, double-blind study of suitable size (several hundred, well-controlled individuals). The study is funded, probably by the hypothetical Cherry Growers Association of North America, and the results analyzed as to the efficacy of cherries in the treatment of high blood pressure. Let us say that the study revealed overall high blood pressure was reduced by 33% with no alterations to normal blood pressure 'control' individuals or to the high blood pressure 'control' individuals. The result is that cherry growers are ecstatic, vitamin marketers begin selling cherry-active constituent ingredients, naturopaths begin selling costly, value-added products, and health food stores flog a vast spectrum of high blood pressure tablets scientifically proven to produce results.
Such studies, which are indeed common these days, are instantly tagged by practitioners in the Alternative paradigm as "Duh-factor" studies. The duh-factor states that due to the overall general ill-health of the population (due in part to educational and economic factors) any given study which feeds people a generally fresh, healthy, natural product will inevitably and invariably produce improved health indicators of which high blood pressure is included. No holistically-accredited science has actually been performed. Most, if not all, holistic practitioners would tell you in advance that giving fresh fruit to a large group of randomly selected or 'average' people will almost invariably improve average high blood pressure readings. "Try to eat more fresh fruit," is the simple, banal holistic practitioner statement when confronted by excited marketing types promoting a myriad of new, claim-filled products. Whole, fresh food is a fundamental tenet of Alternative health and is promoted as a matter of course; no extra charge.
Without explicit guidance from holistically-accredited practitioners the application of the very good natural health product guidelines and their definitions will lead to wildly exaggerated health claims prolifically reproduced on the tiny labels of highly-marketed value-added natural substances -- the duh-factor.
The existing definition clearly favours the use of natural or pseudo-natural substances to be used in an allopathic manner under the guise and good name of natural health care. The definition, without a holistic, controlling component, is a pure, Orwellian co-optation of natural-product language for economic purposes. A nuclear power plant, too, can be said to be all natural as it is constructed entirely from natural materials -- and the vested interests in nuclear power steadfastly assure us that it is cheap, plentiful, and above all, safe.
A System for Labelling
The system proposed for labelling is largely redundant. Adequate food and cosmetic ingredient labelling has long been in-the-que and may be implemented at any time. Canadian food labelling is among the best in the world. The United States has long had cosmetic ingredient labelling, with Canada moving to parallel.
These common sense issues involving product names and contents aside, there remain items proposed in the ONHP Consultation 2000 that bear particular scrutiny with respect to natural health products.
Of primary concern is emphatic use of terms such as "sold only if" or "will not be approved for sale." Such strict enforcement should require a high degree of unanimity among the health product-consuming public.
We do not believe that the health product-consuming public support to any significant degree the Product Identification Number (PIN). In fact, the Product Identification Number is wholly wasteful with respect to traditinal herbal products and serves only benefit producers.
The PIN may make sense for relatively refined items but for the traditionally quaint refinement of herbal products the PIN is unnecessarily restrictive and burdensome. It serves only as a barrier to populist entry into the market. Instead, the PIN should be required only for items undergoing a degree of refinement that exceeds drying, cominuting, and heat- or mechanically-assisted extraction with food-grade substances. Britain currently supports the definition of a 'threshold' refining level with respect to natural health products.
The lot number is, again, yet another unnecessary control when applied generally to herbal products. We agree that lot numbers are excellent product control adjuncts but the lack thereof should not affect the sale of traditional herbal products.
Lot numbers are the natural off-shoot of improved quality control. Certainly certified organic herbs have long been required to be accounted for by lot. Also, most organizations would, in all likelihood, require the use of lot numbers should they choose to endorse or promote any herbal product. Implicit in this proposed mandatory requirement is that the Office of Natural Health Products endorses only those products produced by larger, more sophisticated manufacturers.
The Nova Scotia Herbalist Association (NSHA) foresees national standards organizations endorsing products and requiring as part of the process lot number accountability. Although lot numbers are beneficial and nice, they should not be mandatory for simple herbal products. Declaring a lot number mandatory is a waste of a good governmental edict.
And lastly, adverse effect reporting is barely applicable to traditional herbal products. Certainly herbalists would be disinclined to report possible adverse effects to medico-controlled ruling bodies ... these ruling bodies have a nasty habit of banning everything in sight or, as a minimum, slapping on egregious controls and regulations.
