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The CBD Regulatory Environment in Europe: Part 2

By Shelley Stark
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This is Part Two of a four-part series discussing European cannabis regulations. Click here for Part One. Part Two analyzes the differences between the UK, the EU and the US. Part Three, coming next week, dives into dosage, approvals and more. Stay tuned for more.

EU Regulatory Environment

We Europeans look with envy at the American market and wonder, why can’t we be more like that? The differences between the American market, the UK and the EU economic zone couldn’t be more different, but changes seem to be on the horizon. While both the UK and the EU apply the Novel Food law, implementation varies significantly.

In the EU, applications are submitted to the EU Commission, and approval can take up to nine months – just for approval of the application – not the testing that will follow. And while the application carries no fee, collecting the required data just to make the application can be expensive, and can run into six figures or higher. Once the application is approved, there may still be data gaps and uncertainties, with toxicology testing that can take years to complete, and ultimately must be approved and validated by EFSA (European Food Safety Authority). The required toxicology testing is where things get really expensive, with both the EIHA (European Industrial Hemp Association) and EFSA estimating costs around €3.5 million.

The EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications thus far for CBD as a novel food, with more in the pipeline. According to their website, NDA chair Prof. Dominique Turck reported that they “have identified several hazards related to CBD intake” and that many data gaps need filling before evaluations can go ahead. However, she concluded, “It is important to stress that we have not concluded that CBD is unsafe as food.”

As always, with food and drug reviews, it is up to the applicant to prove that a product is safe for human consumption. And for the EU Commission, EFSA is conclusive. And while initial testing is with animals, it also includes human testing, which helps explain the high cost.

At present, the EFSA has been unconvinced by the applications submitted so far, and seeks more data regarding the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being, as well as the impact on human reproduction.

Thus, in 2019, the EIHA formed a German corporation, the “EIHA projects GmbH”, formed for the purpose of pooling partners money to pay for the application and toxicity testing. The Novel Food applications (NFAs) for CBD isolate and synthetic CBD were submitted on November 4, 2022 and full spectrum will follow in April/May of 2023. It should be noted that the application for synthetic CBD has been completely dropped as no testing was ever preformed.

The applications must be reinforced by a series of tox studies under the auspices of the EFSA and for the UK, the FSA. The EFSA will start the risk assessment as soon as the suitability check is performed. The suitability check is a process performed by EFSA to make sure that they have enough data to perform the risk assessment. According to their webpage, the risk assessment can take nine months.

In the case of the application put forth by the EIHA projects GmbH, the CBD isolate dossier will be submitted to the EFSA in September and enter the risk assessment phase. In this phase, the EFSA will go over the data and can ask for more data, should they feel it necessary. They are allowed 9 months to complete this task and submit their recommendations to the EU commission for a 27-member vote, whereby the EIHA projects GmbH application will be valid and legally binding. The EIHA projects GmbH is expecting a validation during the course of 2024. This is a huge game changer!

The application for Full Spectrum distillate should be readied by the end of 2023, whereby the EFSA should be finished with the risk assessment near the end 2024. As Full Spectrum takes into account minor cannabinoid as well as limited THC, it is more complex. It should be noted, that testing full spectrum distillate with a 0.2% THC limit, tests the limit for how much THC can be ingested by humans without side effects. This study is unprecedented and might well have an enormous impact on the issue of THC and its possible future legalization. It is also costing a further one million euros to bring to fruition.

The UK Regulatory Approach

The UK Novel Food approach differs greatly from the EU’s, which has both strengths and weaknesses. What makes the UK CBD market so robust is that the FSA allows products to be sold as long as they were on the market prior to February 13, 2020 and are linked to applications submitted before March 31, 2021. As a result, the FSA was flooded with applications – many later denied on technical grounds, in great part because they didn’t meet these terms. Currently, some 11,000 products worth a projected 1 billion GBP in revenue remain on the FSA list, having passed pre-validation while the FSA awaits the final toxicology report. Only 400 CBD products have been culled from the list, but to date, not a single application has yet been approved. Pre-validation status is incumbent upon a toxicology report, and it remains to be seen how many companies are able to produce such a report.

Important to note is that due to Brexit, a UK validation when it does come, will not be valid in the EU, but products with an EU application accepted on the Union list will be valid in the UK.

UKflagStill with a projected 1 billion GBP at stake, it is easy to why UK CBD manufacturers work to appease the FSA despite the regulatory hurdles. By keeping the door open, the UK has managed to keep investors interested in the CBD market and the public safe from unmonitored products.

This is certainly not the case in the EU, where despite a smattering of products still ducking the authorities, the EU market remains thin by comparison. Their approach has stymied growth compared to the UK where robust Novel Food regulation is in place, but approached differently.

At present, a market comparison of the EU to the UK or North America seems bleak, at least for now, but following approval, future EU-wide distribution could be highly profitable. As we inch closer to a Novel Food listing, the European market may yet prove to be one of the largest markets for the safest CBD products in the world.

The American Market

Still, it is the American market that makes our mouth water; where oils, tinctures, candies, cakes, and drinks with every cannabinoid from CBD to Delta 9, Delta 8, and HHC are available and producers are on their way to becoming millionaires. With a market currently estimated at $6 billion, forecasts reach upwards of $16 billion by 2026.

FDAlogoAnd the health-related concerns, the testing requirements? Are these limited to the UK and the EU? Let’s take a closer look! A mood of caution is emerging in the American cannabis market, that includes producers and lawmakers alike, who are pushing for stricter laws and enforcement.

In America, the FDA (Food and Drug Administration) has alerted the public to CBD’s potential harmful side effects on their website and hope to force congress to deal with the issue.

