As Germany begins to enter a summer where life seems ever more normal, there are fairly major shakeups underway in the German cannabis market. These are structural but will have a profound impact on the entire market going forward.
A Mass Of Distribution Licenses It is an interesting metric to understand that before 2015, there were no specialty cannabis importer/distributors in Germany. As of July 2020, there are rumors that this number has now shot to close to 80 (either licensed or in the process to become licensed). That is a huge number. So was the last amazing number (40) as of the beginning of this year. Just the previous estimate would mean, literally, 1 specialty cannabis distributor for every 2 million Germans. That obviously is not sustainable. What it does indicate is the huge surge of interest in medical cannabis not to mention acceptance, as well as the amount of money actually now beginning to slosh around in the domestic market.
And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.How many of these distributors will survive is another question, particularly in an environment where the government is looking for just one to fulfil the needs of all of Germany’s pharmacies from what is grown domestically. This does not of course mean the end of specialty distribution. Indeed, far from it. There is not enough cannabis entering the market, presumably this fall, that is grown here to even come close to meeting demand.
No surprises here. This has been one of the enduring criticisms of the entire process, if not the bid itself since 2017.
However, one thing this does mean is that distribution fees, like pharmacy fees for processing the plant before them, are finally hitting a price adjustment phase.
This is also going to be good not only for patients, but also health insurers.
For all the standardization of the industry, including fees and mark-ups, one of the strangest things about the German cannabis market is how widely cannabis prices can differ even between pharmacies. This is as true of flower as it is of dronabinol.
The Wholesale Price Of Medical Cannabis Is Dropping Again, no surprise here, the government will end up buying more cannabis than contracted for under the original bid. This was actually anticipated in the language of the contract that currently exists between the government and the three bid winners. Namely, an automatic 50% reduction in price is mandated for any cannabis sold beyond the 120% agreed upon qualities.
Photo: Ian McWilliams, Flickr
The growers domestically, in other words, who won the bid will be under a severe price restriction. This may have been the ultimate strategy of the government to begin with (namely to attract foreign capital and expertise but then begin to reign in the sky-high prices of medical cannabis so far.)
This means that the price of €2.30 a gram will undoubtedly fall. Where it will float is anyone’s guess, but right now it appears on course to hit about €1.87. Or about the same price that other governments across Europe (notably Italy) had previously negotiated with the big Canadian cannabis companies (notably on this one, Aurora’s military contract in Italy).
Implications For The Import Market With domestic producers under the gun, this also means that all imports will begin to feel the price squeeze too. And that will also have a significant impact on point of sale cannabis prices.
And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.
Gen Z is currently at about 40% of consumers, and this segment will be rapidly growing in the coming years. Most researchers and media define this generation as those who were born between the mid to late 1990s and early 2010s. In the United States alone, Gen Z consumers have an estimated $143 billion in buying power. Businesses that aren’t putting enough marketing strategies toward Gen Z need to reevaluate and switch gears, stat! Start laying the groundwork for your company’s success in the coming years. Kickstart your targeted Gen Z marketing strategies now. Every industry is different, but there are a few key do’s and don’ts to follow when communicating with Gen Z buyers. In the cannabis field, it is especially important to only market to those who can legally indulge.
Do Make Genuine Connections Online
Gen Z is our first truly digital generation. They’ve grown up using social media and the internet. As digital natives, they’re quick to recognize inauthentic communication methods. Whether it’s unnatural comments or trying to cover up negative testimonials, the younger crowd can always spot brands trying to be something they are not. Instead, practice total transparency with followers and friends to ensure that there is never a lack of brand accountability and authenticity. Within the cannabis industry, businesses can use their social media platforms to educate, build relationships and easily refute longstanding cannabis stereotypes that are so common in older generations.
Don’t Try Too Hard to Be Relatable
One way to make genuine connections is to engage with, create and share memes and other trends on social media. Although this is an excellent method for increased interactions, there is also plenty of room for error, so caution is the guiding principle. If not executed correctly, a post about a meme could easily make brands look unprofessional, or behind the times as they’ve missed the actual joke. These techniques can make business accounts seem like they are trying too hard to fit in, and will ultimately cause Gen Z to hit the “unfollow” button. Instead, focus on topics that closely align with the brand’s image and find creative ways to make content relate to exciting and funny trending ideas about cannabis.
