Tag Archives: cannabis

Cannabinoid Research & Pharmacology: A Q&A with Dr. Linda Klumpers

By Cannabis Industry Journal Staff
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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:

  1. 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.
  2. 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.
  3. 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:

  1. Users fill in questions;
  2. A personalized report is generated with the relevant science;
  3. 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:

  1. Literature: There is a lot of available literature, and we make sure to select the most relevant and reliable studies;
  2. 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;
  3. 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.

South Africa Reschedules CBD and THC

By Marguerite Arnold
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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.

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.

Communications in Cannabis: The Playbook for Branding Success

By Trisha Larocchia
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Public relations has a role to play in every industry, providing value for companies looking to promote their services, announce a recent fund raise or want to plant a flag in their domain as a leader or subject matter expert. Some industries, however, are writing a new playbook for the way PR is done. The cannabis space is a prime example of how PR can – and has – evolved in such a short amount of time. This industry has been a part of N6A’s DNA since 2017 when we created a cannabis-specific client service group. Since then we’ve seen the ups and downs, rapid changes and overall growth in an industry that, at the time, very few took seriously. We knew the potential was there, but we couldn’t be prepared for how foreign this would be compared to our other specialties like tech, cybersecurity and professional services.

We had to forget what we knew as media professionals and develop new plays and strategies for an industry in its infancy – all while bearing in mind the plant’s polarizing past and ambiguous future. With so many lessons learned about the way the cannabis and communications industries operate together, here are just a few key takeaways that have shaped our approach and operations in the marketplace.

Build Relationships Across the Board 

It’s often said “it’s not what you know, but who you know,” and in cannabis this couldn’t be more true. While the industry is growing rapidly, it’s still considered a tight-knit community where everyone talks to each other, and leaders lean on one another for expertise and guidance. A competitive nature is inherent in any business environment, but what I’ve noticed about those working in cannabis is that everyone is striving for the same goal: to further legitimize an industry plagued with stigma. Whether it’s developing media contacts or a new business prospect, the foundation lies in building relationships with the key players in the space.

This dispensary ad appeared on Variety.com

From a PR perspective, this includes working closely with the reporters dedicated to the cannabis beat, whether they write for a trade or mainstream publication. Journalists are shifting between jobs faster than ever before, and this beat favors industry veterans. One day your “friendly” at an obscure cannabis outlet will suddenly be spearheading coverage at The New York Times, Rolling Stone or other iconic publications. For the sake of clients and their desired business outcomes, communications professionals should foster ongoing conversations with any reporter interested in covering cannabis; you never know where it could lead.

Understand the Limitations 

Both public relations and advertising have proven to be instrumental in normalizing cannabis businesses within the mainstream media. However, communication in the space can be a compliance minefield due to strict state and federal regulations. While the industry’s growth is nothing short of explosive, opportunities for advertising are extremely limited as the largest digital platforms such as Facebook and Instagram have banned cannabis ads, forcing companies to look for other options.

Paid media has its time and place in every industry, but with so much red tape in cannabis advertising, it provides an opportunity for earned media to take the stage. Aside from a few key trades we all know well, journalists across business, lifestyle, finance and retail verticals are covering the space. Depending on what a business is looking to gain from PR, these initiatives are a great way to get directly in front of the audiences they want to reach without the risk of violating certain advertising guidelines. Companies that are ancillary, and therefore not selling a particular cannabis product, also have a bit more flexibility when it comes to advertising, especially on social media channels. As the industry sophisticates, the demographic of consumers does as well.

Evolve with the Industry 

The cannabis marketplace as it stands today is vastly different than when we began to service clients years ago. For decades, this industry operated in the shadows and outside of the law, but as legalization spreads across the globe, the way that businesses position and talk about their brand has had to change.

Gone are the days of reefer madness as consumers begin to see cannabis as medicine or a wellness supplement. With this comes a significant reduction in the use of words such as “weed,” “stoner,” and even “marijuana,” while words like “cannabis,” “medicinal” and “patients” step into the forefront. Both communications professionals and businesses must be hyper-aware of the verbiage we use if we want to professionalize the industry and fuel worldwide adoption.

As the industry sophisticates, the demographic of consumers does as well. What was once reserved for a younger, male population has now been growing in popularity amongst women, baby boomers, and the elderly. Cannabis businesses are now forced to diversify their messaging to appeal to the masses which often includes taking a minimalistic approach to branding and packaging.

Consumers are no longer looking for the lowest prices, but a brand that they know and trust. Recognition, whether it be locally or nationally, can be gained through a strong communication plan and will become increasingly imperative for long-term success.

