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Pharmaceutical Industry Insiders Claim Product Regulations in ‘War on Natural Health’ Favor Pharmaceuticals


Health Canada’s ongoing efforts to bring natural health products under government control have taken a significant step forward, though critics maintain that the safety concerns are unfounded and that there is a pro-pharmaceutical industry bias.

David Stephan of Hartleyville, Alberta, contends that the government is waging a war on natural health products, mainly to provide pharmaceutical companies with a complete monopoly. As an employee of his father’s natural health product (NHP) business, and a staunch opponent of Health Canada’s regulatory tightening, Stephan fears the potential market impact. He emphasized that the latest regulations, unveiled in June 2023 under the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law),” have been implemented in a rather covert manner.

Under the omnibus budget bill C-47, the Canadian federal government reclassified NHPs as “therapeutic products,” signaling a significant shift in regulatory oversight of the industry.

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As a result of the new regulations, NHPs are now legally positioned somewhere between drugs and medical devices, providing Health Canada with robust mechanisms for overseeing the industry, imposing heavy fines for unsafe products, initiating product recalls, mandating labeling changes, and charging NHP companies for their regulatory oversight expenses. Such stringent measures are likely to drive up business costs, potentially diminishing the availability of NHPs for consumers.

David Stephan and others fear the adverse impact of these regulatory changes, especially in terms of increased product costs and their availability in the Canadian market. The heightened costs and financial and regulatory burden could force NHP companies to discontinue certain products, significantly limiting consumer choices.

Safety Debate

NHPs have long been subject to regulation in Canada, with the authorization and licensing of such products mandated by Health Canada since 2004. In recent years, the regulatory framework for NHPs has faced criticism over its adequacy and was flagged by the 2021 Auditor General’s report for insufficient enforcement and oversight, prompting the current restructuring of regulations in the industry.

Despite Health Canada’s existing regulatory framework, some companies were found to have faltered in compliance, which prompted concerns regarding the accuracy and completeness of product information, including dosages, risks, and ingredients.

The lack of regulatory compliance was accentuated by cases involving the presence of pharmaceutical ingredients in NHPs, resulting in serious risks and hospitalization. Furthermore, the Auditor General’s report also detailed the reporting of serious adverse reactions associated with NHPs, which necessitated a mandatory hospital reporting policy under the new regulations.

David Stephan and other NHP advocates voiced their concerns that these regulations are driven more by a bias towards pharmaceutical companies rather than actual safety concerns. The ongoing regulations have been a cause of contention and have significantly impacted the availability of NHPs in the Canadian market.





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