Industry News

TCM Herbal Update: The Future of Pre-Prepared Formulas

by John Stan | Aug 31, 2010

If you prescribe TCM Formulas in Canada, please take a moment to read this important bulletin

Under Health Canada’s Natural Health Products Regulations, which came into effect on January 1, 2004, Natural Health Products (NHPs) are defined as:
 

  • Vitamins and minerals
  • Herbal remedies
  • Homeopathic medicines
  • Traditional medicines such as Traditional Chinese Medicines
  • Probiotics, and
  • Other products like amino acids and essential fatty acids.

NHPs must be safe for consideration as over-the-counter products and not require a prescription to be sold.

As you may already know, since January 2005 Canadian Law requires that any company or individual importing and selling NHPs have two things:

1) a Site License and

2) a Product License(s).  

What follows are relevant details of the regulations that are important for you to be aware of. (We have provided a link at the end of this article for more information on the regulations).

 

NHP Compounding Policy for Practitioners

As a practitioner, you are free to compound and dispense any formula or combination thereof to your patient without requiring either a Site License or a Product License.

However, if you want to sell your combination outside of the practitioner-patient relationship, you will then require both Site and Product Licenses.  It’s also important to know that if you are importing NHPs, they must be licensed.  We have heard of practitioners ordering product from abroad without issue which has lead them to believe this practice is allowed.  This is simply not true. The reason product is getting through in this manner is that it is currently not being detected by Health Canada. At some point a shipment will be flagged and reviewed. When this happens, your products may be confiscated at the border, and it may also lead to an inspection of your clinic. This has happened already to Marigold Pharmacy (see end of article for related links for more details).

 

Eastern Currents Status with Licenses

Since 2005, Eastern Currents has been diligently working to ensure unimpeded availability of premium quality TCM formulas. To do this, we first had to comply with Site Licensing requirements, which we have done.

The next step is acquiring licenses for every individual formula/product we carry. To date, we have been successful in acquiring NHPs for a number of products. However, there has been a major impediment in acquiring NHPs for some clinically important TCM formulas. Currently, the regulations imposed by the NHPD, as it pertains to Product Licenses, will deny your access to these TCM formulas.

 

How TCM Formulas are Currently Assessed by the NHPD

Eastern Currents carries a long list of Traditional Chinese Medicine (TCM) formulas unmodified from the original text as well as modified formulas to adapt to North American constitutions and patterns of disharmony. 

The current NHPD regulations recognize formulas that were developed for patterns presented by patients in China hundreds of years ago.  While these older formulations are valuable, our current patient population presents with more yin, damp, and excess patterns due to refined sugars, lifestyle and environmental changes. North American practitioners have asked manufacturers to make formulas that address these conditions. Internationally respected TCM practitioners like Giovanni Maciocia, Bob Flaws, John Scott and Jake Fratkin have responded with excellent formulas. These newer formulas are still created using TCM herbal principles, however, these clinically relevant formulas are not considered “traditional” by the NHPD and are being rejected.

Health Canada is not taking into consideration that these products have been in the marketplace for over 10 years, with no adverse effects. Although these formulas are "For Professional Use Only" which means only qualified healthcare practitioners can prescribe them, Health Canada makes no provisions for this type of product in their current regulations. They do not take into account that you as a practitioner are reviewing the formula and deeming it suitable for your patient. In essence, you are being denied access to professional use products that you have come to know and rely on.
 

What this means to you as practitioner relying on these formulas for the health of your patients is that products like Cold Quell (Blue Poppy), Margarita Complexion (Golden Flower) and Chemo Support (Three Treasures) will no longer be available in Canada. In fact, Margarita Complexion has already been refused by Health Canada, and when our quantities run out it will be illegal to continue importing it. This is only one example, and there are many more of your favourite and effective products that will soon be deemed illegal!

 

Current challenges: The Case of Professional Use Products

As mentioned above, you are able to compound individual formulas for your patients. However, setting up a dispensary and trying to find the time to put together a formula for each patient is time-consuming and inefficient. Many practitioners do not have a compounding area in their clinic as convenient, pre-prepared formulas are currently available.
 

To address our concerns about professional use TCM products, we met with the Assessment Department at Health Canadaon July 8, 2010 to reflect our concerns.