Many of their concerns validate those of the FSA and the EFSA. For example: on their website the FDA makes a reference to only one CBD product that has been approved: a medicine called Epidiolex. The FDA cites the review of the Epidiolex’s application in 2018 when they identified certain safety risks, including potential for liver damage. The EFSA requires testing on the same issue.

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Canopy Growth Acquires Jetty Extracts

By Cannabis Industry Journal Staff
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Canopy Growth Corporation, one of the largest cannabis companies in the world, announced the acquisition of Jetty Extracts this week for $69 million. Jetty Extracts was founded in 2013 and is now a leading cannabis brand in California and a top 5 brand in the vape category. The two companies plan to expand Jetty’s offerings in California, Colorado, New York and across the broder to Canada, according to a press release.

Canadian-based Canopy Growth is a massive international company that has been expanding its presence well beyond Canadian borders. For years now. Their medical arm, Spectrum Therapeutics, is a leading brand in Canada and Germany.

Some of the Jetty Extracts product offerings

Back in 2018, Canopy solidified a partnership and took considerable investment from Constellation Brands on a long-term play to enter the cannabis beverage market. Then in 2019, they began their aggressive expansion into the U.S. through the multi-billion-dollar deal with Acreage Holdings who, at the time, was the largest U.S. cannabis company. In April of last year, they inked a deal with Southern Glazer’s Wine & Spirits following the launch of their first CBD-infused beverage line sold in the United States, Quatreau.

Late last year Canopy Growth announced a deal to acquire Wana Brands, the number one cannabis edibles brand based on market share in North America. The latest acquisition of Jetty Extracts this week follows the same pattern of increasing their North American footprint in the cannabis market considerably.

David Klein, CEO of Canopy Growth, says the cross-border potential excites them. “”Canopy Growth is building a house of premium cannabis brands with a focus on the core growth categories that will power the market’s path forward, now including Jetty – a pioneer of solventless vapes,” says Klein. “There are significant opportunities for Jetty to scale at the state-level across the U.S. by leveraging Canopy’s U.S. ecosystem, and we’re actively working on plans to bring the brand to the Canadian recreational market.”

Analysis of 2020 Ballot Measures

By Laura Bianchi, Justin Brandt
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November 3 was a historic night for legalization across the country. Only a decade ago, cannabis was illegal for nonmedical use in all 50 states. Now, the tide has turned, and every presented cannabis-related initiative has passed, pushing the U.S. adult use cannabis market to 15 states with a population of over 110 million. If nothing else, this year’s election results provided clarity that American voters have become more open to the benefits of cannabis.

Here’s a list of states that passed cannabis-related measures in the 2020 election, along with an analysis of each initiative and what it means for the future: 

New Jersey: Public Question 1

New Jersey’s ballot proposed and ultimately passed the measure Public Question 1, making it the first Mid-Atlantic state to legalize adult use cannabis.

Expected to take effect January 2021, this measure legalizes the adult use of cannabis for anyone over the age of 21 along with cultivation, processing, and retail sales. The Cannabis Regulatory Commission oversees the state’s medical cannabis industry and will now be responsible for the new adult use cannabis market. However, since the ballot measure didn’t outline many details, it has left a lot of discretion up to the state’s legislature, leaving residents awaiting specifics about home-grow rules, possession limits, and other retail regulations.

Public Question 1 will apply the state sales tax of 6.625 percent. However, under this measure, the local jurisdictions are permitted to implement an additional 2 percent, so the final tax rates remain undecided. With New Jersey’s nearly 8.9 million residents, it’s projected to have adult use sales of around $375 million in just the first year and estimated to reach up to $900 million by 2024.

Mississippi: Initiative 65 & Alternative 65A

Mississippi had two competing measures on the ballot to legalize cannabis for medical purposes: Initiative 65 and Alternative 65A. Initiative 65 prevailed with 74 percent of the vote.

Between 2018 and 2019, over 228,000 Mississippi residents signed a petition that led to Initiative 65 appearing on the ballot. And by mid-2021, the legalization of medical cannabis is expected to take place. This initiative is designed to allow medical cannabis treatment for people with at least one of 22 specified qualifying conditions, including ALS, post-traumatic stress disorder (PTSD), epilepsy and Parkinson’s disease. The passage of the initiative allows those patients to possess up to 2.5 ounces of cannabis at one time with a cannabis sales tax set at the state’s regular sales rate of 7 percent.

The Mississippi Legislature proposed the competing ballot item, Alternative 65A, in what supporters of Initiative 65 believed was an effort to confuse voters. This measure restricted the use of cannabis to only terminally ill patients but did not specify qualifying conditions, possession limits or a tax rate leaving the results somewhat ambiguous with many details to be set by Mississippi Legislature. Initiative 65 easily won over the alternative with nearly 74 percent of voters approving versus just over 26 percent for Alternative 65A.

Montana: I-190 & CI-118

Montana became the 14th state to legalize adult use, passing both cannabis-related initiatives on the ballot: Initiative 190 (I-190), which creates a legal adult use cannabis market, and Constitutional Initiative 118 (CI-118), which supplements I-190, allowing the state to establish the legal purchasing, consumption or possession age of 21.

These ballot issues will go into effect beginning January 2021. Initiative I-190 legalizes the adult use and possession of up to one ounce of cannabis or 8 grams of concentrate. It also allows individuals to cultivate up to four cannabis plants and four seedlings in their residence.

Depending on the circumstances, anyone serving cannabis-related sentences for reasons no longer considered crimes under I-190 may request to be resentenced or have their conviction expunged.

Cannabis and infused product retail sales will be taxed at 20 percent. Following the Montana Department of Revenue’s deduction of administrative costs to enforce the measure, remaining tax revenue is set to be allocated to the state’s general fund, veterans programs, conservation programs, drug addiction treatment programs, and local law enforcement and healthcare workers.