A Dank Opportunity: Private Equity in the Cannabis Industry & Compliance with the Securities Act

By Kayla Kuri
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Under current federal law, financial institutions are extremely limited in the services and resources that they can offer to cannabis companies. Without access to traditional financing, cannabis companies have been forced to turn to outside investments to finance their operations. The private equity approach can be a “dank” opportunity for cannabis companies; however, these companies should be cognizant of the securities laws implications that are present with this type of business structure. The focus of most cannabis companies when forming their business is compliance with the regulatory scheme of their jurisdiction as it relates to the operation of a cannabis business. While compliance with these laws is important, it is also important that these companies ensure that they are compliant with the Securities Act of 1933 (the Securities Act) before accepting investments from outside sources.

Securities Act Application

Oftentimes, smaller companies don’t realize that they are subject to the Securities Act. However, the definition of a “security” under the Securities Act is very broad1 and under S.E.C. v. W.J. Howey Co., an investment in a common enterprise, such as a partnership or limited liability company, where the investor expects to earn profits from the efforts of others is considered a “security” and thus, subject to the rigorous requirements of the Securities Act.2 In general, all companies offering securities within the United States are required to register those securities with the Securities and Exchange Commission (SEC) unless a registration exemption is available.3 A company can register its securities (i.e., its ownership interests offered to investors) with the SEC by filing a Registration Statement. These statements generally offer investors certain information about the company in order to enable investors to be able to make an informed decision about their investment. Filing a Registration Statement can be both time-consuming and costly, and most companies want to avoid filing one if they can. Luckily, the Securities Act offers certain exemptions from registration requirements to companies who meet certain standards.4 While there are numerous exemptions from securities registration, the most common exemptions used are the Regulation D5 exemptions, which provides three different exemptions based on the size of the offering and the sophistication of the investors, and the Rule 1476 Intrastate exemption.

Regulation D Exemptions

Rule 504-Limited Offerings

Rule 504, often called the “Limited Offering” exemption, provides an exemption from securities registration for companies who limit the offer and sale of their securities to no more than $5,000,000 in a twelve-month period.7 Unlike the other Regulation D exemptions, which are discussed in further detail below, the Limited Offering exemption does not have any limitations on the level of sophistication or number of investors.8 This means that companies who rely on this exemption do not have to verify the net worth or income of their investors or limit the number of investors in the company. Like all Regulation D exemptions, companies relying on the Limited Offering exemption are required to file a “Form D” with the SEC within 15 days of the first securities sale.9 A Form D is a relatively simple form which provides basic information about a company to the SEC, including the registration exemption that is being relied upon. A copy of Form D can be found here.

Rule 506(b)

The “Private Offering” exemption can be found at Rule 506(b) of Regulation D.10 This exemption is commonly used for larger investment offerings with varying levels of investor sophistication. The Private Offering exemption can be used for investment offerings of any size so long as the company: (1) does not use general solicitation or advertising, such as newspaper articles or seminars, to attract investors; and (2) limits the number of “non-accredited investors” to no more than 35.11 “Accredited investors” are those investors whom the Securities Act deems sophisticated enough to properly weigh the risk of their investment in the company. In order to qualify as an accredited investor, the investor must:

  1. Have an individual income of more than $200,000 in the past two years
  2. Have a joint income with their spouse of more than $300,000 in the past two years
  3. Have an individual net worth, or joint net worth with their spouse, in excess of $1,000,000 or:
  4. Be a director, executive officer or manager of the Company.12

If the investor is a corporation, partnership, limited liability company or other non-trust entity, then to qualify as an accredited investor, it must either have assets in excess of $5,000,000 or each of its equity owners must meet one of the requirements for individuals listed above.13 If the investor is a trust, then the trust must: (1) have total assets in excess of $5,000,000 and the investment decision must be made by a “sophisticated person” (i.e., the person who is making the investment decision has such knowledge and experience in financial and business matters that he or she is capable of evaluating the merits and risks of an investment in the company); (2) have a trustee making the investment decision that is a bank or other financial institution; or (3) be revocable at any time and the grantor(s) of the trust must meet one of the requirements for individuals listed above.14

The Private Offering exemption allows a company to have an unlimited number of accredited investors, but only up to 35 non-accredited investors. However, companies should be very cautious of allowing non-accredited investors to invest in the company. The Securities Act requires that companies make extensive disclosures to non-accredited investors which are essentially the same requirements as the company would have to provide in a registered security offering. These requirements include providing investors with financial statements, operations plan, detailed descriptions of the company’s business, description of all property owned, discussion and analysis of the company’s financial condition and the results of operations, biographies of and descriptions of each officer and director, as well as other descriptions regarding the details of the company.15 Failure to provide the necessary information to non-accredited investors can disqualify companies from the benefits offered by the Private Offering Exemption. Companies should be very cautious when relying on the Private Offering exemption. If a company does choose to utilize the Private Offering exemption, they must file a Form D with the SEC within 15 days of the first securities sale.

