One cannabis testing lab in Canada, with several years of experience in the industry, says most of the cannabis they have analyzed is around 18-24 percent THC, with only a fraction cracking the 30 percent threshold.
In data recently shared with StratCann, High North Laboratories says less than one percent of samples they’ve tested showed results of over 30 percent total THC: just 154 in more than 20,000 cannabis samples. The data was anonymized to remove client names and other identifying information.
Rick Moriarity, COO of High North Laboratories, says they are sharing the information now to add to the conversation around consumer expectations for high THC products. While the market increasingly demands higher and higher THC products—sometimes pushing into the high twenties and even thirties—Moriarity says the cannabis flower they have analyzed tends to be around 21 percent THC.
In fact, after controlling for lower-THC products they test (like hemp or more CBD-rich flower), just over half of nearly 20,000 samples were in the range of 18 to 24 percent THC.
These findings mirror research published in 2021 in the US that showed a similar breakdown of THC levels peaking around 18 to 20 percent.
The expectation of high THC being the only indicator of quality, says Moriarity, isn’t realistic. It can be a factor, but not the only one.
“I hope this information can help guide consumers not to be looking at total THC for a purchase decision. There’s nothing wrong with looking at the total THC to see what it is and if it is a CBD or balanced product; however, it should not influence you enough that you walk into a store and say, “what’s your highest THC flower?”
One of the problems, he acknowledges, is that consumers are focussing on THC, at least in part, because they can’t decide based on aroma, as many consumers could do in the pre-legal market.
“With the regulations around packaging, it is not easy to look and smell before making a purchase decision. I know some stores have jars with little air holes that you can look at and attempt to smell the flower. It’s better than not having that option, but the flower gets old quickly that way and is not truly representative. So I understand why, but THC alone isn’t a good replacement for that.
“Terpenes are one other factor to consider, as is our endocannabinoid system and several other important cannabinoids that we’re only just starting to learn more about. The point is, this all amounts to so much more than just that one number for THC. And that’s even if those numbers are accurate, which obviously, they often aren’t.”
He adds that he doesn’t mean all lab testing is inaccurate, but emphasizes that “the numbers are not accurate when being inflated by a select few non-reputable labs.”
Similar to another cannabis lab that recently shared results of off-the-shelf products they tested, High North shared with StratCann what they say are the results of 35 cannabis flower products they purchased from cannabis stores. As with their other internal testing results, High North removed producers names in the info provided to StratCann.
Of these, nine were within an acceptable deviation range of no more than 12 percent, while most were within between 20 to nearly 100 percent deviation from the labelled amounts. One product tested at 19 percent THC but was listed on the label as having 38 percent. Interestingly, one flower sample that High North’s second test showed at a whopping 31 percent THC was labelled as 38 percent.
Moriarity highlights this specific result as an example of how absurd it is that a producer who is already hitting such a high number like 30 percent, would need to boost those numbers even more.
These results indicate that much of the cannabis on the market is actually in a range of around 20 percent THC, and also how inaccurate at least some of the available product labels are, says Moriarity. The results also highlight the folly of consumers and even provincial buyers in making purchase decisions based on THC alone.
In Canada, many licensed producers have built their business models around high THC cannabis, for the simple reason that the system is skewed to reward elevated percentages. The result has been that some licensed providers may be shopping around for the labs that offer the best results.
A licensed provider will come to a lab, get a certain percentage, then shop to another lab and get another percentage.
Luther Smallwood, Pathogenia Lab
“It’s been one of the issues that labs in general run into,” says Luther Smallwood, Business Development Manager at Pathogenia Lab in Montreal. “A licensed provider will come to a lab, get a certain percentage, then shop to another lab and get another percentage.”
This practice is perhaps understandable given the market incentives that favour higher THC. There are entire brands – and stock valuations – that are dependent on cannabis testing above 25% THC.
“These labs could be using older standards or a process that delivers results with slightly more THC,” says Brian Coutts, Strategy and Business Development Manager (Food & Pharma) at A&L Laboratories in London, Ontario. “Many of them also don’t include moisture tests in their certificate of analysis, which in my view calls into question the legitimacy of their processes.”
If a sample is sent to a lab for a potency test, moisture analysis should also be performed on that same exact sample.
Tom Ulanowski, Nextleaf Labs
In Canada’s regulated market, dried cannabis is to be tested “as is”, which means it must represent what is sold to the consumer without additional processing. Labs are not supposed to report potency on a dry weight basis, which would result in higher reported THC and CBD percentages. Ideally, a Certificate of Analysis (CoA) should include the moisture content along with cannabinoid potency – but that isn’t always the case.
“There is a somewhat simple solution to the problem,” says Tom Ulanowski, a Professional Chemist (APCBC), Articling Agrologist (BCIA), and Vice President of Quality Assurance and Regulatory Affairs at Nextleaf Labs. “If a sample is sent to a lab for a potency test, moisture analysis should also be performed on that same exact sample. With this additional information, the concern that the cannabis flower was dried prior to potency testing is mitigated, unless a lab is doing something they shouldn’t be doing.”
It is uncertain as to whether over-drying of samples is an issue in Canada, given that most concerns are anecdotal, and the risk of regulatory penalties for this type of non-compliant practice is high. As well, it is questionable as to whether or not it would even make much difference.
“It’s quite simple to calculate the effect that over-drying has on potency,” says Ulanowski. “If you take a high moisture content flower, and recalculate the potency in a scenario where half the moisture content was removed, that relative change to the potency is – in my opinion – not significant enough in most cases. Improper testing methodology, or biased sampling, is a much greater concern to me.”
A call for better oversight
The cannabis industry in Canada relies on dozens of licensed labs. Some of these are older, more established businesses that also test food and agricultural products – and some labs are newer enterprises that exclusively test for cannabis.
Given the role that THC plays in the value of cannabis products throughout the supply chain, the hands-off attitude on the part of Health Canada has raised some eyebrows and brought about calls for more and better oversight, including surprise audits. Many feel that if Health Canada were to increase its oversight of cannabis labs, the overall market would stand to benefit, including those labs that are doing their best to serve their clients.
“The truth is most of the labs that I’ve spoken to and worked with are all honest, good labs here in Canada,” says Smallwood. “However, it would be good to have a blanket THC extraction procedure so that LPs can choose labs based on what really matters, which is service level, turnaround times, reliability, accuracy, and pricing.”
… as the industry is growing and maturing, we’re seeing less of an emphasis on just THC levels and more on other cannabinoids.
Heather Holmen, Alberta Gaming and Liquor Commission (AGLC)
Health Canada’s resources are stretched, yet the agency’s purview might have to expand beyond licensing labs to include additional scrutiny over sampling procedures, or perhaps conducting regular ring tests and statistical analyses of laboratory data.
“One of the major issues in our industry is that there is generally little control over sampling,” says Ulanowski. “Of course, the producers will be tempted to sample in a manner that has a bias toward the nicer looking and often more potent buds. Unless Health Canada does more due diligence on how licence holders obtain their samples, and perhaps how labs conduct their testing, and demand continues to be driven by cannabinoid content, things likely won’t improve.”
When provinces go AWOL
There is some evidence that the market is moving, albeit slowly, beyond its obsession with THC. Consumers are becoming more sophisticated, and products are increasingly being tested – and marketed – with an understanding of the role of terpenes.
“As new products are coming online, licensed producers are including more terpene profiles,” says Heather Holmen, Communications Manager at the Alberta Gaming and Liquor Commission (AGLC). “And as the industry is growing and maturing, we’re seeing less of an emphasis on just THC levels and more on other cannabinoids.”
Nonetheless, when it comes to the market’s obsession with high THC, some provinces have a tendency to wash their hands of the matter, saying that they are simply responding to consumer demand. This, despite the fact that it is difficult to find cannabis flower at under 18% THC within the regulated market.
“We choose the products we carry based on a number of factors including value, potency, price, quality, and so forth,” says Viviana Zanocco, Manager, Corporate Communications and Stakeholder Relations, BC Liquor Distribution Branch. “We work hard to offer retailers a range of products that meet the needs of their patrons. Whether consumers like high potency or low potency products is something they determine, and retailers meet their needs.”
This comment somewhat obscures the fact that with cannabis, as with alcohol, provinces play a role in consumer education, given that they are responsible for the delivery of a regulated product. Importantly, cannabis differs from alcohol in that the profit motive is driving the demand for a more powerful product.
Some provincial bodies, such as the Ontario Cannabis Store (OCS), are willing to take more of a leadership role in both serving and educating the market.
“We always encourage consumers to ‘start low, go slow’ when it comes to THC levels,” says Joanna Hui, Communications Manager at the OCS. “We are also launching a Craft Designation program to highlight products from smaller-scale production sites that employ artisanal, handcrafted processes when producing dried cannabis and pre-roll products. So, it’s not only about THC levels.”
Certainly, having the provinces take a more active role – as is the case with the OCS, which is advocating for measures that would ensure more consistency in lab testing – would improve how cannabis is marketed to the consumer in Canada, while also easing some of the pressure on LPs and labs to deliver on high THC, often to the exclusion of other product characteristics.
Activation Laboratories was founded in 1987 by Dr. Eric Hoffman, a Canadian geochemist, and has since then expanded its footprint to include 17 labs in Canada and around the world.
Actlabs offers analytical testing services for many markets and industries including geochemical, materials testing, forensics, oil & gas exploration, environmental, Life Sciences, pharmaceuticals, agriculture, and as of mid-2019, cannabis. The cannabis testing services are offered out of their 200,000 sq ft. headquarters in Ancaster, Ontario.
Actlabs’ long history with analytical testing across these numerous industries gives them an advantage over other labs, says Dan Williams, the company’s business development manager.
As the cannabis industry evolves (3.0 and beyond) and products become more complex, the need for other testing regimes beyond just the Health Canada mandated tests will become apparent.
Dan Williams, Actlabs
“With their well-established divisions of agriculture and life sciences already serving agricultural, pharmaceutical and nutraceutical clients, there were many synergies, technologies and methodologies that Actlabs could leverage to quickly engage in the cannabis testing market,” says Williams.
With nearly 150 different labs authorized to conduct analytical testing under the Cannabis Act in Canada, Williams says labs like Actlabs have an advantage newer labs don’t have.
“There are many labs in Canada now licensed by Health Canada for cannabis analytical testing,” Williams explains. “However, a large number of them did not exist a few years ago and may be suffering a significant learning curve and the recruitment and retention of excellent analytical chemists.
“Similarly, there are many LPs and growers who were inexperienced with the required analytical chemistries and interpretation of testing results for the cannabis industry. Actlabs wanted to offer their clients not only the mandated testing but also the potential of much more in a knowledgeable, experienced, friendly and compliant environment.”
One challenge producers face when selecting a lab, he says, is that the lack of a cohesive cannabis standard for testing in Canada which means producers and labs can end up operating in a grey area in terms of methodology and interpreting or reporting results.
Actlabs established infrastructure, technology, and personnel, combined with business volume has allowed us to offer very fair market pricing for all services.
“Health Canada has specified the type of testing to be accomplished on cannabis and cannabis products, but there are no standardized, accredited methods or monographs to refer to. Instead, there are outcome-based regulations and guidelines and considerable anecdotal advice in the market. Thus, each lab has been left to fend for themselves which can lead to vague protocol in establishing and validating methods and inconsistent client experiences.”
