In every industry, there’s an underlying threat and worry that as AI advances, jobs will be at risk. This programming is deeply instilled in labor workers who have grown accustomed to income security to maintain their expenses or quality of life. But what if we’re looking at robots all wrong?
Instead of seeing a robot job apocalypse, what if they’re the machines to lift us to our highest degree? Robots are already proving to improve efficiency and cut company costs, so it’s inevitable they’ll come to a job near you soon.
For the budding cannabis industry, everything is fresh and new as the market is in its infancy. That means new systems and new workers have the opportunity to implement robotics to get ahead of the competition and boost morale earlier than most.
So, here, let’s de-program the way we think about robots today and cover the top three ways robots can help, not hurt, the cannabis industry—and the livelihoods of its workers too!
#1 Labor Shortage Gaps Need To Be Filled
Let’s get real—the cannabis industry is feeling the labor shortage just as much as anyone. Even more, it’s extremely difficult in this day and age to only pay a minimum wage to workers. This is true from coast to coast, but especially in lucrative cannabis markets like California, which have a higher cost of living for workers to meet.
“Robots aren’t here to hurt the cannabis industry, they’re here to help”Another predicament for facility owners? You can’t pay more for low-level repetitive tasks without significantly decreasing margins for your company while remaining competitive in such a bustling market. Moreover, humans just aren’t built to sit in closed, highly regulated areas, repeating the same motions over and over, to fill pre-rolls, vape carts, package jars and beyond.
By implementing robotics and automation tools, cannabis industry owners can not only fill labor shortage gaps but also alleviate labor costs for an improved bottom line. In addition, this will allow executives to better leverage labor costs towards more valuable positions that are more rewarding for employees too.
#2 Human Productivity Declines Over Extended Periods of Time
You know how you move with speed and precision when you first begin a repetitive task? Think exercising. When you first start your set of mountain climbers, your body moves mechanically, hitting the steps on point, repeatedly. But by the end, you’re struggling to get 1 or 2 last pushes in to hit your reps.
An automated pre-roll infusion robot
Manual labor and repetitive tasks are no different. In fact, there are companies in the world that hire workers to pack cases for just one hour a day. Why? Because their analytics have shown that after just one hour of work, the employees zone out and lose focus, which decreases productivity over time and increases the chance of human error.
In cannabis, someone has to fill the pre-rolls, and someone has to pack the jars into boxes. But, scheduling one worker for one hour shifts all day every day is a logistical nightmare to get the most productivity from the time you have. With no creative minds of their own (sorry, not sorry), robots are quite literally built for this type of labor and produce accurate results, too.
This allows cannabis owners to pay one up-front investment for the ’employee’ and can rest assured, financially and operationally, that the position will always be filled with no wage raises to consider.
#3 – More Robots Allows For More Rewarding Roles
Last but not least, there are few people in the world who actually desire or dream of the manual labor that’s required to keep the cannabis industry’s momentum moving upward for good reason. The human mind is meant to explore, create and evolve by putting it to use day in, and day out.
Hence, the uptick in investments towards upskilling in the cannabis industry and the passion for retraining employees for more technical roles. For employees, they’re more fulfilling and hold higher value. For employers, you have more human minds at work towards what matters versus the tasks that just need to get done.
Implementing robots in cannabis facilities for these mundane, repetitive, and low-level tasks help open the doors for more fulfilling roles for employees that share an interest in the plant. In the end, allowing them to put that passion and their unique skills, ideas and creativity towards helping your company prosper.
The Bottom Line – Cannabis Robots Are Here to Stay
With any new trend or shift in the labor and job landscape, it’s natural to be cautious of how it may affect you or your workers, both personally and professionally. However, as you can see, robots aren’t here to hurt the cannabis industry, they’re here to help.
As cultivators and other manufacturers struggle to turn a profit, now is the time for the overwhelmingly cottage industry to go big or go home. Because, whether you like it or not, there’s one thing we can all agree on: robots are the future of manufacturing, the cannabis industry included.
Cannabis sativa contains over 500 different bioactive compounds that can be separated through an extraction process. This is carried out in an extraction lab and the end result is the production of cannabis extracts with a high concentration of specific cannabinoids (such as THC or CBD) with up to 99% purity levels. Cannabis can get easily contaminated with pesticides, heavy metals, residual solvents or other contaminants and thereby pose a risk to the health and safety of consumers. In-house testing allows manufacturers to ensure that the cannabis products they put out to the market are not only potent but also are free of all sorts of contaminants.
The cannabis extraction market worldwide was valued at $9.7 billion in 2020. According to data from Grandview Research, the market size is expected to hit $23.7 billion by 2027, growing at a CAGR of 16.6%. While setting up a cannabis extraction facility can be cost-intensive at the start, the running costs are minimal, making this a profitable venture in the long run. However, you will need to consider these 7 important factors.
1. Location
A schematic representation of the 7 important factors to consider when setting up a cannabis extraction facility (Figure courtesy of CloudLIMS)
Cannabis is a highly regulated industry, regardless of the country. In the U.S, it is illegal at the federal level, and therefore there’s a need for judicious selection of location to avoid run-ins with the federal government. If you are in the U.S, you will need to check the specific laws in your state. These rules dictate how close an extraction facility can be to a daycare facility, children’s park, school, residential areas, etc. The rules may also spell out how many cannabis facilities can be located in one area and how close to each other they can be. At the end of the day, you also want to ensure that the location that you settle for is readily accessible, secure and close to resources.
2. Regulatory Compliance
A cannabis extraction facility needs to meet regulations that apply to the manufacturing and production of consumable goods to ensure that the safety of workers and end consumers is guaranteed. Here are a few that are of priority:
current Good Manufacturing Practices (cGMP): The CGMP is a regulatory standard enforced by the FDA. It defines the creation, implementation and monitoring of manufacturing processes to meet the quality and safety threshold. It requires manufacturers to use technology and have systems in place to ensure product safety and effectiveness. Cannabis extraction facilities should be GMP certified for operational standardization and for performing transnational business.
National Fire Protection Association (NFPA): Extraction labs use flammable materials which can easily trigger fires. NFPA, which is a non-profit organization, has created standards and codes to minimize injuries, death, and economic losses attributable to fire accidents. The standard describes how labs should be set up and how flammable liquids should be stored and transported to prevent accidental fires.
