Industry News

Downward Pressure on Professional-Use Products

by John Stan | Jun 28, 2019

In 2004, when the Natural Health Product Regulations (NHPRs) came into effect, Health Canada (HC) officials assured stakeholders who were selling to health practitioners only that there would be additional regulations to address this category of Professional-Use Products (PUPs).  

Professional-Use-Products-ArticleThe current regulations are geared to managing risks of over-the-counter (OTC) natural products. A practitioner-dispensed product has a reduced risk, as the use of the Natural Health Product (NHP) is managed by a learned intermediary.

Therefore, while the Good Manufacturing Practices (GMP) requirements of the NHPR should be observed across the board for all NHPs, the labelling requirements should be more flexible when a product is prescribed by a health professional. 

Labelling costs are significant. For a manufacturer, to modify labels for small product lines available only to health professionals may exceed the cost/benefit ratio for that company. As a result, many effective product lines are no longer available because companies can not afford to make these changes for the smaller Canadian market. 
Our solution to date was to license the product used by practitioners, but not force companies to change the label. We instead provided online Canadian labels and info sheets with dispensing directions for practitioners to download and give to their patients. (See an example by clicking here

We felt this was intermediary solution while we were waiting to consult with Health Canada on the development of Professional Use Products (PUPs). To date, no consultations were initiated and over the last 14 years no attempt by Health Canada to address PUPs have been made. As our products are not in the general marketplace, we have not had any issues, until recently. 

Health Canada has increased its vigilance on all importers, and as a result is systematically starting to audit all importers to enforce the regulations. Eastern Currents was audited in December 2018. When it came to the labelling issue and our solution to the lack of PUP regulations, Health Canada rejected our solution and forced us to comply with the OTC product standards with regards to labelling. 

This resulted in a few of our manufacturers not willing to comply with the labelling requirements and as a result are no longer available for sale in Canada. 

Furthermore, Health Canada is initiating a new regulatory framework called “Self-Care products” in the attempt to lump all non-prescription products under one regulatory framework. This is of high concern and all practitioners should be aware of this very dangerous move by Health Canada to our industry. See the Health Action Network Society (HANS) communication on this issue. We will also be sending out more information on this matter in future communications. In short, however, these new regulations will require even more label changes and thereby forcing manufacturers to incur more costs!

The net result of all this is that there is a tightening of the screws and a huge downward pressure on the Natural Health industry reducing product choices for practitioners. 

Please take action! See our sample petition letter for MPs - copy the text into a new document, modify it to reflect any additional concerns you have, and send it to your local MP. 

Please share this article and the previous moxa article with your colleagues, as this issue is not just about us as a company, it is about the fundamental rights as Canadians to manage our healthcare needs.

We all need to work together to halt this over-regulation of our industry.

Yours in health,
John Stan, DrTCM and Kelly Kitchen, MA, B.Ed., BPE, RHN
Co-owners, Eastern Currents


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