According to a press release sent out last week, Complex Biotech Discovery Ventures (CBDV) has expanded their testing capabilities considerably with the new addition of a vapor/smoke analyzer. CBDV is a licensed cannabis and psilocybin research laboratory embedded in the University of British Columbia, led by CEO Dr. Markus Roggen.
The ability to analyze vapor and smoke is a relatively novel concept for the cannabis space, but has been utilized by the tobacco industry for years now. In the early days of adult-use cannabis legalization in the United States, stringent testing regulations for contaminants like pesticides were adopted out of a fear for what would happen when consumers ingest toxic levels of contaminants.
One of the common refrains iterated throughout the industry over the past ten years was that there just wasn’t enough research on how different contaminants affect patients and consumers when burned and inhaled. We still don’t know too much about what happens when someone smokes a dangerous pesticide, such as myclobutanil. Beyond just contaminants, the new technology allows for companies to measure precise levels of cannabinoids in vapor and smoke, getting a more accurate reading on what cannabinoids are actually making it to the end user.
This new development coming from our neighbor to the north could lead to a breakthrough in the cannabis lab testing and research space. CBDV claims they can now analyze cannabis material with a much more in-depth analysis than basic compliance testing labs. The new technology for analysis of smoke, vapor, plant material and formulations allows companies to thoroughly understand their materials in each stage of the product formulation process, all the way to product consumption.
Beyond just smoke and vapor analysis CBDV also offers NMR spectroscopy, metabolomics, nanoparticle characterization, computational modeling and other testing services that go far beyond the traditional compliance testing gamut.
“Our new services offer comprehensive insights into plant material, extracts, end-products and even the smoke/vapor by using state-of-the-art analytical instruments,” says Dr. Roggen. “By understanding the chemical fingerprint of the material, cannabis producers can eliminate impurities, adjust potencies, and optimize extraction processes before wasting money and resources on producing inconsistent end products. As a chemist I am really excited about adding NMR and high-res mass spectroscopy to the cannabis testing offerings.”
Dr. Markus Roggen is a chemist, professor, cannabis researcher and founder & CEO of Complex Biotech Discovery Ventures (CBDV). Founder & CEO of Ascension Sciences (ASI), Tomas Skrinskas has been at the leading edge of transformative healthcare technologies, including computer assisted surgery, surgical robotics and genetic nanomedicines, for over 15 years.
Leading researchers from the cannabis industry – Dr. Markus Roggen (Complex Biotech Discovery Ventures) and Tomas Skrinskas (Ascension Sciences) – highlight the challenges facing the industry’s current compliance testing standards and the opportunities emerging from the latest developments in nanotechnology and advanced analytical testing. Here are the key insights from the discussion.
What are the current compliance testing requirements for cannabis products? Are they sufficient in ensuring safety and quality?
In the current landscape, Canada’s compliance testing requirements are clearly laid out in the form of guidance documents. Specifically, for pesticide testing, cannabinoid concentration content in products, heavy metals, etc. Compliance testing can be roughly divided into two categories: 1) establishing the concentrations of wanted compounds, and 2) ensuring that unwanted compounds do not exceed safety limits.
In the first category, cannabinoids and terpenes are quantified. Their presence or absence is not generally forbidden but must stay within limits. For example, for material to be classified as hemp, the THC concentration cannot exceed 0.3 %wt., or a serving of cannabis edible should contain below 5 mg of THC. The second category of compliance testing focuses on pesticides, mold and heavy metals. The regulators have provided a list of substances to test for and set limits on those.
Are those rules sufficient to ensure safety and quality? Safety can only be ensured if all dangerous compounds are known and tested for. Take for example Vitamin E acetate, the substance linked to lung damage in some THC vape consumers and the EVALI outbreak. Prior to the caseload in the Fall of 2019, there were no requirements to test for it. It’s not only additives that are of concern. THC distillates often show THC concentrations of 90% plus 5% other cannabinoids. What are the last 5% of this mixture? Currently, those substances have not been identified. Are they safe? There is no concrete way to determine that.
The aforementioned guidelines have the best intentions, but do not adequately address two key obstacles the industry is currently facing: 1) what happens in practice, and 2) what can easily be audited? Making sure people follow the requirements is the challenge, and it comes down to variability of the tests. Testing has to happen on the final form of the product as well as every “batch,” but there is little guidance on how that is defined. With so much growth happening in the industry, how are these records even tracked and scrutinized?
And finally, there’s the question of quality. How do you define quality? Before establishing quantifiable quality attributes, it can’t be tested.
If compliance testing is insufficient, then why aren’t more cannabis companies testing beyond Health Canada’s requirements?
Compliance testing has always been focused on the end product, THC and CBD levels, and consumer safety. As long as cannabis companies are testing to determine this, doing further testing means added costs to the producer. There is a rush to get cannabis products to the new market because many consumers are eager to buy adult use products such as extracts or edibles, and quality is not the biggest selling point at this very moment.