Local Fire Codes: These are a set of codes/requirements that must be adhered to in all commercial and industrial buildings to prevent fires. They include the availability and proper use of the following:
Fire extinguishers
Extension cords
Smoke detectors
Fire exits
Fire signage
Fire assembly points
Sprinkler heads and pipes
Fire alarms
Here are some important fire codes that should be followed in a cannabis extraction facility:
NFPA 1: The Fire Code Handbook
NFPA 30: The National Code for Flammable and Combustible Liquids
NFPA 45: Fire Protection for Labs Using Chemicals
NFPA 70: The National Electrical Code
NFPA 58: The Liquid Petroleum Gas Code
Occupational Standards for Health and Safety (OSHA): Cannabis extraction facilities are compelled by federal law to comply with OSHA requirements for occupational health and safety, and specifically regarding biological and chemical compounds that lab staff may come into contact with during their work. OSHA standard 29CFR1910.1200 requires labs to have a written hazard safety standard for all chemicals, and the standard should be accessible to all employees at all times. Labs are required to have an inventory of all hazardous chemicals with associated details recorded in a Safety Data Sheet (SDS).
3. Staff Management
Lab staff need to train on all hazards in the facility and be given first aid measures in case of an accident. The staff will need to sign that they have received training on the same.
4. Waste Management
Cannabis waste in an extraction facility includes plant trimmings, leftover extraction chemicals, disposed of samples and other debris left behind. Waste needs to be segregated according to hazardous or non-hazardous categories and disposed of accordingly. The lab needs to put measures in place for proper waste segregation so that the waste does not get mixed.
5. Worker Safety
Worker safety in an extraction facility is of paramount importance and should be based on the kinds of risks that each staff gets exposed to in the line of duty. This makes it necessary to have a Job Hazard Analysis (JHA) to assess hazards and put measures in place to avert accidents and injuries.
A laboratory software for CBD/THC laboratories to schedule staff training and manage staff competency (Figure courtesy of CloudLIMS)
6. Equipment Selection and Management
Cannabis extraction equipment can cost anywhere between $5,000 to $100,000, depending on the type and scale of extraction. When choosing the equipment, you need to factor in the cost efficiency, output, and the final product. All equipment used in an extraction lab should be Underwriters Laboratories Listed (UL-Listed). The equipment also needs to undergo regular maintenance to ensure maximum efficiency and productivity, and to prevent accidents and minimize wear and tear. National Recognized Testing Laboratory (NRTL) certification is necessary to achieve this.
7. Supply Chain Management
Supply chain management refers to the strict monitoring of the entire workflow to ensure effectiveness, eliminate wastage, and boost productivity and profitability. This means tracking raw materials from the time they are received by the extraction facility to when they are released as cannabis extracts. A Laboratory Information Management System (LIMS) comes in handy to support supply chain management in an extraction facility.
Role of a LIMS in Setting Up a Cannabis Extraction Facility
A laboratory software for CBD/THC laboratories, also known as a Laboratory Information Management System (LIMS), helps automate workflows, and thereby improve efficiency and productivity in an extraction facility. A laboratory software for CBD/THC laboratories streamlines in-house testing processes and guarantees that the final extracts produced are potent and free of impurities. A LIMS also comes in handy in managing Standard Operating Procedures (SOPs) and human resources, tracking samples and lab inventory, scheduling equipment calibration and maintenance, and ensuring compliance with the necessary regulations.
When setting up a cannabis extraction facility, sufficient time needs to be allocated to the planning to ensure all-important considerations are in place. This starts with finding an ideal and compliant location, ensuring regulatory compliance, ensuring worker safety, efficiently managing staff, inventory, and waste, and the careful selection of equipment. A laboratory software for CBD/THC laboratories ties these factors together to ensure a smooth workflow and maximum productivity of the facility.
Hangovers are one of the aftereffects often experienced with spirits. Who doesn’t love a good martini or a refreshing margarita? One company is on a mission bring the flavor profile and buzz of spirited drinks without the negative consequences.
Like this article and want to see more? Subscribe to our free newsletter hereMXXN is a California-based cannabis infused beverage manufacturer specializing in 1:1 non-alcoholic replacements for everyone’s favorite spirits, enhanced with a touch of cannabis. By combining new technology in cannabis oil nano emulsions and alt-alcohol, MXXN is able to create flavor matching spirits sold by the 750 mL bottle. MXXN recently launched with three product SKUs including London Dry (gin), Jalisco Agave (tequila) and Kentucky Oak (bourbon) with a rum replacement due to launch soon.
We caught up with Darnell Smith, founder & CEO of MXXN, to ask about the technology going into infused non-alcoholic spirits, regulatory challenges and more. Prior to MXXN, Darnell was a spirits industry veteran, having worked with companies including Diageo, Pernod-Ricard and Bacardi.
Aaron Green: Darnell, nice to meet you. How did you get involved in the cannabis industry?
Darnell Smith: For me, it wasn’t something that was premeditated, in a sense. I had always been a cannabis user in my adult life. I played Division I sports. Cannabis replaced a lot of painkillers and medications that I probably would have had to take just to cope with athletic injuries. That’s how I got introduced to cannabis. And there is the recreational use of it as well.
Darnell Smith, Founder & CEO of MXXN
To get to the origin story of MXXN, I spent a large part of my career working in spirits, namely, on the innovation and commercialization side of bringing new products to market under very well-known trademarks for large multinational companies. A few years into it, my liver was kind of at a point where it was like, “It’s gonna be you or me here, buddy.” So, I made the decision to start making – this is 15 years ago, in New York – a tincture where I would just heat up flower and decarb it and soak it in a high proof spirit. I would cover it for 30 days then strain it and have my tincture.
I’d be the guy in the bar, that would say “Hey, can I get a tonic and lime?” and I would put three drops of my tincture in there, and I would session cocktails along with everyone else. Next day at work, I’m the guy that’s bright-eyed and bushy-tailed and everyone else is kind of feeling a little bit weathered by that alcohol.
Innovation is usually born out of a personal need and that’s the same way here. So, fast forward 15 years and the technology has finally caught up. The rise of non-alcoholic spirits, the rise of cannabis and water-soluble emulsification, those two things combined really made the light bulb go off and say now is the time to offer this product. I feel like MXXN has a very specific place in our consumption of beverages and can fill a unique need that I think is rising.
Green: I’m interested in learning about the technology and the product. We can start with the technology that went into the product development process. I’ll go on to product next.
Smith: From a technical standpoint, up until a few years ago, the way that edibles were made was basically like raw extraction. There was very little ability to be precise about dosage. It was like trying to throw softballs through a chain-link fence. Non-uniformity made it very hard to say, “Here’s how this is going to affect you.” Fast forward and companies like Vertosa and Source have perfected this kind of nano-emulsion technology, which is basically water-suspended cannabis that can uniformly be used in food, beverage and cosmetic applications. And it’s akin to trying to throw sand through a chain-link fence. It’s just much smaller. It can remain more uniform, and thereby be more predictable in terms of dosage and effect.
