Regulation Chinese Herbs in Canada – What’s at Stake?

By Adina Stanescu, C.Ac. DCHM

Many TCM practitioners and patients do not have a clear idea of how Health Canada’s Natural Health Product (NHP) regulations, or the proposed Bill C51, will affect the practice and accessibility of Traditional Chinese Medicine (TCM) in Canada. Indeed, these regulations have already begun to affect us, and we had better try to understand them so that we don’t find ourselves with our hands tied behind our backs, unable to provide or receive the health care we need.

Health Canada introduced NHP regulations in 2004 to govern the use of herbs (including Chinese herbs), vitamins, nutritional supplements and homeopathic medicines in Canada. Bill C 51, recently introduced in the House, proposes to give Health Canada more power to summarily enforce the NHP regulations. The fear is that this enforcement will be arbitrary and alarmist, and not necessarily based on a real risk of harm to the public, but merely on “suspicion of harm.” Who will be the arbiter of this suspicion, and what medical qualifications will they possess, for example in the highly complex medicine of TCM?

First, let’s look at which products and participants in the “supply chain” of TCM are covered under the NHP regulations.

RAW HERBS, SINGLE POWDER EXTRACTS

This is the only good news category: these herbal products are NOT restricted, because they are not “finished goods” – the patient must add hot water or prepare them by boiling before being able to consume them. So in fact, the most efficacious and valuable tool of TCM, that of prescribing a customized formula, is safe, for now. Chinese herbalists well trained in combining individual herbs will still be able to provide exactly what their patients need.

But there are not so many practitioners working this way. Most naturopaths and acupuncturists use an abridged form of Chinese herbs – they prescribe TCM medicines in pill form only, the so-called “patent medicines,” which are covered under the NHP regulations.

PATENT/PILL MEDICINES

Herbal formulas in pre-made, pill form, are “finished goods,” and do fall under the NHP regulations. Each and every one of these products, and there are thousands in Canada, will have to apply to Health Canada for approval, and get an 8 digit NHP number, in order to be approved for sale or dispensation. The fee for such an application is $1000 per product. By 2010, all TCM pills in Canada will have to have this number.

The applications have to be submitted not by practitioners or retail stores/pharmacies, but by manufacturers, importers, distributors, packagers and labelers – in other words, the companies that bring the medicines into the country, largely from the US, Taiwan or China, or companies that wish to produce them here. It is these companies that supply practitioners and pharmacies, and if they fail to have the products approved, they will disappear.

Many small and medium sized distributors cannot afford the huge costs involved, and will shut down, as some already have. If they are selling 500 different pills, they will have to spend $500,000 on the regulatory applications, only to incur a high risk of rejection.

THE APPLICATION PROCESS

Almost all TCM pills are multi-ingredient formulas, which may prove very difficult to approve. Single-ingredient applications currently have a rejection rate of 60-70%. Health Canada has now started reviewing multi-ingredient applications, and industry experts expect the rejection rate to reach 80% or more.

Companies have to provide testing certificates for heavy metals, correct ingredients and support for any health claims they make. Certainly we wish to guarantee that herbs are free of contamination, but in many examples of U.S.-made pills, third party certificates have already been supplied by the manufacturers. Health Canada however, does not accept these, and requires the testing be duplicated here. The manufacturer may not consider Canada a big enough market to pay for this duplicate testing, and choose instead to pull their product from this country. This has already happened: Health Concerns, a US producer of a wonderful TCM line with a long record of safety and efficacy, has done just that, reducing the pool of treatment options.

SUPPORTING HEALTH CLAIMS

This is where TCM may fall into a nether world! Health Canada wishes all product health claims to be supported by evidence, the nature of which, especially for TCM, is unclear. Many readers of this magazine are somewhat familiar with the diagnostic language of TCM: “Yin deficiency”, “Liver-Fire,” “Heat in the Blood,” etc. We wonder how such “claims” are to be supported in Western, science-based terms!

Indeed, some recognition of this problem exists in the NHP regulations. Health Canada has said they recognize the validity of traditional medical systems on their own terms, and that they will use the Pharmacopoeia of China as a guide. This is the official herbal medicine compendium of China, which outlines the botanical, therapeutic and bio-chemical features of thousands of herbs and formulas. Provided the pills submitted for licensing match up with that official guide, they may obtain approval.

However, TCM medicine and prescriptions are constantly evolving. It is often the case that modern manufacturers, like Health Concerns, modify ancient formulas with new ingredients to better suit contemporary Western diseases. The addition of such new ingredients may then pose a regulatory challenge, unless it is accepted that it is safely within the scope of TCM to make such modifications.
n ACCESS – All of this has great implications for access to TCM’s invaluable treatment. This access is largely invisible to the patient, who does not know that the pool of prescriptions that their practitioner can choose from is getting narrower by the day.

Winter 2007/08 provided a chilling example of this for many TCM practitioners who rely on the largest importer/distributor of certified TCM products, Eastern Currents in Vancouver. Mired in the regulatory bureaucracy, Eastern Currents had virtually no herbal products to sell for several weeks. A smaller company would not have survived, nor any unique formulations they may have carried exclusively. John Stan, owner of Eastern Currents, pointed out another issue: some herbal formulas are used only in rare circumstances, and thus may only add up to sales of $2,000 per year. Why would a company bother to pay $1,000 to license such a product?

TCM works precisely because the practitioner can choose herbs flexibly to match the patient’s exact symptomology.

If she must choose the second or third best option, we will compromise a medical treasure whose benefits are only beginning to be appreciated in this country.

ARE HERBS FROM CHINA SAFE?

We are all aware of mistrust about the possible contamination of made-in-China products. In this light, some may welcome Health Canada’s regulations, and indeed, practitioners and distributors agree that some regulation is necessary, but feel that the current ones pose an undue burden and unnecessary duplication. It is a question of proportion: no one has died or become seriously ill in this country as a result of Chinese herbs – in great contrast to pharmaceutical drugs or food contamination. Food contamination, whether bacterial or allergen based, is a much larger problem with a much smaller regulatory burden to overcome.

Additionally, according to John Stan: 80 to 85% of Chinese herbs are still wild-crafted; since 2005, China’s herb plantations are subject to an international Good Agricultural Practice standard on pesticides, sustainability and heavy metals; endangered plant or animal species are already subject to international CITES treaty certificates before they can be imported here; many herbal factories in China subscribe to Australian Good Manufacturing Practice standards; the pills largely used in Canadian TCM clinics, such as Golden Flower, Kaiser Pharmaceutical and Blue Poppy brands, are made by US or Taiwanese companies which already provide every conceivable safety certificate and batch number tracking.

In China, TCM has been under intense government control for decades, and we cannot compare this industry to the manufacture of leaded toys. China exports medicines all over the world, where they are safely used by billions of people. It has a huge financial stake in keeping the industry safe and effective. TCM’s total value of global production was estimated at US$23 billion in 2002. The proportion of problems, in this context, has been infinitesimal, and is usually due not to contamination but to improper use by unqualified individuals.

THE BEST PROTECTION

In fact, there is an inherent contradiction in the inclusion of TCM under the NHP rules, as these are geared toward natural products used in self-care. TCM is not a system of self-care; we do not see TCM products appearing at local Shoppers or health food stores, and while they are available in Chinatown pharmacies, this could be remedied by moving them behind the counter. TCM herbs are intended to be prescribed by qualified practitioners, and as such regulating the profession of TCM across the country provides the best protection for the patient.

Adina Stanescu C.Ac. DCHM runs the Institute of Clinical TCM and The TCM Clinic in Toronto 416 968-3308 www.thetcmclinic.com