On September 14, the FDA published a consumer update on their website, seeking to educate the public and offer a public health warning on delta-8 tetrahydrocannabinol, otherwise known as delta-8 THC.
For the uninitiated, delta-8 THC is a cannabinoid that can be synthesized from cannabidiol (CBD) derived from hemp. It is an isomer of delta-9 THC, the more commonly known psychoactive cannabinoid found in cannabis. Delta-8 THC does produce psychoactive effects, though not quite as much as its better-known cousin, delta-9 THC.
Due to loopholes in federal and state laws, namely the 2018 Farm Bill specifying that hemp must contain less than 0.3% Delta-9 THC, delta-8 THC is technically legal across the country. It grew in popularity across the United States very quickly over the past year, largely due to online sales.
Following the surge in sales, a number of states including Colorado, Alaska, Arizona, Arkansas, Delaware, Idaho, Iowa, Mississippi, Montana, Rhode Island, Utah and Washington have implemented some form of regulation or outright ban on products containing delta-8 THC. Christopher Hudalla, president and chief scientific officer of ProVerde Laboratories, told Chemical & Engineering News that he has a lot of safety concerns about the whole delta-8 THC craze. Hudalla says he’s more concerned about the processing involved to produce it in large quantities. “These are pretty aggressive synthetic conditions that use strong acids,” Hudalla says. “They might be using strong bases to neutralize. They can use metal catalysts. I hear different people doing it different ways.”
The FDA’s consumer update included this picture at the top of the page
The FDA shares similar concerns. Their fourth point in the consumer update mentions that delta-8 THC products “often involve use of potentially harmful chemicals” in its production. They even claim that some manufacturers might be using unsafe household chemicals to synthesize delta-8 THC. “The final delta-8 THC product may have potentially harmful by-products (contaminants) due to the chemicals used in the process, and there is uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material,” reads the FDA report.
In their consumer update, they note that between December 2020 and July 2021, they received 22 adverse event reports. Of the 22 reports, 14 were hospitalized following ingesting a delta-8 THC product. Notably, those reports included reactions consistent with symptoms from overconsumption of delta-9 THC, such as vomiting, hallucinations, trouble standing, and loss of consciousness.
The chemical structure of Delta 8 THC.
The FDA says that national poison control centers received 661 cases of delta-8 THC products, with 41% being unintentional exposure, 39% involved pediatric patients and 18% required hospitalization.
In the consumer update, they tell the public that delta-8 THC products have not been evaluated by the FDA and that they “may be marketed in ways that put the public health at risk.” This includes marketing it as a hemp product, which it is. Still though, many consumers associate hemp products with somewhat innocuous things, like CBD oil, which is mostly harmless.
The FDA also mentions in the update that delta-8 THC does have psychoactive and intoxicating effects. The FDA says they are notifying the public about the delta-8 THC due to an uptick in adverse event reports, marketing that is appealing to children and concerns regarding manufacturing with unsafe chemicals and contaminants.
The WeedMaps parent company, WM Technology, Inc., announced this week that they have acquired Sprout, a cloud-based CRM and marketing platform in the cannabis industry. Sprout’s CRM software is used by dispensaries, distributors and cultivators in 28 different states and offers a variety of marketing services like text marketing, email marketing, coupons, surveys and more.
The Sprout Messenger software was launched back in April of this year and at the time was touted as a gamechanger in marketing technology, allowing companies to interact with their customers via email, text and their in-house chat in two-way chats.
WM Technology, Inc. was originally founded in 2008. Based in Irvine, California, the company’s business-to-consumer platform, WeedMaps, is known as a go-to resource for consumers seeking cannabis retailers. The app and website now offer online ordering, brand listings, product information and consumer education.
On the business-to-business side, WM Technology, Inc. has grown to include WM Business, a cloud-based SaaS solutions platform with offerings like point of sale, logistics, wholesale and ordering solutions software.
The acquisition of Sprout will help the WM Technology team grow their WM Business portfolio to offer more software solutions, according to Chris Beals, CEO and chairman of WM Technology, Inc. “Our strategy focuses on establishing WM Business as the software solution of choice for cannabis businesses,” says Beals. “With the addition of Sprout, we are one step closer to realizing this vision of providing an all-in-one seamless and integrated solution to run, manage, and grow one’s cannabis business. This acquisition will allow our clients to better target, reach, acquire and retain customers at scale.”
WM Technology, Inc. did not disclose the financial details of the acquisition yet.
Hemp & Delta-8 in the United States: The Evolution of the Hemp Testing Market
Charles Deibel, President & CEO, Deibel Labs, Inc.
In this session, Charles Deibel discusses the current state of affairs across the country with respect to hemp testing. This includes a look at hemp testing rules at the state and federal level. He also provides an in-depth analysis on delta-8 THC and the controversy surrounding this cannabinoid, how to analyze samples of it and why the market has exploded around this product.
Kathleen May, Founder & Owner, Triskele Quality Solutions
This presentation discusses where the standard falls short, how poor lab practices may negatively impact the consumer and how poor or insufficient lab practices could result in regulatory action, including product recalls, fines, and loss of licenses.
TechTalk: ANAB
Melanie Ross, Technical Products Developer, ANSI National Accreditation Board (ANAB)
TechTalk: Columbia Labs
Kelly O’Connor, Sales Director Key Accounts, Columbia Labs
Pesticides in Hemp: Challenges and Solutions
Grace Bandong, Business Unit Manger for Contaminants, Eurofins Food Chemistry Testing (EFCT)
This presentation takes a deep dive into understanding the requirements for pesticide testing, approaches to analysis and responding to regulatory requirements with extremely low LOQs.
TechTalk: Perkin Elmer
Tim Cooper, Sr. Manager, Software Development, PerkinElmer
This presentation provides an overview of how standards are developed and used, how Official Methods for cannabis are developed as well as training opportunities and proficiency testing.
What to Expect When Opening a Lab in a New State
Michael Kahn, Founder & CEO, MCR Labs
Kahn explores the lab’s role int he cannabis industry, the importance of knowing and understand state regulations and lessons for growing your lab while maintaining quality.
