In Le-Vel Brands, LLC v The Attorney General Of Canada, 2023 FCA 177, the Federal Court of Appeal (FCA) held that the Federal Court properly determined that Health Canda reasonably decided that Le-Vel Brands (L-Vel)'s Thrive Premium Lifestyle Derma Fusion Technology Patch (the Patch) is a natural health product (NHP), and that Le-Vel must cease all sales of the Patch in Canada.
Le-Vel, a self-described "premium lifestyle" company, began selling the Patch in Canada in 2015 as a cosmetic. Marketing materials for the Patch included claims that the Patch used a "[Derma Fusion Technology] delivery system" that is designed to "infuse the derma (skin)" and "to provide greater bioavailability and absorption" and "fat reduction (including control, reduce and prevent cellulite, weight management)".
In 2016, Health Canada advised Le-Vel that the Patch could not be classified as a cosmetic, including as the label referred to "fat reduction". In 2021, Health Canada issued a final decision that the Patch was an NHP and demanded that Le-Vel cease all sales and marketing activities of the Patch.
The Natural Health Products Regulations defined an NHP as "a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in ... modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health." There was no dispute that the Patch's medicinal ingredients are identified in Schedule 1 of the NHP Regulations, but Le-Vel and Health Canada disagreed as to whether the Patch can be said to be "modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health".
Federal Court found Health Canada's decision was reasonable, and FCA agreed
Le-Vel applied for judicial review of Health Canada's decision, which the Federal Court dismissed in 2022: Le-Vel Brands, LLC v The Attorney General Of Canada, 2022 FC 459.
The Federal Court highlighted the factors that led to Health Canada's decision to classify the Patch as an NHP. In particular, Health Canada's classification decision was based on the submitted product label, how the product and product line are marketed, and the overall representation of the product.
The Federal Court held that Health Canada reasonably determined that Le-Vel suggested a systemic therapeutic use for the Patch, based on the lack of clear directions for its area of application, and the absence of any indication that its benefits are limited to the local area of application. This was a reasonable basis for classifying the Patch as an NHP, and for ordering Le-Vel to cease all sales of the Product.
The FCA dismissed Le-Vel's appeal, holding that Health Canada's decision was reasonable: "Its reasons bear the hallmarks of reasonableness, and its outcome is justified in light of the relevant factual and legal constraints", including that it does not matter whether the Patch can be classified as a cosmetic as the NHP definition does not exclude cosmetics.
Should Le-Vel wish to appeal further, it will need leave to appeal to the Supreme Court of Canada.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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