Natural Health Products in Canada at Risk: Health Canada's New Regulations
Jul 31, 2023In this article, we're shedding light on a new law passed under the Budget Bill C-47 on June 22, 2023, by the House of Commons. Within sections 500-504 of this bill, the Liberal government has granted Health Canada unprecedented powers over the natural health products industry.
Article at a Glance
- The Federal Government's Budget Bill C-47, passed in the House of Commons on June 22, 2023, includes sections 500-504, granting Health Canada unprecedented powers over the natural health products industry.
- Vanessa's Law, initially designed to protect Canadians from unsafe pharmaceutical drugs, now applies to natural health products, leading to heavy regulatory burdens for safe, natural products.
- New fees and stricter regulations to be imposed by Health Canada will have significant financial burden on natural health businesses. These additional costs will either lead to large price increases for consumers and/or force many small and medium-sized companies out of business (or exit the Canadian marketplace all together).
- Health Canada's new regulations will restrict the ability of natural health product manufacturers, practitioners and distributors to share vital information about their products, limiting consumers' knowledge about their health benefits.
- The Natural Health Product Protection Association (NHPPA) is spearheading a national campaign to halt these changes and safeguard our access to natural products and healthcare practitioners.
- The "Save Our Supplements (SOS)" campaign, sponsored by the Canadian Health Food Agency (CHFA), is not addressing the core issues affecting natural health products.
- The regulatory shifts impacting natural health products are part of a global harmonization effort driven by the World Health Organization (WHO), as evidenced by New Zealand's recent 'Therapeutic Products Bill'.
- The escalating restrictions on safe natural health products by Health Canada bureaucrats are alarming. It's time for us to take action and protect our right to choose natural health products.
While not specifically a tax-related issue, many home-based businesses offer products and services in the natural health sector, and therefore also earn an income and claim their tax write-offs. If you're a consumer of natural health products in Canada, you need to be aware of some significant changes on the horizon.
As a man in my mid-50s, I rely on natural products for both my health and my family's well-being. I'm not just a consumer, but also an entrepreneur in the natural products industry. I'm fortunate to have no chronic conditions, require no medication, and place no burden on the healthcare system. However, the impending changes could directly affect my personal health choices and livelihood as a home-based entrepreneur. I believe this is fundamentally wrong and against my Charter of Rights as a Canadian citizen.
Health Canada's New Initiative: The "Self-Care Framework"
Health Canada is implementing a new initiative called the "Self-Care Framework." This framework is part of a broader strategy to regulate all products that Canadians use for their health under a unified set of rules.
The Self-Care Framework is designed to categorize health products into three groups:
- Natural health products
- Non-prescription drugs
- Cosmetics
The idea is to regulate these products based on their risk level, with higher-risk products subject to more stringent regulations. However, the introduction of this framework will significantly reshape the natural health products landscape in Canada. It's anticipated that it could lead to the disappearance of many natural health products and practitioners that we depend on for our health and wellness.
A key concern is that the framework could limit the health claims that can be made about natural health products, restricting them to minor health issues. This could pose challenges for manufacturers in marketing their products effectively and for consumers in understanding the potential benefits of these products.
The Health Canada Self-Care Framework also introduces new regulatory fees and obligations for natural health product manufacturers. This will inevitably result in price increases, making these products less affordable for many Canadians. The heightened regulatory burden translates into higher costs for manufacturers to bring their products to the Canadian market, costs that will inevitably be passed on to consumers.
New Fees and Regulatory Burdens on Natural Health Products
One of the significant changes under Health Canada's Self-Care Framework is the introduction of new fees and stricter regulations on natural health businesses. These changes are part of a broader shift towards a more stringent regulatory environment for natural health products.
The new fees are expected to pose a significant financial burden on natural health businesses, particularly small and medium-sized enterprises. These businesses, which often operate on thin margins, will struggle to absorb these additional costs. As a result, this will lead to many businesses being forced to close, or making the decision to reduce the availability of their natural health products in the Canadian marketplace.
Health Canada's has introduced a series of fees associated with registering and getting a product approved with a Natural Product Number (NPN) license, new fee structure includes an application fee for site licenses or amendments, as well as specific fees associated with different activities such as manufacturing and importing. It's important to note that these fees are cumulative and apply to each building where these activities take place.
Additionally, it’s important to note that the Self-Care Framework is expected to introduce new fees for the distribution and wholesaling, once the regulation of natural health products and chemical drugs are harmonized.
Health Canada is committed to undertaking new activities to regulate the natural health products like drugs, which will require more resources. These include staff for a new inspection program, more staff to handle new review components within the existing NHP framework, more management and management support staff to support new reviewers, invoicing capabilities, more information technology (IT) resources, and increased operating budgets to support these additional resources.
The costs associated with these new activities and resources are not yet factored into the current fee structure. However, Health Canada plans to track these costs and revise the fee structure in the future as appropriate.
The increased costs associated with these changes will likely be passed on to consumers, making the remaining products unaffordable for many, particularly those who already struggle to afford natural health products. As consumers, it's crucial to understand these potential changes and how they might impact the cost and availability of the natural health products we rely on. On top of these new fees, Health Canada is also introducing stricter regulations for natural health products. These regulations could make it more difficult for natural health products to reach the market.
While these new fees and regulations pose a significant financial burden on the natural health industry, they also usher in another concerning aspect - the potential for increased censorship of health information.