Few people will disagree that financial compliance isn’t the most exciting topic within the cannabis industry. But compliance is, and always will be, the engine grease to the legal cannabis market. Cannabis operators have the arduous task of dealing with multiple layers of compliance, both operational (maintaining and adhering to regulations enforced by the state licensing board) and financial. These compliance measures include managing everything from seed-to-sale systems for all plant-related activity to on-site requirements like facility access points and alarms systems to name a few.
With complex compliance requirements for the business, the last thing cannabis operators want to think about is financial compliance. We created Confia on this notion. Just as cannabis regulators impose the tracking of plants through the supply chain via a seed-to-sale system, we have developed a storyboard similarly designed to follow the money, which is the equivalent of a transaction-to-deposit system.
Having experience in regulatory technology, artificial intelligence and machine learning, we’ve been fortunate enough to work with some of the world’s largest banks across multiple countries. This experience has afforded us the luxury of working alongside regulators, chief compliance officers and chief risk officers, understanding how risk is perceived by financial institutions and how it ought to be mitigated. It was this access and knowledge that allowed us to effectively reform, enhance and improve the antiquated BSA programs with a technology-enabled process. Leveraging technology is a necessity, almost a requirement, for the cannabis industry as legalization nears and banking access begins to broaden.
Jamming cannabis requirements into an existing BSA program doesn’t scale well. BSA programs are very manual, descriptive and process oriented. So, we’ve taken our prior experience and success in banking to form Confia, distilling the complexities and simplifying the deliverables surrounding cannabis banking compliance. To best articulate cannabis banking requirements, I break it down into three pillars.
Pillar One: KYC-Enhanced Due Diligence
The first pillar is the client-onboarding bucket or KYC – Know Your Customer. In the complex world of cannabis banking, banks must know and understand their clients to great depths. It’s not enough to simply know that the client exists; you also have to understand whether or not that client could be a potential risk to the bank, and one step further, the financial system. Cannabis is a high-risk industry, so the KYC requirement is escalated to a deeper diligence and review, called Enhanced Due Diligence (EDD).
Cannabis is a high-risk industry so extra due diligence is needed
Banks need to know and understand their customers’ story, and all the key parties (officers, directors, and those with key decision-making powers or access to the bank accounts) within that organization. This includes reviewing personal, business, and legal history – not to mention watchlists and negative news presence. An initial onboarding review must then be followed with daily screening and monitoring of all watchlists and adverse media. Typically, banks do KYC refreshes every three years. In cannabis, a full refresh should be done annually with the daily monitoring systems in place.
The high-risk nature of the industry also requires a level of diligence on all parties to a transaction, even if one of the parties, whether a payer or recipient, is not a client of your bank. Unlike traditional banking sectors, reliance on other banks’ KYC programs is far less defensible in the cannabis industry.
Pillar Two: Transactional Monitoring & Detection
Tracking and monitoring the actual financial transactions comprises the second pillar required for cannabis banking. At Confia, we have focused on streamlining processes, so the cannabis operator can seamlessly support the compliance obligation for every transaction. A bank must demonstrate supporting documentation for every cannabis transaction, and gathering such information is a large undertaking in and of itself and can pose future issues if not done properly, see the pitfalls for lack of compliance. Banks are obligated to understand the nature and reason for each transaction, the source of funds, ensure cannabis licenses are in good standing for all parties, and collect evidence such as accounting records and seed-to-sale data.
Core to transaction monitoring in the traditional sense, is the overarching support through anomaly detection. Relying on information is important, but testing those inputs keeps everyone honest. It is important to evaluate transactions from a holistic point of view relative to peers and relative to the general contents of a transaction. This anomaly detection layer is your last line of defense, and as new information is collected, it continues to refine itself.
Pillar Three: Filing and Reporting Requirements
The third component to compliant cannabis banking is regulatory filing and reporting. Once a client is onboarded, the account requires an initial suspicious activity report or SAR-Initial within 30 days of that client being approved by the bank. Then, a report must be filed every 90 days after that for all the transactions of that cannabis operator. Banks must file the SAR-Initial and the Continuing-SAR reports for each cannabis client they have.
The high-risk nature of the industry requires a level of diligence on all parties to a transaction
Solutions like Confia automate the filing process and support the filing with transactional data evidenced on our distributed ledger of record. This provides immutable audibility and simplifies the process for all parties involved.
Compliance Requirements After US Legalization
The anticipation of federal legalization and banking reform bills has many operators hoping for easier banking. Yet, in my opinion, regulatory oversight and audits will likely increase after such reform or legalization. As other financial institutions start to support cannabis, it will inadvertently create greater opportunity and expose the financial system to nefarious or illegitimate transaction activity. This is why cannabis banking will be carefully monitored by regulators, and more so, why banks will be slow and pragmatic in standing up their internal cannabis banking programs. Some banks may forever avoid the cannabis industry due to the known pitfalls of an industry specific program, while others may simply mitigate the possible exposure to reputational risk.
Choose Wisely: Pitfalls for Lack of Compliance
Financial compliance is the responsibility and duty of the banks, but the real losers and result of non-compliance always fall on the cannabis operators. Regulatory action against an institution may result in the bank shutting down its cannabis program or may require them to complete a remediation of all their cannabis transactions for a certain period from its clients. At the end of the day, regardless of action, the cannabis operator is the one being punished. Operators either lose their bank account and have business massively disrupted, or they are asked to provide all the compliance docs for a historic period, which is a huge undertaking and operational distraction, ultimately impacting business and productivity. So, choose your banking partner wisely.
Summarizing Key Banking Requirements
In summary, banking in the cannabis industry will undoubtedly remain a high-risk industry, with or without legalization. Although banking opportunities may expand as US policies change, there will be continued compliance and regulatory requirements for the foreseeable future.
Onboarding and ongoing screening are critical
Evidence for every transaction is a significant portion of compliance and must not be dismissed
Evaluating activity with broader strokes is essential in mitigating against money laundering
Managing the staggered filing timelines and due dates for each client
Compliance is the most crucial factor in cannabis banking at this point. It cannot be overlooked or taken for granted. Cannabis operators must take an active role in evaluating the compliance programs of their financial providers. To open a bank account is one thing, but the consideration and effort that goes into keeping a bank account is the difference that will protect your business in the long run.
Earlier this summer in July, Senators Chuck Schumer, Ron Wyden and Cory Booker held a press conference where they introduced the first draft of the Cannabis Administration and Opportunity Act (CAOA). During the press conference, the Senators laid out the foundation for their comprehensive cannabis legalization measure, emphasizing the need to address social equity and social justice matters, while also asking for support in revising the draft bill.