The MXXN London Dry
So, that technology made it possible for us to then combine it with another wave that’s happening, which in the spirits industry is called alt-alcohol. What we do is distill all the flavor essences of well-known spirits and skip the alcohol. We then add the emulsified cannabis in place of the alcohol. And so with that, we offer a new kind of experience which is basically all the buzz but none of the booze. That’s really where technology-wise things have evolved. The rise of the non-alcoholic spirits and then the rise of being able to do water-soluble compatible cannabinoid emulsions.
Green: Are you selling this then as packaged goods or are you selling it as bladders similar to Coca-Cola in a bar setting?
Smith: This is a CPG packaged product and it really is analogous to a 750 ML spirits bottle similar to Tito’s or Grey Goose. The form factor is the same as spirits bottles, same 750 ML bottle. It doses just like a spirit would. Standard spirit pour is an ounce and a half. For us, an ounce and a half shot has six milligrams of THC.
For the average consumer, you can session cocktails and we give you the option to dose between two and six milligrams between a half ounce and an ounce and a half pour. So, it’s very analogous to what people are experienced in when it comes to spirits from the bottle to the dosage and to the actual recipes. We pride ourselves on being able to demystify something that has been a little bit complex in terms of making cannabis-infused cocktails. We are sticking close to what people are familiar with. People have a lot of experience with tequila or gin or bourbon and so we wanted to stay very familiar but also give people a chance to make the same recipes but sans alcohol.
Green: What kind of flavor profiles are you launching with?
Smith: We’re launching with three SKUs. Our first is London Dry, which is our take on a gin and that one has cucumber, juniper, coriander, and a nice peppery finish. We have Jalisco Agave, which is our take on a tequila or Mezcal. You have notes of agave, flint, salt, oak, and vanilla. And then the last one is Kentucky Oak, which is our version of a bourbon or whiskey. There you have charred oak, vanilla, and other flavor components that make up what bourbon is.
The MXXN Kentucky Oak
Now we have a rum in development that’s nearing the end of a robust R&D pipeline. We have some other options like ready-to-drink cocktails made with MXXN to more high-dose products for what we consider the “legacy consumer” who is maybe more medically inclined in the hopes of being able to give people more options when it comes to consumption of flavored spirits.
Green: On the cannabis side, with the infusions that you’re doing, is it pure THC or are you doing full spectrum?
Smith: Yes, full-spectrum cannabinoid. You’ll notice some beverage brands have what we consider a hybrid, some THC and some CBD. For us, and for the effects that we wanted to have the product to have we stuck with a THC-forward blend. There is a trace of CBD in there, but we don’t even claim it. It’s not something that we go forward with. Our emulsion is THC-based.
Green: Where are you at today in terms of the launch and presence?
Smith: We just finished a pilot test here in California. We started late-January, early-February and we’ve been selling direct-to-consumer. Just order and you can have it at your door in 24 hours for about 85% of the state. We’ve blown through our entire pilot run. Now we are entering into what we consider our launch phase which will be available in select retailers late-July. We are gearing up for our next big production run here in mid-July. We are basically all systems go.
At the same time, we’re exploring multi-state expansion. We have a lot of interest in states like Colorado, Nevada, Arizona and we’re having constant conversations with partners in those states to help bring the product to market.
Green: Have you looked at lounges?
Smith: Lounges have been our biggest traction as we start the retail rollout. We literally just started the dispensary piece of what we’re doing last month. And this is by design. First, we wanted to go direct-to-consumers for proof of concept to make sure we weren’t, you know, saying the story to ourselves. I think just by the performance of the pilot run and direct-to-consumer sales, we proved okay, this is a viable concept.
MXXN’s Jalisco Agave
So as we go out, our number one targets are obviously establishments that also are connected to or have connections with a consumption lounge. There aren’t a ton at this point. They’re still kind of proliferating. But I will tell you the moment we walk into one of these accounts is like a no-brainer because it allows this account to offer a whole new experience. When it comes to consumption lounges in terms of great cocktails you already know: gin and tonics, margaritas, paloma, with no real education required on the part of who’s ever going to be serving. We basically take 20 retailers a month in chunks and so far of the 15-20 that we’ve done, four or five of them have consumption lounges and you’ll see it in those very soon.
Green: Are there any challenges there with dosing in a lounge where the onus is on the operator to dose? How do the regulations work there?
Smith: It’s similar to alcohol, right? As an establishment, you have a responsibility to kind of pay attention to what’s happening as the consumer is consuming. Typically, most of the legislation that was written is for an inhaled consumption lounge. Ingestibles weren’t necessarily considered heavily when it came to legislation. What we tell folks is you have the same responsibilities you would if you were a bartender. Our recommended pour in consumption lounges is a lighter dose. This way, the customer has a chance to start low and go slow, and really recognize how it’s going to affect them.
Legally, there is no firm guidance on what overconsumption looks like for the typical consumer. So, we tell folks you have to kind of get a feel for who the consumer is. If they’re curious person who doesn’t have a lot of experience with cannabis, we typically recommend not to exceed a five-milligram serve per sitting until you figure out how it’s going to affect them. However, if you have very high dose legacy consumers, who buy and drink these 100-milligram single-serve bottles it’s a different story. You kind of need to gauge that from consumer to consumer, and what their tolerance level is. A lot of onus is on the consumption lounge. And I think that’s why they’ve kind of been slow to really roll out how they deal with beverages, because it’s just a different beast. It’s absorbed differently by the body from inhalable products
Green: What trends are you looking at in the industry?
Smith: I love seeing more food-based options. Edibles to this point have been mostly candies and gummies and I see the trend going to more high-end, curated food selections. I think that’s super interesting. The condiments that go into cooking is a category that I’m keeping an eye on. I came across a THC and CBD-infused Siracha sauce the other day and I was like, “wow, this is fantastic!”
MXXN logo
In the beverage space, there continues to be innovation, which we are on the forefront of. There’s a point of saturation that’s going to come for how many seltzers can exist in the market at the same time. And I think we’re kind of reaching that point. So, it’s going to be incumbent upon the beverage space to continue to innovate.
I’m also watching where things go with hemp-derived THC, the Delta-8s and those things and how is that going to be dealt with when it comes to the legal market. I think you see varying ways that it’s being dealt with across states. That’s a trend I’m certainly keeping an eye on as things continue to roll out across the country.
Green: What, in your personal life or in cannabis are you most interested in learning about?
Smith: Given where the world is today, I feel like we all live in this “OR” mindset. It’s either you OR me, it’s either this OR that. And I think you can see with some of the more recent political things that have happened, it’s this ideology of like, trying to force your beliefs on someone else. For me, it’s more about like, how can we learn to live more in the “AND” right? You can have this AND this and they can coexist, and they don’t have to be in competition. In my personal life, that’s where a lot of my energy is going. How do I spread that thought of getting out of this living in OR. We must move to this kind of mindset of AND. How can we be accommodating for a bunch of different beliefs, a bunch of different approaches? It causes so much friction when we try to impose beliefs on others that may not share the same beliefs.
