On August 8, 2023, the Federal Court reversed Health Canada’s choice that a marijuana item, Edison Jolts, was to be categorized as edible marijuana and not marijuana extract. The Court discovered that Health Canada had actually breached the task of procedural fairness by depending on an item category consider an internal assistance file that Health Canada just released after rendering its choice.
Background
Organigram Inc. makes Edison Jolts ( Jolts), which are marijuana items in lozenge kind. Organigram categorized Jolts as marijuana extract in notifications of brand-new marijuana item to Health Canada. If categorized rather as edible marijuana, Jolts would go beyond the THC material per instant container allowed by the Marijuana Laws
After preliminary exchanges, on January 3, 2023, Health Canada released a Notification of Non-Compliance ( NNC) with regard to the Jolts line of marijuana items. The NNC mentioned that Jolts must be categorized as edible marijuana on the basis of 3 elements: item format, item representation, and public understanding. The 3 category elements were from a file that had actually been formerly released by Health Canada, particularly the Assistance File: Category of items at the food-natural health item user interface: items in food formats ( External Assistance).
On January 6, 2023, Organigram reacted, arguing based upon the External Assistance that Jolts were not appropriately categorized as a food.
Health Canada’s choice
On March 1, 2023, Health Canada released a composed choice finding that Jolts are appropriately categorized as edible marijuana items. In making this choice, Health Canada thought about a 4th category element: item sensory and physical qualities. The 4th element was from an internal Compliance Promo Declaration ( Internal Assistance) that Organigram was uninformed of up until, 2 days after providing its choice, Health Canada made the Internal Assistance openly offered.
Organigram used to the Federal Court for judicial evaluation of Health Canada’s choice.
Judicial evaluation
The Court examined the concern of procedural fairness on an accuracy requirement.
Initially, the Court discovered that, on the basis of the Baker elements, the level of procedural fairness that Health Canada owed to Organigram fell at the lower end of the spectrum. However, the Court discovered that Heath Canada had actually breached procedural fairness by depending on the 4th category element, which was discovered just in the Internal Assistance and had actually not been divulged to Organigram. As an outcome, Organigram was not managed a significant chance to react to Health Canada’s issues associated to that element. Furthermore, Health Canada’s breach of procedural fairness might have impacted the result, as the 4th element “appears to have actually played a not unimportant function” in Health Canada’s choice to categorize Jolts as edible marijuana.
As an outcome, the Court remitted the matter back to Health Canada for redetermination.
Link:
Organigram Inc. v. Canada (Chief Law Officer), 2023 FC 1075