Sen. Schumer unveiling the Cannabis Administration and Opportunity Act
In response to that call for input on the draft legislation, a number of nonprofits and trade organizations last week submitted comments. Among the organizations to submit comments on the new legislative proposal to end federal cannabis prohibition were a lot of cannabis advocacy organizations: The National Cannabis Industry Association (NCIA), the Marijuana Policy Project (MPP), the National Organization for the Reform of Marijuana Laws (NORML), the Minority Cannabis Business Association (MCBA) and the Coalition for Cannabis Policy, Education, and Regulation (CPEAR). To refresh your memory, CPEAR is a controversial trade organization founded in March of this year by corporate interests in big alcohol and tobacco.
Regardless of the interests behind the organizations, all of them seemed to have comments that aligned with one another. All of the comments submitted by those organizations had a common theme: social equity. Even CPEAR submitted comments highlighting the importance of “providing substantial opportunities for small and minority-owned businesses.”
The NCIA’s comments are perhaps the most comprehensive of the group, outlining an equitable, state-centric and small business-focused plan for federal cannabis reform. The MCBA’s comments reflect its mission and focus on things like restorative justice, minority participation, equitable access and inclusion.
The MPP’s comments are noteworthy because of their concerns regarding a number of regulations. Karen O’Keefe, state policies director at the MPP, says certain aspects of the regulatory scheme need clarification. “Our two major areas of concern are: the possible upending of state licensing and regulatory systems — driving sales underground — and the impact on medical cannabis access, including for those under the age of 21,” says O’Keefe.
NORML’s feedback is also particularly poignant. They ask to leave medical cannabis markets exempted from the federal excise tax proposed and for the federal government to balance roles shared between the FDA, TTB and ATF to ensure that individual state markets won’t be adversely affected by federal regulation.
Sleep health is a large and growing global market. According to Statista, the global market value of the sleep market was $432B in 2019 with an expected CAGR of 6.3% from 2019 to 2024. Supplements are a growing category of popular sleep health products with common ingredients including melatonin, valerian root, and more recently cannabinoids such as CBD and CBN.
RealSleep is a cannabinoid formulation company developing personalized products to improve sleep outcomes. RealSleep’s product strategy has been developed by top scientists and sleep experts, and clinically tested to aid individuals seeking to fall asleep faster, sleep deeper and cut down on sleep disturbances. Their studies have shown that 90% of people taking RealSleep have reported experiencing better sleep immediately
We spoke with Michael Kamins, co-founder and partner of OpenNest Labs and RealSleep, about RealSleep’s innovation in personalized formulations for better sleep. Kamins founded RealSleep as an incubated company under OpenNest Labs, where he is also a founding partner. Michael is the Chief Community Officer of the Wholistic Research and Education Foundation, and just led the world’s largest study on CBD and general health with Wholistic and Radicle Science, where he is also an advisor. Prior to RealSleep, Michael worked in tech where he was an early employee at Musical.ly (now TikTok) building brand partnerships.
Aaron Green: How did you get involved in the cannabis industry?
Michael Kamins, co-founder and partner of OpenNest Labs and RealSleep.
Michael Kamins: I got into the industry professionally about two and a half years ago, but my relationship with the plant goes back to high school. Prior to jumping into this space, I was working primarily in digital media. I was an early employee at Musical.ly, (eventually rebranded as TikTok), leading global music partnerships and growth. I helped grow that business by leveraging the social capital of music artists and celebrities and doing partnerships with record labels. At the end of 2018, I really saw the opportunity in the cannabis space. One of my best friends in Los Angeles, Dr. Jeff Chen, someone I did my MBA with at UCLA, became the founder and executive director of cannabis research at UCLA Medical. Seeing all the clinical research that he was doing and the objective health outcome data coming out of that research was really a huge inspiration to me. I saw a massive whitespace and opportunity to help build that bridge between the medical community and the cannabis marketplace. There’s been almost a century of cannabis prohibition setting back our scientific understanding of the plant. We know more about the rivers and plants in the Amazon than we do about the composition and compounds within the cannabis plant with regards to their wellness benefits.
I met my partners, Tyler Wakstein, Kris Bjornerud and Max Goldstein and we started a cannabis venture studio called OpenNest Labs, which is building out a diversified portfolio of cannabis consumer brands. We are focused on leveraging our collective experience at building ventures and communities and rallying those communities around a brand.
Over the last two and a half years, it’s been super exciting building brands that you see on shelves. We’re still in the early stages right now of building brand loyalty. A lot of cannabis consumers are still going into dispensaries and asking, “what is the cheapest product that I can buy with the highest potency?”
Green: Tell me about RealSleep, how did you come up with the idea and what is the basic concept for the end user?
Kamins: RealSleep comes from the passion that I had developed for medicinal aspects of the cannabis and hemp plant, thinking about not only THC and CBD – which are two major cannabinoids in the plant – but also thinking about the other 120 plus cannabinoids, each with their own unique properties.
It turns out that half the world’s population suffers from one poor night of sleep a week, and sleep issues lead to the highest rate of other comorbidities. We were thinking about the addressable sleep market, with ourselves being a part of that market, and wanting to build products that would help not only ourselves, but the countless other people around the world that suffer from poor sleep too, as it impacts their daily lives.
I’ve had issues with sleep myself. I have a genetic hearing condition called tinnitus. It’s a ringing in your ears that other people can experience environmentally from exposure to loud noises. I’ve had loud ringing in my ears my entire life even in quiet situations, like right before I go to sleep. I’ll often be lying in bed awake for an hour or two unable to sleep with the ringing. Everyone else on the team has had their own sleep issues and realized the profound negative impact of lack of sleep on other areas of health and wellness, whether it be next day energy or immunity.
We felt that by leveraging our access to the medical research community and even running clinical research on our own to validate the efficacy of the product relative to other products on the shelves, we could create a product that was safe and effective. We came across a clinical trial on insomnia and CBD by one of our research partners, the Wholistic Research and Education Foundation. What we saw from a lot of that anecdotal data was that CBD, and hemp in general, really helps to provide restful and restorative sleep.
