Behind the Policy
A forward-looking series delivering clear, strategic insight into the policy and regulatory landscape shaping Canada’s natural health, organic and wellness industry. Translating complex developments into business-relevant intelligence, it connects CHFA’s advocacy work to what matters most—growth, innovation, and market access for members.
matters most—growth, innovation, and market access for members.
Executive Summary
- Canada’s natural health product (NHP) framework was created to regulate products according to their level of risk. More than two decades later, that principle must be restored.
- CHFA is not asking for deregulation or less consumer protection. Oversight should reflect risk: rigorous review where warranted, streamlined registration for well-understood products, and targeted GMP, inspections, and post-market surveillance.
- Regulatory resources should target risks across the entire marketplace, including products entering outside Canada’s commercial licensing system.
- Effective regulation is measured by how well it protects Canadians, not by how many requirements it imposes.
Putting Risk and Proportionality Back at the Centre of NHP Regulation
For more than two decades, Canada has been trying to get the regulation of natural health products (NHPs) right.
The Natural Health Products Regulations were introduced in 2004 with an important objective: create a distinct framework that recognized these products were neither conventional foods nor pharmaceutical drugs and regulate them according to their level of risk.
Twenty years later, we are still trying to make that framework work.
Since 2023, Health Canada has introduced a series of changes aimed at strengthening and streamlining oversight, including new labelling requirements, expanded authorities, proposed cost recovery, GMP changes, inspections and evolving quality and post-market obligations.
The intent is understandable. Improve safety and create greater consistency. The challenge is ensuring consistency does not override proportionality, particularly where the risk profile and market realities of NHPs differ from pharmaceuticals.
While consultations have occurred, industry has too often been engaged after key assumptions or policy directions were established, rather than early enough to help shape evidence-based, proportionate solutions. The question is simple —are we regulating the greatest risks, or continuing to tighten the parts of the system already under the greatest regulatory control?
Proportionate regulation starts with evidence
At the Canadian Health Food Association (CHFA), our call for proportionate regulation is sometimes characterized as a request for deregulation.
It is not.
CHFA is asking for oversight that distinguishes among levels of risk: rigorous pre-market review where evidence warrants it; streamlined pathways for well-understood products; strong, targeted GMP and inspection programs; and effective post-market surveillance across the entire marketplace.
Consumer protection must remain at the centre of Canada's NHP framework. Companies must be accountable for product safety, quality and integrity, and regulators need effective tools to intervene when evidence identifies a genuine risk.
Government should also be able to demonstrate that new requirements respond to an identified risk, are proportionate to that risk and deliver a consumer benefit that justifies their cumulative burden.
That is increasingly difficult to see.
Research conducted for CHFA by ParadigmForge found that regulatory changes affecting the sector could impose an estimated $120 million to $170 million in additional ongoing costs every year, alongside an estimated $430 million to $1 billion in one-time costs through 2028.¹
These are extraordinary costs in a sector dominated by small and medium-sized businesses. GMPs, inspections, licensing and labelling matter. But each additional requirement should produce a safety benefit proportionate to its burden.
GMPs, inspections, licensing and labelling matter. But each additional requirement should produce a safety benefit proportionate to its burden.
Risk should determine the regulatory response
A genuinely risk-based system does not apply the same regulatory intensity everywhere.
Canada should examine which products genuinely require extensive pre-market review and which could safely reach consumers through registration, notification, attestation or other streamlined pathways.
That conversation should not be limited to only the lowest-risk product classes. Canadian businesses compete in a global marketplace, including against companies operating in jurisdictions that rely far less heavily on pre-market authorization.
If Canada's system requires substantially more regulatory burden before products reach market without demonstrating a corresponding safety benefit, Canadian businesses will increasingly struggle to compete.
Proportionality must also extend beyond pre-market authorization to GMP requirements, site licensing, inspections, quality standards and post-market obligations.
Where evidence identifies meaningful risk, government should act decisively. Where compliance data identifies a specific problem, regulatory resources should target it.
What we should not do is continually tighten requirements across an entire regulated sector without demonstrating that the scale of the intervention matches the scale of the risk.
Look where the system has less visibility
That principle becomes even more important when we consider products entering Canada outside the commercial licensing framework.
Under Canada's personal importation policy, Canadians may bring in up to a 90-day supply of certain NHPs for personal use. Products entering through this route may not be subject to the same pre-market authorization, facility licensing, inspection and compliance visibility as products sold through Canada's domestic commercial system.
Research conducted for CHFA estimates that approximately $450 million in NHPs may be entering Canada annually through personal importation.
This creates a regulatory imbalance.
On one side, government is continually strengthening requirements for Canadian licensed companies and facilities already visible to the regulator. On the other, a significant volume of products can reach Canadian consumers without going through the same domestic commercial licensing system.
If the objective is consumer safety, that should concern all of us.
It also raises a fundamental question: are we focusing regulatory attention where the risk is greatest, or where regulation is easiest to impose?
Twenty years is long enough to learn
Proportionate regulation does not mean removing accountability. It means designing accountability around evidence and risk.
That means reserving intensive pre-market scrutiny for circumstances where it is justified, expanding the use of registration and other streamlined pathways, targeting GMP and post-market oversight where evidence demonstrates it is needed, and paying greater attention to products reaching Canadians outside the regulated commercial system.
It also means changing how regulation is developed.
Meaningful consultation cannot simply be an opportunity to comment after government has defined the problem and selected the direction. Industry, consumers, experts and regulators should examine the evidence together before major regulatory interventions are designed.
After more than two decades—and particularly the pace of change since 2023—we know that regulating one piece of the framework at a time, without considering cumulative burden and the entire marketplace, does not produce a better system.
CHFA is not asking for less consumer protection.
We are asking Canada to put evidence, risk and proportionality back at the centre of it.
The measure of a good regulatory system is not how much regulation it produces. It is how effectively it protects Canadians from the risks that actually exist.