I am thinking about how I can apply that to the cannabis industry as well. In terms of federal legalization versus state, where can we find that the happy ground? If we think about going across state lines, that’s effectively building a whole other business in the state, and in virtually no other industry does that exist. I can tell you economically this country could use infusion of cannabis to be more freely available. So those are the types of things that keep me moving these days. I’ve had a lot of success in my past and so for me, it’s less about financial achievements, and it’s more about how we can help move folks to this is AND mentality and not everything has to be OR.
Despite the popularity of cannabidiol (CBD) infused edibles among consumers there are storm clouds on the horizon for this market. The potential threat stems from continuing uncertainty about the regulatory status of CBD in the United States (US) and the European Union (EU). Recent statements by government agencies in both areas are reminders that regulators could make decisions or take actions that would suddenly end the viability of this market. Any company that sells, or is planning to sell, CBD infused edibles such as bakery items, candy and beverages needs to understand what the regulators are thinking now and what might happen in the future.
in the US, the 2018 Farm Bill created a category of products called hemp that are derived from the Cannabis sativaplant and contain less than 0.3% tetrahydrocannabinol (THC). This law also explicitly confirmed the authority of the US Food and Drug Administration (FDA) to regulate the safety of hemp-derived infused edibles. This means CBD needs to navigate the New Dietary Ingredient pathway for dietary supplements, and either the food additive petition process or the Generally Recognized as Safe (GRAS) pathway for foods before it can be used as an ingredient in a food. All three of these processes require that someone (an individual, a company or a group) acting as a petitioner or notifier must submit safety data to the agency or arrange for a safety evaluation by independent experts.
Just some of the many hemp-derived CBD products on the market today
In the EU, CBD is regulated as a Novel Food in a process that is triggered by a submission to the European Commission. The submission must include safety data that is evaluated by the European Food Safety Authority (EFSA). In England and Scotland, CBD products are also novel foods and are evaluated using a process like that in the EU. As in the US, it is the responsibility of an applicant to provide the safety data.
The standard used by the FDA to judge the safety of new food substances in all three pathways is that there should be a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” The standard used by EFSA for novel foods is, “the food does not, on the basis of the scientific evidence available, pose a safety risk to human health.”
It is important to realize that both in the US and the EU the safety standard for evaluating new food substances only considers the safety of that substance. The laws or regulations that define agency authority do not allow for consideration of any potential benefits. Approval (or rejection) must be based solely on the safety of the substance. Further, safety is evaluated in the context of the intended use of the substance, the planned level of use and the resulting consumer exposure to that substance.
What do we know about FDA’s and EFSA’s current thinking about CBD safety?
Unfortunately, both the FDA and EFSA have made it abundantly clear that they believe the available scientific data does not meet the required safety standards. FDA has issued multiple warning letters to companies that sell CBD products and has rejected two NDI notifications for CBD. Although these actions were primarily based on non-safety issues (illegal health claims and the drug exclusion provision in the FD&C Act, respectively), in each case the FDA also raised safety concerns. This was done by saying that the agency is not aware of any data that would support a GRAS determination or that the products raise “concerns about the adequacy of the safety evidence.” This doubt echoes statements from the agency in public meetings and advisories. These doubts were expressed as recently as June 2022 during a meeting of the FDA Science Advisory Board.
Similarly, EFSA has stated that they feel that there are critical gaps in the existing CBD safety data. In April 2022, they published a statement with a detailed analysis of the relevant scientific literature and explicitly identified critical data gaps. EFSA said that these data gaps prevented them from evaluating CBD as a novel food.
What do the regulators see as data gaps?
Although the details of each of the data gaps are technically complex, for both the FDA and EFSA they fall into few broad categories.
The first is that the agencies feel that they need better information on how CBD behaves in the human body. This is described as understanding the absorption, distribution, metabolism and excretion (ADMA) of CBD. The agencies also would like to see data on whether repeated use of CBD might cause damage to specific organs that does not occur from single exposures.
The second need is for more data related to the negative effects that have been observed in some previous work. This includes effects on the liver and reproductive system. In particular, the agencies would like to know whether it is possible to identify a level of exposure that is low enough to not cause any negative effects. This is termed the No Observed Adverse Effect Level (NOAEL). In an ingredient safety assessment, the NOAEL is used to establish a safe intake level, called the Acceptable Daily Intake (ADI). Comparing the ADI to the expected exposure for the intended use allows the regulators to assess overall safety for a substance. If the expected exposure is below the ADI, the substance is considered safe. Both agencies feel that the existing data do not allow them to identify a NOAEL for CBD.
The third data need relates to the composition of the CBD products used in safety studies. Food safety determinations are based on the total composition of an ingredient that is produced using a fully defined process. Even if the potential ingredient is 95% or 99% pure, a safety evaluation needs to know what is in that other 5% or 1%, and that this is the same from batch to batch. For example, the presence or absence of residual processing chemicals (such as extraction solvents) and the nature and concentration of substances such as other cannabinoids and terpenes will differ between manufacturers and processes. These differences could affect the overall safety profile for each CBD product. Therefore, it is considered important that studies supporting a safety determination for a new substance be carried out with the actual article of commerce.
Unfortunately, many different CBD preparations have been used in past studies, and in most cases these preparations were poorly characterized. This makes it difficult or impossible to combine the safety data obtained using one product with data obtained with a different product. For example, data obtained using CBD isolates from two different sources cannot be combined unless it can be shown that they were made using the same process and have the same overall composition.
What does this mean for the future?
Neither the FDA nor EFSA is likely to take any positive action on CBD until they receive safety data that fill the gaps that they have identified.
Given these data problems, it is likely that there will be little or no movement on regulatory approvals for CBD in edibles (or dietary supplements in the US) for at least several years. In the US, these products will remain in legal limbo, with state regulations playing the leading role in determining what is allowed on the market. Products with health claims will continue to be particularly vulnerable to FDA action. The situation in the EU will be at least as confusing because, in the absence of action from EFSA, the regulatory and market status of CBD edibles will be determined by each member country independently.
In view of this uncertainty and business confusion, that are three ways that companies making CBD and CBD edibles can respond. First, in the short term, they can develop and implement manufacturing processes that ensure that their products are consistent from batch to batch and that they have the intended dose of CBD per serving or per product unit. This includes working with the analytical community and organizations such as AOAC and ASTM to ensure that there are validated testing methods available for the CBD and for the final edible products.
