It has been a year since the news about medical cannabis recalls in Canada dominated the headlines. The effects of that recall in the world of testing have been deep and impactful. Health Canada has spent the last 11 months considering which pesticides they felt need to be tested for in cannabis and has begun the stakeholder engagement process to make significant changes. Additionally, the federal government has made changes to the information it is providing to Canadians with the goal to improve transparency about recalls. It is now official government policy to post all recalls, regardless of public health risks, on cannabis for medical purposes to the department’s online recall database. It will also continue to publish annual and quarterly compliance and enforcement reports with information about medical cannabis recalls and other compliance and enforcement actions undertaken by the department. Since November 2016, the recall database on Health Canada’s website shows nine recalls of cannabis products. Three of the recalls were related to labeling issues of products, and the remainder of the recalls were due to detection of pesticides.
(Learn more about how Smoking and Vaping Cannabis Poses Health Risks.)
Taking a step back, the recall process is a way for consumers to hold suppliers accountable for the products they produce. When customers feel that a product does not measure up to the promise the producer made, they can contact them about their concerns. If customers experience negative side effects that they believe are related to the product, they can contact the supplier and, in Canada, they can also contact the Canadian Vigilance Program.
The Recall Process
A recall process is initiated when a complaint comes in, either to the producer themselves or through Health Canada. Typically, there are three types of complaints that would start a recall process:
Patient – This usually comes in the form of, “I am a customer, and I have a problem…”
Health Canada – This can be through the vigilance program reporting or related to random testing that Health Canada conducts. It can come in the form of, “We have identified a problem…”
Trade Complaint – This type of complaint is more common than you might expect and happens when a company takes a closer look at a competitor’s product and files a complaint with Health Canada based on label claims. It often also takes the form of, “I have a problem…”
Once a producer initiates a recall process, a number of things begin to happen all at the same time. This is the moment where everyone stops eating, stops sleeping, and the stress meter maxes out. This is a big deal, and everyone understands that every minute matters and every detail is important.
The quality assurance person is the point person for a recall but in most cases, the big items are split between teams so that all the details are not piled on one desk. One team begins to collect the details of the recall and contacts Health Canada. The goal is to deliver the recall message, including details about what to do with recalled products, to affected patients. After the patients are contacted, Health Canada posts a public notice about the recall, including information on the company and the specific products, on its website.
Health Canada has three categories of risk for product recalls, and each recall is assessed and categorized before the initial patient contact occurs. Type I is a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. Type II is a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote. Type I and II also include situations where a product that does not have generally recognized or supported therapeutic value is promoted in such a way that avoidance of recognized therapy occurs and where such avoidance could lead to injury or death. Finally, Type III is a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.
The Recall Investigation
At the same time the first team is working with Health Canada, another team begins an investigation about the recall. The task is to determine what happened. Each organization approaches this differently but essentially, each want to answer some key questions:
How did this happen?
Where did the problem come from?
What other products are affected?
How do we fix the current problem?
How do we avoid repeating this problem in the future?
This last question is where our job in the testing lab can kick into high gear again, as an investigation often raises some interesting questions about the process a client has used. We can be asked to provide support testing to answer the questions that come from an investigation.
On a side note, the process for recalls is an interesting one and from the lab bench, we have a unique perspective on what it takes to initiate and investigate a recall. While we don’t always know for sure that a recall is happening, there are indicators that something is happening with our clients. The first thing that we receive is a call from a client requesting the supporting documentation about testing results. Usually, they also want to see a current license, validation protocols for all testing methods, current training records for our technical team, current preventative maintenance schedules, and calibration records for instrumentation. This one call is usually a big indicator that our client needs to sort out a problem on their end. For us, it creates a number of internal processes to ensure we provide meaningful supportive information as a client begins an investigation.
The final steps in the recall process ensure that the recall has indeed been concluded. A completed recall will include paperwork (lots of paperwork) that documents the collection and destruction of the recalled materials as well as the closing out of the investigation. Closing out an investigation can take some months, as answers from vendors and testing labs take time to understand in the scope of the investigation. This process usually also includes implementing new procedures to ensure that the quality of the product will not be affected in the same way.
(For more on the science of recall testing, check out Testing Medical Marijuana for Pesticides.)