Actlabs, on the other hand, he says, has been able to utilize over a decade of experience with very similar testing methods for related industries (such as pesticides, aflatoxins, heavy metals, microbial contaminants, etc.) to establish robust and validated methods, data interpretation and review techniques and easily understood reporting formats.
Williams says there are several key drivers for most cannabis testing clients: Compliant and knowledgeable testing, competitive and fair costing, and rapid turnaround when required. Actlabs can offer testing for growers of all sizes and shapes.
“Actlabs established infrastructure, technology, and personnel, combined with business volume has allowed us to offer very fair market pricing for all services,” says Williams. “From the larger LPs through start-up micros & processors to individual growers. All are treated equitably within a partnership attitude.
“For a batch or lot of product that requires all testing for a C of A Release, Actlabs targets a 5-7 business day delivery. However many clients often request a much more rapid turnaround on specific requests, such as potency or pesticides. These results are often required for harvest decisions, phenotyping decisions, or product labelling requirements, and so we offer a 1-2 business day turnaround for such requests.”
Beyond analytical testing, Williams says Actlabs is also looking forward to new types of cannabis productions and formulations, that can potentially have new and unique testing requirements. “With that in mind” he continues, “our Actlabs Ancaster headquarters facility is one of the most extensive and well-equipped privately-owned Contract Labs in Canada.
“As the cannabis industry evolves (3.0 and beyond) and products become more complex, the need for other testing regimes beyond just the Health Canada mandated tests will become apparent. This will be particularly true as cannabis research drives development into the clinical and pharmaceutical space. As a result, regulated development, research and investigations tied to product formulations, product development, customer complaints analyses, contaminant identification, etc. could be required. If and when it is, Actlabs is already equipped to assist with such requirements.”
For more information on Actabs, visit Actlabs.com or contact [email protected]
Pathogenia opened its doors in 2017, the vision of long-time analytical food safety expert Prasant Prusty who has over a quarter century of experience working in the lab industry.
Pathogenia started as a lab dedicated mostly to food safety testing but with capabilities for so much more. As the company’s reputation grew, it broadened its scope and started working in other spaces, testing other areas such as livestock and animal feed, environmental testing, pathogen testing in crops and plants and much more.
I think one of the largest issues the cannabis industry faces from the point of view of the LP in regards to testing is finding not just a lab that is accredited to test your products but more finding a ‘testing partner’.
When Bill C-45 was first introduced as an idea, Pathogenia recognized the emerging need for cannabis testing labs and began preparing. As soon as legislation was passed in 2018, they applied for their licence and adjusted their infrastructure to be able to engage testing of cannabis products.
“The need for cannabis testing labs started even before the legalisation of cannabis in 2018,” says Prusty, the company’s founder. “People started preparing for this back in 2016-17 when Bill C-45 was first introduced as just an idea. LPs and labs alike were standing by for the application procedure for licencing. As soon as it was passed in 2018, it was like the floodgates opened. We applied for the licencing immediately and began to adjust our infrastructure to be able to properly test cannabis products.”
In my experience, there is a requirement for… having experts like our staff available to interpret results and consult on any possible issues, such as results that are out of compliance.
Prusty says as more producers and labs enter the market, finding the right fit that works for both parties is key. Having a partnership with a lab who understands the regulations and understands the priorities of each individual producer they work with can be the difference between success and failure, especially when dealing with results that may show a batch or crop that is out of compliance.
“I think one of the largest issues the cannabis industry faces from the point of view of the LP in regards to testing is finding not just a lab that is accredited to test your products but more finding a ‘testing partner’. It’s not enough to just send your product out and receive CoAs and that’s it.
“In my experience, there is a requirement for follow up calls and having experts like our staff available to interpret results and consult on any possible issues such as results that are out of compliance. One of the most devastating things for an LP is to learn that there is an issue with their product and no one is willing to help find where the issue came from and how to fix it which is what we do for all of our customers. When I say “testing partner”, that’s what I mean.”
He also adds that Pathogenia strives to have one of the fastest turnaround times in the industry.
I like to say we are a one stop shop for anything cannabis testing related.
“One of our unique selling points is that we try to provide the best turnaround time, where other laboratories are not very flexible in the marketplace. This is a common complaint, that the lab can take two to three weeks to get the result, and that’s where we try to excel on our end.”
Another issue common to the industry Prusty says Pathogenia tries to address, is a fair price for that partnership. The “cannabis tax” many producers have become used to, with contractors or other partners sometimes charging much more than they would for non-cannabis industry clients, exists in the analytical cannabis testing lab side of things, too.
“Another issue is fair pricing,” continues Prusty. “I am finding a troubling trend in the cannabis industry is price gouging and not just for testing. Without going into detail, we think our prices are extremely competitive. One of the main pillars that Pathogenia was built on was to keep pricing as fair as possible. We do have our bottom line to worry about but Pathogenia is an extremely lean business with almost no unnecessary internal costs. We pass those savings on to our customers to provide them with quality service at a fair price.”
“I like to say we are a one stop shop for anything cannabis testing related. We can test for all Health Canada required tests for lot release as well as a number of qualitative tests for LPs to have more insight into their products. We test dried, fresh, edibles, topicals, oils and extracts. We also provide environmental monitoring of our customer’s facilities if need be which could include soil, fertilizer, water, packaging material, disease scanning etc.”
One important question for cannabis producers to ask, adds Prusty, is ensuring that the results they get from the lab partners are accurate.
“What we do on our end at Pathogenia is to make the results reliable and repeatable so that the variability of results are minimized. We also take the time to ensure we have verified our matrixes for various cannabis products, from fresh or dried cannabis to all the cannabis by products available, so that we have a solid baseline for every product we test.”
The Canadian cannabis industry – from LP to consumer – puts a heavy emphasis on THC levels in dried flower. But how accurate is the reporting? Cannabis flower, as an organic product, has fluctuating levels of cannabinoids across the plant. Ultimately, it’s critical that LPs send representative samples that reflect lot variability.
“We can only test what we’re given,” says Brad Gorski, Head of Laboratory at Zenalytic Laboratories in Kelowna, BC. “I am sure most growers will send the best product for testing purposes.”
That only makes sense – and isn’t necessarily duplicitous. But it means that the THC levels appearing on product labels, which are intended to help inform consumer decision-making, are not perfect.
Not all labs are created equal
Labs can also introduce variability.
“Chromatographs are highly accurate machines that need to be calibrated daily – and throughout the day,” says Ryan Lee, founder of Chemovar Corp. “It’s just like a Ferrari. But you can still drive a Ferrari into a wall.”
A proper lab will not only calibrate scales and pipettes, it will also use automatic dilution instruments that help to remove analyst technique bias. However, the calibration itself can be problematic.
“It is easy to adjust calibration to provide higher results,” says Daryl Patterson, Customer Service & Marketing Lead, Food & Pharma in A&L Canada Laboratories’ expanding cannabis division. “To ensure against this, at times it’s important to use two different comparison standards: one standard for calibration, and another as an instrument quality control check. Data analysis can also be affected depending on the analyst, or the software used.”
Practices also vary. Cryogenic grinding, for example, is one of the best methods to ensure against the loss of cannabinoid compounds, but it presents challenges when processing large sample sizes.
“The grinding and homogenization of flower samples, and how the sample is subsampled, tends to cause a lot of variability,” says Gorski. “Each lab also has an internal quality control that can vary.”
Unique challenges of dried flower
To remove even the perception of bias it can help to have third party validation, such as the ISO 9000 system, which can include random audits. However, even with the best lab practices, variables are introduced as result of lot variability. For THC, experts estimate that this is in the 3% to 4% range – and can sometimes be even higher.
“This means if you have a 20% lot, there will be a range from 18% to 22%,” says Patterson. “It makes it very hard to sell when the industry is using hard cut offs like 18% or 20% for purchasing.”
It might make more sense to sell products with a range of THC levels, or even to use colour codes. The problem is that cannabis was first legalized under a medical model, where both prescribed and over the counter medications require specific valuations.
“We’re dealing with a plant, yet treating flower like a formulated pharma product,” says Patterson. “It’s a problem that stems from the buyers or regulators only wanting to have one value for a flower lot. In my opinion, the industry should accept multiple THC results in order to realize the lots’ variability, and then average.”
While the obsession with cannabinoid levels can seem overdone, there are reasons beyond consumer preference for getting the numbers right.
“It’s a safety issue,” says Lee. “THC is psychoactive, and the regulator has to be looking out for the least experienced consumers. Not only is labelling THC important, but also for CBD, which is like grapefruit or grapefruit juice in that it can interfere with the metabolism of other drugs.”
Then there is the issue of ingestion. To eat or drink a cannabis product with a specific THC or CBD level is similar to taking any other medicine: the product is metabolized after it is ingested, with body weight and individual sensitivity determining the effect.
“There are issues with the stability of the product in dried flower,” says Moe Hararti, QA/QC Director at CannaLabs in London, ON. “All cannabinoids, including THC, will degrade over time. Dried flower products have a shelf life, but as time goes on the THC, as well as other cannabinoids levels, may not be representative.”
For its part, CannaLabs’ analytical methods are validated based on specificity, accuracy, precision, limit of detection/quantitation, robustness, and stability of sample and standard solutions. For example, to validate analytical methods for precision, CannaLabs will inject one sample six times to ensure injection precision repeatability.
Precision must also be ensured for sample preparation, and to this end CannaLabs prepares the same sample six times, and tests. It is critical that variation is under 2%, with the final number arrived at via a regression calculation. There are also rigorous assessments to ensure the robustness of the analytical method.
A stable product, safely delivered
The next challenge is to find a way to ensure that those results remain stable over time.
“A good approach would be to conduct stability tests,” says Dr. Harati. “Then you could have a label indicating that if a product was stored in ambient condition, a refrigerator or a freezer – at a specific temperature – it would be good for six or twelve months after production. Or, you could modify/optimize your final product, add a stabilizing agent, or do an excipient compatibility study. However, most smaller producers are farmers – they often don’t have the budget or the scientific background. For medicine, pharmaceutical regulations require expiry dates. But cannabis is not big pharma.”
The problem isn’t exclusive to dried flower. In any form, THC and CBD will degrade due to oxidation. The industry is working on ways to improve formulations to slow the process.
“My concern is that you can have a high THC in a finalized product, but it may not be delivered or absorbed by the body completely,” says Harati. “Of product with 18% THC, what percent is released and being absorbed effectively in your body? It comes down to how the finished product is formulated, its delivery mode, and the bioavailability of the materials.”
At present, cannabis preference is subjective, and based on a consumer’s familiarity. For the most part, this is a learned experience, and not based on scientific recommendations, as is the case with alcoholic beverages, where there are specific definitions of a “drink”, whether one is discussing beer, wine, or spirits.
“A 20% THC level for a gram of cannabis means 200 milligrams per gram,” says Lee from Chemovar Corp. “But how many milligrams are delivered in your bloodstream when you are smoking? It depends on how deeply you inhale, how long you hold it in, whether you are smoking with a pipe or a bong, even how loosely rolled a joint is.”
Ultimately, THC variation of one or two percentage points have a limited effect on a consumer’s experience – and final valuations themselves are often not perfectly accurate. Surely, there is a better way to produce and market cannabis.
Recent changes to Health Canada’s regulations for dried cannabis products have caused some compliance related concerns for some cultivators. StratCann spoke with several in the industry who say these changes, while potentially challenging, are nothing to fear.
The changes—first communicated in June 2019—represent a shift from treating all cannabis products the same when it came to allowance thresholds for things like microbial and chemical levels, to new limits depending on the intended use of the product, i.e. ingestion, inhalation, topical application.