In the medium term, business risk management plans for companies that make CBD and CBD infused edibles should consider the possibility that new scientific data will push food safety authorities to actively conclude the CBD does not meet the current regulatory safety standards. In that case, the regulators might start to act against all CBD-containing products.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Businesses should also be aware that the agencies could make a positive safety determination but that they would use the available data to establish a low maximum allowed dose per serving or set very low limits on the presence of specific contaminants such as other cannabinoids.
In the longer term, the CBD industry as a whole might consider advocating for legislative changes. The best statutory fix is likely to be one that that regulates all cannabis-derived products in a system or agency that is separate from the food safety system. This approach is being used in Canada under the Cannabis Act. It is also similar to the way that alcoholic beverages are regulated in the US. This approach, if appropriately designed, could avoid the need for safety determinations but might also limit market access. While this approach could bring clarity and certainty to the market, it is important to remember that it will take time and effort to create a functionally system under this scenario.
There are many market reports that forecast on-going high rates of growth for the CBD market. However, the regulatory and scientific developments that are likely to occur of the next couple of years will determine whether those projections can become reality.
Companies making these products need to monitor changes and prepare to respond to either positive or negative events.
These companies should also remember that edible products are mostly made from food ingredients using standard food product processes. It is critical that these products be made under a system that prevents food-borne hazards.
Back in December of 2021, The Pennsylvania Department of Health sent emails to registered medical cannabis patients, notifying them of a safety review being conducted on ingredients found in cannabis vape products.
Then in February this year, the state’s health agency sent a third email. This one notified patients that they were recalling more than 650 products and ingredients. “As you know, the Department recently conducted a statewide review of all vaporized medical marijuana products containing added ingredients,” reads the email to patients. “After finishing this review, the Department has determined that certain vaporized medical marijuana products containing some added ingredients have not been approved for inhalation by the United States Food and Drug Administration (FDA).”
The recall generated a lot of controversy for the state’s medical cannabis market, leaving patients, dispensaries, processors and other cannabis businesses with little guidance from the state’s health department. Cannabis companies in Pennsylvania, like Curaleaf, Jushi and Trulieve, formed a coalition and sued the state’s health department in February, alleging that regulators ordered the recall preemptively and did so without going through the proper channels, according to the Philadelphia Inquirer.
On June 2, the coalition of cannabis companies won and a judge stopped the recall. The very next day, the health department took issue with the judge’s decision and filed an appeal with the PA Supreme Court. For now though, as the appeal makes its way to Pennsylvania’s top court, the recall is lifted and dispensaries can restock their shelves with vape products.
Elevating Edibles: Defining the Next Cannabis Experience
Sam Rose, Director of Operations, Herve
Attendees will learn during this session:
Luxury edibles and form factor: Moving away from get high first and think about what you’re consuming second, a pivot from sugar filled, bad tasting edibles to delicious and refined ingredients. Non-juvenile form factors, healthier options, efficacy
Concentrates and infusion: Providing the consumer with the right high using the right ratios and concentrates. Bioavailability, highlighting the plant, absorption method (sublingual)
Giving the consumer what they NEED not what they WANT: We’re at a fragile point in time where people are either trying cannabis for the first time or experimenting with it again for the first time in a long time. We need to make sure these people have a good experience and not scare them away. High MG edibles and high % Flower is not the way to do this – the how high for cheap model is really toxic for the industry. We need to educate, we need to provide clean low dose edibles and more curated flower.
TechTalk: Millipore Sigma
Dr. Sunil P. Badal, Senior Scientist, Innovations/Advanced Analytical R&D, MilliporeSigma
Cannabis Beverages: The Rise of a New Market & a New Consumer Christiane Campbell, Partner, Duane Morris, LLP
Attendees will learn during this session:
The current landscape and regulatory red tape surrounding cannabis beverage brands
Selecting and adopting a cannabis beverage brand
Protecting a cannabis beverage brand
TechTalk: Berlin Packaging
Julie Saltzman, Director of Cannabis Business Development, Berlin Packaging
One Symbol to Rule Them All! Harmonization is Finally Here! Darwin Millard, Owner & Founder, TSOC LLC, ASTM Subcommittee Co-Chair
A picture is worth 1000 words, but with a hogbog of “universal” symbols, is something getting lost in translation? ASTM International’s new standard, ASTM D8441/8441M, Specification for an International Symbol for Identifying Consumer Products Containing Intoxicating Cannabinoids, serves to establish a truly harmonized international warning symbol. Learn about the significance and use of this all-important standard from one of the members of ASTM Committee D37 on Cannabis who helped developed it.
Leafreport released the findings from their expansive CBD testing study that revealed some pretty alarming results. According to their study, only 7% of CBD brands they sampled actually conduct legitimate contamination testing for pesticides, heavy metals and microbial contamination.
Leafreport is an Israeli company founded in 2019 that does product reviews, independent testing and provides educational resources for consumers. The company produces studies on CBD products in the market and reports their results on its website. Back in 2020, the watchdog company conducted independent lab testing on 22 different CBD-infused beverages and found a lot of inconsistencies with the actual amount of CBD found in the beverage and what the product’s label claimed.
In this latest study, finalized in late May of 2022, the consumer advocacy group found a lot of inconsistencies throughout the CBD market. For their study, they reviewed 4,384 products from 188 brands, with the goal of looking at overall transparency in the CBD products market. Judging by the results they share, the CBD market is unsurprisingly not very transparent.
Here are some highlights from this most recent study:
20% of the brands reviewed didn’t carry out any purity tests to check for the presence of microbes, pesticides, or heavy metals. In 2021, 25% of the brands Leafreport reviewed didn’t carry out any purity tests.
42% of brands test almost all of their products for potency (90%-100% accurate) and share their third-party lab results with consumers — the same as in 2021.
Only 12% of brands had all their products fall within acceptable potency variance limits.
88% of brands that tested their products for potency had at least one product test beyond the 10% variance for potency, in comparison to 84% in 2021.
28% of brands didn’t carry out any testing at all for pesticides (such as glyphosate), 26% didn’t test for the presence of any heavy metals (such as arsenic), and 24% didn’t test for microbes (like bacteria).
Two brands carried out no lab testing at all for either purity or potency, compared to 3 brands in 2021.
Metrc combines a software platform with radio frequency identification technology to track plants and cannabis products from seed to sale. The track-and-trace model quickly became adopted by dozens of states to regulate their cannabis markets over the years, becoming an important standard in the industry.
With government contracts in nineteen states and counting, Metrc has become an omnipresent fixture in the United States cannabis market. States work with Metrc to provide their market’s traceability software for the entire supply chain, which helps prevent diversion to the black market, offers security and safety, aids in recalls and regulatory compliance tools.
We sat down with Michael Johnson, CEO of Metrc, to discuss retail challenges, regulations, cybersecurity, compliance and more.
