The Dispensing of Chinese Herbal Medicine and Health Canada's New Natural Health Products Regulations

Daniel Schulman. Dipl.Ac., R.Ac.

Canada's new Natural Health Products regulations will impact the practice of Chinese Medicine in Canada. Exactly how this impact will be felt at the individual practitioner level is not quite clear at this time. I have spent the past several months trying to figure all this out and it is not easy. There are many complex issues. Part of the complexity arises from the many different forms of herbal 'delivery' currently being used by practitioners. I have prepared the following paper for Canadian practitioners of Chinese Medicine. It is my best attempt at trying to understand what may be coming down the pipe. While I have done my best, it is entirely possible that what I have written contains inaccuracies and misunderstandings.

I have separated the dispensing of Chinese Herbal therapy into a number of different categories based on the distinct possibility that the new regulations will impact each of these categories quite differently.

Consideration of these matters raises many questions unique and specific to Chinese Medical practice. Optimal consideration of many of these questions will require accommodations that are sensitive to the unique nature of Chinese Medicine. It is not clear to me at this point how these matters will be handled by the Natural Health Products Directorate as they bring the regulations into force in the coming years.

At this point, it is difficult to say whether, overall, the new regulations will be beneficial or detrimental to our profession. The answer probably will lie somewhere in the middle. One benefit is that the new regulations finally move Chinese medicinals out of that vague food category ('dietary supplements') which has been a strange and uncomfortable place to be. That is also good because it means that in Canada, Chinese medicinals are not going to be subject to Codex Alimentarius considerations

1. Formulations compounded on-site by a practitioner and dispensed based on a 1:1 patient:practitioner relationship.

These are typically compounded by one of two means, either with whole herbs (a raw herb pharmacy) or with powdered concentrates of individual herbs (a powder pharmacy). In either case, this activity comes under provincial jurisdiction. It is, in fact, presently only regulated in British Columbia. Presumably that will change. But as far as I can tell, this activity is not affected in any way by the Federal NHP regulations. (That is not to say that other regulatory activity may not impact this practice. For example, enforcement of CITES - Convention on International Trade in Endangered Species - regulations is clearly impacting the availability of some Chinese Medicinals.)

2. Herbal formulations compounded on-site
(a) with specific symptomatic claims
(b) for general use by customers who are not patients

This may occur when a practitioner finds they have a formulation that consistently works well for a particular symptom (for example, pediatric otitis media, or treatment of colds and flu). A practitioner may make up large batches of the formulation and sell to people in their community who are not seeing the practitioner for consultations. In other words, the formula is being manufactured on site and sold with a specific symptomatic claim to non-patient customers.

As far as I can tell, this activity would require that a site license and product license be obtained from Health Canada's Natural Products Health Directorate (NHPD)

3. 'Patent Remedies' that
(a) make specific symptomatic claims on label or on insert sheet
(b) are available for over-the-counter sale without professional consultation

These are often available in herbal stores in Chinatowns. Practitioners all know that while there are often symptomatic claims made about Chinese Herbal formulations, correct dispensing requires correct pattern discrimination based on Chinese Medical principles. There is, however, a long history in China of over-the-counter sale of many prepared formulations based on popular symptomatic claims. To some extent that may be culturally appropriate as a 'Chinese' person may have a culturally embedded comprehension of some basic Chinese Medical pattern-thinking - sufficient to know when a symptomatic claim is going to be appropriate or not. For example, a Chinese person may know enough to distinguish 'wind-cold' from 'wind-heat'. But this clearly would not be appropriate for a 'North American' patient population.

Any 'over-the-counter' sale of these products (in other words, sale in the absence of a 1:1 practitioner patient relationship whereby correct pattern discrimination is being undertaken) will require full adherence to NHP regulations. The seller (the store?) will probably require an importation license since these are all imported and they will also require a product license for each product. This will require some degree of proof regarding the effectiveness and validity of the symptomatic claims.

While this does not directly affect practitioners, there is the distinct possibility that a large number of these items will become unavailable in Canada. So if a practitioner is currently selling these items to patients or sending patients to 'Chinatown' to purchase them (even though correct professional pattern discrimination is being undertaken), this may slowly become less and less possible over the next 8 years as the regulations are phased in.

