Advancements in Extraction & the Growth of the Concentrate Category

By Dr. Dominick Monaco

Due to quick progressions in legalization, today’s cannabis industry bears little resemblance to the industry of five years ago. As the cannabis space gains mainstream acceptance, it resembles more “traditional” industries closely. In turn, how we consume cannabis has changed dramatically within this novel legal framework.

A brief visit to a cannabis dispensary quickly illuminates just how much the industry has changed in the past few years.

Within the dynamic of modern cannabis, perhaps no vertical has seen the same advancements as cannabis extracts. It’s precisely the growth of the concentrate category that has given rise to the many branded products that define the legal market.

To give a clear picture of how advancements in extraction have stimulated the concentrate category’s growth, we put together this brief exploration.

Standards & Technology

Before legalization, the production of cannabis extracts was a shady affair done in clandestine and often dangerous ways. Especially concerning BHO (Butane Hash Oil), home-based laboratories have long since been notorious fire hazards. Even more, with a total lack of regulation, black-market extracts are infamous for containing harmful impurities.

In the few short years that cannabis has been legal in Nevada, Washington and other states, extract producers have adopted standards and technology from more professional arenas. By borrowing from the food and pharmaceutical industries, concentrate companies have achieved excellence undreamed of a decade ago.

Good Manufacturing Practices

One of the essential elements in the extracts vertical advancements is the adoption of good manufacturing practices. According to the World Health Organization website, “Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.”

When adult-use cannabis was legalized in markets such as Colorado, cannabis companies were able to come out of the shadows and discuss GMPs with legit businesses. In doing so, they implemented professional controls on extract manufacturing in accordance with “quality standards” of state regulatory agencies.

Supercritical CO2 Extraction

As cannabis businesses adopted GMP from other industries, extract producers also embraced more sophisticated technology. Of these, supercritical CO2 has pushed the cannabis concentrates vertical into the future.

According to the equipment manufacturer Apeks Supercritical, “CO2 is considered to be a safer method of extraction because the solvent is non-volatile. The extract is purer because no trace of the solvent is left behind. It is also versatile and helps protect sensitive terpenes, by allowing cold separation.” By deriving methods from food production, supercritical equipment manufacturers have given cannabis companies a viable option for the commercial production of extracts.

Supercritical technology has helped push the concentrates vertical forward by providing a clean and efficient way to produce cannabis extracts. Nonetheless, supercritical CO2 equipment is highly sophisticated and carries a hefty price tag. Producers can expect to pay well over $100,000 for commercial supercritical CO2 extraction setup.

Products

Just as standards and technology have evolved in the cannabis extracts vertical, we have also seen products rapidly mature. Notably, the legal environment has allowed manufacturers to exchange ideas and methods for the first time. In turn, this dialogue has led to the development of new products, like isolates and live resin.

Isolates

Just as the name implies, isolates are concentrates made from a singular, pure cannabinoid. In today’s market, CBD isolates have grown increasingly popular because people can consume pure CBD without ingesting other cannabinoids or plant materials, including the legal 0.3% THC found in hemp.

Isolates are made by further purifying cannabis extracts in the process of purification, filtration and crystallization. As seen with other concentrates, isolates are used as the base for many cannabis products, such as gummies.

There is also growing interest in CBG isolate, which is another non-psychoactive cannabinoid when consumed orally.

Live Resin

The cannabis concentrate live resin has taken the industry by storm over the past few years. Live resin is a form of extract that is originally sourced from freshly harvested and frozen cannabis plants. The primary selling point behind this extract is the fact that fresh flowers produce much more vibrant aromas and flavors than dried cannabis. Interestingly, this pungency is tied to the preservation of terpenes in live resin.

Just a few of the dozens of various products types on the market today.

To make live resin, producers “flash freeze” fresh cannabis plants immediately after harvest. Valuable cannabinoids and terpenes are then extracted from the fresh, frozen plant material using hydrocarbon solvents. This whole process is done at extremely cold temperatures, ensuring no thermal degradation to the precious and volatile terpenes.

In lieu of these intricate steps to preserve the flower and extracts, live resin has continuously gained popularity. Namely because vaping with live resin is the best way to sample fresh cannabis terpene profiles in its most authentic fashion

It is amazing to see how much cannabis extracts have grown and progressed with legalization. Due to such amazing advancements in standards, technology, and products, the concentrates category has exploded on the dispensary scene. In today’s market, flowers have been largely sidelined in favor of concentrate-based products like gummies. These products now adorn dispensary shelves in beautiful packaging replete with purity and testing specifications.

It’s an often-overlooked fact that the purity standards of the legal extracts have made reliable cannabis brands possible in the first place. You cannot develop a cannabis brand without consistent products that customers can rely on; all things considered, it can be said that advancements in extraction have not only stimulated the concentrate category but the entire industry as we know it today.