Rule 506(c)

Rule 506(c), the “General Solicitation” exemption, is similar to the Private Offering Exemption. Unlike the Private Offering exemption, companies relying on the General Solicitation exemption are permitted to use general solicitation and advertising to advertise their securities to potential investors.16 However, investors relying on the General Solicitation exemption must only sell their securities to accredited investors.17 Under Rule 506(c), the company selling the securities must take steps to verify the accredited-investor status of their investors.18 These steps can include reviewing past tax returns, reviewing bank statements, or obtaining confirmation from the investor’s attorney or accountant that such person is an accredited investor.19 Like the other Regulation D exemptions, companies relying on the General Solicitation exemption should file a Form D with the SEC.Private equity can be a dank opportunity for cannabis companies, but it is critical that these companies ensure that they are in compliance with all applicable securities laws.

Intrastate Exemption

Rule 147, known as the “Intrastate” exemption, provides an exemption from securities registration for companies who limit the offer and sale of their securities to investors who are residents of, if they are an individual, or have its principal place of business in, if they are an entity, the state where the company is organized and has its principal place of business.20 The Intrastate exemption permits general solicitation to investors who are in-state residents, and there are no limitations on the size of the offering or the number of investors, whether accredited or unaccredited. In addition, companies relying on this exemption are not required to file a Form D with the SEC. The Intrastate exemption can be very desirable to companies who wish to obtain a small number of key investors within their communities.

State Requirements

In addition to complying with the Securities Act, companies are also required to comply with the securities laws of each state where their securities are sold. Each state has its own securities laws which may place additional requirements on companies in addition to the Securities Act. Most states (including California, Colorado, Oregon, and Oklahoma) require that a copy of the Form D filed with the SEC be filed with the state securities commission if securities are sold within that state. Before offering securities for sale in any state, companies should thoroughly review the applicable state securities laws to ensure that they are in compliance with all state requirements in addition to the requirements under the Securities Act.

Additional Considerations for Cannabis Companies

Despite the fact that the purchase and sale of cannabis is illegal under federal law, cannabis companies are still subject to the Securities Act in the same manner as every other company. However, the SEC has issued a warning to investors to be wary of making investments in cannabis companies due to the high fraud and market manipulation risks.21 The SEC has a history of issuing trading suspensions against cannabis companies who allegedly provided false information to their investors.22 Cannabis companies who wish to rely on any of the registration exemptions under the Securities Act should ensure that they fully disclose all details of the company and the risks involved in investing in it to all of their potential investors. While cannabis companies are permitted to rely on the registration exemptions under the Securities Act, the SEC appears to place additional scrutiny on cannabis companies who offer securities to outside investors. It is possible to fully comply with the onerous requirements of the Securities Act, but cannabis companies should engage legal counsel to assist with their securities offerings. Failure to comply with the Securities Act could result in sanctions and monetary penalties from the SEC, as well as potentially jeopardize a cannabis company’s license to sell cannabis. It is extremely important that companies seek advice from legal counsel who has experience in these types of offerings and the requirements of the Securities Act and applicable state securities laws. Private equity can be a dank opportunity for cannabis companies, but it is critical that these companies ensure that they are in compliance with all applicable securities laws.


References

  1. See 15 U.S.C § 77b(a)(1)
  2. 328 U.S. 293 (1946).
  3. 15 U.S.C § 77f.
  4. See 15 U.S.C § 77d.
  5. 17 CFR § 230.500.
  6. 17 CFR § 230.147.
  7. 17 CFR § 230.504.
  8. Id.
  9. Id.
  10. 17 CFR § 230.506(b).
  11. Id.
  12. 17 CFR § 230.501.
  13. Id.
  14. Id.
  15. 17 CFR § 230.502; 17 CFR § 239.90; 17 CFR § 210.8; 17 CFR § 239.10.
  16. 17 CFR § 230.506(c).
  17. Id.
  18. Id.
  19. Id.
  20. 17 CFR § 230.147.
  21. Investor Alert: Marijuana Investments and Fraud. (2018, September 5).
  22. Investor Alert: Marijuana-Related Investments. (2014, May 16).

Cannabis Contracting: The Potential Invalidity Defense Created By Federal Prohibition

By Brett Schuman, Barzin Pakandam, Jennifer Fisher, Nicholas Costanza
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The overwhelming majority of Americans now live in a state where cannabis is legal at the state level for at least some purposes.1 However, cannabis (excluding hemp) remains criminal under federal law for all purposes. This conflict between state and federal law presents challenges for participants in the state legal cannabis industry, including enforcing their contractual agreements. This is because a number of federal court rulings have called into question whether contracts involving cannabis are enforceable in federal court.

In this article, we explore how federal courts and state legislatures have addressed the enforceability of contracts relating to cannabis and provide some practical tips for cannabis companies to protect their contractual rights.

