Tag Archives: legalization

Keep ‘em Safe: Cash, Records, Products, People – Technology Helps Cannabis Businesses Succeed

By Dede Perkins
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It wasn’t that long ago that cannabis was underground, sometimes literally, and operators protected what was theirs any way they knew how. Before legalization, cannabis operators needed to secure their plants, cash, supplies and equipment not just from people who wanted to steal them, but also from law enforcement. The legacy cannabis market is now transitioning into a legal one, and licensed operators are joining the industry at an incredible rate, but security is still part of the success equation. Like before, operators need to protect plants, products, equipment and cash, but they now also need to protect records, privacy and data, and do so in a manner that complies with state regulations.

Cannabis regulatory authorities set security guidelines that cannabis business owners must follow in order to obtain and renew operational licenses. For instance, there are state-specific security regulations regarding video surveillance, camera placement, safes, ID verification, and more. While security measures help protect the business, they also protect the public. It’s a win-win for everyone involved. Here are five best practices and techniques to protect cash, records, products and people.

Hybrid cloud storage

State regulations call for reliable video surveillance footage that is accessible, in most cases, 24/7 and upon demand by cannabis regulatory authorities and local law enforcement acting within the limits of their jurisdiction. SecurityInfoWatch.com reports that video data is the industry’s next big investment, meaning there will be an increased demand and need to store video surveillance footage. Most states require video surveillance footage to be retained for a specific amount of time, often 45-90 days or longer if there is an ongoing investigation or case that requires the footage. While some businesses only retain video data for the state-required length of time, others choose to keep it longer.

Storing data on-site can become expensive and precarious. Best practices call for a hybrid cloud storage solution model as it provides on-site and both public and private cloud data storage solutions. This model provides users with the ability to choose which files are stored on-site and which files live in the cloud. Doing so improves file accessibility without impacting or compromising on-premises storage. In addition, it’s helpful to have two methods of digitizing data, for safety’s sake. In the event an on-site storage method crashes—though hopefully this won’t ever happen—there’s a version available off-site via the cloud. That said, with cloud-based storage solutions come cybersecurity threats that must be managed.

Cybersecurity

Dispensaries are prime targets for burglary. Defending a storefront requires a comprehensive security plan

Due to the ongoing COVID-19 pandemic, more businesses are online than ever before. Unsurprisingly, cyberthreats are on an upward trend, including in the cannabis industry. Earlier this year, MJBizDaily reported that a data breach exposed personal information of current and former employees of Aurora Cannabis. The incident involved “unauthorized parties [accessing] data in (Microsoft cloud software) SharePoint and OneDrive”. Although this breach involved only employees, confidential customer information is also at risk of being compromised during a data breach. 

On a separate occasion, an unsecured Amazon S3 data storage bucket caused a large-scale database breach that impacted almost 30,000 people across the industry, according to the National Cannabis Industry Association. The breach included scanned versions of government-issued ID cards, purchase dates, customer history and purchase quantities. Unlike the Aurora Cannabis breach, this one included customer data. 

Just like other more established industries, the cannabis industry needs to protect and secure confidential data. If you don’t have a cybersecurity expert on your team, consider hiring a consultant to evaluate your risk or partnering with a credible cybersecurity technology company to implement proactive solutions. Before signing a contract, do your due diligence. Does the consultant and/or technology company understand the compliance regulations specific to the cannabis industry? Do their solutions meet the regulations in the state(s) where your facility operates? Taking the time to protect your company’s data before a breach occurs is proactive, smart business.

Smart Safes 

A smart safe like this one can helps secure cash handling

Smart safes help secure cash handling, which given the difficult banking environment for cannabis companies, means they’re on the list of best practice security technology products. What is a smart safe? A smart safe is a device that securely accepts, validates, records and stores cash and connects to the other cash management technology solutions such as point of sale systems. They connect to the internet and provide off-site stakeholders visibility into a facility’s cash position.

A high-speed smart safe counts cash by hand faster than a human and is an overall more secure way to deliver cash bank deposits. At the end of the night, making a deposit at a physical bank location can be dangerous, exposing your cash and the individuals responsible for making the deposit to unsecured threats. Using a smart safe reduces that threat and also helps cannabis operators comply with financial recordkeeping and documentation requirements. Due to federal cannabis prohibition, many cannabis businesses lack enough insurance to fully cover their exposure to cash theft, which has led to a trending industry-wide investment in smart safes.

Advanced access control

Best practice access control means more than a ring of keys hanging off the facility manager’s belt. Advanced access control gives cannabis business owners and managers the ability to manage employee access remotely via the cloud. This feature can limit access areas within a facility, enabling an individual to revoke access instantly from a remote location making it a useful tool in the event of a facility lockdown or emergency. A mobile app and/or website can be used to lock or unlock secure doors, monitor access in real time and export access logs.

Advanced access control devices aren’t a standard in the industry yet. Although many state regulators don’t require cannabis businesses to utilize advanced electronic access control, using this technology is a best practice and may be required in the future.