Do Care About Social Issues and Responsibility
Focus on creating high quality, exciting videos and vibrant pictures that highlight cannabisResearch has shown that Gen Z sincerely cares about social issues and responsibilities. These beliefs don’t only apply just to their personal lives, but also to their buying habits and which businesses they want to support. These beliefs provide an excellent opportunity for brands to stake out common ground with Gen Z and support a variety of causes at the same time. Many of these consumers seem to care about topics like the environment, equality, hunger and homelessness. Do note that it’s essential to review and analyze these issues before making statements or posting about them on social media. For the cannabis industry, many businesses tend to raise awareness about medical matters, social equity and community-oriented programs.
Don’t Post the Same Content Repeatedly
After getting into the social media game, it can be tough to figure out how often to post. As much as those aspects do play an essential role in overall engagements, it’s also crucial to pay attention to the type of content that makes it into followers’ feeds. All photos and videos should be related, yet unique. Posting the same marketing content over and over is going to bore Gen Z, and make business accounts look less aesthetically pleasing. Instead, focus on creating high quality, exciting videos and vibrant pictures that highlight cannabis, and then vary your post types.
Navigating Gen Z communication and marketing tactics are going to be pivotal in just a few years, making it critical for businesses to rework their marketing strategies as soon as possible. If cannabis brands can capture the essence of authenticity and social responsibility in their communication methods, while avoiding posting repetitive content, they should be able to reach legal Gen Z-ers seamlessly.
By Dr. Markus Roggen, Sajni Shah, Stella Zhu No Comments
When data analytics was first introduced in the sports industry, it was met with a lot of criticism. But then it began to show results; a popular example being the story of Oakland Athletics Manager Billy Beane, depicted in the movie Moneyball starring Brad Pitt. In the cannabis industry today, we face familiar hurdles. Everyone is focused on extracting as much CBD oil as they can, but not many are optimizing the process. We even hear that data analytics is too difficult, that it does not help and no one has time for it. In contrast, the sports industry nowadays widely uses statistics and analytics, because it has proved to be effective. They use data analytics to choose their players for a team so that they have the best chance to win the championship. NBA teams have entire departments focused on data analytics, so why doesn’t the cannabis industry? Focusing on basketball, what if the approach taken to pick players for an all-star team was employed in the cannabis industry? Imagine your instruments as players and their parameters as their skills. Now, all you need is data analytics to help you decide how best to optimize your team. Paying attention to the numbers, could help you win in the cannabis industry.
When thinking about players in basketball, one factor of interest is the “Players Offensive Rating”, which is the amount of points produced by a player per 100 possessions. In this scenario, you want the player to have a higher offensive rating as it means that they have a better chance of scoring points when they have the ball. Similarly, in cannabis production, you would want your instrument to yield as much product (points) per hour (possession) as possible as well. So, the cannabis extraction analogy for offensive rating is “Yield Per Hour”. By increasing the yield per hour, the instrument can extract more product in the same time frame, increasing overall output and reducing product cost per gram. In this scenario, the biggest extractor is not necessarily the fastest, and any supercritical CO2 extractor will be slower than, for example, ethanol extractors.
Another important factor that’s considered in basketball is “Shooting Efficiency,” which looks at the number of successful baskets made by a player in comparison to the number of shots taken and where the shot was taken from. Having a player with a high shooting efficiency would result in a good chance for that team scoring points over their competitors. This principle is similar in cannabis, while a high yield (number of shots) is great, you also want a high purity (baskets made) of your target compounds or “Percent Purity”. This means you will get a higher percentage of the compounds you want, such as cannabinoids, for every gram of oil extracted. Here, the supercritical CO2 extractor shows its superiority over ethanol, as density modulation of the supercritical CO2 allows for the separation of terpenes or cannabinoids from the rest.You can see that a team that has a better synergy has a higher winning rate. For the same reason, the cannabis extraction process can be optimized by adjusting the parameters of the instrument.
For one last example, let’s look at “Number of Steals” as well. This is the number of times a defensive player successfully tackles the ball from an opposing player before they manage to shoot a basket. If this is high, opponents have fewer opportunities to shoot and score points. Similarly, “Percent Recovery” in the cannabis industry is important to ensure that the target compounds in your flower are being extracted. The solvent should have the chance to extract the compounds (steal from the opposition), before the run ends (the opposition shoots). A high recovery gives a higher overall output for the materials that were input, generating more product overall. In theory, if you wait long enough every solvent can reach full recovery, but for supercritical CO2 in particular there is a practical ceiling around 80% recovery.