Previously, Health Canada required cannabis products to meet those kinds of tolerance limits as defined as “herbal medicines”, an approach that gave companies flexibility in what types of standards they adhered to. A company could choose, for example, limits from the European Pharmacopeia where limits for things like bacteria and moulds were relatively high, in the thousands or tens of thousands of colony forming units (CFUs).
But in anticipation of new product categories that were introduced in October 2019 like edibles, topicals, and extracts, the regulator created new standards depending on the intended use of the products.
Because dried cannabis (or other extracts for smoking or vaporization) are intended for inhalation, they must meet the more strict requirements within their chosen pharmacopeia for the purpose of inhalation. This change represents a move from the thousands or tens of thousands of CFUs to the tens or hundreds of CFUs.
Because of this, some producers have expressed concerns that these new limits will make it more difficult to pass testing, or will force them to use remediation services like irradiation or e-beam sterilization.
This isn’t necessarily the case, though. Devin Sears, Director of Research & Development, Labs-Mart, an analytical testing lab that serves the cannabis industry says the issue ultimately comes down to each producer’s quality assurance standards and practices.
“For some producers the new micro limits may dramatically impact their operations, for others it may not,” says Sears. “It really depends on your methods of production and your quality assurance protocols.”
“If you’re a producer that’s concerned about the new microbial limits, the first step is to go back and look at your historical data to assess whether or not your products will be impacted. If your past test results indicate that your products are already below the new limits, then you may not need to make any adjustments.
“However, if the data indicates that your historical lots would not pass the new limits, then it’s imperative to consider where your operation may need to be updated. At the very least, your documented quality specifications, which outline the typical purity profile of each product matrix, will need to be updated to reflect the new requirements.”
Tairance Rutter, one of the founders of ANC Cannabis, an indoor micro cultivator in Alberta, says the new limits haven’t impacted them at all, although they did catch them by surprise. Although Rutter says he recalls seeing the announcement last year, keeping it on their radar over the last year of operating a new business wasn’t a priority. Still, even prior to the changes he says his products were already meeting the new standards.
“To be honest, we didn’t find out about the changes until the lab we used started testing us under those limits,” says Rutter. “Fortunately for us, we got tested the first time and passed on a full sweep, and then realized after we were being tested under the new limits. So it hasn’t affected us yet, but I can see it being a huge problem for a lot of people because it drops the limits incredibly low.”
“I think it got spun out of proportion,” he says. “Dropping from 10,000 CFUs to as low as maybe 100 CFUs for aerobic counts is a lot, but realistically we’ve been testing in the mid-double digits so we’re already passing anyway. I do see a big issue for maybe the outdoor and greenhouse growers, but there is remediation if needed. We don’t necessarily do it, but it’s something.”
Gord Nichols of North 40 Cannabis, another indoor micro based in Saskatchewan, also says he doesn’t see the changes affecting his operation.
No changes here unless we start failing,” says Nichols, who recently shared with his social media followers that he was temporarily halting his crops as he cleaned out to deal with a powder mildew issue, a very common problem for many cannabis growers. “So far it looks like we will still be okay as our levels will pass the new standards.”
Tom Ulanowski, the QAP at Nextleaf Labs, a BC-based cannabis extractor with several years experience in the cannabis industry, says that the steps a producer takes during production to ensure their product is clean and safe can help ensure they can pass their testing requirements.
“There is no explicit requirement for licence holders to irradiate cannabis products such as dried cannabis,” says Ulanowski. “If the producer’s sanitation and hygiene protocols, building design, climate controls, equipment, and overall processes can consistently ensure that microbial contamination is kept to a minimum, then gamma irradiation or electron beam sterilization is likely not required.”
“I think that cultivators, processors, and testing labs alike were likely aware of the coming changes, but were simply too busy to make the required changes ahead of time. Now that these changes are in force, some licence holders appear to be scrambling to ensure their products meet the new requirements. This has happened nearly every time the regulations governing the production and sale of cannabis in Canada have changed.”
Like Rutter at ANC, he says he can see this being more of an issue for outdoor and greenhouse growers, who have less of a chance to control the environment in which their crop grows.
“I believe that if sanitation standards are kept high, personnel adhere to strict sanitation and hygiene protocols, and adequate climate controls are in place, it may be possible to consistently produce dried cannabis without the need for sterilization,” continues Ulanoswki. “The use of approved pesticides can also help with controlling pests and disease, but there are a lot of growers that refuse to apply pesticides for a number of reasons. Micro cultivators may find that their smaller, purpose-built facilities are easier to clean – and keep clean over time – as compared to a large greenhouse.”
Sears, at Labs-Mart, agrees that the issue comes down to careful production practices.
“Producers should look for a laboratory they can partner with,” says Sears. “The lab you choose should be able to demonstrate that the services they provide can ensure your product quality meets these new standards. If you haven’t done so already, now is an important time to ask your lab three key questions; Have they validated or verified their methods are suitable for the specific cannabis matrices you’re testing?; Has the lab verified their ability to meet the new requirements in cannabis matrices?; and Does the laboratory have the appropriate staff to understand the changes in regulation and ensure the lab’s method remains suitable for use?”
Canada’s cannabis system currently lacks one standard testing methodology for producers and labs to follow.
While each licensed analytical testing lab in Canada must follow certain standards, the lack of a single, cohesive standard across the industry leads to a lot of problems, from product recalls, to lab shopping and inconsistent consumer experiences.
While other countries have a specific cannabis pharmacopeia or monograph to work from, says Jodi McDonald of Keystone Labs in Alberta, offering analytical testing for commercial and home growers, Canada does not. Each lab has to provide evidence of their own standards within their SOPs, as do producers, but without one agreed-upon approach, inconsistencies remain.
“We need to start with the basic piece of information, which is the monograph,” says McDonald. That’s the one big thing that is missing – there’s no monograph that says this is what safe, quality cannabis looks like.
“In Germany, they started with a monograph,” she continues. “In the Netherlands they started with the monograph, and then all the other things started to fall into place. Whereas in Canada we started with what test we wanted to do but there was no requirement that was clearly defined that says this passes and this fails.”
“Other countries and organizations have done the work. I think it’s simple enough to say we reviewed the German monograph for cannabis flower, for example, and say that’s the acceptable standard for Canada.”
Devin Sears, the Director of Research and Development for cannabis and natural health products at Labs-Mart, also in Alberta, says he thinks a unified approach would be helpful, but could also be a challenge for established labs who have already built a specific methodology.
“There are two potential approaches,” says Sears. “First, there’s the approach of a unified pharmacopoeia.. This issue with this avenue is that several labs have invested significant capital in equipment and resources to develop and validate their own methods. This may create some resistance within the industry to standardization, as it means labs will have to redeploy new methods, and verify those methods within their environments.
“Another approach is through rigorous PT testing (Proficiency Testing) and a certification program like ISO where labs would accredit the method they have developed and validated. And then, through the accreditation process and PT samples analysis, they can verify they are meeting a standard set by a regulatory body.”
Labs-Mart, like Keystone, is a GMP lab as well, says Sears, and is considering ISO accreditation within the next year or two for their cannabis methods. ISO, the International Organization for Standardization, is the world’s largest developer and publisher of voluntary international standards for an array of industries around the world.
“The real issue driving the whole industry right now is that Health Canada has mandatory testing where they have specific limits on certain analytics, but there’s no real standardization for how the methods are to be managed. It simply states that a validated method must be used. Unfortunately, there’s no means of really following up on that.”
As home growers continue to increase across Canada many are turning to Canada’s analytical testing labs to give them an understanding of what is in their cannabis.
From personal cannabis growers curious about how much THC or CBD they managed to coax from their plants, to those who want a detailed understanding of full cannabinoid and terpene profiles, along with heavy metal, pesticides and microbial testing, there are an array of labs offering these services. StratCann spoke with just a few below to get a sense of costs and services available.
Canvas Labs
One lab offering such services, Canvas Labs, in Vancouver, BC, says they see about half of their current business coming from either home growers or personal or designated medical growers, with the other half coming from commercial producers.
For those casual home growers, explains Jean-Michel Dentinger, a Manager at Canvas Labs, they can offer basic cannabinoid testing for as little as about $60, requiring only about one gram of dried cannabis. The cannabis can be mailed in a simple, airtight container through Canada Post, getting results back in about three days after the product arrives at the lab.
Although a larger sample can provide a better representation of a larger crop, Dentinger says many growers just want a basic idea of how much THC may be in their product. For those who are looking for a more accurate and representative testing result, they can then produce larger samples.
“If the grower is not too concerned about the consistency across their crop and they believe that just a small sample is representational of their whole batch, it really only takes about a gram of flower per test to run the analysis,” explains Dentinger. “(This) is in contrast with a LP who really needs to know the characteristics or potency of their crops across their operation.”
Demand is high, he says.
“It definitely seems to be something people like to use. We try to make it easy for individuals to access the service and make it affordable, because information is valuable and it’s good for them to know what they’re doing and improve.”
Keystone Labs
Keystone Labs, in Alberta, is another lab offering testing services for commercial and home growers. Keystone has been offering analytical testing services for cannabis since 2015, even developing a specialized Keybox service for home growers, focussing at the time on the personal and designated medical growers, and now offering those services for non medical growers, as well.
Keystone’s Keybox service for about $170, providing analyses for an array of cannabinoids and terpenes, with a small amount of cannabis required, which can be partially prepared by the home grower before sending it in for analysis. For growers only interested in THC and CBD levels, they offer a similar test for about $125, that requires about three grams of cannabis.
Whereas the Keybox gives a wider array of results and gives the grower more control over the sample preparation, growers who are just looking for their THC and CBD levels and don’t want to bother with preparing their own sample can just send in a few grams via Canada Post.
“Patient or home growers can get their home grown bud tested with us a couple of different ways,” says Stephanie Ostrander, an Account Manager at Keystone Labs. “We will definitely point them to the Keybox website, and that gives you analysis for ten cannabinoids and thirty terpenes. And that bang for the buck is probably the best one. Then the next option is to just send your bud to us so that you don’t have to do the sample preparation.”
Turnaround, says Ostrander, is about a week, depending on what they are testing for and the sample size. For additional tests such as microbials, the test is around $155, heavy metals about $100, and pesticides can be upwards of $800, and can require a much larger sample size.
Pathogenia
A third lab offering these services for home growers, Pathogenia Inc. in Quebec, says they have seen a real increase lately in requests from home growers, either looking for services, or simply trying to better understand how the process works and what types of equipment is used to get these results.
Prasant Prusty, the company’s co-founder, says the bulk of their business is currently commercial growers, but that he routinely fields calls from home growers, as well. Like Keystone and Canvas, they require only a few grams of cannabis for each test, and Prusty says he’s happy to answer any questions anyone might have.
“We are always happy to answer those questions for the home growers, and happy to share our methods and how the testing works,” says Prusty. “We really want to make a difference in the testing domain, and feel we can really help home growers not only with testing results, but with understanding the process and methods we use and why.”
Basic THC and CBD testing is about $150 and requires about three grams of cannabis, he says, although he points out the larger the sample the more representative and accurate the results will be. Like the other labs, clients can log into an online platform to read their results in about a weeks’ time, depending on the size and scope of their request. A pesticide array is around $300, testing for microbials around $150 and heavy metals around $100.
“If you’re looking for a certificate of analysis, we’re not that kind of lab” explains Prusty. “But if you’re looking for what’s there, we are the kind of lab who can help you make sure that you understand what you are looking for.”
