Law360 Canada ( May 19, 2022, 6:25 AM EDT) -- Application by Le-Vel Brands for judicial review of a final decision of Health Canada classifying its “Thrive DFT Patch” as a natural health product for which a license was required rather than a cosmetic. The applicant and Health Canada engaged in a detailed exchange of submissions and preliminary determinations prior to the release of Health Canada’s final decision. During that back and forth, the applicant’s promotional materials for the Patch in Canada changed significantly, such that Health Canada was required to consider various versions of representations made by the applicant. In Canada, the Patch was represented as targeting the skin, whereas in the U.S., it was represented as being about nutrition. Health Canada expressed concerns to the applicant that Canadian consumers were not insulated from the promotional materials being employed in the U.S. The classification determination was based on the information presented in the product images and websites. Health Canada determined the Patch included substances set out in Schedule 1 of the Natural Health Products Regulations, that the Patch was represented as providing a whole-body effect on the skin and not limited to local application, thereby via systemic absorption and modifying organic function. To be a cosmetic, the product must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the effect. Health Canada was of the view that the Patch was being represented for therapeutic and systemic use. The applicant disputed Health Canada’s finding that the Patch was represented for use in modifying organic functions in humans, such as modifying those functions in a manner that maintained or promoted health....