While thinking about these variables in isolation is the first step, it is just as important to see how the variables interplay with each other. A concept is introduced here called “synergy”. A team member must establish a good cooperation with the entire team according to their own characteristics. For example, taller and stronger players whose “Offensive Rating” is higher are more suitable for guards, while those with a high “Shooting Efficiency” are more suitable for forwards. You can see that a team that has a better synergy has a higher winning rate. For the same reason, the cannabis extraction process can be optimized by adjusting the parameters of the instrument. For example, if you increase the extraction speed, which is “Yield per Hour”, you may need to compromise on “Percent Purity” as the increased speed may not allow for the optimal extraction of target compounds. Similarly, you may also need to compromise on “Percent Recovery” as a slower extraction rate will do a better job at having a higher recovery. Thus, in order to improve the overall process of extracting oil, there needs to be a focus on analyzing the synergies between different factors to guarantee optimal parameters for your benefit.
These examples highlight some of the basic data analytics that can be conducted on your instruments. However, there’s still one challenge to consider, most professional NBA teams have entire departments just for data analytics. How can you possibly accomplish conducting these analytics for your entire cannabis LP in addition to your regular job roles? That’s where we come in. Other than the “Yield per Hour”, “Percent Purity” and “Percent Recovery” listed above, CBDV can perform customized data analysis based on your company’s data. Let our team help you integrate the “boring” and “half-baked” data, and present you with a visual and clear data analysis report. Let us help you lead your team to win that championship in cannabis!
The e-cigarette or vaping use-associated lung injury (EVALI) outbreak of 2019 caught the attention of many, and has brought with it the scrutiny of both regulators and plaintiffs’ attorneys eager to act as “civil prosecutors.” As Tolkien would say, the Eye of Sauron has now turned its gaze towards the cannabis vapor industry.
With the misinformation and negative publicity that the EVALI outbreak brought to the industry, vaporizer device manufacturers should expect more lawsuits to be filed against them through 2020 and beyond. The cannabis vapor industry should also expect the theories of defect alleged against their products to become more sophisticated as more plaintiffs’ attorneys enter the arena.
One theory of defect you should expect plaintiff’s attorneys to pursue in 2020 is what I generally refer to as “temperature control litigation.”
These pre-filled cartridges are compatible with just about any battery because of the universal 5/10 thread connectors.
Here is the problem:
Typical additives in cannabis oil, while once thought to be safe, can degrade at higher temperatures into toxic chemicals. For example, the Vape Crisis of 2019 was largely attributed to a cannabis oil additive known as vitamin E acetate. While typically regarded as safe for use in nutritional supplements or hand creams, when used in cannabis oil, investigators believe vitamin E acetate can degrade into a toxic chemical when vaped—and is responsible for causing mass pulmonary illness for thousands of consumers.
Researchers do not fully understand how this process occurs, but chemists from the Royal College of Surgeons in Ireland found in a recent study that the key is understanding how temperatures affect chemicals when vaping. Through a process known as pyrolysis, the study found that vitamin E acetate can possibly degrade into ketene when vaped at higher temperatures—depending on the type of coil resistance, voltage and temperature configuration used in a vaporizer device. (Ketene has a high pulmonary toxicity, and can be lethal at high concentrations, while low concentrations can cause central nervous system impairment.) Similar studies have also shown that additives like Propylene Glycol (PG), Vegetable Glycerin (VG), and Polyethylene Glycol (PEG) can degrade into toxic chemicals at high temperatures—which has led Colorado to ban the use of PEG for inhalable cannabis products altogether.
More shocking, is that such temperature control issues are not limited to additives. It is very common for experienced users to experiment with low to high temperatures when vaping cannabis; it is believed that vaping cannabis at low temperatures (325-350°F) results in a mild high, while vaping cannabis at higher temperatures (400-430°F) results in a more euphoric feeling and intense high. But when cannabis is vaped at even higher temperatures (450°F +), industry experts do not really know if or how cannabinoids and terpenes degrade, which combinations of cannabinoids and terpenes affect degradation and what the health risks could be. It’s anyone’s guess.
Cheap batteries with the universal 5/10 thread can heat the product at inconsistent temperatures, raising safety and quality concerns
These temperature control issues are further complicated due to the universal 5/10 thread. Most consumers purchase cannabis oil through pre-filled “carts” (cartridges)—that are compatible with 90% of vaporizer batteries on the market because of universal 5/10 thread connectors. But vaporizer batteries can operate anywhere from sub-300 degrees to 800 degrees and above. Coupled with varying battery voltages, ceramic coil quality and oil quality, vaporizer batteries can produce a wide range of operating temperatures. Consequently, it is possible users could connect a cart to a vaporizer battery (set at too high a temperature configuration) and risk pyrolysis, change the chemicals inside their cannabis cart, and cause unknown harm to themselves.