However, there are unrealized advantages to advanced analytical testing that go beyond Health Canada’s requirements and that offer greater benefits to cannabis producers and product developers. Producers often see testing as an added cost to their production that is forced upon them by the regulators and will only test once the product is near completion. For cannabinoid therapeutics and nutraceuticals, advanced analytical testing is critical for determining the chemical makeup and overall quality of the formulation. This is where contract researchers, such as Ascension Sciences, come in to offer tests for nanoparticle characterization, cannabinoid concentration, dissolution profiles and encapsulation efficiency.
A lack of budget and awareness have prevented cannabis companies from advanced analytical testing. However, testing that goes beyond lawful requirements is an opportunity to save money and resources in the long term. This is where companies, like Complex Biotech Discovery Ventures (CBDV), offer in-process testing that provides a deep characterization and analysis of cannabis samples during every stage of product development. If tests are conducted during production, inefficiencies in the process are revealed and mistakes are spotted early on. For example, testing the spent cannabis plant material after extraction can verify if the extraction actually went through to completion. In another case, testing vape oil before it goes into the vape cartridges and packaging allows producers to detect an unacceptable THC concentration before they incur additional production costs.
Which methods are the most successful for cannabis testing?
The most effective method is the one that best determines the specific data needed to meet the desired product goal. For example, NMR Spectroscopy is paramount in assessing the quality of a cannabis sample and identifying its precise chemical composition.
HPLC (liquid/gas chromatography) is the most precise method for quantifying THC, CBD and other known cannabinoids. However, if a cannabis extractor wants to quickly verify that their oil has fully decarboxylated, then an HPLC test will likely take too long and be too expensive. In this case, IR (Infrared Spectroscopy) offers a faster and more cost-effective means of obtaining the needed data. Therefore, it ultimately depends on the needs of the producer and how well the testing instruments are maintained and operated.
What’s next in analytical testing technology? What are you working on or excited about?
In terms of compliance, regulations to standardize the testing is the hot topic at the moment. For nanotechnology and nanoparticles, the big question now is what is known as the “matrix” of the sample. In other words, what are the cannabinoids, and what else is in the sample that’s changing your results? The R&D team at Ascension Sciences is in the process of developing a standardized method for this to combat the issues mentioned earlier in the interview.
Ascension Sciences is also excited about characterizing nanoparticles over time to determine how cannabinoids are released and how that data can be transferred or made equivalent to consumer experiences. For example, if a formulation with quicker release, faster onset and better bioavailability is found in the lab, product development would be more efficient and effective when compared to other, more anecdotal methods.
At CBDV, the team is working on in-process analytical tools, such as decarboxylation monitoring via IR Spectroscopy and NMR Spectroscopy. CBDV is also looking at quantifying cannabis product quality. The first project currently in motion is to identify and quantify cannabinoids, terpenes, and other compounds present when vaping or smoking a joint using a smoke analyzer.
A lack of budget and awareness have prevented cannabis companies from testing beyond what’s required by Health Canada. Compliance testing is designed to ensure safety, and for good reason, but it is currently insufficient at determining the quality, consistency and process improvements. As the above factors are necessary for the advancement of cannabis products, this is where further methods, such as advanced analytical testing, should be considered.
Since the beginning of this year, more than 8,100 wildfires have burned in California, torching a record 3.7 million acres of land in a state with one of the largest cannabis economies in the world. With the effects of climate change continuing to wreak havoc on the entire West Coast, smoke from those fires has spread across much of the country throughout the summer.
As we approach October, colloquially referred to as Croptober in the outdoor cannabis market for the harvest season, we’re seeing the August Complex Fire creep towards the Emerald Triangle, an area in northern California and southern Oregon known for its ideal cannabis growing conditions and thousands of cultivators. The wildfires are close to engulfing towns like Post Mountain and Trinity Pines, which are home to a large number of cannabis cultivators.
Hezekiah Allen, executive director of the California Growers Association, says losses could reach hundreds of millions of dollars. Fires across Oregon have torched dozens of cultivation operations, with business owners losing everything they had. The Glass Fire has already affected a large number of growers in Sonoma and Napa Counties and is 0% contained. None of these cultivators have crop insurance and many of them have no insurance at all.
The impact from all of these fires on the entire cannabis supply chain is something that takes time to bear witness; a batch of harvested flower typically takes months to make its way down the entire supply chain following post-harvest drying and curing, testing and further processing into concentrates or infused products.
The fires affect everyone in the supply chain differently, some much more than others. Sweet Creek Farms, located in Sonoma County, lost all but one fifth of their crops to fires. Other cultivators further south of the Bay Area have lost thousands of plants tainted by smoke.
Harry Kazazian, CEO of 22Red, a cannabis brand distributed throughout California, Nevada and Arizona, says he is increasing their indoor capacity to make up for any outdoor flower loss. But he said it has not impacted his business significantly. “Wildfires have been a part of California and many businesses have adapted to dealing with them,” says Kazazian. He went on to add that most of his flower comes from indoor grows in the southern part of the state, so he doesn’t expect it to impact too much of his supply chain. Kazazian is right that this is not a new concept – the cannabis industry on the West Coast has been dealing with wildfires for years.
