TCM Prepared Herb Formulas, TCM Herbal Granules and Health Canada – Practitioner Update

The following is an update from John Stan, of Eastern Currents, who has been tirelessly working on the issue of Health Canada’s Natural Health Product Directorate (NHPD) regulations and the impact it is having on our Traditional Chinese Medicine herbal products.

Please also take the time to write the NHPD as suggested by John Stan, as the healthy future of TCM in Canada is at stake!
_________________________

Many of you that are using professional TCM products might have noticed the loss of many formulas that had previously been available. Having a smooth, uninterrupted supply of herbal products is essential to an efficient clinical practice. Therefore, it is important that you participate in making your voice heard as an active member of the herb dispensing TCM professional community.

As you already are aware, since the implementation of the Natural Health Product Regulations in 2004, many of us that are importers and distributors of TCM herbal products, have been working with Health Canada (HC) to comply with the new requirements imposed by the regulations on the importation of Natural Health Products (NHPs). As the regulatory process was new for all parties involved, there has been a considerable amount of back and forth, trial and error, negotiation, and discussion during the implementation of these regulations. As a result, certain formulas have fallen through the cracks and have been denied licencing due to the fact they were TCM formulas that were modified significantly from the original base formula. These are what HC called “Novel” TCM formulas and were not granted licences. This situation was a huge concern for many importers as a large number of formulas have been modified from the classical formula due to environmental and patient population changes; negotiations and discussions continued between members of the TCM community and HC regarding these “Novel” TCM products, and the fact that many of the products were being dispensed by practitioners.

To their credit, HC has been listening to the concerns about these “Novel” TCM formulations. They understood the concerns that the regulations apply to over-the-counter (OTC) NHPs, and not to professionally dispensed formulas. As a result, HC released a document entitled “Pathway for Licensing Natural Health Products Making Modern Health Claims.” This document proposes changes that address concerns regarding the “Novel” TCM pre-prepared formulas and the unintended consequences of the regulations for professionally dispensed products. This new document creates an opportunity for many importers and distributors, that are selling to TCM professionals, to obtain previously rejected product potentially granted an NPN. Our congratulations go out to HC for their positive-solution mindset in their discussions with us, and other members of the health industry in dealing with the “Novel TCMs” issue.

However, another ruling has come down from HC that affects the many practitioners who use concentrated TCM herbal granules: HC has decided that the herbal granules packaged in 100 gram bottles look too much like a finished good and, therefore, will required licensing. Previously, as acknowledged in the regulations, health care practitioners retained the right to compound formulas for their patients. The concentrated granules represent a convenient and modern compounding material that is being used by many TCM practitioners who customize formulas. In early June of this year, after reviewing the standard 100 gram concentrated herb bottle and label, HC determined that bottle and label look too much like a finished product and, therefore, need to have a natural product number (NPN). This decision represents a major shift towards the granules on Health Canada’s part.

Previously, when considered a compounding material, the importers of product still had to maintain their quality assessments of the product but did not have to license each and every one. In total, there are up to 200 formulas and 345 single herbs that are standard and made available by various suppliers. The reality is that only a 50% of the formulas and singles sell in enough quantities that warrant the cost of importation, storage, and sales. The remaining 50% are not as popular and sell at a loss. Many herb companies, however, try to maintain the full selection of TCM formulas and singles as part of their commitment to the TCM professional.

With the requirement of NP licensing for each and every formula and single herb, this will all change as the cost of licensing over 500 products will be significant. It is my guess that TCM herb companies will seek to license only the more common formulas and single herbs as the cost to try and license all of the products will be prohibitive. As a result, the remaining significant number of formulas and single herbs will no longer be available!

This is a tragedy, as committed TCM importers have worked hard to maintain the broadest selection of compounding materials for TCM professionals. Now, due to the decision on HC’s part to take the concentrated granule out of the compounding category and declare them as finished goods, many products will be lost.

As part of my own personal ongoing negotiations with HC, I have suggested label changes that more clearly indicate that the granules are for compounding and remove any indications that may lead an individual to believe that the product can be used “as is.” This would include: Removing the serving size; removing any art work 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 HC’s position that the granules will need licensing. Currently, we are at an impasse and many of you already may have seen access to TCM concentrated herb granules decline.

There is one small hope, however, 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 TCM, has appointed an Advisory Council on TCMs. This group of industry leaders and experts will first gather in Toronto on July 18th, and then at a later date in Vancouver to discuss TCM products in Canada. I have the privilege, along with other members of the TCM industry, of being invited to participate on this council. It is my goal to table the issue of granules as an important topic of discussion during these meetings.

In the meantime, if you are a user of TCM granules, you need to raise your voice and concerns at the potential loss of product and the impact this will have on your practice. 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 100gm bottles are convenient for the compounding process as they save space in your clinic. As well, you can always maintain fresh product and the bottle is easily recycled. (One of the reasons HC said the granules needed licensing was the fact the 100gm bottle looked like it had the size of a finished good’s packaging. Their argument maintained that a compounding product would be in a larger bottle like a 500gm 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 herbs that are less frequently used.)
• Your patients depend on you to have the fullest selection of product to service their health needs.
• The act allows you to have access to compounding materials for your practice.
• And finally, 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 of how the granules are used in a modern TCM setting.

If we could have a number of these letters sent to HC before the meeting on July 18th, it would help us as members on this committee work towards reversing the requirement of licensing the concentrated granules.

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 and Scott Sawler – Director of the Natural Health Product Directorate

Please cc me so I have a sense of what HC has received.

Thank you for your attention and time in preserving our right to dispense the widest range to TCM herb granules.

Sincerely,

John Stan