Unquestionably, all of the above will result in lawsuits. Companies that manufacture cannabis oil will be sued for failing to conduct emissions testing to properly evaluate safe temperature settings for use of their carts. Vaporizer device manufacturers will be sued for failing to publish warnings, instructions and adequate owner’s manuals regarding the same. And the rallying cry against the cannabis vapor industry will be damaging. Plaintiff’s attorneys will accuse the industry of choosing profits over safety: “The cannabis vapor industry knew cannabis oils could turn into toxic chemicals when heated at high temperatures, but instead of conducting long-term emissions testing to evaluate those concerns, the industry chose profits over safety. As long as the industry made money, no one cared what dangers arose from elevated temperatures—and consumers paid the price.”
With the above as background, it is critical for the cannabis vapor industry to get serious about product testing. The industry needs to know if and why certain cannabinoids, terpenes and additives can turn into toxic chemicals when they are vaporized at high temperatures—and how the industry can guard against such dangers. And to cover their bases, the industry needs to publish proper warnings and owner’s manuals for all products. The time to act is now.
Despite the limitations and privations caused by the COVID-19 pandemic, Germany’s market is “up” in terms of sales and overall insurance approvals. For all the victories however, there are still many kinks along the way. That is of course, not just on the medical front (where flower is yet again in short supply this summer), but also in the CBD space.
There is also clearly a drumbeat for more reform afoot in a country which has bested the COVID-19 pandemic like few others in the world. And like France as well as other countries in Europe, the conversation across the region has turned to including cannabis in recovery efforts, and in multiple ways. That includes not only relying on a new crop and industry for economic revitalization, but also of course, on the topic of further reform.
A Brief Overview Of The “Modern” German Cannabis Market Germany kicked off the entire cannabis discussion in a big way in Europe in the first quarter of 2017. The government got sued by patients and changed the law mandating that public insurers had to reimburse the drug. They also kicked off a cultivation tender bid which promptly became mired in several rounds of lawsuits and squabbles. The first German grown cannabis will hit pharmacies this fall, but it is not clear when, and the unofficial rumour is that the pandemic will delay distribution. The German distribution tender has been delayed three times so far this year.
In the meantime, the German market has developed into the world’s most lucrative target for global exporters, particularly (but not limited) to GMP and other certifiable high-grade cannabis (and in all its forms).
The German Parliament Building
Other Issues, Problems and Wrinkles
Nothing about cannabis legalization is ever going to be easy, and Germany has been no exception.
The first problem on the ground is that the supply chain here has had several major hits, from the beginning. This is even though the supply has come from ostensibly otherwise reliable sources. Companies in Canada and in Holland have all had different kinds of problems with delivery (for different reasons) throughout this period.
Right now, there is a major reorganization afoot in Holland which may also be affecting the recent decision on the Dutch side to reorganize how the government picks (private) German narcotics distributors. Aurora also had product pulled last fall because of labelling and processing issues. But these, no matter how momentous momentarily, are also just waves in a cannabis ocean that is still choppy. Domestic sales continue to expand and foreign producers can still find a foothold in a still fairly open market.
As a result, even with a new dronabinol competitor, Israel, Australia and South Africa as well as multiple European countries now in advanced export schemes, the supply problem is still a thorny one, but not quite as thorny as it used to be.
However, On The CBD Front…
Things have gotten even more complicated since the repeated decisions on Novel Food at the EU level. Namely, last year’s decision that the only CBD extract that is not “Novel” is extracted from seeds, has thrown the entire industry into a major fluff. Especially when such decisions begin to filter down via a federal and regional approach. This has begun to happen. Indeed, the city of Cologne, in Germany’s most populous state just banned all CBD that is not labelled per an EU (although admittedly) non-binding resolution on the issue.
This in turn is leading to a renewed push for the obvious: recreational cannabis.
Where Is the Recreational Discussion Auf Deutschland? The recreational movement, generally, has been handed several black eyes for the last three years. Namely, that greater reform was not preserved in the first cannabis legalization that passed, albeit unanimously, in the German Parliament in 2017. However, as many recognized, the first, most important hurdle had just been broached. And indeed, that cautious strategy has created a steadily increasing, high quality (at least for the most part) medical market that is unmatched anywhere in the world except perhaps Israel.
Photo: Ian McWilliams, Flickr
Now, however, there are other issues in the room. The CBD discussion is mired in endless hypocrisy and meddling at both the state country level and the EU. There are many Germans who are keen to try cannabis beyond any idea of cannabis as therapy. Remember that Germany has largely managed to contain the outbreak, despite the emergence of several recent but isolated hotspots of late. In Frankfurt, for example, with the exception of more people on kurzarbeit (which is not visible), most street traffic proceeds apace these days with masks on, but with that exception or two, feels pretty much back to “normal.” And of course, economic development in the form of exports is one of Germany’s favorite pastimes.