Compliance software 

Understanding the ramifications and keeping up with state-mandated compliance is challenging. While state regulations can be found online, they’re often in pieces, leaving operators unsure about whether or not they have them all. Once an operator is confident that they have the most current version of all the laws, rules, and regulations that apply to their cannabis business, making way through the dense legal jargon can be exhausting. Even after multiple readings, it can be unclear about how to apply these guidelines to the operator’s cannabis business, which is one reason cannabis businesses work with a trusted legal counsel to meet compliance requirements. For trusted advisors and cannabis business licensees and operators alike, cannabis compliance software solutions are designed to not just check boxes for a cannabis business, but to help everyone involved understand how the regulations apply to the operation. These solutions improve accessibility so that employees at all organizational levels understand the rules and requirements of their position and the products they work with.

In addition, compliance software can help licensees and operators establish and implement best practice SOPs to meet regulatory requirements. Because the cannabis industry is young and many operators are moving fast, many cannabis businesses are vulnerable to security breaches and threats. Prioritizing security and compliance can help cannabis leaders protect against potential threats. Investing in the latest and most innovative security technology solutions—beyond what is required by state regulations—can help operators outsmart those who seek to steal from them and position their companies as industry leaders that prioritize safety and compliance, protecting not just cash and products, but the people who work in their facilities and the customers who purchase their products.

Technological Evolution of the Cannabis Industry

By Serge Chistov
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Discussions about the evolution of the cannabis industry are often focused on the legalization of adult use and medical cannabis, the growth of the business models associated with the industry and so on. An interesting corollary to those discussions is how technology is impacting the evolution of this growth industry. 

It’s no longer just a question of growing some buds and offering up a high, with little thought as to product, packaging, marketing or the end consumer. Technology has changed the way cannabis is being commodified, and that’s a good thing. After all, with more and more states making adult use legal, creating products that appeal to a wider market and demographic is in part accomplished thanks to tech.

From the growth stage

Few growers are using outdoor facilities, where the elements cannot be controlled. Until recently, indoor growers ran into issues like simulating natural light to a level that would be of maximum benefit to the plants. The amount of lighting required to be effective was very expensive to maintain in terms of electricity consumption, but that is changing.

Then LEDs came on the scene: high quality, low heat light with a far larger and more natural spectrum, versus blue and red light frequencies that are available in standard bulbs. Using far less electricity and emitting less heat, therefore requiring less need for additional air cooling, as well as longer bulb life spans, LEDs have become an industry standard.

Beyond the plant

LED lights use less energy and omit less heat than other more traditional options

As with any agricultural product, the important work is in growing the plants but thanks to technology, producers and manufacturers can now offer their customers a much wider array of products than buds for smoking. Edibles, vapes, oils, capsules and even creams are all products of technology influencing change in the cannabis industry. For consumers who aren’t interested in smoking directly, these offer promising options. 

The issue consumers have often had with edibles has been the lag time from consumption to high, as the THC has to pass through the digestive system, which takes upwards of an hour, and reduces the effectiveness of the dosage as some just doesn’t make it to the bloodstream. Technology has led to the creation of a method for making non-smokable forms of cannabis just as effective as a direct to the lungs hit of a joint: nanoencapsulation.

The point of nanoencapsulation is to reduce the size of the cannabinoid to a nano size and protect it—the encapsulation part of the equation—so that it becomes soluble in water, or in the body which is 75% water. The ability to bypass the digestive system and the gastric fluids that impact the effectiveness of an edible, and get it through the stomach walls to the bloodstream, means that nanoencapsulated formulations can have the virtually the same “time to a high” effects as a joint, without the need to inhale smoke.

It’s now possible for consumers to quantify exactly how much THC they are consuming, allowing for new and different consumption styles, including micro-dosing. Finding the right “dosage” for each individual—as everyone responds differently to cannabinoids—isn’t a simple task but newer technology is setting up a path to personalization that will make it easier.

Personalization

Imagine being able to take a test that would allow you to determine the perfect balance of THC and CBD dosage, as well as the right strain of cannabis, to create the desired effect. Whether that’s a reduction of anxiety, improved sleep or the psychoactive high that cannabis is known for, technology is leading the path to ending the guessing games as to dosage and blending of different cannabinoids.

A perfect example of this is CannabisDNA, a saliva-based swab test that evaluates over 70 of an individual’s genetic markers to establish what strains and dosages are most compatible with that person’s physiology. It’s a matter of time before this technology becomes more readily available and consumers will be able to obtain a range of products created with their personalized profile in mind.

In addition to matching cannabis to an individual’s DNA, there are efforts to decode the DNA of the various strains of cannabis, to better clarify important elements like THC, CBD and other cannabinoids like CBC. This last and far more rare cannabinoid has been associated with very strong anti-inflammatory reactions. This kind of deconstruction of cannabinoids at the DNA level will make it easier for producers and manufacturers to create products that address specific needs, both medical and recreational.

Purchasing power

Boutique dispensaries are popping up to make the more mainstream consumer comfortable. And thanks in part to the recent pandemic, online purchasing has jumped, with apps and websites being developed for purchasing and shipping just the right product, any time. 

