The Future of Natural Supplements in Canada is in Your Hands
Act Now to Secure Natural Health!
The Canadian natural supplement industry is essential to helping Canadians, like you, take an active role in their health care. Your reasons for choosing natural products can be as diverse as “I trust in nature” or “I’m tired of undesirable side effects,” but either way, it’s your choice. Having access to vitamins, minerals, herbs, nutraceuticals, and probiotics of your choosing allows you to live a healthier, happier life. At least for now.
Health Canada is planning monumental changes to treat safe, natural health products like pharmaceutical drugs. These changes will affect your lifestyle and your wallet. This proposed overregulation—and associated added costs—will negatively impact how natural health-product companies operate. It will needlessly increase the cost of products with natural product number (NPN) licences, forcing a negative downstream effect on retailers that will ultimately lead to cost increases that will most likely be transferred to consumers.
Natural products sold in Canada require licences. You will recognize this by an eight-digit NPN on the front of a box or label. Health Canada grants these licences, which include details on the benefits these products provide, directions of use, cautions and warnings, as well as contraindications.
Let’s take a closer look at Health Canada’s proposed cost recovery and plain label packaging proposals.
What does all this mean? Let’s examine the various proposed fees using simple examples.
|Health Canada Licence
|What It Is
|Class I NPN Request
|Product: Vitamin C capsule—single ingredient
Evidence verification required: Fully follows preapproved evidence from an existing monograph. Should take at most 1 hour for a clerk to reference the monograph, review, and approve.
|Class II NPN Request
|Product: Vitamin C and vitamin D—two ingredients
Evidence verification required: Completely follows preapproved evidence from the existing monograph. Easy for a clerk to reference, verify, and approve. No new work or deliberation needed on their part.
|Class III NPN Request
|Product: Probiotic with enteric coating—multiple strains or ingredients
Some ingredients are covered by monograph. Some ingredients require a minimum of two placebo-controlled studies showing efficacy, per ingredient, be supplied as evidence.
Evidence verification required: Studies require evaluation by Health Canada natural-product specialist.
for novel applications.
Once no longer “novel” (a term not yet defined by Health Canada), this decreases to $7,209.
|Class III Novel Safety
and Efficacy Amendment
|Product: Probiotic with enteric coating—multiple strains
If supply chain gets disrupted and a specific strain cannot be procured, this NPN would require an amendment.
Evidence verification required: Verification to see if replacement strain possesses same efficacy.
to continue selling.
|Rights to Sell (RTS)
|Canadian license holders will be charged an annual right-to-sell fee for every single NPN they received and continue to hold, regardless of how many units are sold.
Evidence verification required: Not required, flat fee.
= $5,420 every year
= $54,200 every year
|Canadian NHP manufacturers of nonsterile products would be required to pay Health Canada an annual site licence.
Evidence verification required: Done every three years for established company.
What This Means for You
Increased Prices. Canadian brands and products you love and count on will become significantly more expensive or cease to exist in Canada altogether. Suppliers of natural products will not be able to absorb these exorbitant costs. They will be forced to pass them onto retailers, who will pass them down to consumers.
Reduction in Product Selection. Increased unnecessary costs will force companies to reevaluate their product line and discontinue products that become more expensive to produce or totally unprofitable, resulting in much less variety for you.
No Love for Local. Small, local providers that cannot afford to navigate increasingly complex regulations and lengthy approval processes may be forced out of business, further limiting the product choices and innovation they could previously bring to consumers.
Nothing New. Exciting new products will likely not be available in Canada, because the regulatory burden will be too severe. Imagine if a novel natural ingredient was shown in clinical studies to help maintain motor function in Parkinson’s patients: How long would Canadians have to wait to get access? Would we be forced to order unregulated international brands to find what we need? Have a look at some natural-product labels from the United States. You will often see this disclaimer: “These statements have not been approved by the FDA.”
Penalizing Canadian Manufacturing. Canadian-owned and ‑operated natural-product companies, who manufacture their products in Canada, pay new “site licences” to continue producing supplements—in addition to paying rent, equipment costs, maintenance, employee salaries, and numerous taxes, etc. Now they face additional, unfair fees.
Site Unseen. Canadian companies importing prepared supplements from other countries will also need to pay a site licence, albeit a slightly lower one.
Environmental Burden. Proposed “plain-language labelling” regulation will increase the amount of packaging on every product. Whether it’s additional layers of plasticized peel-back labels on bottles, or additional panels on boxes, this will reduce recyclability, thus adversely impacting the environment.
Money Talks. In 2020, the estimated market value of the natural-products industry in Canada was $5.6 billion. Assuming an average harmonized sales tax of 13%, the amount of sales tax collected from the sale of these products would be $728 million. Shouldn’t this be enough to compensate for work done by Health Canada to keep Canadians safe? This is Health Canada’s stated goal: “To promote access to safe, effective, and high-quality NHPs for Canadian consumers.” One has to wonder how these proposed changes will benefit Canadian consumers.
Who Will Fill the Gap?
What will happen if smaller natural-supplement companies start to struggle? Will they get bought out by multinational conglomerates such as Clorox or P&G? Or will pharmaceutical companies step in? Dealing with Health Canada on a regular basis, they understand all the rules and regulations. Pharmaceutical companies also have very deep pockets, so they are more than able to absorb these types of costs, and over an extended period of time. Would they sell natural products at reasonable, affordable prices, or will profit win out over quality? And what about innovation? If they acquire licences for novel ingredients, who is to say that they will not try to patent them? Or refine the molecules until they are no longer natural?
From a naturopathic doctor’s perspective, the potential increase in the cost of natural supplements can have a significant impact on the treatment of patients. Natural supplements play a crucial role in naturopathic medicine, as they are often utilized to support the body’s innate healing abilities and promote overall wellbeing. However, when the cost of these supplements rises, it can limit patients access to the necessary tools for their treatment.
Some patients may be unable to afford the recommended supplements, which could potentially hinder their progress and therapeutic outcomes. Furthermore, increased costs may also lead to patients seeking cheaper alternatives or self-medicating without the professional guidance, which can pose risks to their health and safety.
When the cost of supplements increases, it often creates barriers to access for patients from diverse socioeconomic backgrounds. This limited accessibility can perpetuate health disparities, as those who cannot afford expensive supplements may be denied the potential benefits they offer.
Moreover, this financial burden imposed by escalating costs hampers the ability of naturopathic doctors to explore and recommend a wider range of supplements that may be tailored to individual patients’ needs. The increase in the cost of applying for new licences and other related fees can impede supplement companies’ ability to develop new formulas based on scientific data and studies. This lack of diversity and innovation in treatment options can limit the potential for optimal patient outcomes and personalized care.
It is vital to address the affordability of supplements to ensure equitable access and foster a climate of innovation that promotes a comprehensive and inclusive approach to patient care.
Now is not the time to increase costs and reduce or limit choices for Canadians! If you are reading this article, we know you care about natural health products, and we need your help!
Please take a moment to tell your Member of Parliament to Save Our Supplements, before it’s too late! SaveOurSupplements.ca
The deadline to act is
July 25 August 10, 2023 (updated June 29, 2023)—after that, it will be in the hands of committees.