The ANSI National Accreditation Board (ANAB) accredited ABKO Labs, LLC, to ISO/IEC 17025. ABKO Labs is a cannabis and hemp testing laboratory based in Warren, Michigan.
According to the press release, ABKO Labs achieved ISO/IEC 17025 accreditation in Michigan with the help of ANAB. The lab earned the accreditation in general requirements for the competence of testing labs, demonstrating competence in chemistry in microbiology.
“We are very proud of our accomplishments in the cannabis lab space in Michigan and we look forward to continuing to offer accurate and prompt results,” says Amy Brown, CEO of ABKO Labs, LLC.
In a press release published last week, Cannabis Testing Laboratories (CTL) announced they have achieved ISO 17025 accreditation as part of the Nebraska Department of Agriculture requirements for cannabis labs operating in the state. CTL is a wholly-owned subsidiary of Doane University, a liberal arts college in Crete, Nebraska.
Dr. Arin Sutlief (in back) and Dr. Andrea Holmes preparing samples for cannabinoid analysis by HPLC.
According to the press release, CTL will be renting space on Doane University’s campus for its primary laboratory. Doane University is working on an effort to foster innovation where they create spaces on campus for entrepreneurial startups. Dr. Andrea Holmes, Director of Cannabis Studies and Professor of Chemistry at Doane University, is the founder of CTL. Dr. Arin Sutlief is the director of the laboratory as well, which means CTL is led by an all-female management team.
Dr. Holmes says hemp testing should be a priority for the state’s new industry. “Being the first ISO-accredited and state approved cannabis testing laboratory in Nebraska will allow farmers, processors, vendors, and even consumers of CBD and hemp products to have local access to high-quality and reliable testing,” says Dr. Holmes. “For farmers, continuous testing is of utmost importance so they don’t grow hemp over 0.3% total THC levels, at which point hemp is categorized as marijuana, which is currently illegal in Nebraska. Consumers of CBD products will also benefit from private testing as oftentimes CBD-infused products don’t actually contain what the label says.”
Hemp weighed for sample preparation for cannabinoid analysis by HPLC.
CTL will operate independently of the university, but the lab will be a resource for faculty and students. There will be internship and experiential learning opportunities available at the lab for students. In addition to that, the lab will also help faculty that teach cannabis-related courses.
Last year, Doane University announced the launch of their Professional Cannabis Certificate Program. In June of this year, the university expanded their course offerings in cannabis, with seven courses available this fall. The addition of CTL to the Crete, Nebraska campus will benefit those new courses and provide more resources to those in the certificate program.
“I am proud to be one of the creators of a fully accredited cannabis testing lab that provides our farmers and processors reliable and quick local testing of hemp,” says Dr. Sutlief. “CTL is among the first ISO-certified cannabis testing labs in the U.S. that is a subsidiary of a university. Innovation, research, entrepreneurship and education will be the central pillars of CTL as we set ourselves apart to become leaders in cannabis testing not only in Nebraska and the Midwest but also nationally.”
In a press release sent out last week, KCA Laboratories announced they have been awarded hemp testing contracts for Massachusetts and North Dakota. They received the notices through the North Dakota Department of Agriculture and through the Massachusetts Department of Agricultural Resources’ Hemp Program that they were awarded the contract.
KCA Laboratories is an independent, third-party testing laboratory based in Nicholasville, Kentucky that specializes in hemp testing.
According to Ryan Bellone, Commercial Director for KCA Labs, they started the company to focus strictly on hemp testing. “The team here at KCA Labs is grateful for the opportunity to analyze North Dakota’s and Massachusetts’ hemp samples for Total THC content,” says Bellone. “We started KCA Labs to elevate the quality of testing in the hemp industry. It has been our goal from inception to service regulators, farmers, processors, and retailers with trusted results. KCA is excited to work with North Dakota and Massachusetts as well as the farmers and processors they serve.”