South Dakota: IM-26 & CA-A

South Dakota made history as the first state to legalize both medical and adult use in the same election, moving from total prohibition to legalization in just one night. First came Initiated Measure 26 (“IM-26”), South Dakota’s medical cannabis ballot item, passing with nearly 70 percent of the vote. Then came the adult use initiative, Constitutional Amendment A (CA-A), narrowly passing with almost 54 percent of votes.

Both ballot issues are set to go into effect on July 1, 2021. IM-26 establishes a medical program for individuals with a physician-certified debilitating medical condition. Patients can possess a maximum of three ounces of cannabis and, for patients registered to cultivate at home, they will be permitted to grow up to three plants at minimum unless otherwise prescribed by their physician. However, under this measure, the Department of Health can limit the number of cannabis products each person may possess and make amendments to the conditions qualified as debilitating.

CA-A legalizes the adult use of cannabis for adults age 21 and older, allowing possession or distribution up to one ounce, and for those living in a jurisdiction with no licensed retail stores, permitting the growth of up to six cannabis plants in a private residence. This measure also requires the state to adopt hemp laws.

Marijuana sales will be taxed at 15 percent under Amendment A, estimating revenue of $29.3 million by 2025. After any revenue is used for costs associated with implementing this measure, remaining revenue will be divided between public schools and the state’s general fund. 

Arizona: Prop 207

On November 3, voter initiative Proposition 207 passed with 60 percent of the vote, and Arizona became the 13th state to legalize adult use cannabis – a movement that’s expected to make a great addition to the state’s already thriving medical cannabis program.

Also known as the Smart and Safe Act, this initiative legalizes the possession and use of cannabis for residents age 21 and older. It requires the Department of Health and Human Services to develop the rules regulating businesses in areas like licensing of retail stores, and production and cultivation facilities. Individuals will now be allowed to grow up to six plants in their private residences, with no more than 12 plants per household.

Prop 207 placed a 16 percent excise tax on cannabis sales in addition to the state’s 5.6 percent, totaling a 21.6 percent tax. It is estimated that legal cannabis will generate $300 million in revenue, which will be divided between community college districts, municipal police, sheriff and fire departments, fire districts, highway funds and a new Justice Reinvestment Fund. This initiative also allows anyone convicted of certain cannabis-related crimes like possession, consumption, cultivation or transportation to petition for the expungement of their record beginning July 2021.

Each of the initiatives above is expected to provide a wealth of job opportunities and economic growth for their state. This transition also allows those in the cannabis law and regulation industry the chance to develop and implement meaningful and accessible social equity licensing programs. In addition to day-to-day business needs, our firm will be working closely with clients as they transition from strictly medical cannabis licenses to dual licensing. We will also help new licensees build out and develop their adult-use licenses with long-term success in mind.

Cannabis has quickly become a mainstream health and wellness solution for people all across the globe. With the estimated annual national market for cannabis being $50-$60 billion, it’s believed to be a real solution to many local economic shortfalls caused by COVID-19, opening up the country and cannabis industry to a whole new world of opportunity.

Sustainable Hemp Packaging is the Future of Industrial Packaging

By Vishal Vivek
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The future of packaging is ripe for capitalization by the drivers of sustainability culture. With the battle lines drawn and forces at play in motion, change is now inevitable. The question arises: how quickly can the industry grow in the space of the next decade?

With an increasing number of nations banning non-biodegradable and petroleum-based plastics in certain uses, the choices at hand have naturally led to bioplastics. Bioplastics are a major ingredient of the renewable packaging industry. We derive them from various renewable agricultural crops, of which hemp is among the chief examples.

The Change for Hemp

The legal ramifications of the European Green Deal and the American Farm Bill of 2018 have created a microcosm where the sustainability discussion has turned into corporate initiatives for crops like industrial hemp, which are a source for bioplastics and numerous other products. The smaller carbon footprint of industrial hemp plays its role in shaping consumer demands towards a greener future.

Farmers are now able to cultivate the plant in the U.S., due to its removal from the list of controlled substances. Agribusinesses and manufacturers are aware of the plant’s versatility, with uses in packaging, building construction, clothing, medicinal oils, edibles like protein powder and hemp hearts, hemp paper and rope. What was once George Washington’s strong consideration as a cash crop for his estate, may gradually become the world’s cash crop of choice.

Hemp’s Sustainability Beckons 

Why is the crop unanimously superior in the aspect of eco-friendliness? Its growing requirements are frugal: water, soil nutrients and pesticides are not needed in large quantities. It absorbs great quantities of carbon dioxide from the atmosphere, and uses it to create 65-75% cellulose content within its biomass. Cellulose is vital in the manufacture of bioplastics. Hemp is also flexible within crop cycles, due to its small harvesting period of only 4 months.

Thus, farmers use it as a rotational crop, allowing them to also cultivate other crops after its harvest. High-quality crops like cotton, though superior in cellulose content and fibrous softness, require far more water quantities, soil nutrients and pesticides. Farmers face greater difficulties in cultivating cotton as a rotational crop, because it requires far more space and time.

Hemp Bioplastics For Packaging                                

We manufacture bioplastics from the hurd and cellulose of the hemp plant. Hemp bioplastics are biodegradable, and take up to a maximum of 6 months to completely decompose; by contrast, normal fossil-fuel-based plastic takes up to 1000 years to decompose.

Manufacturers incorporate these ingredients into existing manufacturing processes for regular plastics, such as injection molding. Thus, we can apply bioplastic ingredients to similar plastics applications, such as packaging, paneling, medical equipment and more. New technologies aren’t necessarily needed, so companies and manufacturers do not have any reservations about its viability as an industry.

