Health Canada Publishes Cannabis Voluntary Recall Guide
Health Canada has a new addition to its library of informational guides for drugs and health products.
The Cannabis Voluntary Recall Guide, published February 11, is written for federal license holders as a guide to the requirements of the Cannabis Act and Canadian cannabis regulations that apply to the voluntary recalls of cannabis and cannabis products. The guide covers the responsibilities of every participant in the cannabis supply chain, from the cultivators to the salespeople, in the event of a voluntary recall. It also describes the complete recall process, from how to identify when one is needed to advice on how to conduct follow ups with supply chain customers and with Health Canada.
Who is the guide for?
While the guide states that it is written to advise those who hold federal licenses or permits for the import or export of cannabis and hemp products, there are many more who could benefit from the advice. As more European countries choose to introduce medical cannabis programs and growing numbers of US states and territories explore recreational cannabis, Health Canada's guide may be pertinent for other regions seeking guidance on how to structure and regulate their budding industries. The guide may also function as a useful template for start-up businesses not based in Canada, looking to make sure they would be compliant with the industry's best practices and procedures.
What is a voluntary cannabis recall?
A mandatory product recall would ordinarily begin with the issue of a recall order directly from Health Canada. In contrast, a voluntary product recall usually stems from a regulated party, such as a cultivator or a processor.
Recalls are usually initiated because a regulated party has become aware of a change in its product, which means that it may no longer meet the requirements placed on the product or where the product might present a public health risk.
A voluntary cannabis recall includes any action that is taken by the regulated party to remove the affected cannabis products from the supply chain, notify the customers and other supply chain operators that may have affected, and to correct the practices that led to the issuance of the recall.
The recall process
The voluntary recall procedure outlined by Health Canada has six detailed steps, divided into two main sections, though the guide does note that many of these actions may occur simultaneously, not sequentially as the list would imply.
Initiating A Recall
1. Identify the need to initiate a recall
2. Develop a recall strategy and determine scope of the recall
3. Inform Health Canada of the recall
Commencing a recall
4. Notify supply chain customers and begin the recall
5. Follow up with Health Canada and supply chain customers
6. Review and close the recall
In summary, it is the responsibility of the license holders to have some form of quality control system that can identify product issues and when it might be necessary to issue a recall. If a recall is deemed necessary, then the license holder must develop a plan that includes provisions for risk evaluation and sets out a scope, timeline, and communication plan. Once these actions are taken, an initial report must be submitted via email to Health Canada which includes the necessary information to issue a recall notice and a risk evaluation. If the recall is expected to last more than two weeks, this must also be justified in the initial report. During a recall, a minimum of three reports must be sent to Health Canada: an initial report, then progress reports, concluding with a final report and review.
Once these three steps are completed, the recall may commence.
There is a strong emphasis on record keeping, with the recalling license holder being advised to maintain a written record of all recall notifications sent, and to accompany all telephone calls with a written follow-up to maintain a clear record. Also notable is the extent to which digital and social media are suggested as effective methods of dealing with a wide-scope recall. In fact, putting up advisory posters in cannabis retail establishments is last on the list of advised recall communication methods, behind using websites, social media platforms, news media releases, and direct email or text alerts to inform affected clients.
In addition to keeping records of these notifications, the recalling license holder is advised to record all of the responses to correspondence to ensure that any non-respondents can be properly followed up, and to track any action they themselves take, such as destroying any returned product or supplying alternate product labelling. All of these records are relevant to the progress reports that must be submitted to Health Canada, as well as the final review.
A valuable guide
The value of this guide comes not from its re-statement of Canada’s rules; these are already publicly available in the Cannabis Act and the cannabis regulations. Its value stems from the inclusion of recommended specific actions that license holders can take to ensure they comply with the relevant standards.
For example, rather than simply stating that a communications plan must be developed, the guide recommends specific communication methods, such as sending a pre-addressed postcard or an email acknowledgement link.
The guide is comprehensive, but also quite widely applicable and accessible, making it well suited for use as a general template for the new or growing cannabis industries that are beginning to develop across the globe.