Canada’s natural health product (NHP) industry is a major sector, generating over C\$5 billion annually. More than 70% of Canadians report using NHPs, but the distinction between NHPs and similar products—such as pharmaceuticals, food, and cosmetics—is not always clear. These distinctions carry significant consequences for manufacturers, as they determine how products are regulated.
Recent legal decisions have helped clarify these boundaries. In a recent ruling, the Federal Court of Appeal upheld Health Canada’s decision that RESOLVE, a product marketed as a smoking cessation aid, does not qualify as an NHP under current scientific evidence. This outcome marks the latest development in a lengthy legal battle between the manufacturer and the regulator.
Legally, NHPs are classified as drugs under the Food and Drugs Act, but they are subject to a separate set of regulations known as the Natural Health Product Regulations. These rules apply to over-the-counter products that are promoted for treating or preventing disease, or for maintaining bodily functions. However, not all substances that appear natural are automatically considered NHPs.
To be classified as an NHP, a product must meet specific criteria. It must be a traditional or homeopathic medicine, or include substances listed in Schedule 1 of the regulations. This includes vitamins, minerals, amino acids, plant materials, extracts, and synthetic copies of natural substances. At the same time, NHPs must not contain any substances listed in Schedule 2, which includes certain antibiotics, injectable substances, and controlled drugs. Products also cannot be prescription medications.
In the case involving The Winning Combination Inc. (TWC) and its RESOLVE product, the core issue was whether its active ingredient could be found in nature—specifically, in passionflower. Health Canada determined that there was no reliable evidence to support this claim. The agency based its conclusion on testing by three independent laboratories and an expert panel review. This panel reviewed both the external test results and TWC’s own evidence and found no credible proof that the ingredient occurred naturally.
TWC challenged the decision, arguing that Health Canada had overstepped by requiring and relying on scientific testing. However, both the Federal Court and the Federal Court of Appeal found that Health Canada acted within its authority. The courts agreed that TWC had received a fair process, had been informed of the testing, and had been given a chance to respond to the findings.
The appeal court concluded that Health Canada had weighed the available evidence appropriately. The flaws in TWC’s testing and the absence of supporting scientific literature meant that the company had not proven the product met the definition of an NHP. Unless the Supreme Court grants leave to appeal, the case appears to have reached its end.
This decision reinforces the importance of scientific evidence in determining how health products are regulated in Canada and highlights the strict criteria manufacturers must meet to classify their products as natural health products.
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