Here are a few types of bioplastics derived from hemp:

  1. Hemp Cellulose-based Bioplastics

This is a substance found in plant cell walls. We use cellulose to manufacture a broad range of unique plastics, including celluloid, rayon and cellophane. These plastics are usually entirely organic. We mix cellulose and its variations (such as nanocellulose, made from cellulose nanocrystals) with other ingredients, such as camphor, to produce thermoplastics and the like. Using natural polymer, we process a broad range of bioplastics and corresponding polymers. The difference in their chemical properties is down to the nature of the polymer chains and the extent of crystallization.

  1. Composite Hemp-based Bioplastics

Composite plastics comprise organic polymers like hemp cellulose, as well as an addition of synthetic polymers. They also have reinforcement fibers to improve the strength of the bioplastic, which are also either organic or synthetic. Sometimes, we blend hemp cellulose with other organic polymers like shellac and tree resins. Inorganic fillers include fiberglass, talc and mica.

We call any natural polymer, when blended with synthetic polymers, a “bio composite” plastic. We measure and calibrate these ingredients according to the desired stiffness, strength and density of the eventual plastic product. Apart from packaging, manufacturers use these bioplastics for furniture, car panels, building materials and biodegradable bags.

A composite of polypropylene (PP), reinforced with natural hemp fibers, showed that hemp has a tensile strength akin to that of conventional fiberglass composites. Furthermore, malleated polypropylene (MAPP) composites, fortified with hemp fibers, significantly improved stress-enduring properties compared to conventional fiberglass composites.

  1. Pure Organic Bioplastics With Hemp

We have already generated several bioplastics entirely from natural plant substances like hemp. Hemp fibers, when made alkaline with diluted sodium hydroxide in low concentrations, exhibit superior tensile strength. We have produced materials from polylactic acid (PLA) fortified with hemp fibers. These plastic materials showed superior strength than ones containing only PLA. For heavy-duty packaging, manufacturers use hemp fibers reinforced with biopolyhydroxybutyrate (BHP), which are sturdy enough.

With the world in a state of major change due to the coronavirus outbreak of 2020, the focus is back on packaging and delivery. In this volatile area, perhaps the industry can learn a few new tricks, instead of suffocating itself in old traditions and superficial opportunism. The permutations and combinations of bioplastic technology can serve a swath of packaging applications. We must thoroughly explore this technology.

Hemp’s Future in Packaging

Fossil fuel-based plastic polymers are non-renewable, highly pollutive and dangerous to ecosystems, due to their lifespans. They are some of the most destructive inventions of man, but thankfully could be held back by this crop. Industrial hemp upheld countless industries through human history and now is making a comeback. After existing in relative obscurity in the U.S. due to false connotations with the psychoactive properties of its cousin, it is now back in business.

With the American hemp industry on the verge of a revolution, hemp packaging is primed to take over a significant part of the global packaging sector. The political, economic and environmental incentives for companies to adopt bioplastics are legion. Its lower cost lends to its allure as well. Consumers and agribusinesses are following suit, making the choice to be environmentally-conscious. By 2030, it is estimated that 40% of the plastics industry will be bioplastics.

We can only mitigate the plastic pollution in oceans, landfills and elsewhere, with the use of biodegradable bioplastics; otherwise, animals, humans and plants are getting adversely affected by imperceptible microplastics that pervade vast regions of the Earth. With hemp bioplastics, we use the cleaner, renewable matter of plants to conserve the planet’s sanctity. We can expect this new technology to continue to light the way for other nations, societies and companies to build upon this sustainable plan.

A2LA Accredits First Labs in Tennessee and Oklahoma

By Cannabis Industry Journal Staff
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According to a press release published earlier this week, A2LA announced the accreditation of two separate cannabis laboratories in two separate states; both are the first cannabis testing labs accredited in their states. Demeter Laboratory, based in Oklahoma City, Oklahoma, and Galbraith Laboratories, based in Knoxville, Tennessee, achieved the ISO 17025:2017 accreditation.

According to Cassy VanTassel, M.S., quality manager at Demeter Laboratory, Oklahoma is still developing and defining their regulatory framework for cannabis testing requirements. “Even though the State of Oklahoma is still establishing regulations and legislation, Demeter will always strive to meet the highest quality standards, so our customers know they are getting the best quality testing,” says VanTassel. “Demeter chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors.”

In Tennessee, Galbraith Labs is looking to aid the hemp industry in product safety testing. Christy Myers, customer service manager at Galbraith Laboratories, says they want to help farmers produce safe hemp products. “We are proud of our commitment to stay current within our industry and achieve the high standards set by A2LA,” says Myers. “Adding cannabis testing to our line of services was a great opportunity for Galbraith Laboratories to serve the community by helping farmers produce safe and legal hemp.”

Galbraith Labs was founded in 1950 as a contract lab in Knoxville serving many industries. With their newly established accreditation, they hope to aid the cannabis industry in Tennessee with hemp testing. Demeter Laboratory is the first medical cannabis lab in Oklahoma. Their goals include “advancing quality controls in medical cannabis, supporting safe consumption of cannabis and ensuring the transparency of the cannabis community.”

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Does Germany Have a Gray Market Problem?

By Marguerite Arnold
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Tilray just did something very interesting. In addition to announcing that it was shipping product to German distributor Cannamedical via its Portuguese facility, it also announced that it had begun outdoor cultivation.

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Even more intriguing: the company is claiming that somehow, via its proprietary technology (apparently), this kind of crop will be legit for distribution within the EU medical system.

There is only one problem with this. Outdoor growing does not sound remotely GMP-certified.