January 8, 2021

The Evolution of Cannabis Entrepreneurship

By Jonathan Monk

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Cannabis presents a plethora of challenges for entrepreneurs not seen in more traditional industries. Akin to the dot-com boom of the early 2000s, the cannabis industry has seen an astonishing flurry of business over the past decade. Within this dynamic landscape, new cannabis companies come and go on a near-daily basis.

To capitalize on novel markets’ potential, hopeful entrepreneurs from all walks of life have “jumped headfirst” into the cannabis space. This new breed of entrepreneurs must not only be smart, but they must also be challenging. Yet, as the cannabis industry evolves under the forces of legalization and innovation, our understanding of what defines cannabis entrepreneurs continues to change.

Cannabis businesses are shaped by the regulations, challenges and opportunities of specific market niches. As such, cannabis entrepreneurs have evolved with the environments in which they do business.

California & Proposition 215

California paved the way for the industry of today by legalizing medical cannabis in 1995. Since the passage of historic Proposition 215, cannabis has continued to gain momentum across the globe. This progress has happened through the visions and hard work of small business owners.

The early days of legal cannabis in California are now criticized for their lack of regulation. During the late 1990s and early 2000s, all you needed to start a cultivation business in California was a place to grow a garden. While early dispensaries did need local business licenses, they could legally purchase and sell untested products from unlicensed growers.

The genealogy of the modern cannabis industry can be traced directly back to the days of California’s Prop 215. During this era, the first cannabis dispensaries were founded – this model has since been replicated thousands of times. Also, the Prop 215 model gave rise to America’s first legal, commercial cannabis farms.

Cannabis entrepreneurs in California’s medical space focused primarily on developing the blueprints for a brand-new industry. To this end, they did not have the time or luxury to finetune the businesses for such things as operational efficiency and brand awareness. Even more, these people did not have to deal with such complexities as employee screening, product testing and seed-to-sale tracking.

Medical Cannabis Entrepreneurs

New medical markets stand in stark contrast to those seen in the early days of California. To this end, today’s medical markets operate within a web of stringent government regulations. For entrepreneurs, these rules set forth major emphases on both compliance and technology.

The Pennsylvania medical cannabis industry provides an excellent platform for understanding how the regulatory system of a market shapes entrepreneurial paths. For instance, medical cannabis cards are only issued to patients that meet the minimum criteria of 23 qualifying conditions, including severe conditions like aids, cancer and epilepsy. Beyond that, cannabis dispensaries in Pennsylvania must meet a slew of challenging criteria to operate and pay large sums of money in licensing fees.

To handle the regulatory requirements in places like Pennsylvania and remain profitable, medical cannabis entrepreneurs are incredibly dependent on technology. To this end, dispensaries utilize point-of-sale (POS) and seed-to-sale software to track inventory and stay compliant carefully. Even more, they use state-of-the-art security systems to safeguard their operations.

Cannabis entrepreneurs in medical markets must be able to run compliant operations and support their businesses with requisite technology. These elements stand in stark contradiction to the “wild west” mentality that pervaded the early industry. As such, it’s safe to assume that the rules of today’s markets force entrepreneurs to be more professional than in the days of CA Prop 215.

Adult-Use Cannabis Entrepreneurs

The most considerable difference between medical and adult-use cannabis companies has to do with their available customer base. Importantly, adult-use cannabis companies are only bound by minimum age requirements and state borders. Furthermore, limited restrictions on licensing create highly competitive markets that require sophisticated sales and marketing operations.

As there are no limits on potential customers, and limited regulations on license counts, business opportunities in adult-use markets are primarily directed by supply and demand rules. Because competition is the driving force in adult-use markets, entrepreneurs in this vertical have a good deal in common with peers outside the cannabis industry.

Perhaps the most defining characteristic of adult-use entrepreneurs is an emphasis on branding and marketing. As adult-use markets mature in places like Colorado, a phenomenon known as “brand concentration” occurs when a few companies come to dominate a majority of the market. As smaller companies fight for market share, they must develop professional brands that appeal to a broad customer base.

Cannabis entrepreneurs in adult-use markets must master the skills required in medical cannabis while also expanding their knowledge base in modern business dealings. Of these, the development of professional brands is one of the most defining characteristics of adult-use entrepreneurs.

It’s astonishing to see how much the cannabis industry has grown and matured looking back just a few short years. As business opportunities come about with new legalization efforts, entrepreneurs quickly rise to take advantage of untapped markets. As the cannabis business continues to evolve with the times, entrepreneurs must pivot to stay compliant, relevant and successful.

While the early Prop 215 market in California barely resembles today’s industry, it’s important to remember where we came from. Namely, our understanding of the contemporary cannabis business results from everyone who came before us. As the industry progresses, we will continue to complement established best practices with the requisite innovations that come with new opportunities.

January 7, 2021

Soapbox

Break Up Vertical Integration

By Ryan Douglas

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Editor’s Note: This is an excerpt from chapter ten of From Seed to Success: How to Launch a Great Cannabis Cultivation Business in Record Time by Ryan Douglas. Douglas is founder of Ryan Douglas Cultivation, a cannabis cultivation consulting firm. He was Master Grower from 2013-2016 for Tweed, Inc., Canada’s largest licensed producer of medical cannabis and the flagship subsidiary of Canopy Growth Corporation.