Beyond that, the needle has absolutely moved across Europe. Several countries, including Greece and Portugal as well as the UK’s Channel Islands, have already jumped on the cannabis economic development bandwagon, and this is only going to encourage the Germans as well as other similar conversations across the region. It has even showed up in France.
And of course, it is not like the implications of Luxembourg and Switzerland as well as recent efforts in Holland to better regulate the recreational industry there, have not been blatantly obvious to those in Europe’s largest medical market.
Look for new shoots and leaves, in other words of the next stage of cannabis reform to take hold auf Deutschland. And soon. It is inevitable.
According to a press release published July 1, ASI Global Standards announced the launch of their newest audit standard: the Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.
With input from a number of stakeholders in the cannabis space, the CSQ scheme is designed for the cannabis industry and by the cannabis industry. Each standard was developed by industry professionals and stakeholders, like growers, manufacturers and processors, to meet market, consumer and regulatory requirements from seed-to-sale.
The CSQ scheme is built on four standards:
Growing and Cultivation of Cannabis Plants
Manufacturing and Extraction of Cannabis
Manufacturing and Infusion of Cannabis into Food & Beverage Products
Manufacturing of Cannabis Dietary Supplements
There is a public comment period in effect now, and those wishing to provide input have until July 31 to do so. If certification bodies or accreditation bodies want to find more information and get involved in the CSQ certification or accreditation process, they are encouraged to reach out via email at info@csqcertification.com.
On June 19, Charles Deibel, president and CEO of Deibel Bioscience, announced two important changes to his cannabis testing laboratory: First, they changed their name from Deibel Laboratories to Deibel Bioscience. Secondly, they achieved ISO/IEC 17025:2017 accreditation.
Deibel Labs is an internationally recognized corporation of 15 testing labs in North America that’s been around for about 50 years, serving the food, beverage and personal care industries. Starting in 2018, Deibel has ventured into the cannabis and hemp markets, and recently rebranded these labs as “Deibel Bioscience.” Currently, Deibel Bioscience operates in California and Illinois, with plans underway to open labs in Florida and Pennsylvania.
Charles Deibel, President & CEO of Deibel Bioscience
Deibel’s brand is very well known in the food testing industry and has recently become a prominent voice and industry advocate in the cannabis testing community. Charles Deibel’s father, Dr. Robert Deibel, was a pioneer of the Hazard Analysis and Critical Control Point (HACCP) system. Charles Deibel has a long career in the laboratory testing space and even worked with the Department of Justice to help shape the legal case against Peanut Corporation of America and testified as an expert witness during the trial.
With respect to their accreditation, Deibel Bioscience of California (Santa Cruz) achieved it through the American Association for Laboratory Accreditation (A2LA). The lab’s scope currently holds seven chemical and microbiological test methods as well as their sampling method, with plans to expand their scope to include four more chemical testing methods in the next month.
“At our level of testing services, any lab should be able to offer accurate testing, at a fair price and a reasonable turn-around time,” says Deibel. “These three qualities are no longer defining features; rather it is our high level of service and exceptional Technical Services acumen that set us apart.”
According to Deibel, their company is drawing on decades of experience in other testing industries to provide a high caliber of technical expertise. “We are a family owned and operated corporation and are not constrained by quarterly investor demands. Our size offers economics of scale that is reflected in our service and pricing.”
According to a press release published earlier this week, ACS Laboratory announced the Florida Department of Health Office of Medical Marijuana Use (OMMU) has certified ACS to test products for medical dispensaries in the state.
This certification comes after the Florida Department of Health adopted an emergency rule, requiring dispensaries to only use a certified lab for product testing. Dispensaries (or medical marijuana treatment centers as the state calls them) in Florida have until December 24, 2020 to sell products tested before June 24, 2020.
ACS Laboratory was founded in 2008. They are DEA- and AHCA-licensed, ISO 17025-accredited and CLIA-accredited with the largest testing facility in the eastern United States, according to their press release. They are USDA-compliant and certified by Florida to test hemp in the state and are now also certified to test medical cannabis products.
As a certified cannabis testing lab in Florida, ACS has to meet a list of requirements, similar to rules one might find in other legal states. The Florida rules mandate that labs are ISO-accredited and qualified to accurately test for contaminants, moisture content and cannabinoid potency.
Earlier this year, ACS acquired Botanica Testing, Inc., which added about 500 new hemp and CBD clients to their portfolio. ACS Laboratory now has customers in 44 states.