Here is the next bit of exciting news. Tilray, apparently, is not the only large Canadian cannabis company now operating in Europe that appears to be trying to get around GMP certifications for medical market penetration. Or appear oblivious to the distinctions in the international (and certainly European market).

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Photo: Ian McWilliams, Flickr

And things are a bit smelly on that front, not only in Denmark post CannTrust, but in truth even in Germany, the supposed “Fort Knox” of regulatory consumer and pharmaceutical standards.

In fact, at least according to insiders, there is apparently quite a bit of gray market product sloshing around in the Teutonic medical market. Even though so far, at least not publicly punished for the same, nobody has been caught. Or at least publically reprimanded.

And who is on the hot seat at least according to most of the licensed if not just pre-licensed indie producers and distributors who were contacted for this story? Sure, there are dark horse “start-up” indie violators, but they are not the only problem. Many who talked to CIJ named big public Canadian companies too. And potentially Bedrocan beyond that.

Who Is Who And What Is What?

Part of the problem, beyond any kind of deliberate flouting of regulations on the part of many companies who are at least trying to understand them, is that global standards are different. “GMP certifications” of every country, even within a region like Europe, are in fact, not uniform. That is why, for example, the new EU-US MRA agreement had to be signed first regionally and then on a state-by-state level across the EU.

Beyond Germany of course, there are other problems that are coming to the fore.In the medical cannabis space, in particular, right now, that is causing problems simply because many with pharma experience are not hip to the many risks in the cannabis industry itself. On the Canadian, Australian and American side, there is also a lot of bad advice, in particular, coming from consultants who should know better.

To be properly EU and German GMP-certified, one of the required steps is to have German inspectors walk your production floor. It is also not good enough to have “pesticide-free” or national organic certification at the crop cultivation site, and add GMP cert at time of “processing.” That piece of misadvise has been showing up not only in Canada, but Australia too. And creates a nasty reality if not expensive retooling upon entering the legitimate market in Europe, for starters.

These Issues Affect Everyone In The Industry

German Parliament Building

In an environment where ex-im is the name of the game, and even the big guys are short of product, compliance is getting granular as smaller players step up to the plate – and many if not most hopeful Canadian producers (in particular) now looking to Europe for sales are not (yet) up to speed.

A big piece of the blame also lies in the lack of proper administration at the federal and state level too – even auf Deutschland. To get a distribution license, a company must actually get three licenses, although there are plenty in the market right now who begin to describe themselves as “distributors” with less than the required certs.

The lack of coordination and communication, including which certs to accept as equivalent and from where is creating a market where those who know how to game the system are.

For example, several people who contacted CIJ, claimed that uncertified product was making its way into Germany via Central and Latin America, through Canada, picking up “GMP cert” along the way. In other words, not actually GMP-certified but labelled fraudulently to make it appear that way.

The same claims were also made by those with on-the-ground industry knowledge in South Africa (Lesotho).

Beyond Germany of course, there are other problems that are coming to the fore. As CIJ recently learned, a firm authorized by the Dutch government to provide cannabis packaging, including for exports, was not GMP certified until July 2019 – meaning that all product they shipped internationally even within Europe before that date potentially has labelling issues. Cue domestic importers. If not regulators.

Grey Market Product Is Making Its Way In Through Official Channels

For those who are taking the time to actually get through the legal registration and licensing process, it is infuriating to see others who are apparently fairly flagrantly buying market position but are in no position to fulfil such obligations. It is even more infuriating for those who intend to meet the requirements of the regulations to realize that the vast amounts spent in consulting fees was actually money paid for inaccurate information.

And the only way ultimately the industry can combat that, is by standing up, as an industry, to face and address the problem.German distributors are so aware of the problem that they are starting to offer gap analysis and specific consulting services to help their import partners actually get compliant.

Government agencies also might be aware of the problems, but they have been reluctant to talk about the same. CIJ contacted both BfArM and the local Länderauthorities to ask about the outdoor grow in Portugal and the lack of GMP cert for a Dutch packager. After multiple run-arounds, including sending this reporter on a wild rabbit chase of federal and state agencies (who all directed us back to BfArm) and an implication by the press officer at BfArM that the foreign press was not used to talking to multiple sources, CIJ was redirected back to state authorities with a few more instructions on which bureau to contact. The state bureau (in Berlin) did not return comments to questions asked by email.

Here is the bottom line that CannTrust has helped expose this summer: the entire global cannabis industry is trying hard to legitimize. Not every company is shady, and there are many who are entering it now who are playing by the rules. But those who are hoping to exploit loopholes (including “name” if not “public” companies) are also clearly in the room.

And the only way ultimately the industry can combat that, is by standing up, as an industry, to face and address the problem.

Editors Note: This is a developing story. CIJ has been contacted by the Dutch Cannabis Agency as it investigates what appears to be an intra-government debate over qualification of EU-GMP cert, acceptance of audit documents and other matters within European countries that appear to have caused much of this confusion with regards to Bedrocan and its packager Fagron. Many reputable, licensed sources within the industry spoke to us on deep background, out of concern that they too would be held liable. That said, so far, nobody can explain why the only licensed Dutch packager, was issued a new EU GMP cert document on July 9, 2019, the same day that Danish authorities halted CannTrust product entering Denmark. That is a government decision. Further it is also still unclear why rival cannabis companies would attempt to contact the cannabis media with a certain (and misguided) spin on this situation.

First Cannabis Clinical Trials All Set In UK

By Marguerite Arnold
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Beckley Canopy Therapeutics, based in Oxford, England has raised ₤7.4 million for the purposes of cannabinoid research and drug development. The new company is a unique partnership established between Canopy Growth Corporation and the Beckley Foundation, a research institute which examines the utilization of psychotropic drugs for the treatment of physical and mental conditions.

Studies focusing on the use of cannabinoids for the treatment of opioid addiction and cancer pain will be conducted in Europe, the UK and the US.

Why Is This Significant?

Here is the first reason: the woman behind it all. Her name is Lady Amanda Feilding, Countess of Wemyss and March. Born into a landed gentry family at Beckley Park (a Tudor hunting lodge with three towers and three moats) she also has a long history of engaging and supporting scientific endeavours that use stigmatized drugs in the treatment of both intractable disease and mental illness via the use of scientific research.

In 1998, Amanda Feilding set up the Beckley Foundation, a charitable trust which initiates, directs and supports neuroscientific and clinical research into the effects of psychoactive substances. She has also co-authored over 50 scientific papers in peer-reviewed journals.

The so-called “hidden hand” behind the rebirth of psychedelic science, Fielding’s contribution to global drug policy reform has been widely acknowledged in international drug policy circles. She was named as one of the bravest men and women in the history of science in 2010 by the British Guardian.

And here is the second reason: The foundation is now partnered with Canopy Cannabis, one of the leading cannabis firms in the world, which is also working closely with Spanish opioid manufacturer Alcaliber.

In other words, this coalition is almost the mirror opposite of the approach taken by the American Sackler family, makers of Oxycontin, who have fought cannabinoids as an alternative or even transition drug in multiple state legalization campaigns. Meanwhile the death rates from overdoses have quadrupled since 1999. In 2016, opioid-related drug overdoses killed about 116 people a day (or about 42,249 for the year). It is estimated that about 11 million people in the U.S. are currently misusing or dependent on opioids.

Amanda Fielding
Image credit: Robert Funke

Beyond The Politics of The Opioid-Cannabinoid War

While opioids clearly have a role particularly in chronic pain treatment, the question now at the global scientific table is this: Are cannabinoids a substitute for longer term chronic pain management? It is a fiercely battled scientific debate that has frequently, particularly in the U.S., crossed over into political drug reform questions.

The unique partnership of Beckley and Canopy is well placed both scientifically and culturally to take on a discussion which has languished for too long in the grass of political debate and reform.

Even better, it is taking place in a country where English is the first language, but outside the U.S. and further, in a country where cannabis has now been legally reclassified as a Schedule II drug.

Do not expect, in other words, the same trials and tribulations that faced noted U.S.-based researcher Sue Sisley, to slow down research, trials or findings.

Why Is A Cultural and Scientific Reset Required?

For the past forty years, since the end of the 1970s, cannabis in particular, has been pushed into a strange scientific territory in part, because of the culture surrounding the drug. This in turn, along with the schedule I classification of cannabis, has led to not only a dearth of research, but a reluctance on the part of prescribing doctors to examine its efficacy.

In the present, this means that doctors are still (beyond insurers who demand medical evidence before approving payment) the biggest hurdles in every medical system where cannabis is becoming legal. See the debate in Canada, the UK and of course, Germany, where patients frequently report asking for a drug their doctors refuse to prescribe.

This is exactly the kind of high-placed, societally influential effort in other words, that might finally break the medical taboo at the most important remaining logjam– at the point of prescription and approval for patients.

Did ABCann Lose The German Cannabis Bid?

By Marguerite Arnold
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In rather shocking news out of Germany on the cannabis front, it appears that Canadian LP ABcann has not been selected as one of the finalists in the country’s first tender bid to cultivate cannabis domestically.

As reported in the German press, the company has not been invited to submit an offer in the final award procedures. The reason per a company spokesman as quoted in the German media? The company proved it met the required qualification thresholds – namely it could deliver the required amount of product as required by the German government. However the amount it could produce was less than other firms being considered.

That is a strange statement, especially because the ten licenses on offer only called for a total of 2,000 kgs of production total by 2019 and 6600 kgs by 2022.

Who Is ABCann?

ABcann has been in business since 2014 in Canada, when it received one of the first cultivation licenses issued by the Canadian government. It has also been aggressively positioning itself in the German and European market this year – and in multiple ways. It got itself listed on both American and German stock exchanges by summer. The company established a subsidiary headquarters in Schönefeld as of August 2017. As late as October, the company also was appearing at industry conferences, like the IACM medical conference in Cologne, as an expected finalist in the first bid.

An ABCann facility in Canada

However, the company’s plans to build a $40 million, 10,000 square meter plant somewhere in Lusatia are now also reportedly on hold. The exact location of the plant is unknown, per German government requirements that grow facilities remain secret. That said, with a year and a half to complete construction, if given the green light even by early next year, it may be that this was the reason the company has apparently not made the cut. Or perhaps the German government did not believe the company was adequately funded. A September exercise of warrants netted the company an additional $45 million in operating cash. But with expansion plans in not only Canada and Europe, but Australia too, did the company pass the German test for liquidity?

Management changes are also afoot. As of October 1, Barry Fishman, a former Eli Lilly executive took over as CEO of ABCann Global. Ken Clement, founder of the company, announced in mid-October that he was stepping down from his position as Executive Chair of the Board to be replaced by Paul Lucas a former President and CEO of GlaxoSmithKline Canada. John Hoff, the Geschäftsführer (or CEO) of ABcann’s German subsidiary, has also recently left the company. When asked by CannabisIndustryJournal about his reasons for doing so at the Cannabis Normal conference in Berlin at the beginning of November, Hoff cited “management and creative differences” with ABcann Canada as the impetus for his recent departure.

However with the news of ABcann’s apparent loss of a front-runner position in the pending bid, such news appears to herald a bit more of a shakeup at the company, if not a refocussing of overall global strategy.