Cultivation businesses should consider specializing in just one stage of the cannabis cultivation process. The industry has focused heavily on vertical integration, and some regulating bodies require licensees to control the entire cannabis value chain from cultivation and processing to retail. This requirement is not always in the best interest of the consumer or the business, and will likely change as the industry evolves. Not only will companies specialize in each step of the value chain, but we’ll see even further segmentation among growers that choose to focus on just one step of the cultivation process. Cannabis businesses that want to position themselves for future success should identify their strengths in the crop production process and consider specializing in just one part.

Ryan Douglas, former Master Grower for Tweed and author of From Seed to Success: How to Launch a Great Cannabis Cultivation Business in Record Time

Elsewhere in commercial horticulture, specialization is the norm. It is unlikely that the begonias you bought at your local garden shop spent their entire life inside that greenhouse. More likely, the plant spent time hopping between specialists in the production chain before landing on the retail shelf. One grower typically handles stock plant production and serves as a rooting station for vegetative cuttings. From there, rooted cuttings are shipped to a grower that cares for the plants during the vegetative stage. Once they’re an appropriate height for flowering, they’re shipped to the last grower to flower out and sell to retailers.

Cannabis businesses should consider imitating this model as a way to ensure competitiveness in the future. In the US, federal law does not yet allow for the interstate transport of plants containing THC, but the process can be segmented within states where vertical integration is not a requirement. As we look ahead to full federal legalization in the US, we should anticipate companies abandoning the vertical integration model in favor of specialization. In countries where cannabis cultivation is federally legal, entrepreneurs should consider specialization from the moment they begin planning their business.

Cultivators that specialize in breeding and genetics could sell seeds, rooted cuttings, and tissue culture services to commercial growers. Royalties could provide a recurring source of income after the initial sale of seeds or young plants. Contracting propagation activities to a specialist can result in consistently clean rooted cuttings that arrive certified disease-free at roughly ¼ the cost of producing them in-house. This not only frees up space at the recipient’s greenhouse and saves them money, but it eliminates the risks inherent in traditional mother plant and cloning processes. If a mother plant becomes infected, all future generations will exhibit that disease, and the time, money, energy, labor, and space required to maintain healthy stock plants is substantial. Growers that focus on large scale cultivation would do well to outsource this critical step.

Intermediary growers could specialize in growing out seeds and rooted cuttings into mature plants that are ready to flower. These growers would develop this starter material into healthy plants with a strong, vigorous root system. They would also treat the plants with beneficial insects and inoculate the crop with various biological agents to decrease the plant’s susceptibility to pest and disease infestations. Plants would stay with this grower until they are about six to 18 inches in height—the appropriate size to initiate flowering.

The final stage in the process would be the flower grower. Monetarily, this is the most valuable stage in the cultivation process, but it’s also the most expensive. This facility would have the proper lighting, plant support infrastructure, and environmental controls to ensure that critical grow parameters can be tightly maintained throughout the flowering cycle. The grower would be an expert in managing late-stage insect and disease outbreaks, and they would be cautious not to apply anything to the flower that would later show up on a certificate of analysis (COA), rendering the crop unsaleable. This last stage would also handle all harvest and post-harvest activities—since shipping a finished crop to another location is inefficient and could potentially damage the plants.

As the cannabis cultivation industry normalizes, so, too, will the process by which the product is produced. Entrepreneurs keen on carving out a future in the industry should focus on one stage of the cultivation process, and excel at it.

December 22, 2020

The Cannabis Industry Sees Record Growth Despite Continuous Obstacles

By Jay Virdi

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Worth an estimated $54 to $67 billion, the bourgeoning U.S cannabis industry continues to grow at record pace despite conflicting state and federal laws that cause obstacles at every turn.

This conflict remains a source of uncertainty for retailers, cultivators and the general public. And, unfortunately, the palpable tug of war between the states and the federal government will only increase when legalization is introduced at the federal level, putting tax dollars up for grabs.

A tug-of-war between the states and the federal government makes it difficult for cannabis businesses to obtain bank accounts, insurance and investors. It also means additional security and compliance challenges. It is the reason that the cannabis industry is an unsupportive environment for start-ups and employees who face primitive or even dangerous R&D conditions in order to advance the extraction process.

As cannabis companies fight to grow their market share, many lag behind when instituting a proper risk management structure from R&D to daily operations. Cannabis businesses that haven’t incorporated risk management will need to in 2021, especially when seeking to secure funding from PE firms.

As the 8^th fastest growing industry in the U.S., maturing at more than 25% annually, adult use and medical cannabis sales are unlikely to decrease anytime soon. Rather, experts predict continued growing pains – and gains – to shape the U.S. cannabis industry in 2021.