George Sadler, President of Platinum Vape, has a similar story to tell – the fires have impacted his supply chain only slightly, saying they had a handful of flower orders delayed or cancelled, but it’s still business as usual. “It’s possible this won’t affect the supply chain until later in the fall,” says Sadler. “There has definitely been an effect on crops that are being harvested now. It may end up driving the price of flower up, but we won’t really know that until January or February if it had an effect.”
Sadler believes this problem could become more extreme in years to come. “Climate change definitely will have an effect on the industry more inland, where we’re seeing fires more commonly – it could be pretty dramatic.”
One beacon of hope we see every year from these fires is how quickly the cannabis community comes together during times of hardship. Sadler’s company donated $5,000 to the CalFire Benevolent Foundation, an organization that supports firefighters and their families in times of crisis.
A large number of cannabis companies, like CannaCraft, Mondo, Platinum Vape and Henry’s Original, just to name a few, have come together to help with relief efforts, donate supplies, offer product storage and open their doors to families.
If you want to help, there are a lot of donation pages, and crowdfunding campaigns to support the communities impacted. The California Community Foundation has set up a Wildfire Relief Fund that you can donate to.
The medical cannabis program in Pennsylvania has only been functional for a few months now; patients began getting access to the drug back in February of 2018. In a press release, MPP says only a small number of cultivators and dispensaries are currently operating. This fact, coupled with the need to purchase processed forms of cannabis, has created product shortages and costly medicine for patients.
It is expected that this move could help alleviate some of those problems in the state’s new program. “Allowing cannabis in its natural, flower form and expanding the list of qualifying conditions will have a huge positive impact on seriously ill Pennsylvanians,” says Becky Dansky, legislative counsel for the Marijuana Policy Project, who helped lead the legalization effort in Pennsylvania’s legislature. “By being able to provide medical marijuana in plant form, producers will be able to get medicine into the hands of patients much more quickly and for much lower cost to patients,” says Dansky. “This is vitally important for patient access right now while the program is still getting off the ground and production is not yet at full capacity. We hope these rules are promulgated as quickly as possible so even more patients will be able to find relief.”
The qualifying conditions added to the list for patients seeking medical cannabis is set to include cancer remission therapy as well as opioid-addiction therapy, which are two very notable additions. With more qualifying conditions and a potentially cheaper form of medicine, these changes could improve the program’s efficacy in treating patients.
Answering questions following a speech in Richmond, Virginia, Attorney General Jeff Sessions told reporters he thinks the Cole Memo is a valid way to deal with state cannabis laws and said medical cannabis is “hyped, maybe too much.” According to a MassRoots blog post by Tom Angell, Sessions spoke yesterday regarding cannabis, addressing it as he tip-toed around his previous statements, like calling cannabis use unhealthy or the infamous “Good people don’t smoke marijuana” line.
This time around, Sessions’ words on legal cannabis were more carefully chosen. “The Cole Memorandum set up some policies under President Obama’s Department of Justice about how cases should be selected in those states and what would be appropriate for federal prosecution, much of which I think is valid,” Sessions told reporters. The Cole Memo essentially set up a framework for states with legal cannabis laws to avoid federal enforcement of the Controlled Substances Act.
These comments do fall in line with some of his previous statements, like suggesting he wants to uphold federal law. During the speech in Richmond, Sessions denied any possibility that cannabis could be a solution to the opioid crisis. “I reject the idea that America will be a better place if marijuana is sold in every corner store,” says Sessions. “And I am astonished to hear people suggest that we can solve our heroin crisis by legalizing marijuana – so people can trade one life-wrecking dependency for another that’s only slightly less awful.” These statements echo much of what White House press secretary Sean Spicer said weeks ago, citing the opioid crisis as possibly linked to recreational cannabis consumption.
Sessions admitted to reporters that he acknowledges the benefits of medical cannabis, but says he is still skeptical of the idea, saying it has been overhyped. “It’s possible that some dosages can be constructed in a way that might be beneficial,” says Sessions. “But if you ever just smoke marijuana, for example, where you have no idea how much THC you’re getting it’s probably not a good way to administer a medicinal amount- so, forgive me if I’m a bit dubious about that.” Sessions pontificating the medical efficacy of delivery methods for cannabinoids could suggest he is trying to familiarize himself more with the science behind medical cannabis.
According to a Politico article, Sessions privately told senators that he would respect states’ rights on the issue and uphold Obama-era policies, perhaps referring to the Cole Memo. While Sessions’ most recent remarks could signal a less aggressive approach toward legal cannabis, he still makes his position clear as a Drug War stalwart. “Our nation needs to say clearly once again that using drugs will destroy your life,” Says Sessions.
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