The “Illegality Defense” in Federal Courts

“No principle of law is better settled than that a party to an illegal contract cannot come into a court of law and ask to have his illegal objects carried out . . . .” Mann v. Gullickson, 2016 WL 6473215 at *6 (N.D. Cal. Nov. 2, 2016) (quoting Wong v. Tenneco, Inc., 39 Cal. 3d 126, 135 (1985)).

Bart St. III v. ACC EnterprisesApplying this principle, a number of federal courts have refused to enforce contracts relating to state-legal cannabis. For instance, in Bart St. III v. ACC Enterprises, LLC, No. 217CV00083GMNVCF, 2020 WL 1638329 (D. Nev. Apr. 1, 2020), the parties entered into a loan agreement wherein the plaintiff-lender, Bart Street III, loaned the defendant cannabis cultivators in Nevada approximately $4.7 million to fund operating costs, pay down debts and purchase land for a cannabis cultivation facility in Nevada. Id. at *1-2. The loan agreement specified that it was governed by Nevada law. The cannabis cultivators defaulted on the loan, and Bart Street III sued for breach of contract and unjust enrichment. The cannabis cultivators argued that they could not be liable for breach of a contract that is illegal under the Controlled Substances Act of 1970, as amended (the CSA). Id. A federal judge in Nevada ruled that certain provisions of the loan agreement (i.e., a right of first refusal provision and another provision concerning disbursement of operating costs) were illegal under federal law and could not be enforced. The judge was unable to decide on summary judgment whether the illegal provisions could be severed from the other parts of the agreement, so on that basis the cannabis cultivators’ summary judgment motion was denied as to the breach of contract claim. However, the judge granted the cannabis cultivators’ motion as to the unjust enrichment claim based on the following reasoning: “Plaintiff cannot prevail for unjust enrichment because the parties’ contract involves moral turpitude. If the Contract is unenforceable, it is because Plaintiff invested in Defendants’ marijuana cultivation business primarily to obtain a pathway to an equity investment therein . . . . Providing funds in exchange for equity violates the CSA because it would allow the investor to profit from the cultivation, possession, and sale of marijuana . . . . Conspiracy to cultivate marijuana is a crime of moral turpitude.”

Polk v. GontmakherThe illegality defense was also raised in Polk v. Gontmakher, No. 2:18-CV-01434-RAJ, 2020 WL 2572536 (W.D. Wash. May 21, 2020), which involved two business partners—Polk and Gontmakher— who owned a licensed cannabis processing facility and retail store through an entity called NWCS. When Polk decided to leave the business, Gontmakher refused to acknowledge Polk’s ownership interest because Polk had a prior criminal record, which violated ownership requirements for cannabis businesses under Washington cannabis regulations. Polk sued Gontmakher for breach of a verbal partnership agreement and sought to recover past and future profits of the cannabis business. Gontmakher moved to dismiss, and the district judge granted the motion: “Mr. Polk’s claim that his requested relief would not require a violation of the CSA defies logic. He is demanding the future profits of a business that produces and processes marijuana in violation of federal law. How does Mr. Polk anticipate NWCS will generate these future profits? The Court cannot fathom how ordering [Gontmakher] to turn over the future profits of a marijuana business would not require them to violate the CSA. And as this Court has previously explained to Mr. Polk, it cannot award him an equitable interest in NWCS because to do so would directly contravene federal law.” Polk, WL 2572536 at *2.

J. Lilly, LLC v. Clearspan Fabric Structures Int’l, Inc.Certain federal district court judges have addressed the illegality defense directly, even when it has not been asserted by the parties. In J. Lilly, LLC v. Clearspan Fabric Structures Int’l, Inc., No. 3:18-CV-01104-HZ, 2020 WL 1855190 (D. Or. Apr. 13, 2020), a licensed cannabis cultivator in Oregon contracted with Clearspan, a lessor of commercial greenhouse equipment located in Connecticut, to lease greenhouse equipment for the facility and also have the facility constructed. After construction began, the cultivator notified Clearspan (and the sub-contractor) of numerous defects in the facility that were impeding cultivation efforts, and after Clearspan allegedly fixed only one defect, the cultivator sued for breach of the agreements and claimed lost profits due to the inability to cultivate cannabis, in the amount of $5.4 million. While Clearspan moved to dismiss the claims on the basis that the cultivator waived any contractual right to consequential damages, the District Court raised the issue of the illegality of the contracts under federal law sua sponte at oral argument. After supplemental briefing on the issue, the Court held that “awarding Plaintiff damages for lost profits [for the sale of cannabis] would require the Court to compel Defendants to violate the [CSA…and] provides an independent basis to dismiss Plaintiff’s lost profits claim in addition to” the issue of waiver, and other merits issues.  Id. at *11-12.

