CHFA Follow-Up Comments on the Self-Care Framework and Consultative Process

Dear Members of the Health Committee, 

Following our appearance before the Committee on October 31, 2024, the Canadian Health Food Association (CHFA) is compelled to provide further insights on Health Canada’s Self-Care Framework and the process that led to its development. 

1. Existing Recall Powers Already Address Consumer Safety 

The government’s concerns regarding a lack of sufficient recall powers to protect consumer safety overlook an essential fact: Health Canada already possesses ample authority to remove non-compliant products from the market under current regulations. The current framework allows Health Canada to take decisive action against non-compliant companies, whether under voluntary or mandatory standards, ensuring swift intervention. Even mandatory powers do not ensure compliance from every organization, particularly those that are resistant to regulatory standards. Expanding these powers not only duplicates existing authority but would impose unnecessary regulatory burdens on responsible businesses that consistently adhere to compliance standards. 

2. Absence of Genuine Consultation 

Despite Health Canada’s claims of “consultation” with industry, CHFA and other stakeholders experienced a process devoid of authentic engagement. We were informed of changes rather than actively consulted, deprived of a fair opportunity to discuss how these changes impact our industry and consumers. What was presented amounted to a series of notifications about impending regulatory changes without transparent details or practical engagement. The opportunity to address each of the specific clauses never happened with Vanessa’s Law. We were never provided the opportunity to share real-world implications and provide data-backed recommendations which are invaluable in shaping a balanced framework. Without this, the industry and Health Canada missed the chance to ensure that the framework's measures would be both appropriate and effective for NHPs.  

We urge the Committee to encourage Health Canada to prioritize transparency and genuine industry collaboration as regulatory and legislative initiatives progress, to better serve public health interests and regulatory clarity. 

3. Overreach through Bill C-47 and Definition Changes in Bill C-69 

Legislative changes introduced through Bill C-47 and Bill C-69, without proper consultation, granted Health Canada unprecedented regulatory powers, inappropriately aligning NHPs with pharmaceutical regulations. These legislative adjustments alter NHPs' legal definition, categorizing them alongside higher-risk pharmaceuticals. NHPs are not pharmaceuticals and require a dedicated regulatory category to reflect their unique, low-risk profile. This expansion of authority, justified as necessary for “precision regulation,” overlooks that Health Canada already possesses interim order powers to enact swift, time-limited regulatory changes when public health demands it, without compromising the regulatory integrity of NHPs 

When the Minister appeared on October 29^th, 2024, he mentioned needing precision regulation powers to restrict the sale of ephedrine and pseudoephedrine as precursors used in meth production; we’d like to clarify that Health Canada already has in place a regulatory framework to deal with controlled substances and precursors as Health Canada administers the Controlled Drugs and Substances Act and its regulations to:  

The need to define NHPs correctly at the Act level is critical, as applying pharmaceutical-level definitions and standards to NHPs has created an intertwined set of consequences. The extension was even made apparent in the Committee meeting on October 31^st, 2024, saying that the definition change was necessary so that precision regulation could be used to create a sand box environment for labelling changes. It is to be noted that this also could have been done without fundamentally changing the definition in the Act but points out the complexity of what happens when you change this definition.  

4. Unregulated Imports and a Misguided Regulatory Focus 

One significant oversight in the current regulatory landscape is the substantial volume of unregulated natural health products entering Canada through the 90-day importation rule. These products bypass regulatory oversight entirely, creating an unfair advantage over domestic businesses that face mounting regulatory demands and red tape. During committee discussions, it was reported that only 0.006% of companies in the regulated sector had refused to comply in a “timely” manner with recall requests. Yet, Health Canada’s focus remains on tightening controls for these compliant businesses rather than addressing the unchecked flow of unregulated products across our borders. 

Health Canada has expressed a desire for expanded mandate powers to compel compliance without needing to actively enforce, which places disproportionate regulatory pressure on companies that already adhere to stringent standards. This strategy misses its policy objectives by targeting the domestic industry instead of addressing the significant risks posed by unregulated imports that evade Canada’s safety, efficacy and quality requirements. 

We support effective regulation to ensure consumer safety, but focusing solely on increasing regulatory powers for the compliant sector is a misdirected approach. A balanced regulatory strategy should prioritize inspections and robust border controls, ensuring that all products—whether domestically produced or imported—meet the same safety and quality standards.  

We urge the Committee to press Health Canada on a framework that addresses unregulated imports comprehensively, leveling the playing field for Canadian businesses and protecting consumers. 

Conclusion 

The current iteration of the Self-Care Framework introduces measures that impose disproportionate burdens on natural health products (NHPs) compared to the risk they present. NHPs have a well-documented safety profile and a history of safe consumer use. The changes in Vanessa’s Law does not appear to recognize these characteristics and instead applies a “one-size-fits-all” regulatory approach, similar to that used for high-risk pharmaceutical drugs. Further, it is essential to recognize that the changes introduced through Vanessa’s Law cannot be viewed in isolation. They are interconnected with other regulatory initiatives in the Self-Care Framework, and in practice, these combined measures are missing their core policy objectives. Instead, Vanessa’s Law has become one of the primary vehicles for discussing issues affecting millions of Canadians who rely on natural health products, underscoring the need for a comprehensive and coherent approach. 

CHFA remains committed to working with Health Canada and HESA to create a regulatory system that both protects consumer safety and respects the distinct nature of natural health products. We respectfully urge HESA to consider these recommendations, support an approach that ensures genuine consultation, and maintain regulatory tools that strengthen, rather than duplicate, the protections already in place. 

Thank you for considering these urgent concerns. CHFA stands ready to collaborate on building a transparent, effective regulatory environment that safeguards consumer access to safe NHPs and supports responsible businesses in this sector.