Lab-shopping is the practice of seeking out favourable testing results from an array of analytical testing labs, rather than working with a lab exclusively, and can damage a company’s reputation and brand. Janeen Davis, Director of Business Development and Client Services with BC Craft Supply Co., who works with several different licensed producers to help get products to market, says it’s something she is seeing more examples of as producers try to reach market.
This is a dangerous game to play with little or no liability for the lab, but massive risk of recall for the cultivator.
Janeen Davis, BC Craft Suply Co.
“I have witnessed many cultivators sending their samples to multiple analytical testing labs to gauge what their THC results are,” says Davis. “These cultivators tend to decide to use the lab that gives them the “best” or highest THC results. They also are using multiple labs to gauge turn around time so that they can avoid old or aging product going to market. Some labs take 2 or more weeks to process a full suite of compliance testing versus others taking only 4 business days.”
“I think other operators are looking for “friendly labs”, continues Davis. “Cultivators have reported that certain labs have offered them inflated THC results or even to pass non compliant lots on a second round of tests. This is a dangerous game to play with little or no liability for the lab, but massive risk of recall for the cultivator.”
Devin Sears, Director Research and Development at Labs-Mart Inc, an analytical testing lab, says the risk for the cultivator in taking this approach can be severe.
“Lab shopping is technically against the law – as per the GPP, a cultivator should have a quality system in place,” explains Sears. “ A component of that quality system is the qualification of vendors, which includes your laboratories. A good vendor qualification program should also address how many “complaints” you make to your lab regarding their results. Once a threshold number of complaints have been made the labs qualification status should be reviewed. This could also mean that an audit of the laboratory is required.”
Despite this, Sears says it’s a practice he suspects many may be engaging in in order to ensure their product gets the full potential value when being sold to a provincial distributor. The difference between the wholesale price for a product just under 20% and just over it, can be significant.
We need to dry the material to do the analysis, but we need to account for that water weight, so if a lab is drying the material prior to homogenization, they should be back correcting their results to account for the water that’s taken out during the drying and testing.
Devin Sears, Labs-MART Inc.
One of the easiest approaches, explains Sears, is to over-dry the product prior to testing.
“The most obvious thing is to dry the sample,” says Sears. “As you dry it, you’re taking water out of the sample, and then when you analyze it, because that water mass is no longer there, the percentage of THC will go up. So that’s the easiest and quickest way to do it.”
Although all labs have to dry the product before testing, he says, reputable labs factor in the water loss when calculating cannabinoid levels, but some may find ways around this.
“We need to dry the material to do the analysis, but we need to account for that water weight, so if a lab is drying the material prior to homogenization, they should be back correcting their results to account for the water that’s taken out during the drying and testing. And that’s what we do here at Labs-Mart.”
It comes down to how one runs their business, and whether both the lab and the cannabis producer are looking at building a good reputation in this new industry, or just looking to make a quick buck.
“The real issue right now is that Health Canada requires testing and they have limits on certain analytics, but there’s no standardization for the management of methods. The Cannabis Act simply states the lab must use a validated method. But there’s no means of really following up on that, which is what’s ultimately creating the opportunity for this type of lab shopping” “At Labs-Mart, we are a GMP facility and have a Health Canada establishment license, but we are also seeking to get ISO accreditation within the next year or two for our cannabis methods, says Sears.
“We feel that having both provides the greatest degree of certainty to our clients that our methods are appropriate for use. It demonstrates that we have undertaken the necessary steps to ensure our methods are validated and will work on our client’s products, and that ultimately the data we provide them is reliable and accurate.
Davis says she knows the issue is not all producers or all labs, and sees the issue being frustrating for those analytical testing labs who play by the rules.
I think we need the analytical lab space to have the same scrutiny from Health Canada that cultivators receive.
Devin Sears, Labs-Mart Inc.
“Labs that I have spoken to that are accurately reporting results, have become frustrated by the lab shopping occurring in the industry,” says Davis. “Their clients are comparing their results to labs that give inflated THC results and the clients are going with the latter, because it results in higher revenue. The consumers are the ones who suffer in this situation.”
Health Canada requires producers to provide testing results for every product they sell, as well as keep representative samples of each product batch for secondary testing. There are a few examples of recalls of products based on inaccurate THC or CBD levels, for example.
In addition, earlier this year, several cannabis producers found themselves facing a multi-million dollar class-action lawsuit over claims that the cannabinoid levels of their products were “drastically different” than advertised. The cost of a recall for a producer can be significant.
The whole point of legal cannabis is to have products that pass rigorous testing, with the results accurately reported.
Janeen Davis, Director of Business Development and Client Services with BC Craft Supply Co.
Davis says she sees some of the responsibility lying with the regulator, who currently isn’t prioritizing oversight or testing of analytical labs offering testing services for cannabis.
“These labs are the guardians of consumer safety,” says Davis. “I think we need the analytical lab space to have the same scrutiny from Health Canada that cultivators receive. Labs should have the same level of audits and accountability that producers suffer. There should be regular ring testing of products to ensure that it is both safe for the consumers and accurately labeled. The whole point of legal cannabis is to have products that pass rigorous testing, with the results accurately reported.
‘Without this consumers might as well be purchasing from the illicit market, it becomes a public safety issue. Independent, random testing of products by Health Canada would discourage producers from trying to game their COA by lab shopping or attempting to get an otherwise non-compliant lot to market.”
The Canadian cannabis market puts an emphasis on THC levels, with a heavy bias toward flower that’s 20% THC, or higher. As a result, many quality products are denied access to the supply chain, and the consumer is being underserved.
“I think this is a direct result of not understanding the importance of the role the broker played in the illicit market,” says Jamie Shaw, a director of the BC Independent Cannabis Association, and an advisor to the National Institute for Cannabis Health and Legalization (NICHE). “Provinces that decided to become brokers typically tend to try and treat it like alcohol, so THC percentage as a marker makes sense to them. The problem is that the broker’s job is even more important when retailers are buying flower sight unseen.”
Provinces that decided to become brokers typically tend to try and treat it like alcohol, so THC percentage as a marker makes sense to them.
Jamie Shaw, BC Independent Cannabis Association & NICHE
Given that the challenge is systemic, it’s fair to say that the market’s emphasis on high-THC cannabis has no single culprit. That said, it is also true that there’s been a lack of leadership among critical stakeholders, in part because there’s little motivation to change. Licensed providers (LPs) get a better price for more potent flower, labs are pressured to deliver results, and the entire marketing chain – from cultivator, to provincial regulator, to budtender – builds incentives around potency.
“Part of the challenge involves the complexity of the product, which has only been legal for a few years,” says Cheri Mara, Chief Commercial Officer, Ontario Cannabis Store (OCS). “The market is still maturing. If you look at the early days after alcohol prohibition, the government was selling bottles in brown bags from behind a counter.”
I expect that cannabis will become more like wine, with products known according to factors such as geographical origin and breeder information.
Cheri Mara, CCO, Ontario Cannabis Store
The OCS, like other regulatory agencies, markets Cannabis according to simple identifiers such as Indica, Sativa, or Hybrid – distinctions that are of limited meaning – as well as THC levels. However, this narrow emphasis is likely to change as LPs respond to more sophisticated consumer demand, and embrace more complex marketing strategies.
“In the early days, THC potency was easy to communicate,” says Mara. “In the future I would like to see terpene percentages, too – for me as a consumer that’s more important than THC. The OCS has a role to play in communicating that, by working with industry and partners. In effect, I expect that cannabis will become more like wine, with products known according to factors such as geographical origin and breeder information.”
It’s good news that the OCS – Canada’s largest cannabis online retailer and wholesaler of recreational cannabis – wants to provide more detailed information to consumers. However, at present the market across Canada is held captive to a near-obsession with THC levels. That’s hard to break, particularly given the financial incentives.
“We are absolutely caught in that loop,” says Shaw. “I’ve seen some amazing flower that ultimately didn’t get picked up due to fear the provinces wouldn’t like the THC level. It also isn’t helped by less educated consumers trying to get the most bang for their buck.”
Some micros, and a few independent advocates, are willing to push for a more sophisticated understanding of cannabis, but it’s been an uphill battle. The reasons are obvious enough: if LPs, labs, and governments are making money with a simplistic, THC-based value model, then there isn’t much incentive to change.
“Buying cannabis based purely on the THC percentage is like buying alcohol purely for the highest alcohol content,” says Nick Jikomes, PhD, Director of Science & Innovation at Leafly. “When I buy alcohol, I don’t purchase pure ethanol and buy the jug. I buy beer or wine that tastes good to me, from brands that I know and trust. Likewise, when I buy cannabis, I don’t buy pure distillate with 99% THC content.”
It’s actually created a serious problem in the industry: many products are tested at labs producing inflated THC results
Nick Jikomes, Director aof Science & Innovation, Leafly
THC and other compounds can produce different effects based on the strength and dose, as well as the receptivity and tolerance of individual consumers. For Jikomes, this speaks to the importance of consistency, and of a marketing message that moves past THC levels to include terpenes. (Leafly has a cannabis guide that colour-codes the various terpenes.)
“Cannabis flower that tests below 20% is harder for retailers to sell, and it’s almost always cheaper than flower labelled above 20%,” says Jikomes. “But there’s lots of absolutely fire stuff out there that tests under 20% THC. Look for buds with lots of frosty trichomes. I often find great flower in the bargain bin of dispensaries this way.”
As it stands, the emphasis on THC levels is distorting the market. High quality cannabis that might have 15% THC can be completely ignored. As a result, the consumer is being denied access to effective products – many of which deliver an excellent experience – based on a narrow emphasis on THC.
This overwhelming desire for high THC prompts companies to produce high THC products as a way to meet the consumers’ wants — thus reinforcing the consumers’ understanding that high THC products are quality. It’s a vicious cycle.
Tianna Wait, Founder of Cannalytics Research
“It’s actually created a serious problem in the industry: many products are tested at labs producing inflated THC results,” says Jikomes. “So, if you buy some flower that is labelled as 25% THC, it might not actually be 25%. It could be much lower. Same for CBD products.”
An understanding of the role of various cannabinoids can result in a sophisticated consumer making purchasing decisions based on aroma and flavour, as much as raw potency. But despite all this, we still have a market that’s heavily distorted by an emphasis on THC levels at 20% or above.
“Though the industry has matured – and research has revealed new insights on cannabis compounds like terpenoids and flavonoids, and how they interact with one another – consumers are already accustomed to looking for high THC labels,” says Tianna Wait, founder of Cannalytics Research. “This overwhelming desire for high THC prompts companies to produce high THC products as a way to meet the consumers’ wants — thus reinforcing the consumers’ understanding that high THC products are quality. It’s a vicious cycle.”
How to break this cycle? Provincial and territorial governments have a role to play, but they tend to be market followers, and not leaders. Labs, positioned in the middle of the supply chain, tend to respond to market demands, and not drive them, though some are more closely involved in product development.
Real change, it seems, will come from those stakeholders at either end of the supply chain: cultivators, many of them micros, who care about delivering quality cannabis; and consumers, who demand more sophisticated products.
“As the consumer becomes more educated, we can introduce complexity,” says Mara from the OCS. “I believe that with cannabis we will be having increasingly meaningful conversations around product differentiation – much as we talk about wine now.”
Cannabis consumers are often attracted to specific, so-called “strains” of cannabis flower, with the name becoming the brand. That’s great – except that there’s a serious lack of consistency, and no regulatory framework to establish a reliable taxonomy.