They acknowledged that while Eastern Currents only sells to healthcare professionals, there is no part of the regulations that gives them the power to regulate “professional use” products. Therefore, their options are restricted to the current regulations. Only after a review of the regulations will the opportunity arise to address the issue of “professional use” products. Please read the following excerpt from their response to our visit with regards to professional use products:

“The NHPD is aware of the fact that the current assessment process does not take into account the experiences of a specific TCM practitioner as the sole determinant for establishing a formulation and/or making extensive modifications to an existing formulation as would be seen within a practitioner-patient relationship. Consequently, the current assessment process is better suited for products that are to be used by a larger population and have been based on an established and well recognized formula, than products that are individualized and based on the experience and practice of a given TCM practitioner.

In 2007 the NHPD conducted a review of the Natural Health Products Regulations at which time professional use products was outlined as an issue for consideration. NHPD was to consider whether there needs to be specific requirements for the professional use products category. NHPD is committed to consider this issue as it moves forward with the next phase of the Natural Health Products Review Action Plan. At this point, professional use products will continue to be subject to the current product and site licensing requirements of the Natural Health Products Regulations."

In essence, they are confirming that the current regulations do not take into account “professional use” products. However, the important point here is that until they do so, your favourite products will be refused licences unless you do something about it.

 

In Summary


We are facing two key problems with the current regulations:
 

1. Contemporary TCM formulas that have been modified from a classical formula to address modern-day disharmonies and constitutions are being denied on the basis that they are not ‘traditional’. These products, if rejected, will not be allowed in Canada.
 

2. Current NHPD regulations do not take into consideration the fact that these products are for “professional use only” and are dispensed by healthcare practitioners on a case-by-case basis. We believe these products should not be assessed using the same regulations as over the counter products, as they are first prescribed by a healthcare practitioner.

 

What you can do now

It is important for you to take action now and write a personal letter to the addresses below to voice your concerns. Please take a moment to compose a letter containing the key points below and ask for assurances that your current practice not be limited due to regulatory gaps.
 

Let Health Canada know:
 

  • Your type of practice (TCM, Naturopathic, etc)
  • That you and your patients rely on pre-prepared/pre-compounded products
  • That you dispense both traditional and modern TCM formulas on a case-by-case basis and they are not sold over the counter
  • That you have successfully been using them, that they are safe, and that no adverse effects have been noted
  • Due to there not being any evidence of negative effects of the current products you have been using, there should be no restriction on your ability to continue to do so
  • It is important for you to impress upon them that your patients and your practice will be negatively impacted
  • You can make the suggestion that TCM Formulas being used by healthcare professionals like yourself be given exemption numbers until a review of the current regulations address “professional use" products and that the regulations have been modified for this special category. You can suggest that when that happens, that the formulas then can be re-assessed within the guidelines of this new category. (Health Canada currently has an exemption process in place due to the backlog of products in assessment. In this case, the importer or manufacturer must sign an attestation that, until their products are fully reviewed, that they are, to the best of their knowledge, safe. We can try and encourage them to use this same process for companies that market products directly to professionals.)
  • That you want assurances that you and your patients will not be denied access to formulas that are clinically relevant and that have been safely used.

Please direct your letters to:

Mr. Don Boyer
Director, Bureau of Product Review and Assessment
don_boyer@hc-sc.gc.ca

Ms. Michelle Boudreau
Director General, Natural Health Products Directorate (NHPD)
michelle.boudreau@hc-sc.gc.ca

Ms. Nancy Richards

Senior Executive Director, NHPD
nancy.richards@hc-sc.gc.ca

Please drop us a note along with a copy of the letter you send so we can keep track of how many letters Health Canada has received.

Thank you for taking the time to read this overview. We hope that you resolve to take action on this matter.

Sincerely,

John Stan, DrTCM
President, Eastern Currents
jstan@easterncurrents.ca


For more information:

Natural Health Product Directorate (NHPD) Main Web Page
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

Marigold Natural Pharmacy
http://www.marigoldnaturalpharmacy.com/index.php?p=home
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_126-eng.php

For more details on the NHPD policy for compounding, see:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/policy_compound-politique_compose-eng.php

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