Ads for CBD products online regularly perform very well

As has occurred in other areas of agriculture, there is a push towards transparency on product provenance and growth methods, so that the end consumer can make choices about what they are putting into their bodies, with as much information as possible. Field to dispensary tracking is on the table as a method to keep consumers educated and informed, which ultimately improves the connection between producers and consumers. 

Add to these ideas the fact that there are serious improvements in packaging being developed, which allow buds to remain fresh and full of flavor by eliminating light, air and moisture, while still remaining child proof. This is all part of the evolution of the cannabis industry, with a view to keeping customers happy and interested in the product.

Technology within the cannabis industry isn’t an end in itself: after all, the most important part of the effort is the growth of the plants themselves. But technology can change the evolution of the industry in ways that make it more interesting for everyone, from the grower, to the manufacturer of products, the dispensary owner and the consumer as well.

Payment Processing & Consumer Credit: An Interview with KindTap Co-Founder

By Aaron Green
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Federal regulations have made compliant credit processing in the cannabis industry difficult to achieve. As a result, most cannabis retailers operate a cash-only model, limiting their ability to upsell customers and placing a burden on customers who might rather use credit. While some dispensaries offer debit, credit or cashless ATM transactions, regulators and payment processors have recently been cracking down on these offerings as they are often non-compliant with regulations and policies.

KindTap Technologies, LLC operates a financial technology platform that offers credit and loyalty-enabled payment solutions for highly regulated industries typically driven by cash and ATM-based transactions. KindTap offers payment processing and related consumer applications for e-commerce and brick-and-mortar retailers. Founded in 2019, the company is backed by KreditForce LLC plus several strategic investors, with debt capital provided by U.S.-based institutions.

We interviewed Cathy Corby Iannuzzelli, co-founder and chief payments officer at KindTap Technologies. Cathy co-founded KindTap after a career in the banking and payments industries where she launched multiple financial and credit products.

Aaron Green: Cathy, thanks for taking the time today. How did you get involved in the cannabis industry?

Cathy Corby Iannuzzelli, co-founder and chief payments officer at KindTap Technologies

Cathy Corby Iannuzzelli: I’ve been in the payments industry for a long time. I was doing some consulting a few years ago for a client in Colorado and that gave me exposure to the issues in cannabis like the fact that you couldn’t have real payments in cannabis. Then, a close family member with health issues turned to medical cannabis when nothing else seemed to work. I was amazed by the difference it made in her life. At that point, I put those two things together and I said, I need to focus on helping this industry get a real cannabis payments solution because I thought it was ridiculous that you had an industry of this size and importance that had been abandoned by the payments industry.

Aaron Green: Can you highlight some of your background prior to entering cannabis?

Corby Iannuzzelli: Throughout my career, I’ve been a banker, I’ve been a payment processing executive and I’ve been a consultant. So, I’ve kind of done it all in the payments and financial services space.

Aaron Green: Why is it that most dispensaries only take cash?

Corby Iannuzzelli: In the US, even though cannabis is legal in many states, it’s still illegal federally. There are big banks and card networks like Visa, MasterCard, etc., who are national, even global companies and frankly, the executives of those companies don’t want to end up in jail for violating national laws. So, they have put cannabis dispensaries on what’s called a “prohibited merchants” list. This means you cannot accept Visa, MasterCard, Discover, American Express, or similar payments as a cannabis business and so it’s forcing the industry to a cash-based solution.

About the only thing you’re seeing that’s not cash in dispensaries are ATMs. But if you think about it, ATMs are machines where the consumer goes and pulls cash out and pays upwards of $5 or more in fees for doing that. They then hand that cash back to the dispensary who then has the costs of having to deal with that cash. The industry is just stuck in a cash-based business until federal legislation changes.

Aaron Green: I’ve been to some dispensaries where they accept credit cards or debit cards. What is going on there?

Corby Iannuzzelli: I’ve heard reports of consumers who’ve been able to use a credit card or a debit card in a dispensary. Sometimes the processor who sold that solution to the dispensary says, “Oh, it’s compliant, I guarantee you it’s compliant.” But if you dig in, that’s not the case. And eventually, Visa or MasterCard figures it out and shuts it down. In some cases, it’s outright fraud where the processor who sold the payment terminal to the dispensary is misrepresenting it as say a doctor’s office rather than a dispensary. There’s no merchant category code in the payment networks that says this is for processing dispensary payments, so they pretend it’s something else until they get shut down.

When they do get shut down, I’ve heard of cases in Las Vegas where it was basically 100% Visa or MasterCard one day and 100% cash the next day. It completely disrupted the whole business. It’s not just the retail store, but the inventories and everything else throughout the business.

“About the only thing you’re seeing that’s not cash in dispensaries are ATMs”

There have also been some cases where you’ll see something called a cashless ATM. In a store, they call it a debit card transaction. It’s really a cashless ATM where the consumer is making what looks to the ATM network like a cash withdrawal in $10 or $20 increments, but the consumer is getting a receipt instead of cash, and they’re turning around and handing that receipt back to the dispensary who then makes a change because the cashless ATM only dispensed in $10 or $20 increments.

