Industry News

Customer Update: TCM Prepared Herb formulas, TCM Herbal Granules and Health Canada

by John Stan | Mar 05, 2011
Since the implementation of the Natural Health Product Regulations in 2004, Eastern Currents has been working with Health Canada to comply with the new requirements for importers and distributors of Natural Health Products (NHPs)...

Customer Update: TCM Prepared Herb formulas, TCM Herbal Granules and Health Canada

Many of you using our professional TCM herbal products have been experiencing frustrating out-of-stock issues with a number of popular products. We sincerely apologize for the inconvenience. We know that having a smooth, uninterrupted supply of product is essential to an efficient clinical practice and we are working hard to continue to be able to import the products you rely on. 

Health Canada and TCM Formulas

Since the implementation of the Natural Health Product Regulations in 2004, Eastern Currents has been working with Health Canada to comply with the new requirements for importers and distributors of Natural Health Products (NHPs).  As the regulatory process is new, there has been a considerable amount of back and forth, trial and error, negotiation and discussion.  Certain formulas were denied licensing as they are TCM formulas that are modified significantly from the original base formula. These included popular Golden Flower products, among many others. (We discussed this issue in a previous communication that can be found on our website here).  

Since the writing of that article, and to their credit, Health Canada has been listening to our concerns about these “modern” TCM formulations. They understood our concerns that the regulations should apply to over-the-counter (OTC) NHPs, and not to professionally dispensed formulas. 

Recently Health Canada released a document entitled Pathway for Licensing Natural Health Products Making Modern Health Claims. This document proposes changes that address our concerns regarding the “modern” TCM pre-prepared formulas, and the unintended consequences of applying the regulations to professionally dispensed products. We now feel we can re-apply to have these formulas licensed using these new revisions, and hope to have the rejected products Golden Flower Formula Bottlesback in stock. This may take up to 5 months, but at least we are moving in a very positive direction.  

We appreciate Health Canada’s solution-oriented mindset in their discussions with us (and with other members of the health industry) in addressing the “novel TCMs” issue.







Health Canada and TCM Herbal Granules

Another ruling from Health Canada affects TCM herbal granules. Healthcare practitioners retain the right to compound formulas for their patients, and concentrated granules are a convenient and modern material used by many practitioners who customize formulas. However, after reviewing the KP bottle and label, Health Canada has determined that the bottle and label look too much like a finished product and therefore require a Natural Product Number (NPN).

This decision represents a major shift.  Previously, the importers of compounding materials had to maintain quality assessments of the product but did not have to license each and every one. While there are 178 formulas and 345 single herbs in granules that we carry, only 50% of them sell sufficiently to warrant the cost of importation, storage and sales. The remaining 50% are not as popular and sell at a loss, however we carry them so that you have available the full spectrum of formulas and single herbs for your clinical use.

The cost of NP licensing 349 single and 178 formulas will be prohibitive, such that only the more popular formulas and single herbs will be chosen to be licensed. The remaining significant number of formulas and single herbs will unfortunately no longer be available.

This is a huge loss, as committed companies like KP and importers like ourselves have worked hard to maintain the broadest selection of compounding materials for TCM professionals. Now, by moving concentrated granules out of the compounding category and into the finished good category, many products will be lost.

As part of my ongoing negotiations with Health Canada, I suggested label changes that more clearly indicate that the granules are for compounding, and the removal of any indication that may lead an individual to believe that the product can be used “as is”. This would include removing the serving size, any artwork on the label, and adding in bold letters on the front panel of the label “For compounding use only”.  These measures, although seemingly reasonable, did not reverse Health Canada’s position that the granules require licensing.  

Currently we are at an impasse. We have, on our part, started to apply for licenses for the popular formulas and singles in an effort to show good faith.KP Granule Bottle But the reality is, as a small company, we can only do so many applications at a time - it will take months to accomplish and many herbs and formulas, due to their smaller sales volume, just won’t make the cut.  

There is one small hope that this decision will be reversed by direction from higher levels within the Directorate. The Health Minister, in her efforts to recognize the uniqueness and the potential significance of Traditional Chinese Medicine, has appointed an Advisory Council on TCM. This group of industry leaders and experts will gather in Toronto on July 18th first and then at a later date in Vancouver to discuss TCM products in Canada.  I have the privilege of being invited to be a part of this council and will table the issue of granules as an important area for discussion. 

What you can do

In the meantime, we need users of TCM granules to voice their concerns at the potential loss of product and the impact this will have on their practice. If this is you, we ask that you please take 15 to 20 minutes to draft a short but clear letter to the NHPD indicating the following:

  • You use the granules for compounding specific formulas for your patients.

  • Compounding granules involves both the combination of granulated formulas, along with other formulas, or single herbs (or both).

  • The smaller 100g bottles are convenient for the compounding process as they save space in your clinic, maintain fresh product, and the bottle is easily recycled. (One of the reasons Health Canada said the granules needed licensing was the fact the 100g bottle looked like it was the size a finished good would be packaged in. Their argument maintained that a compounding product would be in a larger bottle like a 500g bottle.  My argument in return was that a large bottle was inconvenient for many practitioners, and with some herbs the practitioner might not be able to use the entire bottle before it expired, due to the herbs less frequent use).

  • Your patients depend on you to have the fullest selection of product to service their health needs.

  • The act allows for you to have access to compounding materials for your practice.

  • And finally, that you request that they reconsider their decision requiring the licensing for the concentrated TCM formulas and single herb granules as it will have a serious, negative impact on your practice.

I would even suggest you take a digital photo of your compounding area to give the regulators a look at how the granules are used in a modern TCM setting. 

If a number of these letters were sent to Health Canada before my meeting on July 18th, it would help in my efforts to reverse the requirement of having the concentrated granules licensed.

We must all work together to ensure the broadest selection of herbs remain available to practitioners here in Canada, and your efforts can help us lobby on your behalf.

Please take the time - write a few words, and send them to the following addresses below:

General contact address for the  NHPD: nhpd_dpsn@hc-sc.gc.ca and Scott Sawler – Director of the Natural Health Product Directorate: scott.sawler@hc-sc.gc.ca

Please cc me, John Stan, at jstan@easterncurrents.ca so I have a sense of what Health Canada has received.

Thank you for your attention and time.

Sincerely,

John Stan, DrTCM
President, Eastern Currents

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