Issue

There are concerns with the changes being imposed by Health Canada on the Self-care Framework related to the imposition of additional new fees, labelling requirements, new regulatory burdens on natural health product businesses; and inequitable authority over the natural health product community.. The new regulatory burdens and costs on natural health product businesses will make it difficult for small producers to comply and will force them to scale back the variety of their offerings or cease production altogether.  

Background

In Canada, oversight of Natural Health Products (NHPs) falls under the Natural Health Products Regulations (NHPR) of the Food and Drugs Act. These regulations came into effect on January 1, 2004, after consultation with stakeholders and the public to determine an appropriate regulatory framework for NHPs. At that time, it was agreed that it was not proper to regulate natural products under the same regulations as chemical drugs or impose the same standards of evidence onto natural health products. 

In 2017, Health Canada launched a consultation on the regulation of self-care products. In 2021, Health Canada conducted consultations regarding proposed regulations to amend the Natural Health Products Regulations with the purpose of gathering feedback on proposed improvements to natural health product labelling. In addition, it was cited that the proposed amendments were anticipated to decrease the regulatory burden and costs to businesses, as well as introduce greater efficiencies for businesses. 

Since then, new proposed regulations were introduced creating concerns around the future of Natural Health Products (NHP) in the Canadian Market, from new fees and charges imposed, to the increased regulatory burden and the inequitable treatment of natural health care products. Most recently, in 2023, Health Canada provided information related to the fee proposal with the intention to start charging new fees on April 1, 2025, in addition to increasing the regulations. 

There is value in making sure products claiming health benefits are safe, but these standards do not take into account the wide variety of NHPs. While some offer alternatives to pharmaceuticals, many are considered supplemental to pharmaceuticals like vitamins, probiotics, and amino acids. Many of these products are not normally healthcare-associated, like natural deodorants, sunscreens, toothpaste, and skin care products. 

According to the Canadian Health Food Association’s Save Our Supplements campaign, 76% of brands say there is a high/very high chance they will need to pull product from the market as a result of these regulations. One in five companies say they are seriously considering leaving the Canadian market. Additionally, 66% of companies said it would have a negative impact on employment. 

Dating back to 1998, with the report of the Standing Committee on Health, Natural Health Products: A New Vision, it has been recognized that there is a legislative and regulatory regime required to govern traditional medicines (including, but not limited to, traditional herbal remedies, traditional Chinese, Ayurvedic and Native North American medicines), homeopathic preparations and vitamin and mineral supplements, taking into account the needs of associations, consumers, manufacturers, distributors, growers, importers, exporters, retailers and practitioners. The guiding principle since that time has been to establish a regulatory framework for NHPs that (1) protects the health of consumers (2) respects consumers' access to products and (3) guarantees product safety and quality. 

With limited implementation timelines, exorbitant fee increases and additional regulatory burdens, the new standards will cause significant issues within the industry and government. The fees, regulations and compliance costs are viewed as unnecessary changes to a system that was deemed to be working after the Natural Health Products Regulation in 2004. 

Canada already had some of the strictest regulations for NHPs prior to the new regulations. Once fully implemented, it will have the most stringent regulations on NHPs in the world. Many of our trading partners, including the US, Australia, EU, Japan, and China have different classifications based on the product’s composition, claim, and intended use. These factors will determine whether it is a supplement or medicine. 

As of 2022, Health Canada had licensed over 120,000 NHPs. With the increased demand for Natural Health Products and Practices and the increasing regulatory environment, there has been increased awareness regarding the need for legislation that will ensure a better regulatory environment for Natural Health Products and Practices, including calls for a proposed Charter of Health Freedom Act. The health and wellness industry recognizes the need for a more balanced regulatory environment and structure, built in consultation with industry, while still achieving the guiding principles of protecting the health of consumers, respecting consumers’ access to products and guaranteeing product safety and quality. 

Businesses in the health and wellness sector understand the regulations imposed in 2004, citing that they have been the best regulatory regime of NHPs in the world with the expertise and time invested in that process. However, the most recent cost recovery model and amendments to the Food and Drugs Act, as of December 22, 2023, will not achieve the desired outcomes without the same due diligence and consultation as previously conducted with industry. 

Recommendations

The Southeast Alberta Chamber of Commerce and the Canadian Chamber of Commerce recommend the Government of Canada:

1. Replace the definition of therapeutic product in section 2 of the Food and Drugs Act with the following: therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.  

2. Repeal Section 21.321 of the Food and Drug Act and Subsection 21.8(2) of the Food and Drug Act to reverse the changes imposed by Bill C-47 section 500-504.  

3. Eliminate additional fees, until fee levels are re-examined in consultation with industry;  

4. Consult with the Natural Health Product industry to come up with a globally competitive strategy to address safety concerns, and the differentiation between medicinal NHPs, supplements, and other consumer products while taking into consideration costs and the regulatory impacts for businesses of all sizes;  

5. Implement the Standing Committee on Healths recommendations from the report: Natural Health Products: A New Vision;  

6. Only implement new regulatory changes once backlogs are cleared, operations run efficiently, and policies and procedures are in place to ensure stable operations continue for Natural Health Products.  

References

1 Natural Health Products Regulation: https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/
2 Canadian Health Food Association’s Save Our Supplements campaign: https://www.saveoursupplements.ca/changing-regulations 
3 Consultation on the regulation of self-care products: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self-care-products.html 
4 Forward Regulatory Plan 2023-2025: Regulations Amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/self-care-framework.html 
5 Natural Health Productions: A New Vision - Report of the Standing Committee on Health - Recommendations: https://www.ourcommons.ca/documentviewer/en/36-1/HEAL/report-2/page-126  More Information: https://www.canada.ca/en/health-canada/topics/self-care-products.html 
6 Proposed fees for natural health products: Overview https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products/overview.html 
7 Charter of Health Freedom: https://www.charterofhealthfreedom.org/the-charter/ 
8 Food and Drugs Act, current to 2024-04-16 and last amended on 2023-12-22 https://laws-lois.justice.gc.ca/eng/acts/f-27/ 

Date Approved: June 19, 2024