Now ATM networks are looking at these cashless ATM transactions to see if they are compliant. Do consumers know the fees that they’re paying? Are these transactions coming in and looking to the network like real cash when it’s not? Cashless ATM transactions are probably the most common thing you see, but that’s being called into question after the Eaze incident where a large company was misrepresenting its terminals. The federal government stepped in and called it bank fraud and the individuals behind it, the executives, are in jail. Since then, the networks are looking at this and saying, what about these cashless ATMs? Are those transactions within our rules, or is there something funny going on here?

Aaron Green: So, to summarize here: you’ve got federal regulations at the national level that says that cannabis banking is not allowed so major institutions are not offering it. Yet you found a way through the regulations and compliance issues. I’m curious can you pull back the curtains a little bit and tell us how you came up with a solutionhere?

Corby Iannuzzelli: Well, we came up with the solution by stubbornly refusing to believe that cannabis payment processing could not be done in a compliant manner. We just said, “there is a compliant way to do this, let’s figure it out.” We took the same components that are out there for the financial services and payments industry and reassembled them in such a way that we do not violate any rules. We do not use any of the Visa, MasterCard, Discover or Amex rails, we built our own network. We have direct contracts with the merchants and direct contracts with the consumers. We control everything and all the funds flow through regulated financial institutions. So, we designed something that looks and acts to consumers and retailers the way Visa and MasterCard look and act when a consumer goes to make a purchase, but they run on a separate set of payment rails and in compliance with banking regulations and state regulations. When you’re looking at the problem from a different perspective, sometimes you can come up with a better answer.

Green: On the consumer side, what does that user experience look like?

Corby Iannuzzelli: Our product is completely digital. The consumer experience starts with integration at the online checkout. When it’s an e-commerce shopping cart and somebody is placing an order, they will see a button called “Pay with KindTap.” The first time they click that button they’re automatically brought to our integrated web app where they do a quick and easy application for our digital revolving line of credit product. If approved, they instantly go back to the checkout screen and their first purchase will just happen immediately, with flexible payment options over time. If the consumer decides they don’t want our KindTap credit and would rather have a pay now-product where we pull the funds from their bank account, then the consumer can do so. So, there is no physical card per se, it’s integrated like PayPal or Affirm at the point of checkout online. For the consumers who use KindTap credit, there is a mobile app where they can see their transactions, view statements, pay their bills, etc.

Additionally, there is a loyalty program for all purchases – KindTap credit or through the consumer’s bank, because we feel very strongly that a lot of the reasons consumers choose to pay with one card over another is the points and the rewards that they get. So, we’re providing loyalty rewards with KindTap so that consumers can get rewarded for that spending with KindTap and it’s better for the retailers.

Green: On the retailer side, what does that experience look like and what is your business model?

Corby Iannuzzelli: We are not going store by store doing integrations, rather, we’re integrating with various software, delivery and e-commerce providers. That gives us broad reach and ability to expand rapidly in various state markets where cannabis is legal. Once a merchant says “yes, I want to be a member of the KindTap Merchant Network,” then we work to get them set up on our platform in a matter of days. The merchants receive continuous support from our success team, marketing co-investment and a depth of analytics reporting. We made the entire process and ongoing operations streamlined and frictionless for both merchants and consumers.

Aaron Green: What are the benefits of moving from cash to credit type of payments?

Corby Iannuzzelli: On the retail side, there are the obvious benefits of not having all the security, safety and theft issues associated with operating a physical cash business. Consumers very often don’t carry cash anymore, except when they’re making a cannabis purchase. There are a lot of hidden costs to retailers because payments are not just about moving money from the consumer to the business.

“I really am optimistic that with so many scientific breakthroughs we’ve had that we’re going to be able to figure this out.”Payment options – or lack thereof – can shape where people shop, how much they spend and what they buy. It’s a proven science how consumers make impulse purchases. If you’re a cash-based business in cannabis, and you’re trying to get somebody to make an impulse purchase, and they walked in with $100, then you can’t get them to spend more than $100, no matter how creative your marketing is! The consumer is limited by how much cash they have in their bank account or in their pocket at that point in time. So, it’s really about the upsell that comes with the bigger basket sizes that retailers experience when you move from a cash-based business to credit and suddenly, the merchant doesn’t have to deal with long lines of consumers on payday when the store was beyond slow two days before. Now the consumer can spread purchases with the thinking, “I’d rather not be the one standing in that line on payday. I’m going to go Wednesday [instead of Friday] because I have KindTap credit so I can budget and manage my cash flow throughout the month rather than around my paydays.”

So, we think that the lack of an efficient and effective payment system for cannabis is holding back sales. We all focus on how much the industry is growing. KindTap thinks about how much faster it could be growing if it was supported by a decent payment system.

Aaron Green: What are some other cash-only markets you are looking at?