Aaron Green: What are the major compliance challenges retailers face?
Michael Johnson: Major compliance challenges that retailers face will vary from state to state, however, we do see common themes across state lines. Financial services, for instance, has been a historical industry hurdle, as most big banks and credit card companies deny access to their network, making it difficult for retailers across the board – from bank account setup to limited customer and patient payment options to security issues when managing a cash-only retail business. The tides are starting to change with more credit unions and state-chartered banks opening their doors to the industry, along with new payment technologies for consumers to use instead of cash.
Michael Johnson, CEO of Metrc
We also see common operational challenges, including inventory management issues due to human error, lack of consistent quality assurance, and product theft. Retailers regularly face strict packaging, labeling, and product safety laws along with requirements for public health, storage and sanitation procedures and additional layers of security and surveillance.
Finally, access to compliant and retail-friendly technology systems is important as it can have a major operational impact. If a retailer can choose, selecting the right platform will manage all their operational needs – from ID-scanning at check-in to inventory management to banking – while properly integrating with their state’s track-and-trace technology. That’s a major benefit and one that Flowhub brings to the industry, alongside Metrc.
Aaron: How does compliance for retailers differ from cultivators and manufacturers?
Michael: It is important to note that proactive compliance sits at the center of cannabis regulation. Not only does it ensure the maintenance of license(s) and overall businesses, it helps expand and enhance the industry as a whole. As a highly regulated sector, transparent and consistent compliance initiatives provide the necessary foundation for a safe and secure environment, strengthening all levels of the supply chain and the industry at large.
All industry players must adhere to specific licensing and documentation requirements – an expired or illegal license may lead to serious fines and carries the potential of losing the business. In a handful of states, employees may need a license as well. Real estate also comes into play for all license holders, with special cannabis zoning restrictions, such as requiring distance limits between select institutions.
Since retailers are customer- and/or patient-facing, they may experience unique operational requirements compared to cultivators and manufacturers, including ID-checking policies, customer or patient delivery laws, additional packaging and labeling rules, strict dispensation regulations, in-store and on-shelf product placement, retail signage, and product promotion rules, and more.
Just like retail, cultivation and manufacturing compliance will also vary across states, but with a host of additional compliance requirements to keep in mind – for example, biological, chemical, and physical hazards are something that play a larger role at facility operations, which are subject to Occupational Safety and Health Administration (OSHA) rules. Other compliance issues to highlight on the cultivation and manufacturing side include state requirements on inventory reporting, security patrols, waste removal, and meticulous logging.
Aaron: What is your process for evaluating vendor integrations?
Michael: At Metrc, we maintain an efficient and consistent process for evaluating vendor integrations – an example of our commitment to ensuring the safety and security of legal cannabis markets.
First, integrators petition access into specific instance(s) by filling out a form with their basic information (business name, software name, contact info, etc.), along with any state-required agreements that must be signed. The integrator is then given a set of steps to perform in each instance requested. The steps provided are then evaluated by our API Support team. When all steps are performed accurately, the integrator is added into production and an API key is generated for their use. Licensees must also issue the TPI a User API key to gain access to the API. Overall, the process is a combination of meeting state, Metrc, and licensee requirements.
Aaron: Can you address the cybersecurity landscape METRC faces? What is METRC’s process for dealing with cybersecurity threats?
Michael: Cybersecurity threats are shared across industries and although not unique to Metrc or the cannabis sector, cybersecurity threats and the value of data continues to change. Maintaining strict safeguards around data privacy and the security is a top priority at Metrc and we keep a constant pulse on changes in the cybersecurity landscape, to maintain this safeguard for our customers, industry users, and Metrc as a whole.
Aaron: What trends in cannabis regulation are you following?
Michael: Cannabis rules and regulations are ever evolving, which is why it is vitally important for anyone in the industry to stay up to date. Examples of some we are following closely at Metrc include the SAFE Banking Act, Marijuana Opportunity Reinvestment and Expungement (MORE) Act, and Cannabis Administration Opportunity Act (CAOA); and more generally federal legalization, public health protection, and environmental regulations.
Aaron: What’s next for METRC?
Michael: We continue to expand our customer and user feedback loop to ensure our roadmap meets the unique needs of markets and an overall evolving industry/regulatory landscape. Examples include continued performance improvements, more robust analytics capabilities, user-driven functionality updates, and exploring the design of a more sustainable RFID tag.
Infused flower and infused pre-rolls are two segments of the cannabis flower market sought after by consumers for their high THC content. Moon rocks are a type of infused flower product made by infusing flower with sticky concentrate and then rolling the sticky flower in kief. THC content of moon rocks often exceeds 50%.
Presidential is one of the largest infused flower cannabis companies and the third largest pre-roll brand in California, with products available in over 400+ retail stores such as MedMen, Gorilla RX, Sherbinskis, La Brea Collective and Royal Greens. Presidential’s success and growth has primarily been organic through word of mouth. Presidential recently launched the Presidential Suite in WeHo, a speakeasy-style lounge with entrance through a subway car inside a NY-style pizzeria, Esco’s. The suite offers events including exclusive cannabis industry nights as well as “pizza parties” held jointly with Esco’s.
We interviewed Everett Smith, co-founder and CEO of Presidential. Everett co-founded Presidential in 2012 following a professional basketball career in Europe. He has a background in marketing and brand development.
Aaron Green: Everett, how did you get involved in the cannabis industry?
Everett Smith: It was really just by chance. I was in Vegas after I was done playing ball overseas. I was working 9 to 5 at the convention center for a company called Freeman. I was out waiting for some clients and I met this guy who started talking to me about cannabis, about this company he was starting and how his friend was manufacturing the product for him. I didn’t love my job. I was looking for something exciting to do. So, I got their information, and I took him up on it and I called them every day for almost three months. Then it finally got together and long story short, we started.
Everett Smith, co-founder and CEO of Presidential
Green: What year was that?
Smith: That was in 2012.
Green: So, you met this person in 2012 and then three months later had it up and going?
Smith: Long story short, yes. After three months, we finally got together and got all the parameters figured out and then we started to create the brand, get the packaging, get the product, and put it out to the street. That all probably took six to eight months.
Green: Presidential is known for moon rocks and infused pre-rolls. How did you hit upon the concept of infused flower? Why did you make that your focus?
Smith: The gentleman I was talking about before – he’s no longer our partner – was manufacturing for his friend and that’s what he did, so that’s what we got introduced to and then as soon as we started selling it, I just found ways that it could be improved. I listened to the customers we were selling to. My old partner wasn’t willing to do that due to the manufacturing time, so we took it into our own hands and got an investor, my partner now, John Zapp, and we figured out how to manufacture it ourselves. We had zero idea what we were doing and we figured it out. I have to give credit to John, he is the one who figured out the formula we are using right now. There was a lot of bumping our heads, a lot of trial and error, a lot of figuring it out. And luckily, we did.