CBD and CBN are two highly effective compounds for sleep and melatonin is by far the most widely researched and used over the counter sleep aid. We are sourcing clinical research on other ingredients such as valerian root, L-Theanine and GABA, and the list of ingredients goes on. We were interested in formulating a product that incorporates these safe and effective ingredients.
We noticed from our research and our access that sleep is as unique to an individual as their fingerprint. Take brainwave patterns when you are sleeping as an example. No one person’s patterns are the same. You could essentially identify an individual based on those patterns. One solution, or one product, is not going to help everyone. So, we worked with UCLA and the head of their laboratory of sleep and circadian medicine, a gentleman by the name of Dr. Chris Colwell, to understand the science of sleep. He is one of the most renowned sleep researchers in the world and is the head of our scientific advisory board for RealSleep. We’ve done clinical studies with over 900 people and 10,200 nights of sleep and used this data to develop a personalization engine in the form of a quiz that takes 90 seconds and allows us to map ingredients to specific answer selections. From these answers we deliver products that are customized to the individual consumer specific to their unique needs
We’re proud of the journey that we’ve gone on to understand the science and research behind sleep and to develop this personalization engine variations of products that work for each individual and their unique needs.
Green: Tell me how the questionnaire and personalization engine works. I understand the ingredient profile will change based on the customer’s responses?
Kamins: Sleep impacts an individual’s general health and wellness. For me, if I don’t sleep well, my next day is filled with anxiety, and that anxiety leads to worse sleep; it’s a vicious cycle. For other people, it could be a metabolic issue that leads to poor sleep or poor sleep that leads to weight issues. The list of other health issues and diseases linked to poor sleep goes on. So, while we’re looking at combating sleep to prevent other health issues down the road, one person who’s looking to get better sleep to improve one aspect of their life could be different from another person and the area of life they are looking to improve upon.
The quiz is essentially a combination of validated, reliable and flexible measures of patient reported outcomes. We use a combination of gold standard patient reported sleep questionnaires, one of which is called the Pittsburgh Sleep Quality Index, another being the RAND MOS scale, and others. We also work with our scientific advisory board and machine learning experts to advise us on customizing these questions with logic. We then use the responses to generate the appropriate formulations for our customers.
The questions cover everything from very specific questions on sleep, like sleep latency (the time it takes to get the bed) or sleep fragmentation (the number of times you wake up in the middle of the night) sleep duration, sleep quality, and then other areas of health that you’re looking to improve upon. Examples include metabolism, cardiovascular health, skin health, anxiety and stress. So, all these things factor into the different ingredients that we layer into the formulation.
Let’s say you don’t have a problem getting to sleep, but you wake up a lot of times in the middle of the night. Your formulation might be very different from someone who has trouble getting to sleep, but they don’t wake up in the middle of the night. Overall, one of our big goals with the formulation of all these products is that they increase your next day cognitive alertness by giving you that high sleep quality and restorative sleep. We don’t want to make anyone groggy the next day. Because overall, what you’re trying to achieve with sleep is you want to be ready to go the next day and be able to perform at your peak.
Green: So, you mentioned CBD, CBN and melatonin already as ingredients. Are there any other ingredients?
Kamins: Depending on what your answer selections are for the quiz, we will layer in L-Theanine, valerian root, Ashwagandha and even some of the other novel cannabinoids like CBC (cannabichromene). We have about 24 different ingredients that we can layer in, so it just depends. When you look at all the permutations and combinations of formulations and dosages, it’s in the trillions. From a supply chain standpoint, we’ve simplified it in a way that makes it very easy to funnel people into one of many predefined combinations of ingredients and dosage levels.
Our algorithm is an unstructured machine learning algorithm. The more people that take the quiz and the more people that provide feedback on their sleep score makes our programming and our personalization engine smarter.
Green: How does your manufacturing and packaging work?
Kamins: We have a strong relationship with a pharmaceutical partner that we have been growing even before RealSleep. It is a pharmaceutical manufacturing facility underneath a regional health care provider in the state of California. Everything they do is incredible. It’s a state-of-the-art facility and focused on complete transparency and building the products with the highest efficacy and safety profiles. They’re based in LA, and they’ve been such a pleasure to build our supply chain with.
Green: What kind of trends are you looking at in the formulation space?
Kamins: From a cannabinoid side, there’s been a bit more of a look towards some of the novel cannabinoids that have traditionally catered to a niche consumer base that is educated on cannabis. From being inside the industry, it’s very easy for me to talk about all the different cannabinoids, but a lot of people still don’t even know the difference between THC and CBD.
Our goal overall is to build efficacious products and educate people on all the different formulations and the different ingredients going in. Outside of cannabis, this year we’ve seen a large boom in consumer demand for Ashwagandha. There’s just so much hype around it in terms of how it impacts stress and energy and even libido, which is interesting. It’s probably the hottest non-cannabinoid ingredient that we’ve seen. Specific to sleep, the combination of L-Theanine and GABA and how they potentiate each other is impactful. Then there’s valerian root, which has been a big one over the last few years for sleep.
Green: Last question. What are you most interested in learning about?
Kamins: A personal interest of mine over the last few years is understanding from a scientific perspective, each of the cannabis compounds in greater detail. I think part of it is just really the curiosity to know the unknown. We’re at a point in the industry where there are still so many unknowns on the science-side of cannabinoids.
My passion for science has led me to support medical researchers in the space, so much so that I am an advisor and chief community officer to a nonprofit medical research organization called the Wholistic Research and Education Foundation, which to date has funded over six and a half million dollars in human clinical trials with cannabinoid rich therapeutics. One we’re currently conducting at UC San Diego is studying the impact of CBD on autism and other neurological conditions. That’s given me incredible exposure to research in the space. I am also a strategic advisor to a for profit medical research organization called Radicle Science, which is a very swiftly running clinical research for CBD and other cannabis brands in the space.
All in all, I’m driven by the possibilities that come with continuing to unlock the science behind the plant. By doing so, we can innovate products with efficacy and can educate people who are uninformed about the therapeutic benefits of cannabis, which will in turn benefit the industry and society. Striving for research breakthroughs and being transparent about our findings is going to help us destigmatize cannabis and legitimize the industry.
Green: That concludes the interview. Thanks, Michael!
Earlier this year, the Colorado Department of Public Health and Environment (CDPHE) announced a plan to introduce new testing rules for the state’s growing hemp industry. Under the new regulations, hemp products must be tested for residual solvents, heavy metals and pesticides, in addition to making sure they contain less than 0.3% THC.