Adverse Event Reporting System
The adverse event reporting system is critical to the proper control of 'modern' natural health products; however, the Nova Scotia Herbalist Association believes that the proposed system has little relevance to traditional herbal products and practices. Most dangers that will occur with natural health products will occur as a result of lapses in Good Manufacturing Practices (GMP) or in the introduction of novel products.
Again, the Nova Scotia Herbalist Association contends that it is manufacturing / refining above a threshold level (see A System for Labelling) that introduces the greatest levels of inherent risk.
The proposed regulatory framework includes an exemption for natural health products "compounded for individual use." We of the Nova Scotia Herbalist Association are very pleased with this proposed exemption from regulation. It is a practical exemption. However, it is also belittling to the concepts and validity of traditional healthcare in that what may be safely done for 'one' is forbidden for 'two.'
Because the Office of Natural Health Products has failed to recognize in its proposals the validity of the Alternative health paradigm a loop-hole of health risk has failed to be addressed. Moral imperative prevents the holistic herbal practitioner from creating and using the new, modern natural health products but no such restriction exits for medico-oriented herbalists. The medico-oriented herbalist is allowed, through this exemption, to use non-holistic contrivances upon patients. Such products may include genetically-engineered materials, highly refined or complex compounds, and experimental or cutting edge extraction. This is not Alternative health but is instead allopathic use of natural'ish products -- i.e.. drugs.
The Nova Scotia Herbalist Association believes that qualitative risk is as equal for the allopath practicing with compounded, modern-style natural health substances as it is with corporate entities widely distributing the self-same product. Modern products lack the hundreds of years of trial and experimentation that has revealed both the toxicity of herbs and their virtues. This exemplifies, again, the need of recognizing a governing body which can state whether a practice is holistic or merely medico usage of natural'ish products.
A Product Licensing System
The Nova Scotia Herbalist Association wholeheartedly endorses a product licensing system for modern-day natural health products. Traditional, unadulterated natural health products require no such licensing system.
In today's world new solvents, new chemicals, new and here-to-fore unknown ancillary ingredients or reagents are commonly used in the manufacturing process. Further, natural products are becoming more and finely defined to the point where natural substance and drug are hard to differentiate. Such complex machinations require product licensing.
Herbs do not; no more than do apple growers and distributors.
A Facilities Licensing System
The Nova Scotia Herbalist Association has little comment on the facilities licensing system except to reiterate that a threshold level of manufacturing-distribution should be determined before licensing requirements take effect. Specifically with respect to herbs, herbs "compounded for individual use" seems to be too low a threshold for license determination. Perhaps a 'dollar sales' threshold would be more appropriate.
We would like to add that it is in a mass-production facilities' processing & handling constructs that would appear to introduce added risks to the public not directly related to the product itself. The Product Licensing System appears to address inherent product hazards for the most part.
Good Manufacturing Practices
Good manufacturing practices have long been established and applied in Canada. They are currently among the best in the world.
Specific to herbal products and the new regulatory framework, however, the Nova Scotia Herbalist Association again suggests that threshold values be set before specific practices come into force.
For example, testing for quality and purity can be costly additions to the small-scale entrepreneur. Volume of sales should be set at some threshold level before such testing 'kicks in.' Real herbal products in particular do not carry a need for such testing. Modern-day products, due to their complexity or drug-like nature, could stand to be watched more closely.
The Treatment of Vitamins and Minerals as Natural Health Products
The Nova Scotia Herbalist Association does not purport to represent these products. Although they are commonly added to treatment regimens their safety and quality is largely a matter of assumed trust.
We spend much time attempting to 'weed out' types of such product and in eliminating the various brands of product that we perceive to be inferior or sub-standard. Often these tasks must be performed with imperfect knowledge.
The Nova Scotia Herbalist Association would prefer to have an overseeing body with holistic accreditation grade and evaluate such products. Obviously, most such products cannot be rated 'certified organic' but perhaps another similar rating system can be devised so that both herbal practitioners and the public can choose them based upon 'natural-quality' criteria. Further, 'natural-efficacy' as judged by holistic experts is preferable to bought-and-paid-for double-blind studies of medico or supplier origin.
Reiteration
The main points introduced by the Nova Scotia Herbalist Association are: