Health Canada has published a voluntary recall guide for federal license holders (the Guide) that covers topics including the recall process as well as some of the record keeping and reporting obligations related to cannabis product recalls.
The Cannabis Regulations (the Regulations) require cannabis license holders (except for cannabis drug license holders) to “establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of cannabis that has been sold or distributed.” The Guide covers topics including identifying when a recall should be initiated, the process of conducting a recall, as well as the record keeping and reporting requirements that a license holder must follow when conducting a recall. The Guide (found here) also contains a checklist and flow chart of the steps involved in a recall.
When does a product need to be recalled?
A recall should be initiated when a license holder becomes aware that cannabis or a cannabis product presents a risk to health or safety or may not meet the requirements of the Cannabis Act or the Regulations. A recall might be warranted in a variety of scenarios including, for example, a license holder becoming aware of inaccurate labelling or product contamination.
What are the expected timelines for a recall?
The expected timelines depend on the severity of the reason for the recall. Accordingly, it is critical to quickly and accurately identify the health risks posed by a non-compliant product. In the most serious scenarios, which exist where there is a “reasonable probability that the use of or exposure to the cannabis or cannabis product will cause serious adverse health consequences or death,” Health Canada expects a recall to be initiated within a maximum of one business day. When there is a lower risk of serious health consequences, the time period is extended to four to seven business days, depending on the health risk.
What should I do if I think I need to recall a product?
A recall is far from an ideal scenario but even the best-laid plans often go awry and these situations need to be dealt with properly. While the Guide is a helpful resource, each scenario is unique and license holders should promptly consult counsel before moving forward with a recall. Proper guidance through the recall process will ensure appropriate steps are taken and most importantly, that the risk of adverse health consequences is minimized.
The author wishes to thank articling student Daniel Weiss for his contribution to this legal update.