The COVID-19 pandemic will continue to increase the growth of the cannabis industry— with a few roadblocks

Deemed “essential businesses,” many retail outlets and dispensaries stayed open throughout the pandemic and adopted new ways of serving customers, from curbside pick-up to drive-through windows and deliveries. At the same time, the pandemic hindered growth for some cannabis operations on the cusp of obtaining a license, as many applications were put on hold when state offices closed their doors for months. In some cases that meant raised capital was pulled and funding ceased. For start-ups who are seeking to apply again in 2021, it’ll be an uphill climb.

As a result of routine COVID-19 inspections in 2020, state officials uncovered a host of other issues at cannabis operations, including improper labeling, poor health and safety practices, lack of PPE compliance by staff and customers, incorrect counting of cash and more. In extreme cases, these visits resulted in regulatory fines and shutdowns. This led to the need to use seed money for something other than the organization’s original mission. In 2021, these scenarios are likely to turn into lawsuits from shareholders and activate directors & officers (D&O) and employment practices liability (EPL) claims from laid-off workers. These accusations dovetail with another major charge often levied against cannabis businesses —lightning speed growth without the business operations and risk management protocols necessary to support it.

Many cannabis businesses have not procured the necessary liability insurance coverage for the great risk that come with rapid growth. Whether it’s D&O and EPL policies as in the case above, or cyber, property or general liability (GL) policies, it’s critical to think more holistically about insurance coverage. Cannabis operations need to work with an insurance broker who specializes in the cannabis industry and understands different operations and business location, as exposures vary greatly.

R&D extraction dangers lead to unique risks

In 2021, extraction will be a major focus for cannabis organizations. Operations will continue searching for a competitive advantage to increase yield and develop superior products. Cannabis extractors will experiment with new ways to apply existing laboratory methods utilizing ethanol and CO2 as well as innovative cultivation methods adopted from the agriculture industry, using water and light exposure and different nutrients. R&D becomes a potential liability when cannabis extractors modify the use of existing equipment for a different type of extraction. Flammable products are often required, and explosions can occur.

If you are considering experimenting with R&D, engage your insurance broker to ensure the risk is covered within your existing policies and to explore best practices for experimentation and varying equipment use.

Desire for more security both inside and outside the operation

A cannabis operation’s security risk is two-fold. In light of the looting and civil unrest across the U.S. this year, heightened security measures were necessary for cannabis businesses to secure their goods. Additionally, a common risk— employee theft —increased as well.

Cannabis retail operations maintain a large supply of cash and product. As looting occurred, it was impossible to relocate cannabis product away from retail storefronts as a majority of state regulations prohibit cannabis to be removed from retail facilities. Owners and operators who did so risked being fined for non-compliance or losing their license.

The majority of cannabis theft — as high as 90% by some estimates — is employee related. In many cases, employees in cannabis grow facilities and retail storefronts scheme to cheat employers. Part of the challenge is that state regulations require plant and production facility blueprints to be publicly available. Thieves are using these layouts to plot their infiltration. In other scenarios, cannabis operators are recording walk-throughs of their facilities and publishing online documentaries. These also leave operators vulnerable.

Employers can increase security by restricting access exclusively to employee areas, while also investing in better internal access controls. Conduct an audit of your work areas with your cannabis insurance broker who can provide you with a list of best practices and do’s and don’ts for reducing theft.

Complications continue in compliance, banking and financial services

Even though cannabis is legal for medicinal or recreational use in 43 states, businesses still struggle to secure bank accounts, business loans and insurance coverage. Small local banks and savings and loan businesses may be more willing to engage with cannabis businesses in 2021, while large institutions will keep shying away.

At every stop of the supply chain, cannabis business operators need to be proactive when developing strategies to manage risk. That means implementing risk management protocols to protect their business, their workforce as well as securing the proper insurance coverage.

This also includes growing the cannabis business’ safety net by engaging necessary insurance policies, appropriate to the business’ size and exposure, including cyber, environmental liability and crime policies, or applying for emerging loan programs in an effort to secure additional capital.

Evolution of the industry into 2021 and beyond

While the cannabis industry is evolving and changing, much will ultimately remain the same in 2021. Even if the U.S. government takes steps to federally legalize cannabis, a bill would not go into effect until later in the year at best, more likely in 2022 or beyond. Until a bill is passed, cannabis businesses will look to remain viable beyond the state level. For all cannabis businesses, 2021 will be about building on what they’re already doing and preparing for what will hopefully come next.

December 2, 2020

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.

November 18, 2020

Soapbox

The Cannabis Industry, After the Election

By Serge Chistov

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While the 2020 Presidential election didn’t exactly end up in a clear landslide victory for the Democrats, there is one group that did well: the cannabis industry.

The results clearly show that the expansion of cannabis is a recognizable part of today’s society across the United States. States like New Jersey, for example, partly thanks to New York and Pennsylvania—which already allow the use of medical cannabis—traffic will start to force the state of New York’s hand and that’s a big chunk of the population of the Northeast.