“The cannabis industry is full of misinformation,” says Geoff White, the CEO and Founder of both ProgenyBio Agricultural Services Inc. and CanGenX BioTech Inc. “The terms ‘strain’, ‘indica’, and ‘sativa’ are prime examples of this. I’m from the general agricultural perspective that ‘cultivar’ or ‘variety’ are more applicable, especially since cannabis is now in the realm of agricultural commodities.”
White has a well-informed perspective, given that ProgenyBio holds the licensing, and the facility, for which CanGenX BioTech’s technologies are developed and commercialized. He notes that some in the industry feel that ‘chemovar’ would be a better term than strain; however, as a new term chemovar might not get the traction of cultivar or variety, which are already familiar terms.
The problem isn’t trivial. Dried flower sold as a single product variety name can sometimes have inconsistencies. Tests of product sold in Canada, conducted by Richmond, BC-headquartered Segra International Corp., have found examples of differing genotypes – and on occasion genotypes that were not near neighbours. In fact, Dr. John Brunstein, Segra’s Chief Scientific Officer, has pointed out that some products sold in Canada are “nowhere close” to identically branded varieties.
Another 2017 study in Canada (Vancouver and Toronto), and in the United States (Washington State, Oregon, and Colorado), found 2,739 cannabis items under 1,263 names. Of those, nine represented 10% of the total, with 845 used only once. It’s unlikely that all of those 845 products represented unique strains.
“I believe that strain inconsistency is a very big problem,” says White. “All other agricultural crops require registered certified starting material to ensure the consumer receives a consistent product. The cannabis industry needs to look to well established agricultural practises and associations such as the Canadian Seed Growers Association (CGSA).”
The CGSA is the only Canadian organization that monitors and certifies pedigreed seed for all agricultural crops in the country (with the exception of potatoes). Having an organization like this on side would go a long way to ensuring credibility – but the market isn’t there yet.
“Currently, licensed producers of cannabis probably don’t see any value in the services that CSGA brings to the agriculture sector,” says Michael Scheffel, Managing Director, Policy and Standards for the CSGA in Ottawa. “The CSGA provides varietal (genetic) identity and varietal purity certification services, which is very important when selling a product, process or service into a crowded marketplace with many similar offerings. It’s perhaps less important within a vertically integrated operation.”
The majority of breeding efforts in the past have been focused only on a few key traits such as yield and THC concentration. The more genetics we have available, the greater likelihood in finding the traits we are looking for. Lesser known cannabinoids, interesting terpene profiles, pest and disease resistance, as well as faster cropping times are some of the things we’re looking at in our breeding program.
Geoff White, CEO & Founder of ProgenyBio & CanGenX
Risks in inaccurate naming
The costs associated with inaccurate naming for commercial growers include brand risk, and an uneven customer experience. On the medical side, the problems are potentially more serious, given the need for accurate variety and titration to ensure correct dosage within the therapeutic window. And then, of course, there is seller liability.
In the long run, strain inconsistencies also negatively affect medical research and breeding programs. At some point, something will have to give. The CGSA might have a role here.
“In the future, some cannabis companies may see the value of independent, third party certification of their genetics if selling to other LPs, or to the public,” says Scheffel. “We will gain a lot of experience with feminized hemp seed production over the next few years, and would be well placed to provide seed or plant varietal certification services to the cannabis sector in the future.”
For now, the market is reliant on private companies to shed light – and perhaps even to help fix – the problem. When looking at traits, there is clearly a lot of room to grow in terms of having more robust strain identification.
“The diversity of our genetic index is very important for our uses,” says White. “The majority of breeding efforts in the past have been focused only on a few key traits such as yield and THC concentration. The more genetics we have available, the greater likelihood in finding the traits we are looking for. Lesser known cannabinoids, interesting terpene profiles, pest and disease resistance, as well as faster cropping times are some of the things we’re looking at in our breeding program.”
Getting a handle on cannabis can be a more complex task than cultivating – and naming – other agricultural products like hops. As well, the number of characteristics being assessed can include a cultural response: at some point, a variety has to be accepted according to identifiable traits, even if there are some superficial differences. For that, however, we would need an authorizing body – something like a breeders’ organization – to assess which common phenotypic traits are relevant.
We already see this in ornamental flowers, which come in many colours, and even in animal breeds – it’s been determined, for example, that a Dalmatian is still a Dalmatian, whether its spots are black or liver-coloured. That said, there is still a lot of work to do.
“Without any prior experience with this sort of seed production, it’s been a challenge to fully understand and address various risks that could impact the quality of the final product,” says Scheffel from the CGSA. “Strict isolation requirements to prevent contaminating pollen, sanitation regimes for greenhouses, record keeping and plant breeder quality management systems are some of the ways that we plan to mitigate risks.”
A few things are certain. Given that the term strain refers to microorganisms, the market is likely on safer footing using variety or cultivar as descriptors. As well, DNA fingerprinting tests such as those used by Segra International can be reliable and robust, utilizing small data sets – they’re easily analyzed for identity and relatedness.
This means that the era of arbitrary naming may be coming to a close. Whether the final arbiter is the CGSA or a consortium of certified private labs, it seems all but certain that the wild west we live in now, where multiple names can be applied to one clone, may be coming to an end soon.
Cannabis vape pens are a relatively new and increasingly popular product on the market, but much about their health and safety remains relatively unknown due to a lack of product testing and consumer knowledge of those products.
Although these products are often perceived as not only more convenient from a consumer perspective, but safer, one expert on vape pen testing says there is much more to the story that products and consumers need to be more aware of.
Labstat International, an analytical testing lab for cannabis, has decades of experience testing similar products in the tobacco space and is now offering similar testing for the cannabis industry. In 2005, under a contract with Health Canada, Labstat became actively involved with cannabis testing by performing comparisons of the smoke produced from cannabis and tobacco cigarettes. In 2018, Labstat began offering cannabis testing services by transitioning their controlled substance license to an Analytical Testing license under the Cannabis Act.
When you’re consuming via a joint, a vapour product, or a heat-not-burn product, your deliveries are going to be dependent on a combination of parameters
Peter Joza, CTO at Labstat International
Peter Joza, the Chief Technical Officer at Labstat, says the company has created their own testing protocols for inhalable cannabis products like vape pens and pre-rolls, evolving from their work over the past several decades with similar tobacco products. He says he sees many parallels not only in the testing procedures, but in the evolution of these products and how product innovation can often move faster than the health and safety frameworks that seek to regulate them.
Evolution of product testing
“We’ve always been involved with what we call aerosol, and vapour testing. Labstat began heated product aerosol testing in the mid-90’s and vapourizer testing with electronic cigarettes in roughly 2008″, explains Joza. “Labstat came out as an offshoot from the University of Waterloo when they were testing tobacco and tobacco smoke. When we moved off campus in 1976, we were strictly doing work for Health Canada related to tobacco.”
“Our vape pen testing is a progression from the tobacco and nicotine device testing we’ve pioneered. We saw the tobacco industry progress from cigarettes or combustibles to new generation products, like heat-not-burn devices and vape pens.
“You see the same transition happening within the cannabis space as the industry has progressed from whole flower pre-rolls to more elaborate delivery systems like vape pens. Labstat currently focuses on all modes of delivery, but Joza says the biggest demand is currently for vape pens rather than combustible products like dried flower or pre-rolls, although they do offer all processes for licenced producers to better understand and address potential safety concerns. There is some interest from a few companies looking at different filter types on pre-roll products, he says, but most of the interest from producers at this point is for extract-based vape pens.
In order to properly test these different products, Joza says Labstat looks at several variables to give an accurate overview of potential consumer consumption behaviours.
Smoking Machine for cannabis pre rolls
A less harmful product?
“When you’re consuming via a joint, a vapour product, or a heat-not-burn product, your deliveries are going to be dependent on a combination of parameters,” he explains. “How deep of a draw you’re taking, the puff duration, the puff frequency, along with the device itself all become factors. For example, how long is it between each puff, and how long is the puff itself? During our testing protocols, these parameters are all controlled by machines so we can generate a consistent puff volume for a consistent duration and a consistent frequency.”
Generating less compounds is likely less harmful, but I wouldn’t use the term ‘safe’.
By refining their equipment and processes, he says, and their decades of experience in the tobacco space, it helps them to look not only at what type of solution is in the vape pens themselves, but also what happens to that solution when it is heated in a vape pen and then aerosolized, before arriving at a consumers lungs.
Because most vape pens on the market don’t provide an opportunity for a standard mode of inhalation, along with accurate temperature controls, consumers are potentially inhaling unknown and unlabeled byproducts that could have negative health impacts over time.
Although he’s careful to note that vaporization is potentially less harmful than combustion, it’s important for consumers to understand that “less harmful” doesn’t necessarily mean safe.
The only driver right now is what I would call good product stewardship.
“When you burn anything; tobacco, cannabis, paper, wood, etc., it generates smoke that predominantly consists of similar by-products from the combustion and pyrolysis processes of these materials. Depending on which literature you believe, you’re generating anywhere from 4,500 to 7,600 (or more), different compounds. If you are simply heating the material, you are generating less compounds (in number and concentration) from these materials. Generating less compounds is likely less harmful, but I wouldn’t use the term ‘safe’.
Since there are currently few regulations around these kinds of testing requirements, Joza says all of Labstat’s work is producer-driven, meaning the companies who are approaching them, are taking the extra steps to identify and address potential safety concerns.”
Good product stewardship
“Right now, in the cannabis industry, there really isn’t any regulatory driver for the vapour analysis,” says Joza. “The only driver right now is what I would call good product stewardship, which comes from asking yourself: Do I know what I am selling and how it is delivering? Am I selling a consistent product?”
One of the challenges, he says, especially for smaller companies looking to compete in the vape pen market, is that product testing for cannabis vape pens can be very costly because of the nature of the product itself, unlike more common and more affordable tobacco vaping products.
“It can be a costly endeavor to take on the depth of testing we recommend for vape pens. For example, when we’re looking at say a nicotine delivery system and its a prefilled pod, those pods from a manufacturing standpoint may have a $2-$3 value on them and you’d need to test multiple pods for each independent test in order to get good, relevant statistical data because the devices themselves can still be extremely variable in their delivery.
“When you’re talking about a cannabis product, the value of the cannabis oil or liquid in that product is considerably higher. So doing, say, seven replicates across seven tests requires 49 replicates and from the inventory these producers are supplying for testing that really takes away from what’s available to be sold on the shelf. I think everyone at this point in time in the cannabis market is under pressure to generate revenue.”
With producers now using a variety of liquid formulations, it’s critical to not only test the liquid and the device separately, but to also harmonize the liquid to the device.
Product innovation moving faster than safety testing
One of the issues he’s seen that is parallel to that of similar products in the tobacco space, says Joza, is consumer perception and behaviors with these products. Although the tobacco industry has had many years to refine their vape oil formulations, cannabis companies are only just starting that process, and often trying to create new, unique formulations to distinguish themselves from the tobacco industry.
There’s the perception that as long as I’m putting in a natural extract and cutting it with other natural extracts, that it’s good because it’s all natural. That may not necessarily be true.
“There are some things that I feel are incredibly important in understanding these devices,” says Joza. “We often see a device that may have been designed for use as a nicotine delivery system and now the client is considering a very similar device design for a cannabis product. With producers now using a variety of liquid formulations, it’s critical to not only test the liquid and the device separately, but to also harmonize the liquid to the device.