On the other hand, if the manufacturers and/or importers do one of two things, these products will continue to be available. They will have to either (a) eliminate all symptomatic claims on labels and insert sheets and make these products only available to practitioners or (b) provide proof of the validity of the symptomatic claims that is considered adequate by the Natural Health Products Directorate.

4. Pre-formulated products (pills, capsules, etc.) that
(a) adhere closely to established traditional literature
(b) make no claims on bottle
(c) have product literature that primarily makes Chinese Pattern claims
(d) have product literature that may secondarily offer symptomatic or disease-based suggestions
(e) are sold by a distributor to practitioners only and only intended to be available from and after consultation with professional practitioner

This category pertains to the many product lines carried by Chinese Medical practitioners across Canada. Example product lines include K'an Herbals, Golden Flower, Three Treasures, Blue Poppy, KPC, etc. These are all imported into Canada by a distributor and resold to practitioners. They are not intended for over-the-counter use but only for dispensing to patients who are engaged in a 1:1 relationship with a professional practitioner.

I am unclear on where these products fall under the NHP regulations.

It is clear to me that individual practitioners will have no direct involvement with the regulations here so long as they are not making these products generally available to non-patient customers (i.e. 'over-the-counter').

However, the availability of these products may be affected by what is precisely required of distributors and whether distributors (and their suppliers) will be able to meet those requirements. On the one hand, it seems to me that if distributors are only making these products available to practitioners, then there is nothing required of them under the NHP regulations. However, the NHPD may take the position that since practitioners are 'unregulated' in most of Canada and practitioner regulation is a Provincial matter that, as long as natural health products are entering Canada, they must be regulated. In that case, the distributor(s) will have to obtain importation licenses and product licenses for each product. That is quite a monumental task as there are hundreds and hundreds of products that fall in this (and the next) category. If distributors (and their suppliers) choose to meet the requirements, these products will continue to be available to practitioners. If distributors (and/or their suppliers) choose not to meet the requirements, these products will no longer be available in Canada. For practitioners who primarily use products in this category, the future may lie very much in the hands of the distributors (and suppliers) and what actions they choose to take.

The good news is that if a product closely adheres to a traditionally documented formulation, the Product License application (if it is necessary) will only require reference to the traditional source (e.g. Bensky and Gamble's Formulas and Strategies).

Consider the following example as a discussion base for both this and the next category:

The well-known formula for Enriching Kidney Yin and Securing Essence.
Liu Wei Di Huang Wan (Rehmannia Six Formula)
is specified in Bensky and Gamble's Formulas and Strategies as follows (attributed to Qian Yi's 1114 A.D. Formulary for Pediatric Patterns and Medicine)

Shu Di Huang 32%
Shan Zhu Yu 16%
Shan Yao 16%
Fu Ling 16%
Mu Dan Pi 12%
Ze Xie 12%

The commercially available pre-formulated KPC version of this formula as detailed in Andrew Ellis' Guide to Concentrated Herb Granules, Notes From South Mountain adheres precisely to this traditional formula. And so, as far as I can tell, getting a product license for this product will simply require documentation of the traditional literature from where it originates.

Finally, it must be noted that product literature for formulations such as these often list symptoms and diseases for which the formula may be useful. But these are always secondary to the Chinese Medical pattern and are just meant as very loose guides for the practitioner. I hope that NHPD does not take such lists literally as disease cure or symptom resolving claims without appreciating the Chinese Medical pattern context within which these suggestions are made. This very same concern applies to the next category of product as well.

5. Pre-formulated products (pills, capsules, etc.) that
(a) are based on Chinese Medical principles but
(b) are significantly modified from traditional literature by recognised modern-day 'master practitioners' in our profession
(c) product literature primarily makes Chinese Pattern claims
(d) product literature may secondarily offer symptomatic or disease-based suggestions
(e) are sold by a distributor to practitioners only and only intended to be available from and after consultation with professional practitioner

Many commercially available pre-formulated products are based on traditional formulas, but with modifications typically based on the experience of individuals I will call 'modern-day master practitioners'.