And in Ricatto v. M3 Innovations Unlimited, Inc., No. 18 CIV. 8404 (KPF), 2019 WL 6681558 (S.D.N.Y. Dec. 6, 2019), Ricato (an investor) and M3 (the intended cannabis operator and licensee) entered into an agreement to purchase a plot of land in California for M3 to develop as a cannabis processing facility. The investor sued to enforce the investment instrument, and M3 moved to dismiss. The court granted M3’s motion to dismiss on other grounds but noted that “it is not readily apparent to the Court that it could [even] enforce such a contract [as] ‘[m]arijuana remains illegal under federal law, even in those states in which medical marijuana has been legalized,’” such as California. Id. at *5, n.4.

Ricatto v. M3 Innovations Unlimited, Inc.However, under some circumstances a federal court may enforce a cannabis contract. In Mann v. Gullickson, Mann loaned Gullickson money to be used in a cannabis-related business. The agreement was governed by California law. When Gullickson defaulted on the promissory note, Mann sued for breach of contract. Gullickson asserted that the contract was illegal under federal law and moved for summary judgment. In an order denying Gullickson’s motion, the court said that “even where contracts concern illegal objects, where it is possible for a court to enforce a contract in a way that does not require illegal conduct, the court is not barred from according such relief.” 2016 WL 6473215, at *7.

Federal courts are wary of parties seeking the enforcement of cannabis contracts. If there is any possibility that the issuance of a court order enforcing the contract would result in a party violating the CSA, federal courts are likely to deny relief.

State Laws Protecting the Enforceability of Cannabis Contracts

At the state level, legislatures in some states that have legalized cannabis for adult use have enacted laws to protect the enforceability of cannabis contracts. These statutes specifically exempt commercial cannabis activities from general laws voiding contracts that are in furtherance of illegal activities. Examples of these state laws include:

Massachusetts: In December 2016, Massachusetts enacted a statute providing that “[c]ontracts pertaining to marijuana enforceable” and providing that contracts entered into by cannabis licensees or their agents, or by landlords of cannabis licensees, “shall not be unenforceable or void exclusively because the actions or conduct permitted pursuant to the license is prohibited by federal law.” (Mass. Gen. Laws ch. 94G, § 10)

California: In January 2019, California enacted a statute providing that “commercial activity relating to medicinal cannabis or adult-use cannabis conducted in compliance with California law and any applicable local standards, requirements, and regulations” shall be deemed the lawful object of a contract and not contrary to law or against public policy, notwithstanding any law that requires all contracts have a “lawful object” under state or federal law. (Cal. Civil Code § 1550.5)

Nevada: In 2016, a ballot initiative was passed in Nevada, which was then codified under state law, declaring “[i]t is the public policy of the People of the State of Nevada that contracts related to the operation of marijuana establishments under this chapter should be enforceable,” and that such contracts “shall not be deemed unenforceable on the basis that the actions or conduct permitted pursuant to the license are prohibited by federal law.” (N.R.S. § 678B.610).

Similar statutes have been enacted in other states, including in Oregon (January 2018), Michigan (December 2018), Illinois (June 2019) and Colorado (January 2020). See Or. Rev. Stat. § 475B.535 (In Oregon, “[a] contract is not unenforceable on the basis that” commercial cannabis activity legal in Oregon is illegal under federal law); Colo. Rev. Stat. § 13-22-601 (similar to Oregon); Mich. Comp. Laws § 333.27960 (Public policy in Michigan is that “…contracts related to the operation of marihuana establishments [are] enforceable.”); 410 Ill. Comp. Stat. § 705/55-75 (similar to Michigan).

However, many states that have legalized cannabis do not have statutes exempting contracts relating to cannabis activities from the illegality defense.

Contracting Tips for Cannabis Companies

Notwithstanding the uncertainty and inherent risks caused by the conflict between federal and state law, there are certain steps parties entering into commercial cannabis agreements can take to protect their contractual rights, including:

  1. Always include a forum selection clause specifying resolution of disputes in state court and waiving any right to remove the dispute to federal court.
  2. If entering into an agreement in a state that has enacted a statutory provision exempting cannabis contracts from the illegality defense, consider selecting that state’s law (as opposed to New York or Delaware law, which are often the jurisdictions of choice for transactional lawyers who don’t know better) in a choice of law provision.
  3. If neither the parties nor the performance of the agreement have any nexus to a state that has enacted a statutory provision protecting the enforceability of cannabis contracts, consider incorporating the contracting entity in one of those states. In the same way that Delaware is the jurisdiction of choice for incorporating most companies, a state like California may on balance be the better choice for cannabis industry participants due to the legal recognition of commercial cannabis activity.
  4. Consider using an arbitration clause in commercial cannabis agreements. These clauses require parties to arbitrate disputes that may arise in connection with the agreement. As a general rule, arbitration is both more efficient and less expensive than litigation, and arbitrators are less likely than federal judges to refuse to enforce an agreement because it relates to federally illegal cannabis activity.