If the question of legalization was on the ballot, it was an issue that overwhelmingly succeeded in delivering a clear mandate. Adult use of cannabis passed handily in Arizona, Montana, South Dakota and as mentioned above, New Jersey, and was approved for medical use in Mississippi and South Dakota.

With only 15 states remaining in the union that still outlaw the use of cannabis in any form, the new reality for the industry is here. All of these outcomes show promise as the industry’s recognition is growing.

Election outcomes and the position of the average American on cannabis

Americans are definitely understanding, appreciating and using cannabis more and more. It is becoming a part of everyday life and this election’s results could be the tipping point that normalizes the adult use of cannabis. It is becoming more widely understood as an effective and acceptable means to help manage stress and anxiety, aid in sleep and general overall wellbeing.

Voters in New Jersey overwhelmingly passed their adult use measure

This image of cannabis is aided by the many different forms of consumption that exist now: edibles, transdermal, nano tech, etc. No longer does a consumer have to smoke—which isn’t accepted in many circles—to get the beneficial effects of cannabis.

Knowledge expansion is going to move these products across state lines and eventually, the federal government will have to take notice.

Do Democrats and Republicans view cannabis through the same lens?

Cannabis is and will always be state specific. Republicans in general tend to be a little bit more cautious and there are a lot of pundits who believe that as long as the Republicans control the senate, there isn’t much of a chance for federal legalization.

President-Elect Joe Biden & Vice President-Elect Kamala Harris

There is some hope, however, that the industry will get support from the Biden administration. While President-Elect Biden has been on record as being against legalization of cannabis at a federal level, even he will eventually see that the train has left the station and momentum continues to build. In fact, Biden’s tone has changed considerably while he running for president, adding cannabis decriminalization to the Biden-Harris campaign platform.

Ultimately, how cannabis is viewed from each side of the aisle matters less than how it is viewed at the state level.

Cannabis reform under Biden

Biden had an opportunity to legalize cannabis federally in the U.S. during the Obama administration and it didn’t happen. It’s clear that the mandates of the Biden-Harris administration are going to be overwhelmed by current issues, at least in the beginning: COVID-19, the economy and climate change, to name but three.

What will be interesting is if the Biden-Harris administration goes to greater lengths to decriminalize cannabis. For example, cannabis is still a Schedule 1 drug on the books, which puts it in the same class as heroin. Biden couldn’t unilaterally remove cannabis from all scheduling, but his government could reschedule it to reduce the implications of its use.

This could, however, create more problems than it solves:

“It’s generally understood, then, that rescheduling weed would blow up the marijuana industry’s existing model, of state-licensed businesses that are not pharmacies selling cannabis products, that are not Food and Drug Administration-reviewed and approved, to customers who are not medical patients.

Biden rescheduling cannabis “would only continue the state-federal conflict, and force both state regulators and businesses to completely reconfigure themselves, putting many people out of business and costing states significant time and money,” as Morgan Fox, chief spokesperson for the National Cannabis Industry Association, said in an email on Monday.” (Source)

In reality however, there is little chance that Biden will spend any political capital that he has, particularly if the Senate remains in Republican control, dealing with the legalization of adult use cannabis.

What needs to happen for legalization to become a reality

Outside of the law, if Trump suddenly decided to legalize adult use cannabis before leaving the White House, the states would still need to agree on issues such as possession, transportation, shipment and taxation.

It’s clear that further normalization of cannabis use is required—which will likely take a good couple of years—in order for it to become as understood and as simple as wine, liquor or cigarettes.

Beyond that, it’s Congress that dictated that cannabis be illegal at the federal level and it will have to be Congress that makes the decision to change that. Even the Supreme Court has been reluctant to get involved in the question, believing this to be an issue that should be dealt within the House.

What does all of this mean for investment in the cannabis industry?

Cannabis should be part of most long-term investors’ portfolios. Like a group of stocks in a healthy market with the right balance sheets, cannabis is an expanding industry and growth is there.

Whether or not this is specifically the right time to invest, it’s always important to evaluate each stock or each company individually, from the point of view of the merits of the investment and investment objectives, as well as risk tolerance perspectives.

There isn’t any unique or special place to buy into the cannabis industry, unless it is connected to some new real estate or other opportunity that is COVID-19 related. This moment in time isn’t really any different from any other when it comes to the opportunity to own some cannabis stocks. It’s always a good time.

The short term returns of this market shouldn’t be speculated upon. There are just way more factors than the fundamentals of a company that will affect the short-term play. The country is in a transition of power, in addition to much international change taking place that can also contribute to returns in the short term, making speculation unhelpful.

The cannabis market in 2021

The cannabis industry is likely to continue to expand and grow with the select companies acquiring more and more and getting back to their cash flow. Some companies will slowly be going out of business and/or will be acquired by others going into a certain consolidation period of time. Whatever the outcomes in specific tourism dominated markets, the industry as a whole can really go in one direction.