Bellone says they have started seeing a backlog of samples in a number of states for hemp regulatory compliance testing. “For years, a lack of laboratory testing was a bottleneck for the industry and now that the market has more options, testing turnaround time should not be a barrier.”
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.
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.
The news is intriguing in a world overwhelmed with pandemic news. THC Global, a Canadian-Aussie company now raising money and signing global deals, has just bought a “clinic network” of 30 prescribing physicians that will be able to supply up to 6,000 Australian patients this year.
In doing so, this entity is clearly beginning to establish a pattern of expansion in a new medical market not seen so far outside of Canada. Namely being able to obtain the all-important prescription for one’s brand at the doctor or prescriber’s office which is affiliated with a certain producer. Pharmacies and dispensaries downstream have no discretion for any other product to sell if the brand is written right on the prescription itself.
And this marks a new step in an industry frustrated with the high prices and high levels of red tape in other international environments where more widespread medical cannabis reform has come.
The Situation in Germany Germany represents, so far at least, the destination market of choice for Canadian cannabis firms (for the last several years at least). This is for several very sound business reasons (at least in theory).
Photo: Ian McWilliams, Flickr
The German medical market is the largest in Europe. Health reforms which swept the country at the time of reunification also created a system that is in its own way a hybrid of the more European (and British) NHS and American healthcare. Namely, 90% of the German population is on the system, but it is tied to employment and income. Freelancers, even of the German kind, must use private healthcare as must all non-passport foreigners. If you make over a certain amount of money (about $65,000), you must also pay for private healthcare. As the cannabis revolution rolls forward, many cannabis patients are caught in changing rules and a great reluctance by public health insurers to allow fast entry of any new drug, including this one. This is based on “science” but also cost.
Bottom line? Yes, the market is lucrative and growing, and yes, cannabis is covered under public health insurance, but the ability of any producers to be able to maintain a reliable, steady market of “prescribers” is highly limited. Furthermore, unlike anywhere else in the world, pharmacists play an outsized role in the process – namely because there are no chains (more than four brick and mortar outlets are verboten). Prices and availability vary widely across the country.
There are also no “online” drug stores where patients can send prescriptions in the sense that this vertical has developed in other countries.
Hospital dispensation is, for all the obvious reasons, highly expensive and generally prohibitive for the long term, if not serving much larger numbers of patients.
The Problem in the UK Like Germany, the UK decided to launch medical “cannabis” – or at least cannabinoid-related drugs under the purview of the NHS, but there are several issues with this.
The problems start with the fact that the system remains a monopoly for one British company, GW Pharmaceuticals. The medication produced by them, including Sativex and Epidiolex is expensive and does not work for many patients that it is produced “on label” for (such as MS or childhood epilepsy).
And then of course, the largest group of cannabis patients anywhere (chronic pain) have been explicitly excluded from the list of conditions cannabis can be prescribed for under public health guidelines in the UK. This, like Germany, has created a highly expensive system where those patients who obtain the drug on a regular (and legal basis) have to have both private healthcare and obtain help through private clinics. While there are several chain clinics now forming in the UK, this is not the same thing as “buying” patients in the thousands – the model seen in Canada from the beginning of 2014.
The market has a lot of potential, in other words, but like Germany, via very different paths to market than seen in Canada, in particular.
Why Is Canada Different? The development of the medical market came through federal change in the law around the turn of the century. Namely, after patients won the right to grow for themselves, via Supreme Court legal challenge, patient collectives gradually formed to grow and sell cannabis that was more “professionally” cultivated. This, in turn, became the right of private companies and indeed household names in the Canadian market saw buying patient pools as their path to financing on the equity markets as of 2014.
This is not widely popular within the industry. Indeed, the last legal challenge mounted by the industry to ban non-profit patient collectives fell apart in 2016 – the year that the larger Canadian companies began to look abroad to Europe.
It is also undoubtedly why, beyond the red tape they face in Germany and the UK if not across Europe, Canadian firms are looking to hybridize a model which worked well for them at least in the early days of capitalization of the private industry. And maybe Australia will be “it.” Stay tuned.
