What is a natural health product? Federal Court of Appeal resolves a scientific debate

The natural health product (NHP) industry in Canada is considerable with over CDN$5 billion of annual revenue.¹ Over 70% of Canadians report having used an NHP.² Despite the ubiquity of NHPs, it is not always clear what separates them from related products, like pharmaceuticals, food, and cosmetics. However, the legal lines separating NHPs from related products can be critical to manufacturers, as falling on one side of a line or the other determines the regulatory burden they face in making and marketing their products.

The legal lines between NHPs and related products have been illuminated by judicial decisions in litigation between manufacturers and the regulator, Health Canada. In the most recent decision in this jurisprudence, the Federal Court of Appeal (FCA) upheld Health Canada’s finding that RESOLVE – a proposed smoking cessation aid – is not an NHP based on the available scientific evidence.

How natural health products are defined

NHPs are perhaps best understood as a legally defined class of over-the-counter health products. NHPs elude simpler descriptions. For instance, while it is true the medicinal ingredients in NHPs are found in nature, the same could be said of many prescription drugs (e.g., paclitaxel) and controlled substances (e.g., psilocybin). Moreover, the medicinal ingredients in an NHP can, in some circumstances, be obtained from chemical synthesis and not from a natural source. 

Legally, all NHPs are “drugs” under the Food and Drugs Act.³ This is because, like other drugs, NHPs are substances represented for use in “the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms” or for “restoring, correcting or modifying organic functions.”⁴ Therefore, NHPs are a subset of drugs with distinct regulations governing their sale, manufacture, packaging, labelling, importation, distribution, and storage (the NHP Regulations).

NHPs are distinguished from other drugs by a set of positive and negative criteria:

• Positive criteria: An NHP must be a traditional medicine, a homeopathic medicine, or a substance set out in Schedule 1 to the NHP Regulations (or a combination of such substances).⁵ Schedule 1 includes discrete classes of substances (e.g., vitamins, amino acids, minerals). It also includes a broad, omnibus class of substances – “A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material” – as well as an “extract or isolate” of those substances and a “synthetic duplicate” thereof.
• Negative criteria: An NHP must not be a prescription drug.⁶ An NHP must also not contain a substance set out in Schedule 2 of the NHP Regulations, which includes certain antibiotics, certain biologic drugs in Schedule D of the Food and Drugs Act, substances administered by injection, and controlled substances.

Testing the line between NHPs and other drugs

How the legal definition of NHPs applies to real-world products is not always obvious. Whether a product is an NHP or not can be “a matter of legitimate scientific debate.”⁷

Such a debate was addressed in the FCA’s recent decision in The Winning Combination Inc. v. Canada (Attorney General), 2025 FCA 101. The FCA upheld Health Canada’s finding that the RESOLVE product, manufactured by The Winning Combination Inc. (TWC), is not an NHP and accordingly cannot receive an NHP product licence. The FCA’s decision appears to bring an end to 18 years⁸ of litigation between Health Canada and TWC over the RESOLVE product, subject to leave to appeal being sought from the Supreme Court.

The dispute between Health Canada and TWC concerned whether the confidential and undisclosed medicinal ingredient in the RESOLVE product is found in nature, such that the product falls within Schedule 1 of the NHP Regulations. Health Canada determined there was no reliable evidence that the medicinal ingredient was naturally present in passionflower and as a result the product was not an NHP. 

Health Canada reached this decision after retaining three independent laboratories to test passionflower samples and an expert panel to assess the testing results. The expert panel considered the laboratories’ results as well as results from testing performed for TWC and concluded that neither provided reliable evidence the medicinal ingredient was in passionflower. When TWC sought judicial review of Health Canada’s decision, the Federal Court found that the NHP Regulations did not prohibit Health Canada from ordering testing and TWC had received procedural fairness, as it had notice of the testing, was provided with the results, and had an opportunity to address the expert panel.⁹

On appeal, the FCA sustained Health Canada’s decision for substantially the same reasons as the Federal Court. The FCA found that Health Canada had “acknowledged the deficiencies” in the independent laboratories’ testing, but that this testing was “only part of the evidence considered,” which also included the “numerous and serious flaws” in TWC’s expert testing and the “absence of a reference in the scientific literature supporting TWC’s position.” The FCA concluded that Health Canada’s decision was reasonable and, at the end of the day, TWC had not met its burden to establish that the RESOLVE product is an NHP.