New proposed changes to Natural Health Product (NHP) regulations Leave a comment

by John Stan and Kelly Kitchen 

Call to Action! – Time to speak up and make our collective voices heard!!

This post concerns you. Whether you are a TCM/Acupuncturist, Naturopath, Physiotherapist, Chiropractor, Massage practitioner or other allied health practitioner. A concerning effort by the Natural and Non-Prescription Health Products Directorate (NNHPD), a division of Health Canada (HC), is in play that requires your action right now. Unless we engage now and interrupt the sequence of dominoes currently falling, your access to TCM single herbs, formulas and the Natural Health products currently being used in your practice or for personal care will be severely reduced by the spring of 2025. 

The deadline to act is now! The cutoff date and time for input is July 26, 2023, at 11:59 p.m. Eastern Daylight Time (EDT). Any action taken after this date and time will have little or no impact and be mostly inconsequential. The NNHPD has put forth a proposed Cost Recovery Fee Structure that, if implemented, will eliminate a number of products.

You can read the details here: https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-proposed-fees-natural-health-products/overview/overview.pdf, but we will outline the main concerns below.

Here are the facts: 

Pre-amble of what got us to this point. 

  • HC initiated a regulatory framework for herbal medicines that pushed this category of products into a pharmaceutical type of framework in 2004.  
  • At that time, there was a significant public outcry that forced the government to pull back on their initial attempt to control the public’s and healthcare professionals’ access to herbal products. These “Natural” substances have been in use by professionals and individuals to support health and wellness with success with little to no adverse effects.
  • As a result of this outcry, HC created a third category of products different from pharmaceuticals, called Natural Health Products (NHP). This imposed a broad set of regulatory requirements for Importers and Distributors to meet in order to import and sell products in Canada. These requirements were harsh and difficult for many companies to comply with, however, they were not as restrictive as the regulations pharmaceutical companies have to deal with. 
  • The reason why is that NHPs are low-risk products! Yet, since the initial backing down in 2004, HC has continued to push this new category of products under the umbrella of pharmaceutical regulations. There is apparent resistance to having two sets of regulations and would prefer to group everything under the Pharmaceutical regulations. 
  • In addition, although initially promised at the onset, there are currently no plans to create a category of professionally dispensed NHPs. This means HC views NHPs as “self-care” products where individuals can sidestep the practitioner and read a label and make their own choices about an NHP and its use. This is why dose levels on products have been dumbed down and cautions and warnings are excessively and ridiculously long for substances that have had minimal reports of adverse events. 
  • Small companies like ours, with much effort and expense, have jumped through the hoops to continue to provide quality NHPs to the professional community. Much larger companies have more easily done so because they sell primarily in the retail market generating a much larger revenue stream. The domino effect is pushing aside the medium to small companies and their unique products. Already, Canadians have lost access to NHPs from small manufacturers unable to meet HC requirements. 

The Current Reason for the call to action.

  • HC has put forth a new proposal to collect fees from businesses manufacturing, importing and selling NHPs. The fees are multilayered and include an Importer fee, manufacturer fee, and right-to-sell fee, along with a set of licensing fees for new NHPs.  
  • In addition to the Importer and Manufacturing fee amounts, there is a proposed “Right to Sell fee” for each NHP which is most concerning and alarming. This annual fee for the right to sell an NHP is $542.00” for each product. For TCM supply companies with 400 to 1000 licenses for this can range in the annual costs from $200,000.00 to over $500,000.00. These are unsustainable figures for medium to small companies, and the result will be the loss of access to these products in Canada. Other Natural Health product suppliers servicing the Naturopathic profession will also suffer. 
  • Medium to small companies will not be able to afford to keep the full range of TCM single herbs and lesser-used TCM formulas. Other prepared NHP formulas and supplements lines also will have be limited to only the most popular. 
  • The crazy making part of this is that NNHPD continues to stress “these proposed regulations do not limit the practitioner from compounding or dispensing formulas in the clinic”. But, it does in fact limit practitioner access to the source materials practitioners use for compounding in the clinic! 
  • If we don’t act now and raise our collective voice to the loudest of decibels, we will lose access to single herbs, formulas and likely double the cost of those that do survive this money grab by HC. This increased cost will make them inaccessible to many practitioners and patients.
  • We also now need to push back to prevent NHPs from being dragged into the Pharmaceutical disease model. This model is what big business is pushing for, as it frames the patient as the victim and the pill as the savior. The result is the patient remains a victim on multiple medications or NHPs and reliant on the pharmacy for supplies for life (no wonder big business is pushing this model). Our model is the opposite, as we claim that disease is a reflection of an imbalance. Once this imbalance is corrected with natural substances, lifestyle and dietary changes, the patient is empowered and healthier than at the onset of the problem.
  • YOU NEED TO GET ACTIVE TODAY! Why? Because you care about preserving the right of individual choice and because you care about natural health products and their use in maintaining and supporting health. You are receiving this email because you believe in the body’s ability to heal given the proper circumstances. This is in serious jeopardy unless action is taken.

Here is what to do. 

  • Buy a packet or two of envelopes. 
  • Download both of the attached files, “Practitioner to Health Minister letter” and “Patient to Health Minister Letter”. Adjust the “Practitioner” to include your business name and your address. Use the suggested content and adjust if you like to make them your own words. Send your personal letter to the Minister of Health. Do not just email it to his office. We have been informed emails are easily dismissed, but when wheel barrels of letters come in, they cannot be ignored or dismissed. With the “Patient” letter, print out a number of the letters to have on hand for your patients. Explain the situation to your patients, and ask each of them to address and sign the letter. Once they sign it, you put it in an envelope, address it using the patient’s address as the return address on the envelope and mail it. Note: No stamp is required when mailing a letter to an MP. Yes, we all will have to invest some money for envelopes, paper and our time, but this small investment saves your right to access natural products in the future. Do this until the last patient on July 26. Mail frequently your daily batch of letters to the Health Minister. Imagine if all of us sent in 5 to 20 letters a day the Health Minister’s office will be receiving thousands of letters. THIS IS WHAT WILL MAKE A DIFFERENCE!  
  • As soon as possible, reply to the NNHPD request for feedback. https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products.html 
  • Before filling out, see the attachment “Practitioner or Personal response suggestions”, here we outlined the questions they are asking. We have offered a response that you can copy and paste into the appropriate box, or paste into a letter that you mail into the NNHPD. You can modify them as needed and add your own thoughts. But the more practitioners reflect that they need their supply chain protected, the more the NNHPD and the folks at HC will have to listen to the Roar! 
  • Next, find out who your MP is and request a face-to-face or Zoom meeting with them. We created a “List of Concerns” document included with this email that you can use to prep yourself and also print out the second section to leave with the Minster.

The actions we are suggesting are important to protect our right to Life, Liberty and Security of Person as listed in Section 7 of the Canadian Charter of Rights and Freedoms. By taking the above actions you are protecting your right to access NHPs required for your business and personal self-care.  

Other resources that come from the retail segment of Natural Health Products are listed below for your reference. The ones we have suggested are for health professionals.

Thank you for your engagement and participation! 

Let’s protect our Natural Products today! 

Sincerely

John Stan and Kelly Kitchen 

Owners Eastern Currents Ltd 

Download the Word Documents:

Practitioner to Health Minister letter

Patient to Health Minister Letter

Practitioner or Personal response suggestions

List of Concerns

 

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