Corby Iannuzzelli: We are laser-focused on the cannabis ecosystem and bringing a compliant credit and loyalty-based digital payments solution to cannabis merchants and customers and rewarding those stakeholders for accepting/using KindTap. Additionally, we are planning to extend the KindTap Merchant Network so that consumers can use/earn our loyalty points with other goods and services they’re purchasing that are adjacent to cannabis or that are important to the cannabis consumer. That’s the direction we’re going.

Aaron Green: Today people can receive gas points for spending with their credit card. Now with KindTap, you can spend to get cannabis points?

Corby Iannuzzelli: That’s exactly right.

Aaron Green: What in either cannabis or your personal life are you most interested in learning about?

Corby Iannuzzelli: Personally, I am most interested in seeing breakthrough technologies in climate change. We’re going to need to correct this situation and I’m reading about collecting carbon dioxide from the air and burying it in the earth and things like that. I really am optimistic that with so many scientific breakthroughs we’ve had that we’re going to be able to figure this out. Certainly, it’s going to take a lot of smart people and a lot of investment, but I really look forward to watching them do their stuff and hopefully taking us out of this nightmare situation that we’re heading into if we don’t make some changes.

Aaron Green: Thanks Cathy, that concludes the interview.

Corby Iannuzzelli: All right, thanks Aaron!

Ask the Experts: The Business of Cannabis Meets the Law

By Cannabis Industry Journal Staff
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Practicing Law Institute Press’s Legal Guide to the Business of Marijuana: Cannabis, Hemp and CBD Regulation is a one-of-a-kind deep dive into the many regulations governing the industry. Aimed at attorneys representing clients in this space, the treatise offers guidance on a range of interrelated topics including state regulation of medical and non-medical cannabis; federal law, enforcement and preemption and their implications for employment, taxes and banking; and the various aspects of establishing and managing a cannabis enterprise, from growth to licensing, transport and distribution. We spoke with co-authors James T. O’Reilly, professor of Public Health Policy at the College of Medicine of the University of Cincinnati and author of leading references on food and drug law, and Edgar J. Asebey, a founding partner of Keller Asebey Life Science Law and a life sciences attorney with over twenty years of experience, about the intersection of the cannabis business and the law.

Q: From the legal industry’s perspective, how has this area of the law evolved over the past few years – and what would you advise clients in cannabis to look for when engaging legal assistance for their businesses?

James T. O’Reilly & Edgar J. Asebey: Over the past few years, we have seen a growing acceptance of the idea that lawfully serving the needs of cannabis consumers is a commendable business initiative. This evolution in thinking – tied to the myriad business opportunities cannabis presents – has given large, mainstream corporate law firms the incentive to grow practices and develop specialists in this area, which is a very positive development.

But it is not enough for lawyers to know their way around M&A and the capital markets; they must also have experience with federal regulatory bodies. As regulations continue to evolve, it is essential for practitioners to be familiar with the Food, Drug and Cosmetics Act as well as the Federal Trade Commission Act. The framework for regulating cannabis products already exists, as can be seen in the Warning Letters sent to hemp and CBD companies by both the Federal Trade Commission and Food and Drug Administration (as well as, most recently, the FDA and CDC’s warning about delta-8 THC). If a client places their hemp or CBD product into the stream of commerce, that product will be subject to FDA, FTC and relevant state laws. We strongly recommend seeking out advisors who truly understand these regulations and how they align with the regulatory agencies’ procedures and agendas.

Q: What are the most urgent legal and regulatory topics the industry is watching these days?

O’Reilly & Asebey: Our treatise follows and analyzes the most pressing legal issues facing those in the cannabis and hemp space. In our most recent edition, we add discussion of the Final Rule for the establishment of a domestic hemp production program. We think this is a significant development in that it attempted to address some of the industry’s criticism of some provisions found in the Interim Final Rule, par­ticularly around issues of sampling and testing for THC content. The Final Rule clarified issues around THC percentage testing methodologies, but disappointed many in the industry by leaving in place the low 0.3% dry weight threshold for an acceptable hemp THC level. On the other hand, The Final Rule raises the threshold for a negligent violation from 0.5% to 1.0% total THC and limits the number of violations a grower can receive in one year to one, easing potential penalties for violations.

Of course, the regulation of CBD products is on the minds of many in the industry. Key questions remain about whether cannabinoids such as delta-8 THC can be lawfully sold. Since the FDA has provided no clear guidance with regard to the sale and use of CBD and other hemp-derived cannabinoid-containing prod­ucts, well-meaning businesses find themselves operating in a regulatory gray area. While some states have raced to place delta-8 THC on their controlled substances lists or otherwise regulate it, at the federal level it remains unclear. Our book provides a legal argument showing that current regulations support the lawful production and sale of delta-8 THC. To date, this and other legal arguments have not been tested in the courts and, without FDA guidance, the delta-8 THC sector will remain gray.

Editor’s Note: The Legal Guide to the Business of Marijuana: Cannabis, Hemp and CBD Regulation is now available for purchase here.