A source within the company who wished to remain anonymous also said this when contacted directly by CannabisIndustryJournal. “Our top priority currently is to acquire an import license. We also fully intend to pursue all of our plans in the German market, but we have no firm dates on the construction front.”

The State of Medical Cannabis Reform Auf Deutsch

The German medical cannabis question has certainly jerked forward over the past several years through several rough patches. This year it has gotten even stranger. And nobody is quite sure where it will end up.

The news about ABcann is also the latest episode in a very strange story that has continued to develop mostly out of sight of the public.

That bid process, which was expected to announce the winners by late summer, has now dragged on through the fall.Germany began moving forward quietly on the cannabis issue in the first decade of the century. Patients could only access the drug in basically trial mode. Most patients who qualified with a doctor’s prescription and a special permit to take the drug, could also access only Sativex (which is very expensive) or the synthetic form of the drug, dronabinol, manufactured domestically in a facility near Frankfurt. All bud cannabis was imported from Holland by Bedrocan. Strictly controlled not by German, but rather Dutch law on cannabis imports.

In 2014, the first German patients successfully sued the government to grow their own plants if their insurance companies refused coverage of the drug and they proved they could not afford alternatives.

This year, in January, the German government voted unanimously to change the law to mandate public health insurance. The law went into effect in March. Mainly driven by a desire to halt home-grow, the rules changed again. Post March 2017, patient grow rights have now been revoked. Now patients are theoretically allowed to get cannabis covered under public health insurance. In reality, the process has been difficult.

In April, the German government created a new “Cannabis Agency” under the auspices of BfArM. And BfArM in turn issued a tender bid for the country’s first domestic licences in April.

That bid process, which was expected to announce the winners by late summer, has now dragged on through the fall.

When Will The Winners Be Announced?

That too is unclear. It is very likely that the final announcement will not be made by the government until the beginning of the year – after the new government is formed. The so-called “Jamaica Coalition” – of the mainstream CDU, the Greens and the liberals (FDP) is under major pressure to address the issue of access. So far Chancellor Angela Merkel has signalled her resistance for additional changes to the new cannabis law. That said, the current situation in Germany, which is untenable for patients and doctors, as well as companies trying to enter the market and investing heavily, is unlikely to hold for even the next several years.

Problems with finding doctors and medical reimbursement under insurance have kept this patient population from growing the way it would otherwise.In late October, the news broke that two legal complaints had been unsuccessfully filed against the bid itself. Both parties’ complaints were dismissed. Yet there also appears to have been a third complaint that has actually devolved in to a real Klage – or lawsuit. Lexamed GmbH’s claim directly addresses issues expressed by many German-only firms this year. Namely that they were unfairly left out of the bid process because of a supposed lack of experience. As such it is likely to be closely watched by other existing German hopefuls.

This lawsuit has now formally delayed the announcements on the bid decision until at least after December 20th of this year, when the oral arguments will be heard in the case. A decision about the bid will go forward when this has been decided, by the beginning of 2018.

In the meantime? Cannabis imports are starting to enter the country. In late summer last year, Spektrum Cannabis, formerly MedCann GmbH, located just south of Frankfurt, received the first import licenses from the German government to bring medical cannabis into Germany from Canada. Both Aurora and Tilray were granted import licenses this fall.

There are 16 different kinds of cannabis on the market right now. And about 170 kilos of cannabis were imported into the country in the last year. There are also currently about 1,000 patients although this number is artificially low. Problems with finding doctors and medical reimbursement under insurance have kept this patient population from growing the way it would otherwise. There are easily a million patients in Germany right now who would qualify for cannabis if the system worked as it was originally intended in the legislation passed in January.

That said, despite the recent news that ABcann is “out” – at least for this round– apparently the pan-European bid process is still very much alive, despite many recent rumours that it was dead in the water. And plans also seem to be afoot for a separate and additional cultivation licensing round potentially as soon as next year. Details however are unclear and nobody either in the industry or the government is willing to be quoted or give any further information.

CWCBExpo Removes Roger Stone From Keynote

By Aaron G. Biros
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Last week, the Cannabis World Congress & Business Expositions announced they have removed Roger Stone from their conference’s keynote talk. The news follows a month-long boycott led by a group of women with the #DisownStone campaign, exhibitors, activists and the Minority Cannabis Business Association (MCBA), among other organizations.

According to the press release, conference organizers met with a number of people and organizations to discuss inclusivity and made the decision to oust Stone, citing the distraction his keynote was causing. “Following collaborative discussions with numerous partners, participants, and interested parties who support the legalization of cannabis in an inclusive manner, Cannabis World Congress & Business Expositions, (CWCBExpo) is announcing that Roger Stone will no longer be featured as a keynote speaker at the upcoming CWCBExpo events in Los Angeles and Boston,” reads the press release. “The forums created by CWCBExpo are crucial to the growth and legalization of the cannabis industry and they supersede the distractions that have surrounded the events.”

When the Minority Cannabis Business Association announced they would boycott the conference unless Stone was removed, support poured in from throughout the cannabis industry and a Change.org petition was created. Shortly after, we published an op-ed in support of the MCBA and their boycott. The boycott received national attention from major news outlets across the country. New Frontier Data, prominent cannabis law firm Greenspoon Marder, Denver Relief Consulting, Cannabis Industry Journal and Dope Media are among the signatories on that petition.

The petition reached 750 signatures in just two weeks and now has 840 signatures. That petition launched the #DisownStone campaign, which was ultimately successful in their mission. According to a statement put out by the #DisownStone campaign, the movement was led Amanda Reiman, Betty Aldworth, Bonita Money, Lauren Padgett, Leah Heise, Tiffany Bowden and Wanda James. It quickly garnered support from organizations involved in the conference. 20 speakers and 11 sponsors and partners signed the petition.