Censorship of Health Information on Natural Health Products
Another concerning aspect of the Self-Care Framework is the potential for increased censorship of health information. Health Canada's new regulations could significantly limit the ability of natural health product manufacturers and practitioners to share information about their products - regardless of their proven health benefits or even if they are backed by studies.
The new fees collected by Health Canada will be used to create a new enforcement arm to impose stricter regulations and censor truthful health information. This could mean that producers and practitioners will no longer be able to publicly share truthful information about the health benefits of natural products.
This censorship could extend to various forms of communication, including product labels, marketing materials, and even social media posts. As a result, consumers may find it more difficult to access reliable information about natural health products and make informed decisions about their health.
As consumers, we need to be aware of this potential loss of access to valuable health information. The ability to freely share and access information about natural health products is crucial for maintaining our health and well-being.
Vanessa's Law and Huge Fines
Vanessa's Law, officially known as the Protecting Canadians from Unsafe Drugs Act, was initially introduced to protect Canadians from the potential risks associated with pharmaceutical drugs. The law was named after Vanessa Young, who tragically died of a heart attack while on a prescription drug that later was deemed unsafe and removed from the market.
However, Health Canada has applied the powers and penalties found in Vanessa's Law to natural health products through changes in the Budget Bill (Bill C-47 sections 500-504). This means that the same regulations and penalties that apply to pharmaceutical drugs now also apply to natural health products.
The Food and Drugs Act defines "drug" so broadly that it includes anything used for a therapeutic purpose. Consequently, selling any drug without Health Canada's prior permission in the form of a license is illegal. This legal reality implies that anything used for a therapeutic purpose is considered illegal unless Health Canada grants it permission in the form of a "Natural Product Number (NPN) license." However, this structure has led to a situation where only treatments approved by Health Canada bureaucrats are accessible to Canadians, excluding our ability to make our own choices regarding natural health products.
One of the most concerning aspects of this application is the potential for huge fines. These fines, which could be as high as $5,000,000 a day, could cripple and destroy the natural health community. This is particularly alarming given that natural health products are generally considered to be safe and have been used for centuries.
As consumers, it's important to understand these potential penalties and how they might impact the availability of natural health products. The application of Vanessa's Law to natural health products is a significant change that could have far-reaching implications for our access to these products.
Get Involved: The Natural Health Product Protection Association (NHPPA)
The NHPPA is leading a campaign to halt these changes and safeguard our access to natural products and healthcare practitioners. The association's president, Shawn Buckley, is a constitutional lawyer with expertise in drug regulation. He has defended more natural health companies in court than any other Canadian lawyer.
To educate yourself about what Health Canada set into motion on June 22, 2023 with the passing of the Budget Bill (Bill C-47 sections 500-504), I encourage you to download and read the Discussion Paper written by Mr. Buckley.
You can support the NHPPA's efforts by visiting their website, signing up for their newsletter, participating in their campaigns, and sharing this with your fellow Canadians.
A Note on the "Save Our Supplements" Campaign
It's important to note that the NHPPA's initiatives are not associated with the “Save Our Supplements (SOS)” campaign you may have heard about. The SOS campaign, sponsored by the CHFA (Canadian Health Food Agency), is advocating for issues like toothpaste, fiber, and font size on natural supplements. However, they are not addressing the true issues you are learning about here in this blog article.
The SOS campaign is clouding the bigger issue that I have outlined here, and they are not advocating for change at Health Canada. It's crucial to understand the differences between these campaigns and to focus our efforts where they can make the most significant impact on preserving our access to natural health products.
A Global Trend: The Case of New Zealand
It's important to note that this regulatory shift isn't unique to Canada. It's part of a worldwide harmonization effort driven by the World Health Organization (WHO). Those living in the United States and other countries can expect similar regulatory changes in the future.
A recent example of this trend can be seen in New Zealand. The country has just passed the 'Therapeutic Products Bill,' marking the most significant change to the regulation of medicines, medical devices, and natural health products in nearly 40 years.
As written on the New Zealand government website "This new law will provide fit-for-purpose regulation of medical devices, cell, gene, and tissue therapies, which are currently not fully regulated. It will also cover natural health products, which will have their own regulations under the Bill. It will also align with international standards and uphold the quality of regulation currently carried out by the Ministry of Health."
This global trend underscores the importance of staying informed and advocating for our rights to access natural health products regardless of where you live in the world.
Final Thoughts and Call to Action
The increasing restrictions on safe natural health products by Health Canada bureaucrats are a cause for concern. These chemical-drug-style regulations are becoming stricter and stricter, potentially limiting our access to products that are vital for our health and well-being.
Remember, it's not just your health at stake, but also the health of your loved ones. We all have a right to choose natural health products, and it's time we stood up to protect that right.
I've personally taken action by starting with writing letters to the Prime Minister of Canada, the Minister of Health, my local Member of Parliament, all 338 members of The House of Commons, as well as the two government bureaucrats at Health Canada who are driving these changes.
Now, I urge you to do the same. Write a letter to your local MP expressing your concerns about what Health Canada is doing. Demand the repeal of sections 500-504 of Bill C-47, call for a stop to cost recovery on natural health product businesses, advocate for the enactment of the Charter of Health Freedom, and push for the halting of the Self-Care Framework and the deregulation of natural health products.