Green: You mentioned you felt like other companies weren’t doing it right. What was the difference that Presidential brought to the table?
Smith: Quality. These other companies were focused on profit margin. They weren’t using quality products. They were using the same product twice in different things, which is the ultimate no-no. I just found that if you started with high-quality raw goods, and put them together, you are going to have an even better product.
Growing up my mom was kind of a hippy. We just like stuff from the earth. Good organic stuff. So, we were taking flower that I knew was being grown organically at the time and then infusing it and it created a better product. We packaged it better than anybody else’s packaging at the time. I have a background in marketing so at that time, I was just trying to create a product and a brand that my friends and I would like. I thought we were our target user at the time. I was working in my late 20s.
Green: Where were you located at the time?
Smith: We were in Los Angeles.
Green: What were some of the challenges of launching a brand in Los Angeles back in 2012?
Smith: Some of the challenges included: education of the consumer; getting clients in the door and making them feel safe to come into a dispensary and purchase medicine at the time; and the legalities – maneuvering all the different propositions that were coming down and being able to do it legally and safely. The legal issues were probably our biggest hurdle. Then there was the challenge of introducing people to Moon Rocks. Infused flower was a brand-new concept, so we had to find as many people as we could to introduce the product to.
Green: I’m just imagining back to 2012, I think Moon Rocks would have been completely new to me. How did you get customers over the hump of trying something new?
Smith: I would get big jars of Moon Rocks. They look crazy. We saw people walk by and just watched the reactions. It was like, “Whoa, what’s that? What in the world is that?” Then we use the tagline: “World’s Strongest”. We’re starting with nice, tasty flower. We’re putting 90% THC distillate on it and then when we’re taking kief in the mid 40s 50s (% THC), and we’re covering it. So we’re putting THC on top of THC of on top of THC.
Putting “The World’s Strongest” on there and just putting big jars out in front of as many people, at as many conventions, and at as many dispensaries that would let us set up a patient appreciation day. That’s how we did it.
Green: You are in retailers across California. What were the keys to your success in building out your distribution network?
Smith: Sales. Knocking on doors. My partner comes from the car business. He was a fixer-upper helping dealerships all over the country become more profitable. So, just having that mentality of going out every day and knocking on doors trying to get every single possible client. I want to say it was like being a car salesman and Hollywood, or something similar. At first it was me and John every day knocking on doors. Then the business built on itself.
We have the same process now. Knock on the doors and send our brand ambassadors in there to do customer appreciation. They get our product in front of people and it’s worked for us. The marketing money we do spend we spend in the stores, because we see a direct correlation there. At the end, it really goes back to the knocking on doors.
Green: Do you notice anything different between 2012 sales and prospecting versus today now that your brand awareness has changed?
Smith: Absolutely. Everything is very corporate now. Before 2014, you could knock on the door and the person that you needed to see was sitting right there. The owner was the buyer. Now, you have to get through layers of people to get to the actual decision-maker because they’ve become so corporate. So that’s the biggest difference I see, but I wouldn’t say it’s a negative. I would say that our industry has become more positive. We can guarantee regular pay. We can guarantee that the products are going to be on the shelves and we can cut or markup the pricing. Those are the changes I see and they’re not always easy, but I think they’re for the better.
Green: What does the future look like for Presidential? More broadly, what does the future look like for the industry in terms of infused flower and pre-rolls?
Smith: Right now, the infused flower market is one of the fastest-growing markets. I see that becoming the norm, and the same for pre-rolls. We’re looking at expansion and trying to become one of the national players in this game. We’re swinging for the fences.
Green: What geographies are you looking at?
Smith: Right now we’re in California. We are in negotiations to launch in Nevada in July. We were getting ready to launch in Oklahoma, but had a deal fall through so now we are kind of switching gears. I would say by end of year we’ll be in Oklahoma, and my partner John is trying to close a deal for Michigan. So, those are the markets we have on the table right now. We’re looking to close those all before the end of the year.
Green: What trends are you following in the industry?
Smith: We have the number one selling blunt in California, but in terms of pre-rolls we are number four in terms of sales. The three companies ahead of us all sell minis and packs of minis, whereas we sell single 1 gram and 1.5 gram pre-rolls. So, in July, we’re launching three-packs of minis, so three 0.7 gram blunts and three 0.5 gram pre-rolls.
You can infuse the flower with pretty much any kind of concentrate the way that we do it. I’d like to come out with some diamond products, that’s hot right now. We’re following the wave and trends of the concentrates.
Green: What in your personal life or in cannabis are you most interested in learning about?
Smith: In my personal life, I’m interested in financial craftiness. You know, make your money and make your money work for you. I personally, in the business, would like to learn more about the smokeless form factors of cannabis. Things like beverages and capsules. I think that’s where the industry will end up going. So, I’m interested in learning more about the manufacturing of beverages and capsules and what it entails.
Green: Thanks Everett, that concludes the interview.
As the regulated cannabis industry matures, M&A activity is expected to continue accelerating. Whether they are existing licensed businesses looking for acquisition opportunities or new investor groups seeking to enter or expand their positions in the industry, investors should recognize the special due diligence challenges associated with cannabis industry transactions.
Above all, investors should avoid the temptation to omit or short-circuit long-established due diligence practices, mistakenly believing that some of these steps might not be relevant to cannabis and hemp operations. Despite the unique nature of the industry, thorough and professional financial, tax and legal due diligence are essential to a successful acquisition.
Surging M&A activity
Over the past few years, as the cannabis industry matured and the regulatory environment evolved, M&A activity involving cannabis and hemp companies has undergone several cycles of expansion and contraction. Today, the expansion trend clearly has resumed. Although the exact numbers vary from one source to another, virtually all industry observers agree that 2021 saw a strong resurgence in cannabis-related M&A activity, with total transactions numbering in the hundreds and total deal values reaching into billions of dollars. Moreover, most analysts seem to agree that so far, the pace for 2022 is accelerating even more.
Today, many existing cannabis and hemp multistate operating companies are in an acquisitive mood as they look for opportunities to scale up their operations, enter new markets, and vertically integrate. At the same time, the projections for continued industry growth over the next decade have attracted a number of investment funds and private equity groups, which were formed specifically for the purpose of investing in cannabis and hemp businesses.
These two classes of investors often pursue distinctly different approaches to their transactions. Unlike the largely entrepreneurial cannabis industry pioneers now looking to expand, the more institutional investors are accustomed to working with professional advisers to perform financial, tax and legal due diligence as they would for a transaction in any other industry.