About James T. O’Reilly

James T. O’Reilly of the University of Cincinnati College of Medicine is former chair of the 8,000-member Section of Administrative Law & Regulatory Practice of the American Bar Association and has been active in numerous ABA, Federal Bar Association, and state and local bar activities. He retired as Associate General Counsel of The Procter & Gamble Company to teach full-time, and served as a consultant to three federal agencies and to the Deputy Secretary General of the European Commission. He has authored fifty-six texts and more than 230 articles, and his work was cited numerous times in appellate opinions, including “The experts have written . . . ” in a March 2000 opinion of the U.S. Supreme Court (Food & Drug Administration v. Brown & Williamson Tobacco Corp., 120 S. Ct. 1291). He has received numerous honors and awards for his professional and electoral activities and has been listed in Who’s Who in American Law for twenty-five years. He is a graduate of Boston College and the University of Virginia School of Law.

About Edgar J. Asebey

Edgar J. Asebey, a partner at Asebey Life Sciences Law PLLC, is a regulatory and transactional attorney with over two decades of experience in federal regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement and cosmetics companies. Since 2015, he has been working on cannabis-related matters and transactions, and since 2018, he has provided regulatory compliance, business transactional, venture finance and international trade services to hemp/CBD companies. Mr. Asebey practices before the FDA, the USDA, the CBP, the EPA, and the FTC, representing client companies on regulatory compliance, product approval/registration and FDA enforcement defense matters. He founded and served as president of Andes Pharmaceuticals, Inc., a natural products drug discovery company, from 1994 to 2000, and has served as in-house counsel to two life sciences companies. Mr. Asebey is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), the Food & Drug Law Institute (FDLI), the Dade County Bar Association, and BioFlorida.

Content sponsored by Practicing Law Institute

“Keep the Buds Fresh” – Packaging & Paraphernalia Laws

By Justin T. Starling, Michael C. Tackeff
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Cannabis law in the U.S. is currently incoherent. What is illegal under the federal laws on the books bears little relation to what is actually happening in cities, states and counties where cannabis is legal for medical and adult use. Although legislators, lawyers and business interests are focused primarily on whether it is legal to buy, sell or grow the cannabis flower itself, the industry’s emergence is also affecting another manufacturing stalwart: packaging. If you can grow it, you can transport it. And if you can transport it, you need a container to sell it in.

As cannabis growers and retailers begin to recognize that attractive, compelling and moisture-retentive packaging can help market and sell their products to a wider audience, packaging companies are presented with an opportunity to expand into this Wild West industry. Seth Rogen is living proof that there is money to be made here: his cannabis company, Houseplant, trades on antique vibes, limited edition releases, celebrity artist sponsorships and old-school tobacco-adjacent products, splashing its unique and charismatic packaging across its website homepage.

But what do packaging industry executives need to know before venturing into the cannabis industry? Although manufacturing packaging that could be used to contain or transport cannabis products is not entirely risk-free, U.S. courts have generally refused in the past to hold manufacturers liable for making products that can be used later as drug paraphernalia. For packaging executives, two questions are of utmost importance. First, could I be held liable for producing drug paraphernalia? And second, what packaging standards must my company follow? This article will address these questions.

Criminal Status of Cannabis Under Federal & State Law 

All cannabis containing more than 0.3% THC remains illegal under federal law and under the laws of many large states, including Texas, Georgia, Tennessee and Iowa. But that’s not the full story. While facilitating cannabis production or trafficking is illegal, the federal government has enforcement priorities and restrictions on its resources. And many state and federal law enforcement officials have little incentive to pursue industries supplying trucks, packaging or lighting to a cannabis retailer in another state, as such products and services are not illegal and can be used for other industrial purposes. No law enforcement official is going to sue Staples for selling paperclips to a cannabis retailer.

Cannabis is still a “Schedule I” substance under the federal Controlled Substances Act, which is defined as substance having a high potential for abuse, no currently accepted medical use in treatment, and no accepted safe use.1 Cannabis was always a poor fit for this definition, given its efficacy in helping oncology patients cope with symptoms like nausea, but its continued classification as a Schedule I substance means that cannabis remains illegal under federal law. Despite this federal illegality, the federal government has little power—legally, practically and politically—to prosecute those engaged in the cannabis industry through activities that are legal under state law.

First, since 2014, Congress has banned the Department of Justice (DOJ) from spending a dime enforcing the federal cannabis law against individuals complying with state medical cannabis law via an appropriations rider.2 Courts have interpreted this language to mean that the DOJ may not prosecute individuals complying with state medical cannabis law,3 although there are still instances where individuals are convicted of violating the federal ban because they were found to have been out of compliance with state law.4 Though the rider only pertains to medical cannabis laws, the federal government has historically treated adult use cannabis regimes by states in a similar way.

Second, from a practical standpoint, no federal agency has the manpower to pursue even a tiny fraction of medical and adult cannabis users who are in compliance with state law, much less the industries providing support, logistics and inventory management. Though the federal ban is still on the books, no one has the power or the money to enforce it. The federal ban is thus becoming a dead letter.