Dr. Linda Klumpers has a Ph.D. in clinical pharmacology of cannabinoids. Originally from the Netherlands, she began much of her career in studying cannabis there. She now lives and works in the United States, where she has worked on a number of projects, started her own company and is continuing her research on cannabis as an effective medicine.
After studying neuroscience at the University of Amsterdam, she went on to train at the Centre for Human Drug Research and Leiden University Medical Center, where Dr. Klumpers obtained a clinical pharmacology degree and a Ph.D. in clinical pharmacology of cannabinoids. She has been researching cannabinoids in humans since 2006. Dr. Klumpers co-authored a number of peer-reviewed cannabinoid publications and she has received five honors and awards for her work, including the BJCP Prize from the British Journal of Clinical Pharmacology.
Dr. Linda Klumpers
In 2016, she moved to the United States and founded Cannify, an online tool that helps patients and clinicians with product matching and providing legitimate cannabis education based in sound science. In 2018, Dr. Klumpers joined forces with Dr. Michael Tagen, another clinical pharmacologist, to launch Verdient Science, a consulting partnership. Their work at Verdient Science includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies, among other areas of focus.
Right now, Dr. Klumpers is waiting to hear back from a grant application they submitted to study THC and CBD ratios for medical efficacy in chronic pain patients. We sat down with Dr. Klumpers to hear her story, what she is working on now and how she hopes to continue researching cannabis as an effective medicine.
Cannabis Industry Journal: Tell us about your background as a research scientist. How did you get involved in cannabis?
Dr. Linda Klumpers: During my Ph.D. work, we studied the effects of so-called cannabinoid receptor antagonists that block the effects of THC – I prefer to say “we”, as research is always done by multiple people. The problem with studying these compounds in healthy volunteers is that you can’t observe acute effects, which means that you won’t measure any effect after a single dose. To circumvent this issue, we applied a trick and developed a ‘challenge test’: after you give the ‘invisible’ blocking compound, you stimulate the cannabinoid system by giving people THC. If the subjects don’t feel the effects of THC, you know that the blocker worked. One thing lead to another and we ended up studying various administration methods, such as intrapulmonal (via the lungs) with vaporization, oral and sublingual. We studied the behavior of cannabinoids in the body and how the body responded to them.
CIJ: Can you share some information on the projects you are working on? What is Cannify and what is Verdient Science?
Dr. Klumpers:Cannify was founded in 2016 after I saw that too many people had opinions about cannabis that were more based on emotion than fact. Besides, I noticed that a majority of the scientific literature on cannabis pharmacology was left unnoticed and unapplied to the people getting exposed to cannabis, such as patients, the cannabis industry – that was in a very different stage at that time – healthcare providers and regulators. With my Ph.D. in cannabis pharmacology, I wanted to add a level of objectivity to cannabis education and research. Cannify’s goals are to understand the science of cannabis, and share this with others.
The way we do this is multi-fold:
Cannify Quiz: Patients with an interest in cannabis often want to know the science about cannabis and their condition. Our quiz helps these people by asking in-depth questions and showing them relevant scientific literature in a personalized report. After that, an overview is given with products and product matching scores. Our account system allows users to track their progress over time. Product manufacturers, dispensaries and other companies can use the quiz for their websites and their stores to help out retail employees and save them time, and to receive insight with our analytics on customer desires and behavior. Needless to say, an educated customer is a better customer. It is important that customers come and leave stores well-informed.
Education: Speaking of education, our website contains educational articles about everything cannabis: from plant to patient and from product to mechanism of action. We regularly publish educational quizzes for people to test their knowledge level. With a free Cannify account, you can find all of our educational quizzes and save your results. We also provide customized courses, and have educated a wide audience varying from industry professionals to CME-accredited courses for healthcare providers. On top of that, our educational videos in dispensaries (in collaboration with our partner, Enlighten) reach customers and retail employees.
One of Cannify’s educational graphics, showing the difference between topical and transdermal product administration
Research: To expand the knowledge on cannabis, performing and especially sharing research is essential. We have already performed and published some of Cannify’s results on descriptive statistics and effect prediction during conferences, as well as a review paper on cannabis therapeutics in a peer-reviewed journal and a book chapter. This year, we expect to co-publish the results of a survey in different sleep patient groups. We collaborated with the Centre of Excellence for Epilepsy and Sleep Medicine in the Netherlands on a peer-reviewed paper from which we expect new research to follow to benefit these patients. We have also co-submitted a grant to study THC and CBD ratios in chronic pain patients: fingers crossed! Another important next step is to test a healthcare provider-specific version of Cannify’s quiz in the clinic once COVID dies down. I want to add that after working in a clinical lab for many years, it is important to combine the results of clinical trials to what people do in real life, which is what we do with Cannify.