“Some devices work very well with a thin or less viscous liquid, while if you put that less viscous liquid in other devices it will leak out. You need to have really good harmonization between the device and the liquid, and I think a lot of people are still trying to figure that out.
“Consumers use various types of devices differently. For example, some will take what’s called the short ‘mouth puff’ and others will take a very deep, large volume-long duration ‘lung puff’.” I think it’s really a matter of good product stewardship for the manufacturer or the licensed producer to understand who they’re marketing to. For instance, you’re not going to drink a bottle of Jack Daniels the same way you would drink a can of Bud Light. You’re going to have different concentrations of the intoxicants that are consumed differently.”
Joza, with a Bachelors of Science in Chemistry from McMaster University, says he thinks concerns with negative health implications associated with electronic nicotine delivery systems (ENDS) using vegetable glycerin (VG) and propylene glycol (PG), have moved people to select more “natural” products like terpenes in their cannabis vaporizer This can potentially give consumers a false sense of ‘safety’ and lead to producers experimenting with new ingredients that have little product testing when it comes to use for inhalation.
“There’s the perception that as long as I’m putting in a natural extract and cutting it with other natural extracts, that it’s good because it’s all natural.
“That may not necessarily be true. It’s a matter of whether the liquid is harmonized or working well with the device that is producing the vapour. If you’re overheating some of these extracts , there’s the concern that other potentially harmful compounds or by-products are being generated. So producers are actively considering different carriers for carrying the cannabinoids through the aerosol. In the nicotine world they focus primarily on using vegetable glycerin and propylene glycol. Their devices are a little more mature in being able to handle a relatively consistent matrix.”
“I think the cannabis world really tries to differentiate itself from the nicoine world by avoiding the use of vegetable glycerin and propylene glycol, so many of the producers are looking for new options.”
He says this process is in part what led to some black market vape pens last year, primarily in the US, utilizing things like Vitamin E acetate as a vehicle oil or thinning agent as they tried to get away from vegetable glycerine and propylene glycol and the reputation for having negative health effects. Increasingly, he says, some manufactures are using added terpenes to serve this same purpose which consumers may see as a safe alternative since terpenes naturally occur in cannabis, although in much smaller concentrations.
“I’ve been in the lab business for at least thirty years now, and things are changing faster and faster. What seems to have taken forty years for regulation to creep into the tobacco industry, I see happening at a much steeper rate of change in the cannabis industry.”
Ultimately, until there are regulations in place to require testing these kinds of products, Joza says it’s up to product manufacturers to take it upon themselves to address safety concerns for their consumers.
There will be some variation between the vapour you inhale in the first five puffs of using the device and the vapour you inhale during than the last five puffs of the devices. Especially if the device is designed to last you 100 puffs.
“There are two specific trains of thought that people are looking at. From one angle you can consider the vapour testing as an important part of good product stewardship. If you’re going to claim to have a gold standard product you must ensure that product is consistent. Meaning, if a consumer buys that product in March and goes back in April for more, they are ensured to get the same experience every time. That’s good product stewardship. The other consideration is whether or not the product is delivering what it’s supposed to deliver and not delivering what we don’t want it to deliver.”
Product standardization
“In the nicotine world they have gravitated to a few standard products and approaches, like PG and VG, so it’s easier to standardize how it works in various devices. With cannabis you’ve got a lot of unknowns. Especially if your liquid does not harmonize with your device, and you increase the probability of the atomizer itself overheating and creating undesirable compounds.
“When we’re talking about vaporizing, the aerosol that is generated from the vaporizer should simply be a distillate of the liquid that is in the pen. That’s the ideal world. In reality, that is not always the case.
“Your primary constituents coming through the vapour may be just a distillate. However, the more complex your liquid solution is the compounds you’ll have distilling, breaking down and sometimes concentrating at different rates.. In some cases, you may have compounds that because they are so heavy, they will concentrate themselves in the liquid and not even get transferred into the vapour. So you’re not necessarily even getting what you want from them, and maybe even getting some things that you don’t want.”
“What we’ve seen with the nicotine industry is that they’ve tried to simplify their solutions as much as possible so they have a better understanding of what’s distilling into the vapour. I think in the cannabis world right now the solutions are potentially much more complex..
“You’ve got so many different cannabinoids and terpenes in these formulations, some in higher concentrations than others, it’s a very complex mixture. There will be some variation between the vapour you inhale in the first five puffs of using the device and the vapour you inhale during than the last five puffs of the devices. Especially if the device is designed to last you 100 puffs.”
The cannabis industry has many vital players, yet people are often unaware of how growers, processors, and labs work together to build strong brands. As the market matures, partnerships remain critical for brand development, with labs often playing a central role.
“At CannaLabs we help clients with full development services,” says Michael O’Reilly, CEO of CannaLabs in London, ON. “We can help cultivators not only by testing their products for Health Canada compliance, but we can also work with these customers during the growing phase to test potency and pesticides.”
A company like CannaLabs can take a customer through proof of concept, to pre-formulation and optimizing current formulations for higher bioavailability – all the way to longer shelf life, if desired. The company will also help with developing and validating analytical test methods based on a variety of guidelines, from International Council for Harmonisation (ICH), to the Federal Drug Administration (FDA), and European Union regulations.
This speaks to the size and diversity of the market; and for a lab to thrive, it has to keep track of where its customers are going.
“We’re very excited to be working with a number of customers who are developing new products from edibles to topicals, and even a company looking at topical for animals,” says O’Reilly. “Over the last 12 months I’ve had discussions with breweries, large and small, in Canada and the USA.”
This is a quickly-changing market, and cultivators have little patience with labs that can’t keep up. At least one micro-cultivator has been left in the lurch by a lab, and has decided that the best move will be to work directly with a processor, and to let them assume the responsibility for testing.
“We chose a lab based on geography,” says Katy Connelly, co-owner of Sea Dog Farm in Saanichton, BC. “That was a bad choice, and a large waste of money. With Covid-19 we wanted to support a local business, as they were only ten minutes away, but they were unable – or unwilling – to give us the services we needed.”
The challenge faced by Connelly was that the lab was stuck in a fixed business model, and expected her to have the ability to evaluate test results.
“Our lab didn’t understand us as a micro,” she says. “We were their first micro, and they assumed all the rules were the same, that we would have someone on staff to read those lab reports. I thought: ‘This is crazy, I have no time for this.’”
There are labs across Canada producing reports that cultivators can read. However, for micros this step may not be necessary, given that it’s ultimately the processor’s responsibility to test for Health Canada, not the grower. For many micros, then, the challenge is to develop a strong, trusting relationship with a processor.
“Right now, I have no relationship with a lab at all,” says Connelly. “I’ve found a processor that won’t test it until it comes out the other end. I don’t want to go and find a new relationship with a new buyer for every crop.”
But that isn’t always possible – even for a micro. Many processors won’t commit to taking an entire crop, as one might focus on oil, another on flower. And though in-house testing has appeal, that might be an onerous and unnecessary expense for a smaller company given that, at the end of the day, the processor still has to test.
Which is to say: the product is going to hit a lab, sooner or later. And in order for that lab to be effective – whether working with a cultivator or a processor – it must adapt.
“If a client is new to the cannabis industry, or an expert, we will alter our services’ package to meet their needs, whether that’s requiring regulatory expertise, or licensing navigation, or help in creating a formulation for a specific use,” says Brishna Kamal, founder of Whistler Therapeutics in Whistler, BC. “Clients can be just curious individuals with funds wanting to get into the market, and doing their research, or they’re ‘experts’ who want to create specific products, acquire specific licenses, or create new processes.”
This level of flexibility can be offered by labs big and small. It is critical for cultivators who are willing to invest in a partnership that can contribute to brand development – and a stronger footing with processors.
“By working closely with our customers, we can provide valuable information so the cultivators can make informed decisions based on science and data,” says O’Reilly from CannaLabs. “What today’s customer is looking for is quality product, and consistency with a strain.”
And where is the market going? O’Reilly from CannaLabs says that flower is still the highest grossing category, but that as the consumer becomes more educated – and as products become more plentiful and diverse – we’ll start seeing a shift from smoking and vaping to edibles. With regard to trends in edibles, chocolates seem to be the leader, though product development is in its infancy stages. More tasty product alternatives will be coming to market soon.
Organic is also a niche that shows promise. This is an area where Whistler Therapeutics sees real opportunity.
“Practically all solvent free extraction can be certified organic,” says Kamal from Whistler Therapeutics. “With certified organic processing we hope it will make more cultivators want to go the organic route. Regardless of the certification, many consumers prefer the taste, effect and smell of rosin over solvent products, so it seems the organic method may have other advantages.”
At the end of the day, the lab market is a competitive space. Focussing on the customer’s need – as appears to be the case with CannaLabs and Whistler Therapeutics – can make all the difference. Labs that don’t could find themselves in trouble.
“So many labs are trying, and putting out information for free,” says Connelly from Sea Dog Farm. “Many are asking: ‘What do micros need?’ And that’s fantastic. Why go with a lab that doesn’t do that?”
Tokyo Smoke confirms that they and their parent company, Canopy Growth, took steps recently to ensure that any vape pen products they are carrying in their stores do not contain any added phytol, pending results of a new study on the effects of the terpene.
First reported on StratCann in early August, Tokyo Smoke had sent out an email to vape pen manufacturers stating that Canopy will be placing immediate stop-orders on any vape products that list phytol as an ingredient and that the company will be following up with any vape pen manufacturers who list “terpenes” as in ingredient to determine if the terpene phytol is used.
Tokyo Smoke declined to note which of their suppliers vape pens contained the terpene phytol, citing a confidentiality agreement, but did note that the Dosist penn “Bliss” is publicly listed as containing phytol. Tokyo Smoke still lists other Dosist products on their website, but not the Bliss pen. Tokyo Smoke’s reply to StratCann is posted below:
“In order to ensure the safety of our consumers, Canopy Growth refrained from adding phytol to our vape cannabis products pending the receipt of study data from Lovelace Biomedical. Accordingly, none of Canopy Growth’s products contain added phytol.
“Canopy Growth took immediate action to examine all third party products sold in our stores, including by reaching out to our vape suppliers, all of whom are licensed under the Cannabis Act, to confirm which products contain added phytol. Products that contained added phytol were removed from shelves immediately.
“Because those are not Canopy Growth products, we would recommend that those who have questions or concerns should contact the manufacturers or contact Health Canada. The manufacturer’s contact information can be found on the vape cannabis product label.
“Canopy reached out to each of our third-party vape suppliers to determine whether their vaping products contain phytol as an additive. Our suppliers provided responses under confidentiality agreements, and so unless we are required to do so by Health Canada we are unable to disclose those responses without the consent of the suppliers. However, because this is public information, we can advise that the Dosist “Bliss” disposable vape pen lists phytol as an ingredient. We have no information as to concentrations or quantities of phytol in this device.
“We hope that more information will come out from manufacturers in the near future about which products do/do not contain phytol as an additive.”
StratCann has reached out to Dosist and several other vape pen manufacturers in Canada for comment, only one has provided comment so far.
A representative for Figr says the company did not receive such a letter from Tokyo Smoke, but confirms they do not use phytol in their products. .
“We do not use phytol in any of our cannabis products at Figr,” Alex Smith, VP of Product Strategy and Operations at Figr Brands, Inc. told StratCann via email on August 11. “Last week, we received a letter from Health Canada informing us of the recent research on this terpene and we’ve informed them it is not an ingredient we use.”