Drug Paraphernalia Laws

Drug paraphernalia laws were written to provide law enforcement with other offenses to charge drug users and producers in addition to simple possession. The idea was to criminalize every aspect of the process of consuming and producing cannabis. While drug paraphernalia laws are written incredibly broadly, courts have been reluctant to apply them to companies producing packaging products.

Most packaging companies would have a defense to a suit alleging they are producing paraphernalia

Federal law explicitly defines drug paraphernalia as “any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter.”5 There are 15 categories of items listed as “per se” paraphernalia, including roach clips, electric pipes, and bongs.6 Packaging products do not fit any of the “per se” categories. The statute also specifies that, in determining whether an item constitutes drug paraphernalia, the court must consider “whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products[,]” among other factors.7

In addition, federal courts have been reluctant to apply the drug paraphernalia laws to packaging products.8 In addressing the predecessor statute to the current federal paraphernalia law,9 the Second Circuit ordered an indictment dismissed against a producer of glass vials commonly used for crack cocaine: “Since congress in enacting the Paraphernalia Act deliberately omitted ‘packaging’, ‘containing’, and ‘cocaine vials’ from its definition of drug paraphernalia, we conclude that the plastic containers produced by Lin were not ‘drug paraphernalia’ as defined by the act.”10 The law is not uniform, but even if a zealous federal prosecutor wants to crusade against a cannabis supplier, he must contend with the appropriations rider and this adverse case law.

Nevertheless, the federal Controlled Substances Act does allow property used to manufacture narcotics to be seized.11 It is possible that if a company created packaging for cannabis products, and the customer then used that packaging to pack cannabis, the inventory and packaging could be seized by federal law enforcement. But the same obstacles to enforcement discussed above would apply.

Every state has different paraphernalia laws, but most packaging companies would likely have defenses to a suit alleging they are producing or possessing paraphernalia, including lack of intent to use the paraphernalia for illicit purposes and applying federal caselaw as a defense.

Packaging Laws

State law is the primary vehicle for regulatory guidance on cannabis packaging. Any packaging company selling to cannabis retailers will need to consider both state law and federal packaging standards, which are often incorporated by reference into state law.

Federal Packaging Law

Producing a product that complies with all state standards at once might be a challenge, but adhering to individual state rules is doable.

The Poison Prevention Packaging Act is the primary source of child-resistant packaging law.12 This law does not currently apply at all to any sales of cannabis because cannabis is illegal in the eyes of federal law. There is no private right of action under this statute.13 That means that a packaging company cannot be sued by a private individual for violating the statute. At some point, if Congress chooses to loosen restrictions on cannabis, this would be a very easy statute to simply make applicable to sales of cannabis. The law already has a specific provision for liquid nicotine containers.14 But currently, this statute does not apply to cannabis at all.

State Packaging Laws

State laws are a different matter – each state that allows sales of medical or adult use cannabis has enacted different requirements for cannabis packaging. A comprehensive survey of state cannabis packaging law is beyond the scope of this article, but some state cannabis regulatory regimes explicitly incorporate provisions of the federal Poison Prevention Packaging Act.15 California has a similar requirement, as does Washington state.16 Producing a product that complies with all state standards at once (i.e., a “national” standard) might be a challenge. Contracts with buyers could include a representation that the packaging complies only with the laws of state X or Y.

Products Liability Issues

A detailed assessment of products liability is beyond the scope of this article. But in short, as this industry matures, packaging companies undoubtedly will be subject to the usual kinds of products liability issues for cannabis packaging. In other words, in a cannabis-tolerant state, a packaging company could theoretically be sued under a products liability theory if the cannabis is somehow spoiled by a manufacturing defect in the packaging or if the packaging product permits mold to grow and eventually be consumed by a user. Cannabis contract litigation is a complex subject given its unique legal status. One strategy to avoid these issues is to include a very specific dispute resolution procedure (e.g., mediation, arbitration or the like) in any contracts with cannabis companies in the U.S. It is also important to include a waiver of any defenses of the contract being against public policy due to the uncertain legal status of cannabis.

No transaction in the cannabis industry is entirely risk-free, and packaging executives should consult with local counsel in the states in which the packaging is manufactured and in the states in which they intend to sell products to ensure compliance with the law. But this industry is rapidly growing, and opportunity awaits for the packaging companies that are willing to work through the incoherence in the current laws.