Conclusion

Notwithstanding expanding legalization at the state level, and general federal tolerance of the state-legal cannabis industry, federal courts remain a dangerous place for cannabis companies. If possible, cannabis companies should specify state court (or arbitration) for resolution of disputes in their contracts, and they should choose a state law that expressly excludes cannabis contracts from the illegality doctrine.


References

  1. Cannabis is legal for medical purposes in 33 states plus the District of Columbia; cannabis is legal for adults over 21 in 11 states plus the District of Columbia. Approximately 76.5% of the population of the United States lives in a state with some form of legal cannabis. See https://www.census.gov/data/tables/time-series/demo/popest/2010s-state-total.html#par_textimage_1574439295. This figure excludes Texas, which has a limited medical cannabis program as of this writing. However, if Texas is included, then over 85% of the population lives in a state with some form of legal cannabis.

Why Employee Training is Your Key to Financial Success

By Shannon Tipton
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So, there you are, pondering your finances, there are many expenses and costs that go into running your business and when your budget is already tight, should you add or increase training to the expense list? Why frustrate yourself, looking for ways to train people, when you could be focusing on things like technology, product development or sales that help with business growth?

We all know that product development and sales are important. But what differentiates training from other expenses is that while on the surface training might appear as an expense, it’s not.

Think about this analogy: We know one achieves a greater plant quality and yield by using advanced cultivation practices. That said, the quality of the plants also greatly depends on the lighting, the nutrients and the nurturing they receive. The training and development of your people depends on the quality of effort you give them. Therefore, it is not so much a cost as it is an investment in the growth of your people, and when your people grow, you experience business growth.

Why invest in continual training?

The answer as to why continual training is important can be summed up in four points:

  1. Well trained employees = happy and loyal employees.
  2. Happy employees = educated and happy customers.
  3. Happy and educated customers = customer loyalty.
  4. Customer loyalty = increased business revenue

Any break in the chain breaks the relationship with the customer. There isn’t any business right now that can afford to lose a customer over something as intuitive as keeping people knowledgeable and happy.

This approach does, however, come with a caveat. Your training needs to be amazing and it needs to stick. You need to be willing to give your people the tools they need to succeed, and amazing training doesn’t come with a low-price tag. It requires not only a monetary investment but the investment of time and energy of the entire team.

Consider this, according to a Gallop research paper, happy and well-trained employees increase their value, and dedicated training and development fosters employee engagement, and engagement is critical to your company’s financial performance.

In short, this means your happy people will be earners for you. They will help you exceed industry standards, sell more and hang around longer. This means lower turnover costs.

Who doesn’t want that?

Educated and loyal employees lead to increased financial results

According to another Gallup study, businesses that engaged workgroups in continual development saw sales increase and profits double compared to workgroups that weren’t provided with development opportunities. The pressure to succeed among competitors of the cannabis industry is intense and rewards high. Having a good product is a start, but if your customer does not trust you or your employees…then what?

You can have the best product in the world, but if you can’t sell it, you still have it.

Can your business survive without trained people and loyal customers? The growth rate for legalized cannabis will be $73.6 billion with a CAGR of 18.1% by 2027. Plus, total sales of illicit cannabis nationwide were worth an estimated $64.3 billion in 2018, projections call for the U.S. illicit market to reduce by nearly $7 billion (11%) by 2025.

Those customers are going somewhere, will they be coming to you? Are you and your people prepared to earn potential customer trust and build critical relationships? Can you afford to miss being a part of this growth because your people were not carefully trained and your customers were uninformed about you, your product and your services?

A common adage is, “What if I train them and they leave? What if you don’t and they stay?” – where does your business stand?

Time for non-traditional approaches for high-impact training

With the rapid growth of the industry with ever changing regulations, new types of edibles, better product with exponentially more options – your customers will demand higher quality standards and expect your people to be in-the-know. This requires “just-in-time” knowledge as opposed to formalized training delivery.

Disappointingly, only 34% of businesses feel their overall training is effective. So, as the industry continues to evolve, it is important to know how to make your programs as effective as possible for your people. The traditional training that has failed corporate America is not the answer for this non-traditional cannabis industry. The need for new and non-traditional training methods will be critical for your people to be efficient, productive and adaptable to react to fluctuating business needs.

Six areas to focus your non-traditional training

1) Build a strategy

As the gap begins to widen and the competitive “cream of the crop” starts rising to the top, you will need to take the initiative in training and upskilling employees. This means planning future training efforts and reimagining current ones.

The steps involved in creating a training plan begins with establishing business goals. Ask yourself what business factors and objectives you hope to impact through training? You will also need to decide what critical skills are needed to move the business forward. Start your training focus with high-impact skills. These are the skills, if mastered, that will lead to customer loyalty and education. Ultimately impacting your bottom-line.