And here’s some information on Verdient Science:
Verdient Science is a consulting partnership I have with clinical pharmacologist Dr. Michael Tagen. We provide clinical and translational pharmacology expertise to improve the quality of product development & clinical testing. While both working as independent consultants, we decided from 2018 to start working together to offer better services. Since then, our work has been very variable and includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies to make them more efficient and cheaper, performed scientific due diligence and much more. When clients want additional services that are beyond our expertise, we are typically able to introduce them to various people per expertise area, or refer them to our partner companies, Complex Biotech Discovery Ventures (CBDV) with Dr. Markus Roggen, and Via Innovations with Dr. Monica Vialpando. A benefit of working with the same partners includes smooth handovers and the feeling of a one stop shop.
CIJ: How does Cannify match available products to consumer needs? Is there an algorithm you developed that matches moods or feelings to cannabinoids or chemical profiles?
Dr. Klumpers: That is a great question and the core of what we do! So back to the Cannify quiz: there are three steps:
Users fill in questions;
A personalized report is generated with the relevant science;
The user gets a product overview with product matching scores.
Another Cannify educational graphic, showing THC distribution throughout the body over time
The report and the matching scores are generated using algorithms that are regularly updated. These algorithms are based on various data sources:
Literature: There is a lot of available literature, and we make sure to select the most relevant and reliable studies;
Raw data: There is only so much one can find in the literature, and lots is hidden in the raw data. Therefore, we piled up data from studies done at various research institutions, including the University of Kentucky and Johns Hopkins University, and used them in our algorithms;
Internal studies: From the thousands of users filling in their results, there is a lot of information that we should learn from. This feedback loop helps us to better understand how the lab relates to real life situations.
CIJ: The world of cannabis research has been historically stymied by red tape, DEA interference and a host of federal regulations. How have you managed to work through all that? Do you have a DEA license? What did it take to get it?
Dr. Klumpers: Luckily, a majority of our research was and is done outside of the US. You still need to obtain the appropriate licenses, but I was perhaps lucky to have filled in every form very thoroughly and we got the licenses within months. The process is quite meticulous, as you need separate licenses for almost every step from manufacturing to administration. An additional complication is that our cannabis is not stored in our own building, but in the hospital pharmacy across the street, involving transport via the public road. Despite the roadblocks, including a legal procedure about this matter that was going on in parallel, I had no major issues getting our work done. For our research in the US, we were lucky to have been working with partners that already have the required license.
Also with publishing, I have never had an issue with the cannabis stigma. Generally, in my field of science, good quality science is very much welcomed and appreciated, and this was even before the time that there were four different cannabis-related journals, as is the case nowadays.
CIJ: Looking to the future, where do you hope to focus your research efforts? Where do you think the cannabis community should be focusing their efforts in the next 5-10 years?
Dr. Klumpers: Besides continuing to analyze the data generated from Cannify, I keep my fingers crossed for the grant application I mentioned earlier on THC and CBD ratios in chronic pain patients. Although we know that CBD is able to influence THC-induced effects, it is not known at what dosages, which ratios and how the effects are related to each other. For example: is CBD able to decrease certain side-effects of THC without decreasing pain-relieving effects?
Whatever is done, wherever in the community: good quality data are keyNext to that, I am also interested in other neurological and psychiatric disorders, and, of course, my Ph.D. love: the cannabinoid antagonists. Sadly, all the research efforts on this compound group were halted more than a decade ago. However, there is a renewed interest. I would love to help turn these compounds into effective and safe medicines.
Regarding the cannabis community: 5-10 years sounds really far away for an industry that is relatively new to many, but a lot has already changed since I started cannabis research more than 14 years ago and time has flown by. Some changes have been positive and others less so. Whatever is done, wherever in the community: good quality data are key. Many companies gather data and even publish them in peer-reviewed journals, but that does not always mean that the data are useful or that the studies were done well. Only a few minor changes to how and which data are gathered, and so much more can be done. What can help with achieving this is to let the right people do the right thing: many call themselves a ‘cannabis scientist’ or ‘cannabis expert’, but that does not mean anything. What has someone truly achieved and what is their exact expertise? A Ph.D. in chemistry is not going to help you in setting up effect studies, neither will I be able to improve your product’s shelf life or extraction yield. Getting the right people in the right place is key. Lastly: the cannabis community should stay critical. The length of one article in Cannabis Industry Journal wouldn’t be enough to lay out all the misconceptions that people have about cannabis. Make sure that those misconceptions do not live on and do not be afraid to admit you don’t know something, irrespective of the branch you work in: only then, can the cannabis community progress to the benefit of all.