What is unclear to me is how much deviation from the traditional source will be tolerated before additional documentation will be required. And furthermore, if the 'modified' formulation is still only making Chinese Medical claims, how will NHPD evaluate the claims anyway? How will NHPD, for example, determine if a modified version of Liu Wei Di Huang Wan is 'effective' in Enriching Kidney Yin and Securing Essence?

To continue from the above example, consider two commercially available modified formulations of Liu Wei Di Huang Wan:

K'an Herbals Quiet Contemplative Formulation
developed by Ted Kaptchuk
is a modified version of Liu Wei Di Huang Wan with essentially the same Chinese Medical application adapted to what its modern-day modifier, Ted Kaptchuk, considers to be the typical modern-day patient with this pattern:

Shu Di Huang 18%
Shan Zhu Yu 11.9%
Shan Yao 11.9%
Fu Ling 8.9%
Ze Xie 8.9%
Mu Dan Pi 8.9%
Sang Shen 4.5%
Gou Qi Zi 6.0%
Shou Wu 6.0%
Tu Si Zi 6.0%
Han Lian Cao 4.5%
Nu Zhen Zi 4.5%

In the K'an herbals product guide, it states that the additions of Han Lian Cao and Nu Zhen Zi were added following the documented experience of Wang Ang in his Collected Prescriptions and Explanations published in 1692 A.D. In addition, Ted Kaptchuk has added Tu Si Zi and Sang Shen to further the 'concept' of the Wang Ang additions of Han Lian Cao and Nu Zhen Zi. And finally, recognising that using this formula in a modern context, we are typically working with patients who have depleted Kidney Yin and Essence quite deeply, Kaptchuk has also added Shou Wu and Gou Qi Zi.

How will NHPD handle this type of product? It is based on a 'classical' formulation with acceptable documentation. The modifications can be completely justified using Chinese Medical logic. It has been developed by someone who most would agree can be considered a 'modern-day master practitioner'. But this particular formulation cannot be found in its precise composition in a traditional source. Will NHPD reject this formulation? Will they ask for 'proof of its effectiveness'? How will proof that it 'Enhances Kidney Yin and Secures Essence' be obtained and how will NHPD deem such proof to be acceptable or unacceptable? I have no idea whatsoever how this matter will be handled by NHPD.

As another example, Golden Flower Chinese Herbs offers their own modification of Liu Wei Di Huang Wan. They call it 'Nourish Essence Formula'. It comprises the following

Shu Di Huang 14.7%
Shan Yao 8.9%
He Shou Wu 8.9%
Shan Zhu Yu 7.05%
Fu Ling 7.05%
Fu Pen Zi 7%
Tu Si Zi 7%
Gou Qi Zi 7%
Mu Dan Pi 5.9%
Wu Wei Zi 5.9%
Rou Cong Rong 5.9%
Ze Xie 5.3%
Suo Yang 4.7%
Feng Mi 4.7%

In addition to the extra Kidney Yin / Essence supplementation of Gou Qi Zi and He Shou Wu found in the K'an modification noted above, this product has some more herbs that enhance the Kidney Yang and Essence such as Rou Cong Rong, Suo Yang and Tu Si Zi as well as astringent herbs that help retain Kidney Essence such as Wu Wei Zi and Fu Pen Zi.

Clearly, this Golden Flower product is still within the full intention of the original Liu Wei Di Huang Wan formula although it extends its reach to Kidney Yang Supplementation and Astringent action. These are still very logical additions to the formula. But if NHPD chooses to strictly adhere to the idea that only precise copies of traditional formulations can be licensed based solely on their existence in the traditional literature, a formula such as this will be faced with a regulatory conundrum, 'proof of effectiveness' (whatever that means?) or non-compliance.

