In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. These distinctions are important as they determine the regulatory burden required to market a product in Canada.
The statutory definition
In Canada, natural health products are defined as drugs under the Food and Drugs Act but are generally not subject to the Food and Drug Regulations. Instead, the Natural Health Products Regulations (NHP Regulations) govern the sale, manufacture, packaging, labelling, importation, distribution, and storage of natural health products.
In its August 16, 2023 decision in Le-Vel Brands, LLC v. Canada (Attorney General), 2023 FCA 177 (Le-Vel), the Federal Court of Appeal (FCA) noted that the definition of natural health product, under the NHP Regulations, has substance and functional requirements.
- Substance requirement: A natural health product is a substance set out in Schedule 1 to the NHP Regulations (or a combination of such substances), a homeopathic medicine, or a traditional medicine. The substances listed in Schedule 1 include amino acids, certain vitamins, and “[a] plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material”.
- Functional requirement: A natural health product must be manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans.
Substances that meet the two requirements may still be excluded from the NHP Regulations, including substances set out in Schedule 2 (e.g., antibiotics) and prescription drugs.
Natural health product vs. cosmetic
In Le-Vel, the appellant, Le-Vel Brands, LLC (Le-Vel Brands), marketed the Thrive Premium Lifestyle Derma Fusion Technology Patch (Patch). The Patch was initially sold as a cosmetic, but Health Canada advised Le-Vel Brands that the Patch should instead be classified and regulated as a natural health product.
Le-Vel Brands accepted that the Patch met the substance requirement for a natural health product, but argued that it did not meet the functional requirement. Health Canada disagreed, finding that the Patch did meet the functional requirement of “modifying organic functions in humans”. Health Canada’s rationale was that, although no explicit therapeutic claims were made on the Patch’s Canadian label or website, the Patch was represented as having a whole body effect on the skin, which requires ingredients from a locally-applied Patch to have systemic absorption and action.
When Le-Vel Brands applied for judicial review, the Federal Court (FC) and the FCA upheld Health Canada’s decision as reasonable. Of note, the FCA found that the definitions of a cosmetic and a natural health product are not mutually exclusive, such that the Patch could potentially be classified as both.
Natural health product vs. regulated drug
In Winning Combination Inc. v. Canada (Attorney General), 2023 FC 1465, Health Canada refused a licence application from The Winning Combination Inc. (TWC) for its product Resolve, a smoking cessation aid, which it alleged is a natural health product subject to the NHP Regulations. Health Canada disagreed, finding that Resolve is instead a drug subject to the Food and Drug Regulations.
Health Canada made this finding as part of a Court-ordered redetermination of TWC’s licence application. In the redetermination, the key question was whether Resolve’s active ingredient is a naturally-present constituent of passionflower. Three independent laboratories were asked to address this question with testing, including using TWC’s methods. An external panel of scientists analyzed the testing results. Based on the panel’s report, the scientific literature, and TWC’s own testing, Health Canada concluded that was no reliable evidence that Resolve’s active ingredient is naturally found in passionflower. Therefore, Resolve was not a natural health product as it did not meet the substance requirement under the NHP Regulations.
When TWC applied for judicial review, the FC upheld Health Canada’s decision. TWC alleged, inter alia, that Health Canada had no power to order laboratory testing as part of the redetermination process. The Court disagreed, finding that TWC had received procedural fairness as it had notice of, and a full opportunity to address, the laboratory testing process and results.