“Testing and research like this is so important within the cannabis production process. At Figr, all cannabis products, including our vape products, are tested through independent third parties prior to market launch in order to ensure confidence-inspiring product quality and consistency.”
The head of an analytical testing lab in BC says his company uncovered concerns with phytol as an additive in vape pens earlier this year, as well.
If you start to get above (180 degrees Celsius), you get to a zone where there’s enough energy to start stimulating chemical reactions within the material, and that includes terpenes. And as you get higher, you get to things where the molecules can rearrange or they can form different things. One of the most stable structures for material that has six carbons is benzene. And benzene is a known carcinogen and is very dangerous to you.
Rob O’Brien, CEO of Supra Research and Development
Rob O’Brien is the CEO of Supra Research and Development in Kelowna BC, which does analytical testing for several different industries, including cannabis.
O’Brien, who is also an adjunct professor at the University of British Columbia, says he and his colleagues began looking at the issue of additives in vape pens after watching the topic of suspected problems with vitamin E acetate emerged in the US last year.
He says he saw that labs were looking at the ingredients inside vape pens, but not looking at what was happening to those ingredients when they were being heated and then inhaled. By January of this year, O’Brien says Supra started offering these testing services for cannabis producers in Canada, just as these products were beginning to emerge in the legal market.
“We test consumer products for contaminants, to ensure that when people use them as intended, they are not exposed to dangerous contaminants and chemicals,” explains O’Brien.
“When you use a vaporizer, the intended use is elevated temperature and when you use those at elevated temperatures, they can produce – depending on the ingredients – hazardous things that we only see at these high temperatures. That’s when they begin to break down. So if we want to evaluate those that are contaminants, we need to understand what happens at different temperatures.”
Hubert Marceau, the Director of Development at Laboratoire PhytoChemia Inc. in Quebec, says he thinks people need to look beyond individual terpenes like phytol, since terpenes of all kinds are susceptible to similar problems when heated in vape pens for inhalation.
“Is it more a problem that phytol is being used as a thinning agent or is it more of a problem that we are using flavours and terpenes of all kinds that can degrade into another product,” says Marceau.
“Phytol may not be the only culprit here. It may be one, but any other agent may have the same problem eventually. I think heating up terpene products (of all kinds) will potentially create similar problems.”
This kind of problem applies to just about any vape pen in general. Using more terpenes will certainly produce more of these degradation products. Even in nature they will degrade with contact with air and temperature and degrade into other products. I don’t think there is a safe way to use them. You are heating up chemical compounds that are kind of the precursor to some of these solutions and degraded products.
Hubert Marceau, Director of Development at Laboratoire PhytoChemia Inc.
Marceau says that consumers may think terpenes are safe because they are natural, but points out they are still volatile compounds that can be problematic both in their current form, as well as when they break down into more problematic substances with heat.
“This kind of problem applies to just about any vape pen in general. Using more terpenes will certainly produce more of these degradation products. Even in nature they will degrade with contact with air and temperature and degrade into other products. I don’t think there is a safe way to use them. You are heating up chemical compounds that are kind of the precursor to some of these solutions and degraded products.”
O’Brien, at Supra, says he and his team are working on an education campaign for consumers to try and encourage people to use low temperature vaping that can help avoid some of those problems.
The ideal temperature, he says is around 180 degrees Celsius, where consumers can get the cannabinoids and terpenes they are seeking to experience, without any chemical changes in those compounds into potentially more dangerous substances. For the sake of a memory tool, he says Supra is working on an education campaign for consumers, encouraging people to remember to not go over 420 degrees Fahrenheit, or 215 degrees Celsius. But even that, he says, is probably a little over any necessary temperature.
“We have found that about 180 degrees Celsius, which is around 370 degrees Fahrenheit, you will actually get most of the terpenes and the cannabinoids liberated from the material and transferred into the gas phase. In fact we’ve developed and validated analytical methods that profile terpenes at that temperature. When you get much hotter than that you can have that negative breakdown.”
“You get everything you need out of a cannabis product when you heat it up to about 180 degrees Celsius. More heat doesn’t give you any more cannabinoids or terpenes, but it can create problems.”
Those problems, he explains, are because when some of these otherwise relatively common ingredients, even various terpenes that can be naturally present in cannabis, they can change their chemical structure into potentially far more dangerous compounds, including carcinogens like benzene.
“When you smell a flower or a pine tree, what you’re smelling is these terpenes but those are at room temperature,” says O’Brien. “As you heat things up, you get more released. We’ve found that at around 180 degrees C, you get most if not all of the terpenes very effectively. And that’s also a temperature where you’ll see the cannabinoids released
When you use a vaporizer, the intended use is elevated temperature and when you use those at elevated temperatures, they can produce -depending on the ingredients – hazardous things that we only see at these high temperatures. That’s when they begin to break down. So if we want to evaluate those that are contaminants, we need to understand what happens at different temperatures
ROB O’BRIEN, CEO OF SUPRA RESEARCH AND DEVELOPMENT
“If you start to get above this,” he continues “you get to a zone where there’s enough energy to start stimulating chemical reactions within the material, and that includes terpenes. And as you get higher, you get to things where the molecules can rearrange or they can form different things. One of the most stable structures for material that has six carbons is benzene. And benzene is a known carcinogen and is very dangerous to you.”
O’Brien says he thinks there is a need for more regulatory oversight from the government, especially when it comes to requiring temperature controls on vape pens, as well as more self-regulation by the industry itself when it comes to the ingredients being used.
“We should have a regulation that none of these devices should go above 240c,” he says.
There’s no reason to, it’s just going to lead to trouble. I’d also like to see the industry regulating the types of ingredients people are using. If you’re producing products in this sector, you should be concerned with the safety of your users and you should make sure that your product is safe. And then we just need consumer education around these things”
Without self regulation, he says the industry could face much more drastic action by politicians reacting to community concerns. Although there are many health concerns with inhalation of any product, he feels vapes can be safe, but only with careful oversight.
“I think there’s potentially a safe zone for vaping, but we need to base this on science, not knee jerk reactions from scientifically illiterate politicians. If industry doesn’t police themselves better, we could see these products being removed entirely.”
Concerns with unlisted or mis-labeled ingredients in vape pens has led at least one cannabis retail chain to seek clarification from vape pen manufacturers in Canada.
In an email from Tokyo Smoke’s Vice President of Operations in Ontario sent to vape pen manufacturers, dated July 31, the cannabis retail chain’s Ontario operations said they were giving companies 48 hours to respond to the request or face a stop-sale order on the company’s vape carts and filled pens. The stop order would be in place until the manufacturers can provide written confirmation that their products do not contain the additive phytol.
Phytol, like other terpenes found in cannabis and other ingestible products, is sometimes used as a thinning agent in vape pens. The cannabis oil used in vape pens requires a thinning agent to ensure it is fluid enough to be effective with a pen’s heating coils. Pure cannabis oil would be too thick to properly heat and inhale.
The email states that Tokyo Smoke’s concern is associated with a 14-day inhalation toxicology study to be published “in the coming weeks”, that Canopy Growth Corporation has shared with Health Canada. It also states that in their letter to Health Canada, Canopy will be placing immediate stop-orders on any vape products that list phytol as an ingredient and that the company will be following up with any vape pen manufacturers who list “ terpenes” as in ingredient to determine if the terpene phytol is used.
Canopy acquired Tokyo Smoke’s parent company Hiku in 2018.
In mid-July, Health Canada also sent out a request to licence holders selling cannabis vape pens to provide additional information on the “composition of certain vaping products which may be used to determine if products contain substances that are prohibited or that may be injurious to health”.
This decision is based on the results of a soon-to-be published study on the safety of added phytol in vaping oils. This new information underscores the need for consistent, science and evidence-based regulations for cannabis products so people have access to safe cannabis products they can trust, made by producers that act with integrity.
Dr. Mark Ware, Chief Medical Officer, Canopy Growth
“More specifically,” states the letter from Health Canada, “it is requested that you respond with the following information: The composition of the product (i.e. the full list of individual ingredients, and the net weight, net volume or concentration by weight or volume of each of those individual ingredients); The supplier or manufacturer of each of those ingredients; For each ingredient, identify whether it is a (a) carrier substance, (b) flavouring agent, or (c) necessary to maintain the quality or stability of the cannabis product; If applicable, the composition of each ingredient (e.g., for a flavouring agent, the list of substances in that flavouring agent, and the net weight, net volume or concentration by weight or volume of each of those substances)”.
Traditionally, vape manufacturers have used thinning agents propylene glycol, polyethylene glycol, vegetable glycerin, or medium chain triglycerides (MCT), generally from coconut oil. But as increasing health concerns have been associated with heating and inhaling those products, manufacturers have moved to other thinning agents, often using terpenes, either sourced from cannabis, other botanical sources, or synthesized.
Many consumers have come to see terpenes as being more “natural” because they can be found in cannabis and other plant based products. However, heating and then inhaling large concentrations of these volatile organic compounds has many known, and potentially many more unknown, health risks.
Terpenes can be used both as a thinning agent as well as flavouring. Terpenes are generally either cannabis-derived, or botanically derived from other plants.
In 2019, a major public health scare associated with cannabis vape pens from the black market was associated with an increase in lung infections, primarily in the US, which many researchers were connecting to thinning agents being used in these products.
Although there has been no definitive evidence of the specific culprit, many have pointed to thinning agents like Vitamin E acetate. Some have also pointed to terpenes being used as a thinning agent as a potential culprit. Phytol is an acyclic diterpene alcohol that can be used as a precursor for the manufacture of synthetic forms of vitamin E.
Canada opened up the market to cannabis vape pens in October 2019, with products appearing on the shelves beginning in late 2019 and early 2020. Producers are not currently required to list ingredients for vape pens other than cannabis.
Some cannabis vape pens simply list their ingredients as “cannabis extract”, “THC Distillate”, or “Full spectrum cannabis oil (including terpenes)”. Some also list specific terpenes, or just the presence of terpenes. One company, Dosist, lists it’s ingredients as Cannabis extract, beta-Caryophyllene, Farnesene, Linalol, alpha Humulenem and Limonene, but no phytol.
StratCann reached out to Tokyo Smoke, Canopy Growth, and others for this article.
EDIT: Canopy provided this followup reply on August 8:
“The health and safety of our consumers is our number one priority. Canopy Growth takes great care in researching its vaping formulations prior to launch, and we stand behind the quality and safety of our products. Canopy Growth products do not contain added phytol, and as a precautionary measure, Canopy Growth has ceased sales of third-party vape cannabis products with added phytol in its corporate owned retail stores and confirms that all franchise retail locations have done the same. This decision is based on the results of a soon-to-be published study on the safety of added phytol in vaping oils. This new information underscores the need for consistent, science and evidence-based regulations for cannabis products so people have access to safe cannabis products they can trust, made by producers that act with integrity.” – Dr. Mark Ware, Chief Medical Officer, Canopy Growth
The cannabis market in Canada is a dynamic place, with multiple companies jockeying for market share, including a host of smaller producers eager to get their products into the supply chain. One of the biggest drivers of product success is THC levels.
“There’s an incentive to exaggerate cannabinoid profiles,” says Dr. Brigitte Simons, CEO of BC Craft Lab Services, an eCommerce platform that pairs Canadian producers with accredited labs. “When cultivators are engaged in procurement discussions, they’re also pushing labs for results that match past expectations. They can’t complete the sale without validated test results from a licensed laboratory, and until the results come in, a deal can’t be made on a cannabis cultivar-type alone.”