According to a press release, the University of Colorado at Boulder is offering a new course focused on cannabis science through the Continuing Education program at the university during the upcoming Summer and Fall semesters.
The class is called Modern Cannabis Science and will involve a lot of genetic research. The course is sponsored by the Agricultural Genomics Foundation, a non-profit dedicated to scientific research and education in cannabis. In the press release, they describe the course as meant for students who are well informed, but “seek a deeper appreciation of scientific advancements in cannabis genetics.”
Here’s a snapshot of what students can expect to learn from it:
In Modern Cannabis Science, we will explore the range of Cannabis research currently available covering topics such as evolutionary history and global distribution, sex chromosomes, genetic contribution to chemotype, and analyses to aid law enforcement and forensic investigations. We will examine how genetic data allow us to understand relationships between strains and common categories in the Cannabis genus, and why this is important for breeding, policy-making, and medical purposes.
The press release suggests students who enroll can expect to use this knowledge in the cannabis industry. “For example, a budtender will be able to more accurately recommend strains to users,” reads the press release. “Similarly, medical personnel will more fully understand the relationship between strains, the compounds they produce, and how to properly advise Cannabis patients.”
On May 13, months after the Israeli government originally signed off on cannabis exports, a free export order was finally approved by outgoing Minister of the Economy Eli Cohen. This is also sixteen months after the government approved exports of locally grown cannabis (at least in theory) and after the country began importing earlier this year as domestic patients were given priority for existing medical supplies.
However, all the internal barriers have now been officially removed. Exporters who wish to sell medical cannabis abroad are now able to obtain a license, as the order enters into full force by mid-June. The new regulation specifically requires that such products have obtained GMP certification (the pharmaceutical-grade cert required for all medical cannabis in Europe’s medical markets).
Licensing Already Underway
At least two Israeli companies have already obtained such licensing approvals. Cannabics, a company located in both Israel and Bethesda, Maryland, has obtained final approval of its drugs for export to both Canada and Europe, as well as Australia. The company is licensed by the Israeli Ministry of Health to conduct research and development on cannabinoid-based medications and cancer and operates a facility in Rehovot.
Cannabics describes itself as an American pharmaceutical company with R&D operations in Israel.
However, there is another interesting twist to all of this. Cantourage, a German company founded by entrepreneurs behind Pedianos, one of the two earliest importers of medical cannabis into the country (created in 2015 and subsequently purchased by Aurora), announced its import of the synthetic dronabinol to Germany from BOL Pharma, based in Israel, in late April. In doing so, they also became the first company to challenge Canopy Growth in its domination of the synthetic cannabinoid market which remains about one third of reimbursed prescriptions by volume (at least ffor publically insured patients) of cannabinoid medications.
Why Is This Development So Significant? The European and Canadian markets are clearly leading the world in at least the consumption of cannabinoid-based medications – which by definition are based on extractions of the plant, beyond floß (or flower). Israeli producers have been banned from entering these markets for the last several years due to internal political struggles domestically, and an apparent deal between Israel and American presidents Benjamin Netanyahu and Donald Trump to delay market entry.
This delay also impacted Israeli firms hoping to enter the first German cultivation bid, which was finally decided last spring. It is expected that the first domestically cultivated product will be distributed to local apothekes as of this fall, although this may be slightly delayed as a result of fallout from the COVID-19 pandemic.
This delay is not expected to impact the import market in the country, which is the source of all flower-based medicine here, and will continue to be a strong market segment. The bid itself only called for a limited production of cannabis in Germany, and was already too little to meet the needs of domestic patients.
However, what the potential lag in German product also does is open a door for Israeli products to now enter the market before German-produced cannabis becomes available.
A Steep Uphill Climb What the COVID-19 pandemic has clearly affected, more than drug entry, however, is something almost as important – namely doctor education. For a producer or distributor to get sales via German pharmacies, they also have to ensure that doctors are prescribing the drug. This is a lot easier if the product is a generic, like dronabinol, because doctors can write prescriptions for a drug which can now be sourced from several sources. It becomes a little harder to do that with any formulated substance, and further one with a “brand” name. Especially because German doctors are right now are on the forefront of an uneasy “flattening the curve” scenario as the economy continues to cautiously resume somewhat normal operations.