The Facebook post from MCBA where they announced the boycott

The #DisownStone statement praises the CWCBExpo for their decision to remove Stone. “We applaud the leadership at the Cannabis World Congress and Business Expo for their decision to remove Roger Stone from the keynote slot at CWCBExpo in Los Angeles and Boston,” reads the statement. “In choosing to release Roger Stone and to remove the employee that displayed egregious and reprehensible behavior towards members of the industry, the CWCBExpo set an example for the industry to follow. We understand that this decision was a difficult one and respect that the conference chose this route.”

The campaign ended their statement with a forward-looking sentiment, vowing to fight racism in the cannabis industry. “We will continue to denounce racism whenever we see it in the cannabis industry and elsewhere, and look forward to the day when no person can be arrested and jailed for using cannabis,” reads their statement. “We are excited to attend CWCBExpo and continue the conversation in person with their leadership and with attendees.” The campaign is hosting a #DisownStone after party at the LA event to celebrate their victory on September 14th.

Stone told LA Weekly that he plans on suing the conference organizers for $1 million. “The expo is in breach of contract,” Stone told LA Weekly. “I will be suing them for $1 million. I will not be deterred from my efforts to persuade the president to preserve access to legal medicinal marijuana consistent with his pledge to the American people.”

In an email to LA Weekly, Jesce Horton, chair of the board at MCBA, told reporters he is now willing to work with the conference organizers, given their decision to remove Stone. “Roger Stone’s deplorable rhetoric was just a piece of our inability to be involved,” Horton told LA Weekly. “More important is his history of advocating for regulations that work directly against an industry inclusive to small businesses and minority entrepreneurs. I look forward to working with CWCBE and support their decision to stand with us.”

How Science Is Going To Save Your Cannabis Business

By Kay Smythe
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Marketing cannabis and the products that accompany recreational use is set to become one of the biggest industries in the United States. With 29 states promoting legal medical cannabis, 14 with it decriminalized and 8 having legalized it completely, you might be thinking this will be the easiest ad-campaign of all time. Unfortunately, science suggests otherwise.

The Science of Marketing

You heard correctly, marketing is a science, but almost half of what we know about the process cannot be applied to cannabis. Why? Because cannabis lives in the grey area of the American psyche. How do I know this?

Science.

In 2015, I completed and published The Safe Haven theory, a socio-demographic linguistic analysis of attitudes toward recreational drug use in the United Kingdom. I won’t bore you with the intricacies of the study, but the findings are important.

The study, using theoretical sociological trends, found that even non-recreational drug users in the United Kingdom favor cannabis legalization. A great number of police jurisdictions have chosen to not longer punish cannabis users, meaning that the law is (mostly) on our side – the side of full legalization and taxation of cannabis as a product for recreational usage, not so dissimilar from alcohol.

In the UK, we could easily put a huge billboard of someone’s grandmother smoking a spliff and make a million on the first day.

Unfortunately, the same can’t be done in the United States.

Advertising law aside, Americans just don’t have the same view of cannabis as Brits. In the last two years, I applied the same framework to a host of American demographics, and – as I hypothesized – localism rules the American market.

If you live in a Red town and you’re a recreational cannabis user, stigma will prevail over the scientific data, and changing that stigma is almost impossible without hard scientific evidence to back-up the marketing campaign.

Qualitative research is key when understanding why people buy into particular industries. This might not be the general belief held by most folks in advertising, as stats and numbers are distinctly easier to work with. However, as last year’s General Election and Brexit vote showed: numbers can lie. Therefore, the best means of understanding what people really want is to actually talk to them – and I mean in-person.

Marketing rules are shifting. More and more, the heads of marketing departments are turning to scientific and scholarly data to assess the current trends in social development, molding their campaigns around this data as a means of showing that they are industry leaders in understanding the phenomena, as well as speaking to target buyers in their own language.

Am I being too wordy? Let me put it simply.

Say your new product is an indoor indica strain with sleep/stress aid properties, this is how you should market it to three specific demographics:

  • Californian recreational smoker in the 50+ age demographic with a moderate knowledge of cannabis strains, “Indoor indica, grown locally with minimal chemical input, good as a sleep aid and positive for stress reduction.”
  • New York medical user, 30+, business background, “This strain is an excellent sleep aid, can decrease stress without taking off the edge of your day-to-day workload; highly recommended for those employed in a full-time, private sector position.”
  • Small town with predominantly low-income demographic employed in blue-collar industry, “affordable means of relaxing after a tough day at work that won’t give you the same cancer risk as tobacco.”

We market the same strain to each of these demographics, but the language used in the campaign is more important than the product itself. In the UK, the same strain would be marketed across the country using something like:

“Dank strain with sleep aid and relaxation properties, best for chilling out at the end of the day – definitely not recommended prior to work!”

What this means for the United States cannabis marketing specialist is simple: you need to invest as much as you can in getting scholarly researchers out into the field and figuring out the local socio-demographic linguistic trends for your target buyers. Luckily, this can be a fairly affordable means of research.

Marketing specialists have two options in uncovering this data:

  • Use students currently enrolled in universities and colleges, either offering paid internships or college credit for bulk research.
  • Hire an academic consultancy corporation. This is rapidly becoming a norm in for companies looking to expand their marketing by using scientific data, particularly in industries related to sport and the outdoors.

Just like how Pepsi really missed the mark with their latest failed advertising campaign, cannabis companies are at significant risk of ostracizing themselves from a wealth of demographics that would otherwise be open to recreational or medical cannabis use as an alternative to harsh pharmaceuticals, alcohol and even some forms of therapy.

Language is key, and if you can’t talk to your buyers on their level then you’ve already lost your edge over the competition.