A judge has approved Organigram’s application for judicial review of Health Canada’s decision that Jolt’s “ingestible extracts” were in contravention of the federal Cannabis Regulations.
The judgement, posted on August 8, states that Organigram’s application for judicial review has been granted. The matter will now be sent back to Health Canada for redetermination, taking the judge’s reasons into consideration.
The filing, posted March 31, 2023, as Organigram Inc. v. Minister of Health et al., falls under Section 18.1 Application for Judicial Review. Judicial review is a process by which the courts can ensure that the decisions of administrative bodies like Health Canada are fair, reasonable, and lawful.
Organigram was seeking a judicial review following Health Canada’s move to end the production and sale of so-called “edible extracts” earlier this year. The company is one of a handful producing products in this category that were packaged exceeding the federal limit of 10mg THC per package for edibles. These were generally in the form of lozenges and gummies.
The company had hoped to see Health Canada’s order quashed or set aside, instead requiring Health Canada to determine that its Jolts lozenges are a cannabis extract and do not constitute edible cannabis under the Regulations.
Organigram and others who have made these products contend they are compliant products.
Organigram, which has been selling its Edison Jolts products as cannabis-infused lozenges in packaging exceeding 10mg THC, said in March that it had paused production. It maintained that the products were compliant with federal regulations.
Health Canada issued a public warning about these products on March 3.
“Some edible cannabis products were found to contain more than the allowable limit of 10mg of THC per package,” notes the press release. “These non-compliant products in product formats similar to gummies and other confectionery products, such as hard candy, have been incorrectly marketed and sold as cannabis extracts.”
The federal health authority also issued a new online document providing clarity on the issue of the classification of edible cannabis. The document, in part, notes that a cannabis edible is defined as any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, or any ingredient that may be mixed with food for any purpose.
“Licence holders should verify if their cannabis products are classified correctly. Licence holders are encouraged to review the definitions of, and requirements for, cannabis and cannabis products in the Guide on composition requirements for cannabis products and Packaging and labelling guide for cannabis products.”
Although Organigram had argued that Health Canada’s decision that their edible or “ingestible” extract products weren’t compliant was incorrect, the judge disagreed. Instead, the judge ruled that the federal health agency’s process to reach that conclusion was not fair and deserved further analysis.
The judge ruled that the unfairness of Health Canada’s decision on the ingestible extracts was, in part, due to it including additional factors in its decision-making process that Ogranigram was not provided an opportunity to respond to.
For example, court records show that Health Canada introduced a “fourth factor” in the decision that was omitted from the Notice of Non-Compliance that it issued to Organigram. The judge argued this factor—the product’s sensory and physical characteristics—is not found in Health Canada’s Guidance Document because Organigram was not given an opportunity to respond to Health Canada’s objection to the Jolts’ size and shape or suitability for sublingual and buccal absorption.
Organigram was not afforded a meaningful opportunity to respond to that concern and thereby prejudiced in its ability to respond to that concern,” wrote the judge in their analysis.
“Given my finding that Health Canada breached the duty of procedural fairness by relying on a product classification factor found only in the Compliance Promotion Statement, which was published after the decision was issued, I need not address Organigram’s further procedural fairness submission based on delay, nor the submissions as to the reasonableness of the decision,” concluded judge Cecily Y. Strickland.
“I am satisfied that a lower level of procedural fairness was owed to Organigram and that several opportunities to respond were provided to it throughout the decision-making process, with which Organigram engaged,” the judge also wrote in their ruling. “However, when all of the circumstances of the case are taken into account… I find that there was a breach of procedural fairness arising from inadequate notice of Health Canada’s reliance on a factor contained in the Compliance Promotion Statement and, as a result, that Organigram was not afforded a meaningful opportunity to respond to that concern and thereby prejudiced in its ability to respond to that concern.”
The case will now go back to Health Canada for their opportunity to respond.
Health Canada initially issued warnings to some producers or manufacturers of so-called “edible extracts” in January, warning them they were not compliant with federal regulations. One producer, Vortex Cannabis, confirmed they received an order from Health Canada to stop sales of their Full Spectrum THC Jelly Cubes due to these being inaccurately classified as extracts rather than edibles.
The Vortex Jelly Cubes came in 10mg THC squares, sold with multiple units per pack.
Several other companies make similar products, including Indiva, Organigram, Loosh Brands, and Aurora Cannabis.
The court documents also reference the Vortex Jelly Cubes, which caused one woman to be taken to hospital where she was told she had overdosed on cannabis after consuming several of the product, assuming they contained only 10mg THC for the entire container, rather than 100mg THC.