Some product lines creatively combine two or more traditional formulas into one product. These products are very useful for patients with complex multi-pattern presentations. For example, Bob Flaws has designed the Blue Poppy product called ColdQuell for treatment of early stage colds and flu in patient with a particular background pattern of Blood Vacuity. This product is actually a combination of three traditional formulations - Yin Qiao San, Xiao Chai Hu Tang and Si Wu Tang. The label on this product also calls it 'Xiao Chai Hu Tang Er Si Wu Tang Er Jian'. Which literally means 'Xiao Chai Hu Tang and Si Wu Tang with additions and subtractions'. Once again, although this is a completely new formulation, it has been developed fully within the spirit of Chinese Medicine and is only to be dispensed to patients engaged in a one to one relationship with a practitioner.

While I would hope that NHPD would reasonably and rationally come to grips with Chinese Herbal Medicine as a very fluid medical art and allow for a considerable degree of flexibility in their assessment of products, I have no idea whether that will occur.

6. Pre-formulated products (pills, capsules, etc.) that
(a) are based on Chinese Medical principles but
(b) have been developed by recognised modern-day 'master practitioners' in our profession.
(c) make no claims on the bottle.
(d) have product literature clearly targeting a specific symptomatic problem.
(e) are sold by a distributor to practitioners only and only intended to be available from and after consultation with professional practitioner

There are some commercially available formulations that actually do make quite specific symptomatic claims. They are often either developed by modern-day master-practitioners here in the West or based on modern 'research in China'. Some examples include specific products by both Blue Poppy Enterprises and Golden Flower for pediatric otitis media. Another example would be the Three Treasures product developed by Giovanni Maciocia called Chemo Support which has been developed quite specifically for use by patients undergoing chemotherapy. Maciocia's website has a very detailed discussion of this formula and the rationale for its application to the Chinese Medical patterns most chemotherapy patients are likely to develop. And that is the key point here. Although it has been developed for application to the side effects of Chemotherapy, those side effects have all been analysed from a Chinese Medical perspective and this formula has been developed on that basis. Specifically, this formula 'tonifies Qi, nourishes Yin, cools Blood and resolves Dampness'. This is not a formula that can be found in a traditional source. So a product license application could not be based on 'traditional sources'. But that leaves the open question, how would the applicant be able to prove to NHPD that this formula is 'effective' in 'tonifying Qi, nourishing Yin, cooling Blood and resolving Dampness' in chemotherapy patients?

7. Products with ingredient proportions unavailable in the product literature.

Most product lines of pre-formulated Chinese Medicine have the exact proportions of each ingredient available in their product literature, practitioner guides or associated books. A few product lines, however, do not make ingredient proportions available. In particular, the Blue Poppy products designed by Bob Flaws and the Three Treasures / Women's Treasures products designed by Giovanni Maciocia do not list ingredient proportions. Beyond that, however, they do support their products with excellent and detailed practitioner information. One assumes that these two herbalists do not disclose ingredient proportions because they have invested their personal expertise greatly in the development of their formulations and wish to 'protect' their work. Other herbalists like Ted Kaptchuk (Jade Pharmacy, K'an Herbals) or John Scott and Lorena Monda (Golden Flower) have chosen to share the ingredient proportions in their products.

It is unclear how NHPD will handle this matter. It may well be that if certain product lines are not willing to make their ingredient proportions available (at the very least, to the NHPD), they will become unavailable in Canada.


In Conclusion.

It seems to me the most prudent thing for NHPD to do regarding Chinese Herbal Medicine is to concern itself primarily with the over-the-counter aspect of the business. While the profession is not well regulated in Canada, that is a dynamically evolving situation that will probably sort itself out in the next 10 years or so. In the mean time, as long as distributors are being as prudent as possible in selling products only to qualified practitioners and practitioners are only dispensing products based on one to one professional relationships with patients, NHPD should restrict its concerns to such things as proper labelling and good manufacturing practices. The nature of Chinese Herbal medicine makes the matter of proving 'effectiveness' without simply accepting the Chinese Medical model a highly problematic undertaking.

However, what actually ensues over the coming years is very difficult to predict. One thing is clear. The more dialogue between Chinese Medical practitioners and NHPD staff, the greater the likelihood of appropriate regulatory developments. I would certainly encourage all Chinese Medical practitioners to learn about the process and open active dialogue with the Natural Health Products Directorate.