November 12, 2020

Soapbox

Being an American Cannabis Entrepreneur in Europe

By Michael Sassano

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I have heard everything from “No one in their right mind would spend the energy in Europe when the U.S. has the most developed infrastructure in the world and $13 billion in sales” to “Is it even legal there?”. And yes, when you come from the West Coast cannabis world, it’s hard to imagine anywhere else but the West Coast of the U.S.A.

Europe has taken an infrastructural leap forward by starting off the pharmaceutical, medical and GMP supplements path. As an American-European from the West Coast cannabis world, remembering how the U.S. started/progressed, remaining patient and stretching the grey matter crossing the thresholds of pharmaceutical manufacturing, is serious.

Costs to Do Business

Which country you choose to begin operations in decides if cannabis is more or less expensive cap-x and opp-x to the U.S. And don’t forget the Euro conversion. Clearly, working near main cities like Berlin and Geneva will be expensive both for land and competition for talented staff. I chose Portugal, which greatly reminds me in terms of geography to a mini-California on the coast of Europe. Portugal also boasts the most progressive cannabis rules and is home to large cannabis producers like Tilray and Clever Leaves paving the way in the EU market. Greece is also one of our top locations, due to being cannabis friendly and another coastal country with great talent and reasonable costs to live and operate.

Excitement

All of Europe is buzzing with cannabis. Somai Pharmaceuticals tracks over 387 star-ups in cannabis around Europe, South America, Australia and Asia. The excitement when Colorado first announced cannabis legalization in 2014 is the same feeling in Europe now. Most groups are collaborative yet guarded at the same time with the uncertainty of how EU cannabis plays out. Patient demand exists, and similar government wills are at play, but all in the direct backyard of big pharma.

Right now you see huge companies that will always exist and small companies that will always be a part of competition. It’s likely that Europe will shake out to be 30% large to medium company mix and 70% medium to small companies. So, the feeling of room for everyone exists there. This is not surprising considering the legal market in the world is $17B in sales while the illegal market is estimated at ten times that market. And new demographics from around the world are opening up to cannabis for pain relief, sleep and other ailments for new age groups.

Brand New Infrastructure

european union states — Member states of the European Union

Conforming to standard guidelines like pharmaceutical manufacturing, GMP supplement manufacturing and GACP farming is just plain normal. U.S. state-by-state expansions really missed the boat on this, and state rules without federal guidelines aren’t good for businesses left guessing or consumers. Eventually, with federal legalization, some infrastructure rebuilding will be needed to conform to standard procedures. I am unsure if the systems are even capable of handling tens of thousands of operating facilities with or without regulation, but starting off at the highest level of pharmaceutical grade is a good way to build consumer and regulator confidence. Learning pharmaceutical and supplement GMP manufacturing is a precise and studied endeavor coming from the U.S. cannabis market. The US hemp industry is embracing this on a supplement level. I now curl up to online courses and formulation books.

In time, all of Europe’s 741 million population will have access to cannabis related products. With standardized processes, new infrastructures and good-old fashioned entrepreneur energy Europe will be a massive market. Sure, the early adopters will need to struggle through regulations and rule creation, but the lifestyle in Southern Europe is the envy of West Coast USA, where laid-back lifestyle and organic food is the minimum standard.

November 10, 2020

The Brand Marketing Byte

Spotlight on Aster Farms

By Cannabis Industry Journal Staff

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The Brand Marketing Byte showcases highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies.

Here is a data-led, shallow dive on Aster Farms:

Aster Farms is based in Lake County, California and operates with an ethos of environmental sustainability. They call themselves the “cleanest, meanest and greenest around” and produce sungrown cannabis with “good genetics, clean cultivation and the power of nature.”

According to Pioneer Intelligence, Aster Farms is showing increased strength in each of the pillars they track: social media, earned media and web-related activities. The reason for such an improvement in performance? It starts with a number of earned media placements driving greater awareness for the brand, like this piece in SFWeekly or this one on Benzinga.

Engagement rates for Aster’s Instagram account have been growing for about two months and received a recent boost in the form of a sweepstakes giveaway. Their web activity performance improved as a result of keyword growth on their site.

All of these factors helped Aster Farms get on Pioneer’s list of Top 100 hottest U.S. cannabis brands for October, coming in at Number 60.

October 28, 2020

Soapbox

How to Vote for Cannabis Research on November 3rd

By Dr. Jordan Zager

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It was 1996. I was four years old. California Proposition 215 passed and for the first time, legal medical cannabis became available. I don’t remember it honestly, but that moment triggered a reckoning of outdated and ineffective efforts to control cannabis, which continues on November 3rd.

The moment in 1996 created for me and my generation of millennials a new, decriminalized lens for which to view cannabis and its potential. In my lifetime, from first experimenting with cannabis after high school and then earning my PhD in plant biochemistry, advancing cannabis research, to starting an agtech company dedicated to the genetic improvement of cannabis, we continue this march toward legalization. But another march hasn’t started yet.