The CDPHE are planning on a gradual rollout to prevent any supply chain issues or a lab testing bottleneck, similar to what we’ve seen in other states launching new testing requirements in years past, such as Arizona or California. Well, the Colorado rollout appears to be hitting similar snags and because of supply chain issues related to instruments and consumables in laboratories, the implementation of those testing rules is somewhat delayed. What was originally supposed to be implemented over the summer was pushed back to an October 1 deadline, and that deadline has now been pushed back to 2022.
The pesticide testing list to be implemented January 1, 2022
As a result of supply chain shortages and the learning curve to test for such a wide range of pesticides, Colorado is opening hemp testing to out-of-state labs in an effort to stay on schedule with the rollout. Dillon Burns, lab manager at InfiniteCAL, a cannabis testing company with locations in California and Michigan, just completed an audit with the CDPHE in their work to get certified and start conducting hemp testing for businesses in Colorado.
Burns says they’re well-acquainted with the list of pesticides because of how similar the list is to California’s requirements. “For the pesticide testing rules that were supposed to go into effect on August 1st, it’s basically the same list as California just with slightly different action levels,” says Burns. “I would say these action limits are generally stricter – they have much lower LOQs [limits of quantification].”
The pesticide testing list (continued) to be implemented January 1, 2022
Come January 1, 2022, they are expecting an additional 40 pesticides to be required under the new rules. “But currently, it’s still unclear when these regulations will actually go into effect,” says Burns. The full pesticide testing list is currently slated to be implemented on April 1, 2022.
The supply chain issues referenced above have a lot to do with what the state is asking labs to test for. Previously, most of the pesticides tested for under Colorado’s adult use and medical cannabis programs could be analyzed with an LC/MS. A handful of pesticides on the new list do require GC/MS, says Burns. It’s entirely possible that a lot of labs in Colorado just don’t have a GC/MS or are in the process of training staff and developing methods for using the new instrument. “Cleanliness of these instruments is such a priority that it takes time to acquire the right skill set for it,” says Burns.
Dillon Burns, Lab Manager at InfiniteCAL
The new testing rollout isn’t just another compliance hurdle for the cannabis industry; these rules are about protecting public health. Dillon Burns said he’s seen hiccups in California with the amount of new hemp farmers getting into the space. “The hemp products we’ve tested in California often fail for pesticides,” says Burns. It’s a lot easier in most states to get a license for growing hemp than it would be for growing adult use cannabis. “You’ll see a lot more novice growers getting into hemp farming without a background in it. They’ll fail for things they just haven’t considered, like environmental drift. We see a lot of fails in CA. Hemp is bioaccumulating so it presents a lot of problems. If they’re not required to look for it, they weren’t monitoring it.”
When asked how the market might react to the new rules, Burns was confident that Colorado knows what they’re doing. “I don’t anticipate that [a testing bottleneck] happening here. The regulators are reasonable, supportive of the industry and opening it up to out-of-state labs should help in preventing that.”
Let’s just say it. There is an undeniable chaos in the cannabis industry. It doesn’t matter if you’re a big or small operator, it’s likely that you don’t have a documented system for creating and managing ever-changing SOPs or for consistently training all employees on the most current versions of those SOPs. This chaos is often the result of rapid growth, mergers and acquisitions, and the ever-present turnover in our industry. When department leadership changes, and it often does, established policies and procedures are often left behind. In some cases, this is a positive sign of growth. As a company outgrows SOPs and as it develops more sophisticated ways to cultivate, extract, process, manufacture, package and sell cannabis and cannabis products, inevitably, the old ways of doing business need to be replaced. For those operators who have prioritized operational excellence, whether they want to position their company for new investment, merger or acquisition, or just want to create a consistent and standardized, branded product, it’s critical to get control of SOPs, training and documentation.
By standardizing and documenting safety procedures, manufacturers mitigate the risk of cannabis-specific concerns
As with most big goals, to obtain operational excellence, you need to break the goal into manageable steps. Assuming you have accessible quality policies and procedures in place, properly training employees when they first start work and on an ongoing basis as policies and procedures change is the number one key to successful operations. When employees know how to do their job and understand what is expected of them, they are positioned for success. When employees are successful, it follows that the company will also be successful. Documenting operations is a second important step in obtaining operational excellence. While training and documentation appear to be different, in best-practice organizations, they are inextricably linked.
One Set of SOPs
Those of us who have been in the cannabis industry for a while have experienced firsthand or heard stories of facility staff working off of two sets of SOPs. There’s the set of SOPs that are printed or digitally available for the regulators, let’s call them the “ideal” set, and then there are the SOPs that actually get implemented on a day-to-day basis. While this is common, it’s risky and undermines the foundation of operational excellence. Employees often know there are two sets of SOPs. Whether they express it or not, many are uncomfortable with the intentional or unintentional deception. When regulators arrive, will they have to bend the truth or even lie about daily operations? Taking the time to establish and implement one set of approved SOPs that is compliant with both external regulations and internal standards is good for employee morale, productivity and ultimately, profits.
What’s the best way to get control of a facility’s SOPs? Again, break it into manageable steps:
First, task someone with reviewing all SOPs that are floating around. Determine if any are non-compliant, which ones need to be tossed and which ones need to be revised so they work for the company as well as outside regulatory authorities.
At a minimum, establish a two-person team to draft, review, publish and distribute the final SOPs. Ensure that at least one member of the team has management level authority. Assign that employee the responsibility of reviewing the SOPs before “publication” and distribution.
Archive, delete, or actually throw away outdated or non-compliant SOPs
Revise or create new best-practice SOPs that are in compliance with external regulations and internal standards
Establish a system to update SOPs when external regulations and internal standards change
Use a naming convention that distinguishes draft SOPs from final SOPs, for example, “Post-Harvest Procedure, FINAL”
Inform employees that they will be retrained on the new SOPs and that approved SOPs will always have the word “Final” in the title
Store the final SOPs in an easily accessible location and give employees access, not only during training, but on an ongoing basis
Centralized Repository for Final SOPs
Storing final, approved SOPs in one easily accessible, centralized location and giving employees access sounds simple, but again, this is the cannabis industry, so this often doesn’t happen. Many of us have or are currently working for an organization that stores SOPs in multiple places. Each department may have its own way of updating, disseminating and storing SOPs. Some SOPs are stored in a printed binder stuffed in a drawer or left on a bottom shelf. Others are stored digitally. Some use both systems, which creates confusion. Who knows if the digital versions or the printed versions are the most current? Surely someone knows, but often the front-line staff do not.“Once you’ve established a single set of compliant SOPs and have stored them in one accessible location, it’s time to train your employees.”