The South African government has taken a leap into the future (ahead also of the expected World Health Organization (WHO) decision on cannabis this December). Namely, it has begun to regulate hemp (more in line with Europe intriguingly, than the U.S.) and attempted to remove the THC part of the equation from a domestic list of plants and drugs with no medical use.
The notice was signed by South African Minister of Health Zweli Mkhize and published a week after a domestic moratorium on CBD expired. The moratorium permitted the sale of some kinds of CBD products.
This is an intriguing new development, although it will also undoubtedly cause headaches for the burgeoning industry in the region.
On The CBD Front…
South Africa’s new hemp guidelines – namely for the amount of THC allowed in legit hemp crops that are also regulated – are that plants contain no more than 0.2% THC. This makes the guidelines absolutely in line with what is generally developing across the EU. And even more intriguingly, below federal guidelines for most U.S. domestic hemp crops (which are 0.3% at a federal level and only differ in a few state cases where the amount is lower by state law).
However, there is also a unique twist to all of this: The South African government has now created a two-pronged regulatory schemata just for CBD. The default approach to the cannabinoid is that it is in fact medication, scheduled under South African internal and global drug guidelines as a “Schedule 4” drug.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
The other designation is reserved for CBD packaged in sizes of 600mg or less (and limited by instructions to no more than 20mg a day). This kind of CBD (despite the dubious understanding of cannabinoid science) will henceforth be labelled a “supplement” and on “Schedule 0”.
However, do not be fooled: This is not “descheduling.” This actually means that all CBD has been classified as a medical substance except in packets that are under a certain size, with portion suggestions on the outside of the wrapper or package.
That is hardly scientific. However, what is more burdensome is that any CBD cultivator in South Africa must also be GMP- (or internationally medically) certified (even if bound for the supplement market). By definition, in other words, it will make the cost of production for the supplement (commercial, food and cosmetic) part of the equation as expensive as pharmaceutical production. While from a purist’s point of view, having ultra clean cannabis in any product (at the level of pharmaceutical standards) is a wonderful idea, but this gets ridiculous when it comes to reality, and will ultimately never stand.
This development is also undeniably inconvenient (at minimum) for any who had envisioned outdoor hempires, which most of the cannabis grown in South Africa is. The only people who have the money to build indoor grows, starting with GMP certified greenhouses, are, for the most part, white people, foreigners or those who own property and have access to external, international equity.
The sins of Apartheid, in other words, are being writ large on the entire cannabis industry at present in South Africa. And CBD is contained right in the middle of the mix.
On The THC Front…
There are several interesting aspects to this.
The first is that THC has been removed from the South African “Schedule 7” which is roughly equivalent to the international “Schedule I” that cannabis also resides in until the WHO re- or deschedules the same.
However, this also means that all CBD as well as THC must be produced by those with pharmaceutical-grade facilities – and this of course includes more than just indoor, temperature-controlled greenhouses. It also includes a complex supply chain that is European and Western centric, starting with the requirement to access a rather large amount of capital to construct the same.
Global Re-Alignment Or Stopgap Measure?
This new regulation, in other words, specifically leaves the vast majority of what has already been seeded, or what is most likely to be, in the hands of a few Canadian and other companies who have been moving in this direction for the last several years.
It also implies, intriguingly, that the intra-African cannabis market is low priority at present for those writing the (health) rules. And that also means that eyes are being set more on creating an export market than for treating South African citizens.
It is not an unusual move, rather tragically so far. And almost certainly one that will be challenged, and in several directions, both by events, but also by firms caught up in the mix.
Why? For starters, the South African cannabis market also effectively controls the Lesotho cannabis regulatory scheme (namely all exports from Lesotho, which has seen quite a lot of cannabis investment over the last several years). All such crops must be labelled per South African guidelines if they, literally, can hit a port to be exported.
The vast majority of those grows, even with relatively decent foreign backing, are also outside – and of course as a result ineligible for GMP certification.
Of course given the fact that the UN is likely to clarify both the status of THC and CBD by the end of the year, this current situation in South Africa is also fairly clearly intended to be a stop-gap regulatory measure to last up until at least this time.
Where it may go after that is anyone’s guess. This measure, however, is also clearly being made to protect those who have invested in GMP-grade facilities as opposed to those who have been clearly angling for reform on the CBD front, starting with the beer market. Stay tuned. Interesting developments clearly ahead.
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