The cannabis we consume today is still largely the same (albeit more potent today) as the cannabis that was legalized in 1996. There’s been little advancement in our scientific understanding of the plant. This can and should change. I believe the future and legitimacy of the cannabis crop in the medical field and in farmers’ fields is on the ballot this November.

In 33 states, medical cannabis is currently legal and in eleven of those, including my home states of Nevada and Washington, legalized adult-use recreational cannabis is generating millions in tax revenue every month. But compared to every other commercial crop, cannabis is still decades behind.

We are seeing a glacial cadence with cannabis research. As voters in five more states consider this November whether to legalize cannabis, that same tipping point we reached in 1996 comes closer to being triggered for cannabis research.

Here’s what cannabis scientists, like me, face as we work to apply real scientific methods to the long-neglected crop: I published one of the most cited papers on cannabis research last year, titled, Gene Networks Underlying Cannabinoid and Terpenoid Accumulation in Cannabis. But, as per university policy, we were unable to touch the plant during any of our research. We could not study the physical cannabis plant, extracts or any other substantive physical properties from the plant on campus or as a representative of the university. Instead we studied cannabis DNA processed through a third-party. Funding for the research came from private donors who were required to be unassociated with the cannabis industry.

While we were conducting our heavily restricted, bootstrapped cannabis research, the university lab in the next building over was experimenting with less restrictions on mice using other drugs: cocaine, opioids and amphetamines. (Quick note, marijuana is listed as more dangerous than cocaine, which is a Schedule II drug.)

I get it. Due to the federal prohibition on cannabis as a heavily regulated Schedule I drug, universities cannot fund research without the risk of losing all of their federal funding. While the USDA does not support research and SBIR grants are all but impossible, one government agency does allow research, from cannabis grown only in Mississippi. It’s the Drug Enforcement Agency (DEA) and any research conducted using its crop is as ineffective as you’re imagining. Relevant research is likely impossible using the crop which dates back to a 1970’s strain with a potency that’s about 30 percent of today’s commercial cannabis offerings.

To change this anti-research climate, do what those in California did with Prop 215 in 1996. Vote.

Dr. Jordan Zager, author and CEO of Dewey Scientific

Vote for legalization of cannabis if you’re in those five states where legalization is on the ballot; that’s Arizona, New Jersey, Montana, South Dakota and Mississippi. The more states that align with cannabis legalization, the stronger the case becomes for the federal government to reschedule the drug from a Schedule I controlled substance. Currently cannabis is listed as a Schedule I alongside heroin. The DEA claims cannabis has no currently accepted medical use and a high potential for abuse. Both are not true, just listen to the scientists.

Those outside of the five states putting cannabis on the ballot can still play a role in creating a Congress that is more receptive to cannabis reform. This Congress is the oldest, one of the most conservative and least effective in our country’s history. Younger, more progressive representation will increase our odds of advancing cannabis research.

Cannabis holds far too much possibility for us to allow it to be an unstudied “ditch weed.” THC and CBD are just two of nearly 500 compounds found in cannabis which, when scientifically scrutinized will harvest – I believe – vast medicinal and commercial benefits and the tax windfalls that accompany both. But first you have to vote.

If cannabis and your representatives are not on the ballot, do something millennials have built somewhat of a reputation for failing to do; pick up a phone and call your current representative. Tell them cannabis deserves scientific attention and investment. There’s too much potential in the cannabis plant to wait any longer.

October 27, 2020

How GW Pharma Won CBD

By Cathleen Rocco

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As of this writing, the United States Food and Drug Administration (FDA) has approved GW Pharma’s CBD drug Epidiolex for treating profound refractory pediatric epilepsy syndromes (Dravet syndrome and Lennox Gastaut syndrome) as well as for treating seizures associated with tuberous sclerosis complex (TSC) in patients one year of age or older. The product is a very simple, orally-administered formulation comprised of 100mg/ml cannabidiol (CBD), dehydrated alcohol, sesame seed oil, strawberry flavor and sucralose – basically, an alcohol-based solution with sesame seed oil to help solubilize the CBD oil, flavoring and sweetener.

On April 6^th, 2020 GW Pharma performed a regulatory miracle when they succeeded in convincing the Drug Enforcement Administration (DEA) to deschedule Epidiolex (i.e., remove it from the Schedule 1 and Schedule 5 lists of substances that the agency regulates due to concerns regarding safety, potential for abuse or both) for all indications – including indications for which it has not yet been approved by the FDA.¹ The benefit to GW of having their product descheduled is incalculable. This status change removed potential barriers to insurance reimbursement and made the need to set up and administer an expensive REMS² drug safety program less likely. In part because of this regulatory coup d’état, the drug recently posted yearly earnings of nearly $300 million.