Among both groups, however, there is sometimes a tendency to misunderstand some of the transactional risk elements associated with cannabis M&A deals. In many instances, buyers who are generally sensitive to potential legal and regulatory risks will underestimate or overlook other risks they also should examine as part of a more conventional financial and tax due diligence effort.
For example, since much of the value of a licensed cannabis operation is the license itself, investors often rely largely on their own industry understanding and expertise to assess the merits of a proposed acquisition, based primarily on their estimation of the license’s value. This practice provides acquirers with a narrow and incomplete view of the deal’s overall value. More importantly, it also overlooks significant areas of risk.
Because cannabis acquisition targets typically are still quite new and have no consistent earning records, acquirers also sometimes eschew quality of earnings studies and other elements of conventional due diligence that are designed to assess the accuracy of historical earnings and the feasibility of future projections.
Such assumptions and oversights often can derail an otherwise promising transaction prior to closing, causing both the target and the acquirer to incur unnecessary costs and lost opportunities. What’s more, even if the deal is eventually consummated, short-circuiting the normal due diligence processes can expose buyers to significant unanticipated risk down the road.
Recurring issues in cannabis acquisitions
The most widely recognized risks in the industry stem from the conflict between federal law and the laws of various states that have legalized cannabis for medical or adult recreational use. The most prominent of these concerns relates to Section 280E of the Internal Revenue Code (IRC 280E).
Although its use is now legal in many states, cannabis is still classified as a Schedule I substance under the federal Controlled Substances Act. IRC 280E states that any trade or business trafficking in a controlled substance must pay income tax based on its gross income, rather than net income after deductions. As a result, cannabis businesses are not entitled to any of the common expense deductions or tax credits other businesses can claim.
The practical effect of this situation is that cannabis-related businesses – including growers, processors, shippers and retailers – often owe significant federal income tax even if they are not yet profitable. Everyone active in the industry is aware of the issue, of course, and any existing operating company or investment group will undoubtedly factor this risk into its assessment of a proposed acquisition target.
The challenge can be exacerbated, however, by other, less widely discussed factors that also affect many cannabis businesses. These issues further cloud the financial, tax and regulatory risk picture, making thorough and professional due diligence even more critical to a successful acquisition.
Several of these issues merit special attention:
Nonstandard accounting and financial reporting practices. As is often the case in relatively young, still-maturing businesses, acquisition targets in the cannabis industry might not have yet developed highly sophisticated accounting operations. It is not uncommon to encounter inadequate accounting department staffing along with financial reporting procedures that do not align with either generally accepted accounting principles or other standard practices. In many instances, company management is still preparing its own financial statements with minimal outside guidance or involvement by objective, third-party professionals. Significant turnover in the management team – and particularly in the chief financial officer position –is also common, as is a general view that accounting is a cost center rather than a value-enhancing part of the management structure.
Such conditions are not unusual in young businesses that are still largely entrepreneurial in spirit and practice. In the cannabis industry, however, this situation is also a reflection of many professional and business services firms’ longstanding reluctance to engage with cannabis operators – a hesitancy that still affects some organizations.
When customary business practices are not applied or are applied inconsistently, acquiring companies or investors should be prepared to devote more time and attention – not less – to conventional financial due diligence. The expertise of professional advisers with direct experience in the industry can be of immense benefit to all parties in this effort.
Restructuring events or nonrecurring items in financial statements. Restructuring events and nonrecurring items are relatively common in many new or fast-growing businesses, and they are especially prevalent among cannabis operations. In many instances, such companies have engaged in multiple restructuring events over a short period of time, often consolidating operations, taking on new debt, and incurring various one-time costs that are not directly related to the ongoing operations of the business.
The inclusion of various nonrecurring items within the historical financial statements can make it much more difficult for a buyer or investor to accurately identify and assess proforma operating results, especially in businesses that have not yet generated consistent profits. Here again, applying previous experience in clearing up the noise in the financial statements can help improve both the accuracy and timeliness of the due diligence effort.
Run-rate results inconsistent with historical earnings or losses. A company’s run rate – an extraction of current financial information as a predictor of future performance – is a widely used tool for creating performance estimates for companies that have been operating for short periods of time or that have only recently become profitable. In cannabis businesses, however, run-rate estimates sometimes can be unreliable or misleading.
Because it is based only on the most current data, the run rate often does not reflect significant past events that could skew projections or recent changes in the company’s fundamental business operations. Because such occurrences are relatively common in the industry, the results of run-rate calculations can be inconsistent with the target company’s historical record of earnings or losses.
Historical tax and structuring risks new owners must assume. Like many other new businesses, cannabis operations often face cash flow and financing challenges, which owners can address through alternative strategies such as debt financing, stock warrants, or preferred equity conversions. Such approaches can give rise to complex tax and financial reporting issues as tax authorities exercise their judgment in interpreting whether these items should be reported as liabilities or equity derivatives. The situation is often complicated further by various nonstandard business practices and the absence of sophisticated accounting capabilities, as noted earlier.
As a consequence, financial statements for many cannabis companies – including a number of publicly listed companies – often contain complex capital structures with numerous types of debt warrants, conversion factors and share ownership options. Although an acquisition would, in theory, clean up these complications, buyers nevertheless must factor in the risk of previous noncompliance that might still be hidden within the organization – a risk that can be identified and quantified only through competent and thorough due diligence.
Not as simple as it seems
On the surface, the fundamentals of the cannabis industry are relatively straightforward, which is one reason it appeals to both operators and investors. For example, participants at every stage of the cannabis business cycle – growing and harvesting, processing and packaging, shipping and distribution, and ultimately marketing and retailing – can readily apply well-established practices from their counterparts in more conventional product lines.
The major exception to this rule, of course, is the area of regulatory compliance, which is still shifting and likely will continue to do so for the foreseeable future. Outside of this obvious and significant exception, however, most other aspects of the industry are relatively predictable and manageable.
When viewed in this light and in light of the continued growth of the industry, it is easy to see why cannabis-related acquisitions are so appealing to existing business operators and outside investors alike. It is also easy to understand why buyers might feel pressure to move quickly to take advantage of promising opportunities in a fast-changing industry.
As attractive as such opportunities might be, however, buyers should take care to avoid shortcuts and resist the urge to sidestep established due diligence procedures that can reveal potential accounting and financial statement complications and the related compliance risks they create. The unique nature of the cannabis industry does not make these practices irrelevant or unnecessary. If anything, it makes professional financial, tax, and legal due diligence more important than ever.
Crowe Disclaimer: Qualified organizations only. Independence and regulatory restrictions may apply. Some firm services may not be available to all clients. Given the continued evolution and inconsistency of various state and federal cannabis-related laws, any company should seek competent legal advice relating to its involvement in the cannabis industry, including when considering a potential public offering as a cannabis-related company.
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