2) Target skills that build relationships

Building relationships is often placed in the category of, “soft skills.” However, this is a misnomer; “soft-skills” are core strengths you will need for your business to stand apart from your competition. This goes beyond smiling at the customer. Your business requires adaptable, critical thinkers who can problem solve and communicate effectively. Soft skill training is never “finished.” Therefore, consider how reinforcement is going to be delivered and how coaching will evolve.

3) Personalize training to individuals

Many traditional training programs approach people with a “one size fits all” mentality. Just put all the people in all the classes. This is a common failed approach. Each person on your team has individual skills and needs that require attention. This means creating and planning the delivery of training programs to address specific strengths and skills challenges. Not everyone will be at the same level of knowledge. If you are hiring for culture (which you should) rather than specific skills this means providing ongoing support at different times. This requires developing a training plan that allows people to choose their training path.

4) Create digital learning spaces

Ensuring employees make time for learning was the number one challenge talent development teams faced in 2018. One way to combat this challenge is putting training in the hands of people through platforms they are already using. Most notably, their cell phones and mobile applications.

Training should be created and delivered through multiple platforms (mobile and on-demand), where the training can be personalized, and offer ongoing job support. For example: Consider training to be delivered through mobile apps, text messaging or instant messenger. This type of training is targeted, direct, can be tracked and supports “just-in-time” delivery of help. Help when the people need it and when the business needs them to have it.

5) Make training interesting through gamification

There is a general misunderstanding about how gamification and training programs work. Many business owners discard the idea of gamification because they believe it means turning training programs into video games. Understandably, owners do not want critical and regulatory compliance training to be like a game of Candy Crush. What is important to realize is that gamification is a process of building a reward system into training that imitateschallenge games. Allowing people to “level-up” based on skill or knowledge acquisition. The use of badges, points and leaderboards encourage participation in online experiences. Thus, making training interesting and more successful.

6) Plan to educate your customers

As stated, providing customer training around your products or services is a fantastic way to differentiate yourself from competitors. It also boosts customer engagement, loyalty and enables them to gain more value from you.

Customer training is now considered a strategic necessity for businesses in every industry and within the cannabis industry, education programs will play a critical role in attracting new customers. Although, keep in mind your new customers do not need “training.” They need educational awareness. Consider the education you are providing customers as an onboarding process. Thoughtfully designed educational content can help customers make the right decisions for them, and you are there every step of the way.

Choose a different path for your training efforts

Your business needs a non-traditional training plan to help your people to be better, smarter, faster than your competitors and to gain customer trust and loyalty. Cannabis is a non-traditional industry, why box your business into traditional corporate training models proven to be unsuccessful? Your business and your people deserve better.

Contact Learning Rebels to learn more about what we can do for you to help you develop training tools and resources that will make your people stand above the rest.

Will Australia’s Cannabis Program Follow Canada’s Lead?

By Marguerite Arnold
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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).

german flag
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.

Epidiolex-GWThe 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.

european union states

Why Europe May Serve as an Important Bellwether for Hempcrete Use in the United States

By Stephanie McGraw
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european union states

Hemp-based construction materials are an attractive option for achieving environmentally friendly goals in construction, including reduced emissions and conservation of natural resources. Hemp construction materials dating back to the 6th Century have been discovered in France and it has long been eyed with interest by hemp growers and manufacturers, as well as environmentalists in the United States and abroad. As the European Union moves forward with its 2019 European Green Deal, United States hemp, construction and limestone industries, as well as regulatory agencies, will be provided with an important preview of the benefits, risks and issues arising out of the use of hemp in construction.

The European Green Deal and Circular Economy Action Plan

Hemp applications in construction are gaining increased interest as the EU seeks to neutralize its greenhouse gas emissions by 2050. Much of the specifics for this transition to zero emissions are outlined in the EU’s “A New Circular Economy Action Plan,” announced on March 11, 2020. According to the EU, “This Circular Economy Action Plan provides a future-oriented agenda for achieving a cleaner and more competitive Europe in co-creation with economic actors, consumers, citizens and civil society organisations.” The plan aims at accelerating the transformational change required by the European Green Deal and tackles emissions and sustainability issues across a number of industries and products, including construction.

Construction in the EU accounts for approximately 50% of all extracted natural resources and more than 35% of the EU’s total waste generation. According to the plan, greenhouse gas emissions from material extraction, manufacturing of construction products and construction and renovation of buildings are estimated at 5-12% of total national greenhouse gas emissions. It is estimated that greater material efficiency could save 80% of those emissions. To achieve those savings, the plan announces various efforts to address sustainability, improve durability and increase energy efficiency of construction materials.