It is important to note that the DEA descheduled the Epidiolex formulation and not cannabis-derived CBD itself. Thus, GW Pharma is now in the enviable position of being the only company that can legally sell cannabis-derived CBD. More importantly, because the DEA descheduled the formulation and not the active ingredient, other companies who wish to market cannabis-derived CBD pharmaceutical formulations will have to repeat whatever it is that GW did to get Epidiolex descheduled.³ The DEA effectively gave the company a huge head start with respect to competitors who are developing other cannabis-derived CBD formulations that would compete with Epidiolex. That advantage will remain in place unless and until cannabis-derived CBD itself is descheduled or cannabis is legalized at the federal level.

GW Pharma’s attorneys demonstrated considerable virtuosity in devising this approach. However, there is another aspect of the GW Pharma story – one that could have profound implications for the exploding CBD consumer packaged goods (CPG) industry. The Federal Food, Drug, and Cosmetics Act⁴ (FFDCA) prohibits the introduction into interstate commerce of any food to which has been added an approved drug or a drug for which substantial clinical investigations have been instituted and made public.⁵ Because CBD was and is still the subject of clinical trials run by GW Pharma and others, even hemp-derived CBD is currently illegal to use as a food additive or dietary supplement under the FDCA

The FDA has recently re-started the public commentary stage of a long process that will hopefully result in the creation of a regulatory pathway for CBD to be used as a food additive – something that would seemingly be a straightforward matter given the copious amounts of safety data being generated from all of GW Pharma’s clinical trials. However, as long as the FDA continues to drag its feet in providing a regulatory pathway for CBD CPG products, CBD, regardless of its source, will remain illegal to use as a food additive or supplement under either the CSA or the FFDCA despite the existence of safety data obtained through the Epidiolex clinical trials. If, as many people in the industry anticipate, the agency decides to begin enforcement action, this could have a hugely negative impact on the industry.

In addition to the potentially disastrous effect that federal law could have on an important new industry, the federal regulatory scheme introduces unnecessary regulatory complexity and cost by imposing two different regulatory schemes depending on the source of the CBD. CBD derived from hemp is chemically identical to CBD derived from cannabis. Despite that identity, the 2018 Farm Bill nonsensically exempts only hemp-derived CBD from the Controlled Substances Act. If a regulatory pathway is created for hemp-derived CBD, but the DEA insists on maintaining cannabis-derived CBD as a schedule 1 substance, then the same molecule will be subject to two different regulatory schemes. This scenario would require tracking and certifying CBD sources and thereby impose regulatory and economic burdens that are entirely unnecessary from a public health point of view.

An alternative, economically disastrous scenario: given the pharmaceutical industry’s formidable lobbying power, it is entirely possible that the FDA could decide to limit the use of CBD exclusively in prescription drug formulations. This could kill the entire US hemp CBD CPG industry, currently estimated to reach $22 billion by 2022.⁶

Overall, the current state of affairs is unfair, expensive, uncertain and entirely unworkable over the long term. The CSA must be amended, ideally to deschedule both hemp and cannabis entirely, but at least in the short term, to deschedule CBD and preferably all non-THC cannabinoids regardless of their source. Further, the FDA must provide a regulatory pathway to allow the use of low doses of cannabinoids shown to be safe, either by existing clinical trial data or future testing pursuant to the NDIN submission process.

A 2019 Gallup poll found that 14% of Americans – 1 in 7 – use CBD products.⁷ The demand is there, the industry is thriving, and adequate safety data exists to justify a regulatory system that allows low-dose over the counter CBD products provided those products are produced using Current Good Manufacturing Practices (CGMPs) for food and dietary supplement manufacturing prescribed by the FDA and that such products undergo regular testing that demonstrates they are safe, unadulterated and accurately labeled. It is time for the industry to collectively fund a New Dietary Ingredient Notification (NDIN) submission that would provide safety data sufficiently compelling to force the FDA to either recognize CBD and other non-THC cannabinoids as being GRAS substances regardless of their source, or in the alternative create a regulatory path for CPG products containing low-doses of CBD and other non-THC cannabinoids.

Editor’s Note: The opinions expressed in this publication are those of its author. They do not purport to reflect the opinions or views of the Cannabis Industry Journal, its editorial staff or its employees.

References

Clincialtrials.gov lists 256 different clinical trials in which Epidiolex has been, is being or will be tested for a wide variety of other indications, including but not limited to opioid use disorder, several types of prostate cancer, alcohol use disorder, musculoskeletal pain, and a host of others.
REMS – risk evaluation and mitigation strategy – are drug safety programs that the FDA requires in cases where mediations pose serious safety concerns with respect to potential abuse and other adverse effects.
Exactly what they did isn’t clear, and won’t be for a long while given the snail’s pace at which FOIA requests are filled.
Title 21 United States Code Chapter 9
Title 21 United States Cod Chapter 9, Sections 331(ll), 342(a)(1) and Section 342(d)(f)(1)
“Exclusive: New Report Predicts CBD Market Will Hit $22 Billion by 2022” Rolling Stone Magazine, September 11, 2018, citing cannabis industry analysis from the Brightfield Group.
Gallup poll on American CBD product usage