The challenge that remains, indeed not just for Israeli entrants, but everyone with new product formulations, is educating doctors about prescribing such medications, and further, obtaining insurance approvals for those who have been prescribed such drugs.
Cost, which is beginning to be addressed by the regulated pricing established here for domestically produced cannabis, is still in the room too.
The Market Continues To Open Regardless of the struggle, and the costs involved, it is clear that the German market is obviously now finally opening to Israeli firms and on the processed medical front (as opposed to “just” flower).
Further it is also a sign that the market here is maturing, and even specializing.
No matter the obstacles, in other words, and despite the pandemic, the global market for cannabinoid drugs continues to expand.
UPDATE: Late in the evening on May 15, the House of Representatives passed the HEROES package, voting 208-199 (with 23 abstentions). The bill now now heads to the Senate where its fate is more uncertain.
Earlier today, Speaker Nancy Pelosi debuted the latest piece of legislation to help Americans impacted by the coronavirus pandemic. The Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) is a large bill containing emergency supplemental appropriations more than 1,800 pages long.
On page 1,066, those in the cannabis industry will find a very exciting addition: the Secure and Fair Enforcement (SAFE) Banking Act. For the uninitiated, the SAFE Banking Act would ensure access to financial services for cannabis-related businesses and service providers.
Currently, federally regulated financial institutions face penalties for dealing with cannabis companies due to the Controlled Substances Act. The bill, if passed, would eliminate the possibility of any repercussions for doing business with cannabis companies.
The impact of this bill becoming law would be widespread and immediate for both the cannabis market and banks looking to invest in the cannabis industry. With banks given the green light to conduct business with the cannabis industry, there is no doubt that many financial institutions will rush to the opportunity. Cannabis businesses will benefit greatly, no longer having to deal with massive quantities of cash and gain access to things like loans, bank accounts and credit lines. Furthermore, cannabis companies will benefit from the rush of banks getting in the game, leading to a competitive and affordable banking market.
It is no secret that cannabis businesses have had a cash problem for decades now. Given the coronavirus pandemic, CDC guidelines dictate minimizing the handling of cash and encourage payment options like credit cards. Cannabis businesses dealing with large quantities of cash puts them, their employees, their customers and even regulators at risk.
Aaron Smith, executive director of NCIA
According to Aaron Smith, executive director of the National Cannabis Industry Association (NCIA), the cash problem is a serious, unnecessary health risk. “On behalf of the legal cannabis industry, we commend the congressional leadership for prioritizing public health and safety by including sensible cannabis banking policy in this legislation,” says Smith. “Our industry employs hundreds of thousands of Americans and has been deemed ‘essential’ in most states. It’s critically important that essential cannabis workers are not exposed to unnecessary health risks due to outdated federal banking regulations.”
In fact, it was the NCIA and a handful of other industry organizations that lobbied Congress last week to include language from the SAFE Banking Act in the HEROES Act, citing the known fact that cash can harbor coronavirus and other pathogens, along with the “personal proximity required by cash transactions as reasons for urgency in addition to the other safety and transparency concerns addressed by the legislation.”
The SAFE Banking Act was already approved by the House of Representatives. In September of 2019, the bill made a lot of progress through Congress, but stalled once it made it to the Senate Banking Committee.
The HEROES Act will be debated by the House of Representatives prior to a floor vote. If it passes the House, it moves to the Senate, which is about as far as it made it the last go around. However, because the banking reform is included in coronavirus relief legislation, there is a newborn sense of hope that the bill could be signed into law.
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According to the press release, ABKO Labs achieved ISO/IEC 17025 accreditation in Michigan with the help of ANAB. The lab earned the accreditation in general requirements for the competence of testing labs, demonstrating competence in chemistry in microbiology.