How Hemp Could Help Europe Achieve Neutral Emissions

Hemp, and specifically hempcrete, is being eyed with heightened interest as the EU enacts its plan. Indeed, recent mergers and acquisitions in the European hemp industry signal just how attractive this hemp-based product may be as international, national and local green initiatives gain momentum. But how would hemp be utilized in construction and what types of legal issues will this industry face as it expands?

Image: National Hemp Association

The primary hemp-based construction material is “hempcrete.” Hempcrete is typically composed of hemp hurds (the center of the hemp plant’s stalk), water and lime (powdered limestone). These materials are mixed into a slurry. The slurry petrifies the hemp and the mixture turns into stone once it cures. Some applications mix other, traditional construction materials with the hempcrete. The material can be applied like stucco or turned into bricks. According to the National Hemp Association, hempcrete is non-toxic, does not release gaseous materials into the atmosphere, is mold-resistant, is fire– and pest-resistant, is energy-efficient and sustainable. To that last point, hemp, which is ready for harvest after approximately four months, provides clear advantages over modern construction materials, which are either mined or harvested from old forests. Furthermore, the use of lime instead of cement reduces the CO2 emissions of construction by about 80%.

Watching Europe with an Eye on Regulation and Liability Risks

Hempcrete indeed sounds like a wünder-product for the construction industry (and the hemp industry). Unfortunately, while it may alleviate some of the negative environmental impacts of the construction sector, it will not alleviate the threat of litigation in this industry, particularly in the litigious United States. The European Union’s experience with it will provide important insights for U.S. industries.

Hempcrete blocks being used in construction

Because hemp was only recently legalized in the United States with the passage of the 2018 Farm Bill, it is not included in mainstream building codes in the United States, the International Residential Code, nor the International Building Code. Fortunately, there are pathways for the consideration and use of non-traditional materials, like hempcrete, in building codes. However, construction applications of any form of hemp, including hempcrete, at this point would likely require extensive discussions with local building authorities and an application showing that the performance criteria for the building are satisfied by the material. Such criteria would include standards and testing relating to structural performance, thermal performance, and fire resistance. Importantly, the ASTM does have a subcommittee working on various performance standards for hemp in construction applications. European progress on this front would pave an important regulatory pathway for the United States, as well as provide base-line standards for evaluating hempcrete materials.

Insights into regulation and performance standards are not the only reason to watch the EU construction industry in the coming decades. Introduction of hempcrete and hemp-based building materials in the United States will likely stoke litigation surrounding these materials. Although there is no novel way to avoid the most common causes of construction litigation, including breach of contract, quality of construction, delays, non-payment and personal injury, the lessons learned in Europe could provide risk management and best-practice guidance for the U.S. industry. Of particular concern for the hemp industry should be the potential for product liability, warranty, and consumer protection litigation in the United States. The European experience with hempcrete’s structural performance, energy efficiency, mold-, pest- and fire-resistant properties will be informative, not just for the industry, but also for plaintiff attorneys. Ensuring that hempcrete has been tested appropriately and meets industry gold-standards will be paramount for the defense of such litigation and EU practices will be instructive.

The United States construction industry, and particularly hempcrete product manufacturers, should pay close attention as the EU expands green construction practices, including the use of hempcrete. The trials and errors of European industry counterparts will inform U.S. regulations, litigation and risk management best practices.

 

Soapbox

COVID-19 & The Hypocrisy of Essential Cannabis Business

By Dr. Leslie Apgar, Gina Dubbé
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The cannabis industry is fraught with hypocrisy. Cannabis is good medicine as has been established by the numerous patients we have seen who are now off of their opioids, benzos and sleep agents due to the addition of medical cannabis products to their regimen. We see patients using cannabis when nothing else has worked and they tell us about their decreased suffering on a daily basis and thank us profusely for staying open during the COVID-19 shutdown, due to our designation as an essential business in Maryland.

Gina Dubbé (left) and Dr. Leslie Apgar (right), co-founders of Greenhouse Wellness, a medical cannabis dispensary in Maryland

The fact that this essential business has seen an increase in business due to the anxiety surrounding Covid-19 is an indication that our society will be dealing with the ramifications of anxiety, PTSD and depression for a long time to come as we deal with the fallout from the pandemic. Our forced shutdown of the workforce has resulted in the opportunity to look deeply at our basic assumptions and policies. Policing and incarceration for what is now a medically-necessary component to society is the crime. We believe that we have the opportunity to rectify the errors of our past and release those still imprisoned for cannabis possession, use, etc.

Further, as evidenced by our country’s recovery from the great depression, the legalization of alcohol certainly helped to bolster the economy. The US has the same opportunity with the cannabis industry. Tax revenue from the legalization of cannabis nationwide is sure to add a much-needed economic boost to help us recover from the disaster of this pandemic.

Our country has had an unfortunate historical relationship with a plant that has the potential to ease suffering safely and bring about some much-needed economic stimulation. It’s high time we fix the mistakes of our past and create a kinder and more inclusive future.