Establishing a centralized repository for final, approved SOPs is the foundation of operational excellence. It lets employees know that operations are organized and controlled, and it reassures regulatory authorities and external stakeholders—think insurers, bankers, investors—that the company prioritizes compliance and organization. And external stakeholders who believe that an organization is proactive and well-run tend to be more forgiving when the inevitable missteps occur. Companies that are organized, have effective training systems, regularly conduct internal audits to identify potential issues and take identifiable action steps when necessary to remediate issues, receive fewer deficiency notices, violations and fines than their less organized competitors.
Train Employees
Many states require cannabis operators to provide a specific number of training hours prior to an employee beginning work, and a specific number of continuing and refresher training hours annually. Once you’ve established a single set of compliant SOPs and have stored them in one accessible location, it’s time to train your employees. To do so, set clear expectations and decide who is responsible for what. Is the HR manager responsible for initial onboarding and training? Are department managers responsible for ongoing and annual training? Create a training responsibility chart that works best for your company; write it down and share with all stakeholders.
Documenting all key areas of operation on a recurring basis will help you keep track of a large facility and workforce
The next step is to figure out how to train your employees. Individuals have different learning styles, so ideally, you’ll offer multiple ways for them to master the requirements of their position. Assign written materials and if possible, attach short videos showing the best way to complete a task. Follow up with a quiz to determine comprehension and a conversation with a department lead or manager to answer questions and review the key take-aways. Ideally, the department manager or lead employee will work with the employee until they are competent and comfortable taking on new assigned tasks and responsibilities.
Sum It Up
Operational excellence begins with:
Knowledge of and access to current external rules and regulations and internal standards
One set of approved and easily accessible policies and SOPs that comply with both external and internal standards
An initial training system with clearly assigned roles, responsibilities, and goals
An ongoing training system with clearly assigned roles, responsibilities, and goals
Systems to:
Test knowledge before employees begin unsupervised work
Stay up-to-date with all changes to external rules and regulations and internal standards
Control policy and SOP revision process
Inform all stakeholders when policies and SOPs change
Test that employees understand new standards
Document all key areas of operation on a recurring basis
Address deficiencies and evaluate whether SOP revisions are warranted
Document and implement necessary remediation when necessary
For those of you rolling your eyes and thinking you don’t have time for this, ask yourself, “Can you afford not to?”
For those of you committed to operational excellence and doing what it takes to get there, congratulations on being a visionary leader. Your efforts will pay dividends for your own company and will help the cannabis industry grow into a well-respected, profitable industry that improves lives.
The rise in the number of optimistic regulatory frameworks instigated by various regional governments will positively anchor the forecast for the cannabidiol (CBD) market. The growing awareness regarding the benefits and effects of the product as an alternative treatment method has accelerated its preference among consumers and suppliers. Moreover, the continued advancements in the approval processes by various authorities worldwide have also made way for numerous opportunities supporting CBD market growth.
According to a report by Global Market Insights, Inc, the global CBD market size could exceed $108.8 billion by 2027.
Growing presence in cosmetics
The overall industry share from creams and roll-on products is poised to hit a 35.8% CAGR up to 2027. This is owing to the increasing scope of CBD in cosmetic applications as it is highly effective in treating skin conditions. This, as well as its anti-inflammatory characteristics from a medicinal perspective, are leading to increased demand for CBD products like creams and roll-ons.
Scope in the treatment of mental health
Some of the many infused products on the market today.
CBD market value from anxiety/stress applications exceeded USD 1.5 billion in 2020 due to the growing need for helping mental health. The World Health Organization reported that over 4.5% of the total population in Europe suffers from depression. This escalating anxiety and stress rate has encouraged healthcare practitioners to increasingly make use of CBD-based medications.
Higher demand for oral administration
Demand for oral cannabidiol administration held nearly 45% of the industry proportion in 2020 due to its growing preference considering the gradual relief of pain compared to other disorders. The increasing dependency on the oral administration route for product development by several manufacturers will add positive impetus to market growth.
Medical benefits of cannabis
Annual revenue of the CBD market from the segment of the market dealing with THC (and CBD) products is expected to cross USD 30.1 billion by 2027. This is largely due to its increasing penetration across various countries and regions on account of its legal status. Furthermore, the relatively higher THC content of the compound has led to its growing usage to combat medical conditions, including Alzheimer’s and Parkinson’s disease, among others.
Online distribution to see a considerable footprint
Ads for CBD products online regularly perform very well
The online CBD industry was responsible for more than 46% of the market in 2020. This is mainly due to the numerous advantages of online channels, like on-time delivery and adequate inventory, compared to their offline counterparts. Besides, this distribution platform minimizes the operational costs related to the maintenance of brick and mortar retail.
Australia to lead the regional landscape
Australia dominated the Asia Pacific CBD market by holding over 25% of the market share owing to the expanding geriatric population and the liberal stance of the regulating bodies in the region. The permittance to the medicinal and cosmetic use of CBD products is likely to spur regional adoption. The rising amendments in regulatory scenarios have also triggered awareness regarding the potential benefits of the product in the country. For instance, in April 2020, the Australian government released a new proposal for over-the-counter CBD in a bid to relax its narcotic scheduling whilst making it a Schedule 3 substance.
Providers of various CBD products are actively indulging in numerous growth strategies, like acquisitions and partnerships, to reinforce their market presence. For example, Mota Ventures Corp., in January 2020, acquired Spanish producer and online retailer, Sativida OU in a USD 2.2 million deal. The acquisition expanded the company’s presence in Europe and Latin America.
Although the demand for CBD is likely to experience certain hesitation from consumers in the short term, the market will witness lucrative growth in the long run. However, counterfeit and substandard quality products may potentially restrain industry expansion to some extent.
In this “Flower-Side Chats” series of articles, Green interviews integrated cannabis companies and flower brands that are bringing unique business models to the industry. Particular attention is focused on how these businesses integrate innovative practices to navigate a rapidly changing landscape of regulatory, supply chain and consumer demand.