They asked for us to convert and report as Dry, because it reported a 4% higher THC value. We didn’t. We will always stay within Health Canada’s regulations.
Pay-to-Play model
For some time in Canada, there have been rumours that a few labs have embraced a “pay-to-play” model, though the challenge appears to be mostly with regard to standardization and expertise. No one contacted for this article would go on the record with a direct accusation, but it is clear that the pressure to deliver high THC numbers is a problem, as are inconsistent practices.
“There are some new labs that don’t understand how the chemistry and reporting relate to cannabis,” says Daryl Patterson, Operations Manager Food & Pharma (Cannabis) at A&L Canada Laboratories, in London, Ontario. “As well, the assumption that there’s a ‘pay for THC result’ could be confused because of the ‘Dry’ reporting issue.”
THC levels can really affect the business model. The market is saying that you have to hit high THC content, or else the consumer won’t look at your product.
Dry testing
In Dry testing, labs use the analyzed moisture content to calculate the “AS-IS” tested THC value to a Dry value. This artificially inflates the reported value – hence its appeal to product marketers.
“I had a recent example of a newly-licensed provider that didn’t like the AS-IS result we gave them,” says Patterson. “They asked for us to convert and report as Dry, because it reported a 4% higher THC value. We didn’t. We will always stay within Health Canada’s regulations.”
Health Canada’s Good Production Practices (GPP) guide clearly states that the AS-IS result must be used for labelling products. A Dry result – known as anhydrous – can never be used to market THC levels in a product. Nonetheless, the incentive to report higher THC levels is real.
If a Health Canada audit determines that the THC numbers are wrong, then the licenced provider, the lab, and retailer are all accountable for auditing their records.
“I have had clients contact me saying that they’re being pressured to use other labs,” says Brian Coutts, A&L’s Strategy and Business Development Manager (Food & Pharma). “THC levels can really affect the business model. The market is saying that you have to hit high THC content, or else the consumer won’t look at your product.”
Educating the consumer
Coutts adds that Strainprint, a cannabis data and analytics company, and Leafly, the largest web-based source of cannabis information, are doing a good job educating the consumer on the “entourage” effect, wherein THC works synergistically with other compounds.
However, the challenge is that levels of THC, terpenes, and other cannabinoids can vary within cannabis plant varieties, yet batch testing is based on a reductive, molecular understanding of the product as a mixture. One possible solution would be to design product specifications based on sampling multiple tests in a batch. Unfortunately, this is costly for start-ups managing cash-flow, and not practical for cannabis wholesale buyers focussed on quick product acquisition.
The C-45 Quality Association… is a peer-to-peer network of quality assurance professionals, lab operators, and agency representatives that bring a collective intelligence to business practices.
Record auditing
“If a Health Canada audit determines that the THC numbers are wrong, then the licenced provider, the lab, and retailer are all accountable for auditing their records,” says Simons from BC Craft Lab Services. “The three parties reconcile the product discovered out-of-specification. Then they try to remove themselves: the retailer says ‘We accepted your product data at face value’; and the lab confirms their results with a hold-back sample. That leaves the risk of recall with the licensed producer.”
Many new brands are exposing themselves to liability if they engage with the wholesale market with questionable THC numbers. These smaller companies often don’t possess the required risk management skills given the high degree of uncertainty involved in getting manufacturing off the ground, and ensuring consistent quality.
“I’m protective of the micro license suppliers that have just entered the industry,” says Janeen Davis, Director of Business Development and Client Services at BC Craft Supply Company. “Everyone wants to do business with them. They’re the shining light of Canadian cannabis, but a recall could damage reputations and relationships.”
C-45 Quality Association
Some action is being taken, with one example being Canada’s C-45 Quality Association. The Association is a non-for-profit, private sector organization that advocates for compliance and quality. It is specifically geared toward supporting the cannabis industry by providing centralized resources, and information on regulations.
“The C-45 Quality Association was formed in early 2019,” says Simons. “It’s a peer-to-peer network of quality assurance professionals, lab operators, and agency representatives that bring a collective intelligence to business practices. The goal is to get everyone on an even playing field, and to support the industry.”
The issue came to a head last month when some of Canada’s bigger cannabis companies were told they might be facing a multi-million dollar class-action lawsuit. The claim, which may never get to court, references wildly variable levels of THC in a cannabis oil purchased in Calgary last February. The effect has been to shine some light on the government’s priorities regarding laboratory oversight.
Standardization
“Even though cannabis is a recreational product, the government still needs to protect the health of Canadians,” says Stephanie Ostrander, Account Manager at Keystone Labs in Edmonton. “The analytical testing license is more about working with a controlled substance, and the security of it. You don’t need to prove your capabilities as a lab.”
Standardization issues could be mitigated with wider adoption of the International Organization for Standardization (ISO) 17025 accreditations, as well as the availability of certified reference materials for testing and for instrument calibration. Right now, obtaining an analytical testing licence for cannabis is an arduous process, but many observers believe it won’t determine lab proficiency until validated methods, and lab procedures, are ISO and International Electrotechnical Commission (IEC) certified.
“Most cannabis labs commercialized their test offerings late 2018, and early 2019,” says Simons. “They had their initial inspection, and had to validate their methods. However, it is periodic audit and employee training that maintains lab competency.”
With cannabis lot release test prices running into the thousands of dollars, smaller producers can be anxious about getting the desired results in order to secure a good price for their products. At the same time, larger producers with more sales registrations may source lab results, looking for a company that delivers the desired THC numbers to meet sales demands.
‘“I personally don’t think fraud is rampant in the industry,” says Simons. “However, it is remarkable how results can swing between harvested plant crops and labs hired for the lot release testing – and that suggests to me that what we need is better standardization and methodology. The C-45 Quality Association will bring visibility to these matters, as would wider adoption of ISO 17025, and the availability of reference materials to measure proficiency with these service providers.”
The Alberta Gaming Liquor and Cannabis agency that manages Alberta cannabis issued a product recall today for two cannabis beverages sold by Ontario producer AgMedica Bioscience.
The Alberta cannabis distributor and retailer is asking consumers who purchased AgMedica Bioscience Sparkling Beverage, Vertical Pomegranate Blueberry beverage – Lots EXPE-18-20073B1, EXPE-18-20074B1, EXPE-18-20105B1 and EXPE-18-20106B1 – and Vertical Lemon Lime beverage – Lots EXPE-18-20075L1, EXPE-18-20076L1 and EXPE-18-20076L2 to return their product to the retailer where it was purchased in order to receive a refund.
The recall says it is due to mislabeled THC levels in the beverages, with lower THC levels than advertised on the product itself. Because of this, the provincial agency says there are no health hazards associated with the recall.
AgMedica has marketed the 55 ml products as ready-to-drink “beverage minis”.
Retailers that purchased the beverages are instructed to remove them from their shelves and mark them as ‘Do Not Sell – Recalled Product’. The AGLC can then, at a future date, issue a Return Merchandise Authorization (RMA).
Recalls for mislabeled products are not uncommon, making up the bulk of the more than two dozen cannabis product recalls over the last several years.
AgMedica announced a ‘liquidity crisis‘ earlier this year, saying they are seeking interim financing and protections.
UPDATED: On June 12, Health Canada issued a recall notice for this product as well, stating that the recall was the product of stability testing conducted by AgMedica Bioscience, which they say indicates that the quantity of THC in the product may decrease over time.
Neither Health Canada nor AgMedica have received any adverse reaction reports for the recalled cannabis product lots. 11,869 units of recalled product were sold from April 20 to June 1, 2020.
Product: AgMedica Bioscience – Pomegranate Blueberry Sparkling Beverage – 55 ml CNB Number: CNB-01701027 Lot Numbers: EXPE-18-20073B1, EXPE-18-20074B1, EXPE-18-20105B1, EXPE-18-20106B1
Product: AgMedica Bioscience – Lemon Lime Sparkling Beverage – 55 ml CNB Number: CNB-01701033 Lot Numbers: EXPE-18-20075L1, EXPE-18-20076L1, EXPE-18-20076L
A judge from Nova Scotia’s Court of Appeal has ruled that public injury claims made against Organigram Inc by patients who consumed their cannabis products cannot be established. It will continue to allow the plaintiff to seek financial compensation, though.
The original case filed in early 2018 came after a class action suit which consisted of a group of people who had been using the medical cannabis producer’s products. The patient and plaintiff argued they had experienced negative health effects after consuming cannabis from the producer which had been found to have been using an unapproved pest control product, myclobutanil.
The judge in this recent appeal agreed with Organigram that there was little evidence of, or methodology, to prove the health claims made could be connected to their cannabis products.
Organigram’s unauthorized use of myclobutanil and/or bifenazate triggered public recalls for the cannabis producer in 2016 after testing by a third party lab discovered evidence of unauthorized pesticides. In addition to the product not being allowed for cannabis production in Canada, Organigram was also certified as organic by Ecocert, a third party organic certifier, who also disallowed those products. After initially losing their certification from Ecocert, they received it again in 2018.
Organigram had not challenged the fact they used a disallowed product, but did challenge the associated health claims. The company argued that there was no evidence that its cannabis products caused any negative or adverse health effects, and that there is any manageable way to establish any causal connection between its cannabis and the symptoms complained of in this case.
Following the recalls, a class action suit was initiated by patients who said they had experienced negative health issues related to using their cannabis which potentially contained trace amounts of bifenazate and/or myclobutanil.
The burden of proving this array of negative health effects was a tough case to make, which helped guide the judge’s most recent decision, stating that the adverse health claims were “too generic”.
“Ms. Downton failed to lead some evidence of a workable methodology that could establish general causation on which the personal injury claims depended. The “adverse health claims” were too generic. “
The court also noted that the generic testing described by the plaintiff’s doctor did not meet the “workable methodology” requirement of the law.
Among one of the concerns raised by the plaintiff was the fact that when combusted myclobutanil releases hydrogen cyanide, which has numerous negative health concerns.
The plaintiff had argued that the symptoms she had experienced “coincide” with those associated with exposure to hydrogen cyanide, including lightheadedness and gastrointestinal symptoms.
In support of its decision, the court noted research that showed that cannabis itself also releases hydrogen cyanide, and in far greater amounts than would be attributed to any myclobutanil on the cannabis the patients in question consumed. The court document shows the judge stating “The amount of hydrogen cyanide produced by myclobutanil is obviously infinitesimal compared to the amount produced by smoking cannabis in the ordinary way.”
The recalls associated with the product noted that the levels of myclobutanil found on the cannabis products were incredibly low, up to 20 parts per million (ppm), potentially because the pesticide was applied at a very early stage in the plant’s growth, not in the flowering stage.
For reference, one ppm is one part in one million. One ppm is comparable to one second in 11.5 days or four drops of ink in one 55-gallon barrel of water.
In the wake of pesticide-related recalls from Organigram and Mettrum late last year and early this year, Health Canada recently announced new surprise testing for all licensed producers, as well as required testing for Organigram and Mettrum. Then, after Health Canada released the results of their spot-testing, showing trace amounts of pesticides on leaf samples from one producer, the regulator announced new required testing for all licensed producers.
The judge agreed and dismissed this aspect of the class action. The associated reimbursement payments that are also part of the class action suit were allowed to remain and will continue to make their way through the courts.
Organigram says they will continue to challenge these as they have already provided refunds.
“Organigram will continue to defend what remains of the Class Action as it has already voluntarily reimbursed many of its customers for this recall via a comprehensive credit and refund program”
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