4Front Ventures Corp. (CSE: FFNT) ( OTCQX: FFNTF) is a multi-state operator active in Washington, Massachusetts, Illinois, Michigan and California. Since its founding in 2011, 4Front has built a reputation for its high standards and low-cost cultivation and production methodologies earned through a track record of success in facility design, cultivation, genetics, growing processes, manufacturing, purchasing, distribution and retail. To date, 4Front has successfully brought to market more than 20 different cannabis brands and nearly 2,000 unique product lines, which are strategically distributed through its fully owned and operated Mission dispensaries and retail outlets in its core markets.
We interviewed Andrew Thut, chief investment officer of 4Front Ventures. Andrew joined 4Front in 2014 after investing in the company in 2011. Prior to 4Front, Andrew worked in investment banking and later moved on to public equity where he was a portfolio manager at BlackRock.
Aaron Green: How did you get involved in the cannabis industry?
Andrew Thut: I came at it from the investment side of things. I started my career as a junior investment banker right out of school and then I was a public equity analyst and Portfolio Manager. I ran small-cap growth portfolios for BlackRock where I was on the team for a better part of 11 years.
Andrew Thut, Chief Investment Officer of 4Front Ventures
One of my friends, Josh Rosen, who came from the finance industry, got interested in the cannabis industry really in 2008. He founded 4Front as a consulting company officially in 2011 and I came in as an investor. After that original investment, I left BlackRock and I was looking for something different to do. I was tired of chasing basis points and running public market portfolios. Josh said to me “This industry needs more talent,” and I became more and more involved at 4Front as the years went on. In 2014, I came into the business full time. Originally, I was someone that was kind of the gray hair in the room when we were applying for licenses. We had to go to different municipalities and convince them that we were going to be responsible license holders. I also spent a lot of time on the capital raising side for our business leveraging my career in corporate and more traditional public finance. These are incredibly complex businesses that require a fair amount of capital in some places. So, that’s how I originally got into the business.
These are complicated businesses in a lot of cases. The “sausage making” in cannabis is incredibly complicated. There’s friction at every step along the way. As an example, when you’re buying a building where you want to cultivate your product, you can’t get a mortgage from a typical bank.
While those of us that have been in the industry like to gripe and complain about it, this friction is also the opportunity. Because more traditional investors can’t invest in this industry yet, it allows us more time to build our businesses and have some protective moats around it from a competition standpoint until those folks do come in. So, all this friction is a pain and it’s brutal, but it’s also the opportunity here in cannabis.
Green: Can you speak to the transformation of 4Front from consulting to MSO?
Thut: The original business was consulting. Our original investor was sensitive about touching the plant – it’s one thing to offer services to a federally illegal business, it’s another thing to directly run a federally illegal business. For example, 4Front would have consulting clients that were interested in acquiring a license in Massachusetts. Because of our expertise and our standard operating procedures, we could apply for licenses in limited license states on behalf of our clients and help them show regulators competence and give the regulator’s confidence that these operators knew what they were doing. So, we would help our clients win the licenses and then once those licenses were won, our operations folks would come in and help them get up running.
When I came into the business we said, “well, geez, we have quite a track record helping clients win licenses and get open. If we’re good at winning these licenses and getting them open, why aren’t we just doing this on our own behalf?” So, in 2015, we shifted the business from consulting to being a multi-state operator. We leveraged our capabilities in regulatory compliance and winning licenses to go and get those on our own behalf. We also leveraged our financial expertise in M&A to add to our portfolio, so what we ended up with was a seven-state portfolio at the time.
Green: Chief Investment Officer is an uncommon title, even in the MSO space. What does your day-to-day look like?
Thut: I spend an awful lot of time helping management plot our strategy, and then figuring out how we are going to pay for our growth. Not only structuring finances for the company, but also having contact with our existing and new investors.
I spend a lot of my day to day thinking about where we want to be as a business and what geographies we want to be in. If you look at cannabis longer term, we have less interest in being cultivators or farmers. We think that’s going to be the most quickly commoditized piece of the value chain. We like retail as a business, but I think that we have less interest in managing hundreds of retail locations scattered across the country. We ultimately want to be a finished goods manufacturer. What we think is going to matter longer term is establishing low-cost production.
There is a lot of price elasticity in the end markets for cannabis meaning if you get customers a quality product at a much better price than the competitor, you’re going to take outsize market share. To offer that lower price, you have to be efficient. Over the years, we have figured out how to bring the labor cost out of our production. We have 25 different brands with 1000s of different SKUs of products that have dominant market share in states like Washington. And we’re now putting them into Illinois, Massachusetts, California, Michigan, and hopefully New Jersey.
Green: Do you have a preference towards acquisition, or do you seek growth through internal investments?
Thut: We are always weighing build versus buy. We want our products to have dominant market share, or very strong market share in every state we are in, and we have a lens towards what gets us there faster and most efficiently. For instance, we have two cultivation facilities and one production facility here in Massachusetts – about 15,000 square feet of canopy in the state. That will just about serve our three retail locations in Massachusetts.
Back to our bigger investment thesis, we believe that we should be a finished goods wholesaler in every state that we’re in. We know our products are incredibly well received and we know that consumers love our price point. In Massachusetts, for instance, we’re currently evaluating if we need more capacity from a cultivation standpoint and a production standpoint. And if we do where do the lines cross in terms of whether we should build versus buy that additional capacity?
We are currently in five states, including our facility in Washington has dominant market share in one of the toughest markets in the world for cannabis – somewhere close to 9% market share in Washington. Our brands are in the top 10 of every single category from flower to vapes, to edibles everything across the board. And what we’re doing our strategy is simple. It’s taking those tried-and-true products and operating procedures that have been so effective in Washington, and we’re replicating them in other states where we have licenses: Massachusetts, Illinois, and Michigan, California and hopefully New Jersey. We’re looking for more state, but we want to be deep in the states we’re in.
We also have a lot of confidence that you know, having been having translated some of these, having been able to effectively take our Washington success story and port it to other states. We’re looking for other states to sort of bring into the portfolio because we feel like we’re in a position now to stamp it out.
At our facility in Washington, which is the number one edibles manufacturer in that state, we produce the edible Marmas which is our the number one selling gummy in Washington. We produce 3,500 boxes of those in one shift using 25 people in Washington. Our facility is one of the lowest cost producers in the country.
We are opening what we think is going to be a very disruptive facility in Southern California right now. The facility is 170,000 square feet of purely automated finished goods production. So, rather than making 3,500 boxes of our gummy squares in one shift using 25 people, with the automation that we have in California, we can make 30,000 boxes. So, 10x one shift for the same number of people. We look more like the Mars Candy Company than most investors would think of when they see a typical cannabis company. We’re bringing that kind of scale and automation.
Green: What are some of the industry trends that you’re watching closely?
Thut: We keep a close eye on limited license states. States like Massachusetts and Illinois. For various reasons Massachusetts is very tough to get zoned. So, there’s going to be a limited number of players in a state like Massachusetts, which means you can have pretty good moats around your business and pricing will hold up over several years. We love limited license states like that, where price is going to hold up. On the other hand, we’re not afraid to enter a state like California where we think our low-cost production expertise uniquely qualifies us to go into a huge market like that and be disruptive and take a lot of the pie.
“You’re starting to see the market expand. There’s some anecdotal evidence that we’re taking a fair amount of share from the beer industry.”What we’re seeing in terms of industry trends, particularly on the THC side of this business, has just been phenomenally strong. You’ve had robust medical markets where, by and large, we’re seeing those dominoes start to fall quickly and going recreational. When that happens, the size of the market increases – call it from 2% of the population to as much as 10% of the population. So, from a state regulatory standpoint, having states go form medical to adult use is a huge deal in terms of the market opportunity.
We’re also seeing states get a lot more comfortable with the idea of selling cannabis. I’ve been around for close to seven years in this industry. When I started and I went into a municipality, and I said we wanted to open a cannabis store you’d have people following me to my car with pitchforks. As these municipalities open and public acceptance comes around, people are realizing that these stores are providing jobs and providing a good tax base for communities. So, the acceptance of cannabis has a snowballing effect that just continues to roll.
It’s not just the ultra-frequent users of cannabis who are totally driving the bus in terms of the demand growth for your business. You’re starting to see the market expand. There’s some anecdotal evidence that we’re taking a fair amount of share from the beer industry. So, the fundamentals of this industry are phenomenal. I think that we’re probably in the second inning of what is a mega-trend of legalization of cannabis and the investment opportunity here.
Green: I think one of the interesting things about the fundamentals is you’ve got this hardship of 280E, that all the companies are facing, and yet you still have groups that are surviving, profitable and growing. What are your thoughts on 280E’s effect on cannabis businesses? Do you foresee anything happening there?
Thut: There was a huge liquidity crunch in cannabis in 2019, meaning it was hard for people to come up with capital to grow their businesses. You had a bunch of companies that had licenses who didn’t really know how to operate and weren’t really focused on profitability. That liquidity crunch of 2019 made people get religious about being profitable and being efficient with capital allocation. Fast forward to 2021 and if you look at the top 10 cannabis MSOs in the US, I think we’re all profitable.
So, here you have an industry with accelerating top line growth and they’re already profitable. That profitability should only improve as you’re able to leverage your operating expenses and that’s a unique thing. When the internet craze was started in 1999 you had companies that a weren’t profitable, didn’t have business models, and no one really knew what they wanted to be. You have companies here in cannabis that are growing the top line 50% a year, and they’re profitable, and they’re trading at under 10 times EBITDA, which is totally disjointed.
Sen. Schumer unveiling the Cannabis Administration and Opportunity Act
So, that leads me to your question on to 280E. 280E has been a problem. Banking has been a problem. Having to list our companies over the counter instead of on exchanges like the NASDAQ and NYSE – that’s been a problem in terms of attracting capital. But the good news is Senator Schumer, Senator Booker and others have put out some bold initiatives on what they want to achieve from a legalization standpoint. From an investment standpoint, the biggest thing that investors should be focused on is access to banking, which is included in the senators’ proposed legislation.
Once we get access to banking services, the federal government is basically acknowledging cannabis as an industry will be able to not only have more traditional financing for our growth, but it will also lead to uplift into exchanges and real institutions like the Fidelity’s and the BlackRock’s of the world being able to come and invest in these companies. It also acknowledges 280E is an antiquated law. Getting rid of 280E will give us a much lower tax rate and will allow us to have a bigger proportion of our pretax cash flow into growing our businesses rather than having to go outside for that funding. My crystal ball is probably no better or worse than others in the industry, but if you fast forward 18 months to two years, I have a tough time seeing 280E still in place.
Green: Last question here. What’s the thing you’re most interested in learning about in the cannabis industry?
Thut: I’m just fascinated to see how these various business models will play out. People are placing bets on picks and shovels. People are placing bets on whether being a finished goods manufacturer works. People are placing bets on whether a retailer business model is going to win the day.
If you look at the leadership in the cannabis industry today, it’s totally different than it was four years ago. People that were foregone winners four years ago like MedMen had to do significant recaps. I put Acreage in that sort of bucket too. The leadership had shifted and so I’m really curious to see just from an intellectual standpoint, how this business evolves.
I sometimes scratch my head, you know, do you really want to be a cannabis company with 200 retail locations? You’re going to have a tough time growing same store sales in three to five years in 200 retail locations. So, I’m just most curious in proving out our thesis of being finished goods producers and low cost finished goods producers in the value chain. I’m most curious in seeing how that plays out. I think we are seeing our strategy play out in the most competitive markets in the world. We have a high degree of conviction that we’re on the right track here, but our eyes are always open and we’re always making little pivots here and there trying to make sure to stay on top of the sweet spot in the value curve.
If you describe the cannabis industry generically and you didn’t say cannabis, you said “widget” I think it’s the most fascinating Business School case ever presented. If you’re taking this market that already exists, it’s just illegal. So, all it needs to do is switch from the black market to the legal market and then you’re always trying to plot a course and steer the ship towards where the highest value creation can be. So, I’m fascinated to see how it’s going play out here.
Green: That concludes the interview. Thanks Andrew!
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Due to loopholes in federal and state laws, namely the 2018 Farm Bill specifying that hemp must contain less than 0.3% Delta-9 THC, delta-8 THC is technically legal across the country. It grew in popularity across the United States very quickly over the past year, largely due to online sales.