References

  1. 21 U.S.C. § 812.
  2. Consolidated Appropriations Act, 2020, Pub. L. No. 116-93, § 531, 133 Stat. 2317, 2431 (Dec. 20, 2019).
  3. United States v. McIntosh, 833 F.3d 1163, 1179 (9th Cir. 2016).
  4. United States v. Trevino, No. 20-1104, 2021 WL 3235751, at *4 (6th Cir. July 30, 2021) (Michigan dispensary owner could never have been in compliance with Michigan’s medical cannabis laws given his prior felony conviction for cocaine possession).
  5. 21 U.S.C. § 863(d); see also generally United States v. Assorted Drug Paraphernalia, 90 F. Supp. 3d 1222, 1229 (D.N.M. 2015).
  6. 21 U.S.C. § 863(d)(1).
  7. 21 U.S.C. § 863(e)(5); see also 21 U.S.C. § 863(f)(2) (specific exemption for items exported or sold through the mail, “and traditionally intended for use with tobacco products, including any pipe, paper, or accessory”).
  8. Posters ‘N’ Things, Ltd. v. United States, 511 U.S. 513, 526 (1994) (“Similarly here, we need not address the possible application of § 857 to a legitimate merchant engaging in the sale of only multiple-use items.”) (head shop case where establishment was devoted substantially to drug paraphernalia).
  9. 21 U.S.C. § 863; see also 511 U.S. at 516 n.5.
  10. United States v. Hong-Liang Lin, 962 F.2d 251, 258 (2d Cir. 1992); see also United States v. Big Apple Bag Co., 306 F. Supp. 2d 331, 334 (E.D.N.Y.), on reconsideration in part, 317 F. Supp. 2d 181 (E.D.N.Y. 2004) (“[T]he Second Circuit has determined that trafficking in items that are used merely to package or contain drugs does not violate 21 U.S.C. § 863.”). But see also United States v. Main St. Distrib. Inc., 700 F. Supp. 655, 659–60 (E.D.N.Y. 1988) (no legitimate market for glass stirrers used in crack pipes, and where customs agent had placed dummy order using common street term for crack pipes; denying company’s motion to suppress).
  11. 21 U.S.C. § 881 (a)(3) (“The following shall be subject to forfeiture to the United States and no property right shall exist in them: All property which is used, or intended for use, as a container for property described in paragraph (1), (2), or (9).”).
  12. 15 U.S.C. § 1471 et seq.; 16 C.F.R. § 1700.20(a)(2)(iii).
  13. Doane v. Metal Bluing Prod., Inc., 568 F. Supp. 744, 746 (N.D.N.Y. 1983).
  14. 15 U.S.C. § 1472a.
  15. See, e.g., Fla. Stat. Ann. § 381.986(8)(e)(11)(e) (“When processing marijuana, a medical marijuana treatment center must: Package the marijuana in compliance with the United States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.”).
  16. Cal. Bus. & Prof. Code § 26120(a) (“Prior to delivery or sale at a retailer, cannabis and cannabis products shall be labeled and placed in a tamper-evident, child-resistant package and shall include a unique identifier for the purposes of identifying and tracking cannabis and cannabis products. If the cannabis or cannabis product contains multiple servings, the package shall also be resealable.”); Cal. Bus. & Prof. Code § 26001(i) (“‘Child resistant’ means designed or constructed to be significantly difficult for children under five years of age to open, and not difficult for normal adults to use properly.”) (identical to federal standard); see also Wash. Admin. Code 314-55-105(2)(b)(i) (all cannabis concentrates must be packaged consistent with the Poison Prevention Packaging Act).

Where Are We Now? Social Equity in the US Cannabis Industry

By Dede Perkins
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As state legalization measures begin to legitimatize the US cannabis industry, stakeholders, both those currently in the industry and those who plan to join in the not-too-distant future, grapple with the best ways to right the wrongs from the decades-old War on Drugs. While some stakeholders support residency requirements and setting aside a percentage of a state’s cannabis licenses for social equity and economic empowerment applicants, others contend that these solutions are discriminatory. Reuters reports that lawsuits against social equity programs have been filed in Michigan, Illinois, Missouri and Maine, and some have received decisions that rule against existing social equity programs. While there is disagreement on the best way to create an equitable cannabis industry, few dispute that we’re dealing with an oppressive legacy against low-income individuals and people of color and the cannabis industry is in a unique position to shape a socially responsible industry that focuses not just on profits, but also on the greater good.

Challenges for Social Equity Applicants and Licensees 

Currently, Black Americans make up 13% of the US national population, but own less than two percent of cannabis businesses owners, according to Leafly’s Jobs Report 2021. Why? There are five primary factors.

  1. In most states, cannabis licenses are expensive and difficult to get. The application process requires a team of experienced individuals to work on everything from finding and negotiating real estate contracts; to vetting and hiring architects, safety, and security consultants; to working with community stakeholders to gain local approval.
  2. After the pieces are in place, applicants have to write it all down, which is a challenge in itself. It is not uncommon for one state cannabis application to be over one hundred pages.
  3. Since cannabis is still federally illegal and listed as a Schedule 1 drug, it’s nearly impossible to get a business loan to fund the application process or, if an individual is lucky enough to get a provisional license, to renovate or build out cannabis cultivation, processing and/or retail facilities.
  4. Because of the low-income status of many social equity applicants, few have access to accredited investors or low interest loans.
  5. Finally, if an individual or organization makes it through the application process and receives both a license and funding to operate, they face ongoing operational challenges including ever-changing laws, rules and regulations. Maintaining compliance is a process in and of itself.

If cannabis industry stakeholders don’t make honest efforts to provide real solutions to these challenges in the near future, inequalities will proliferate.

Current State of Social Equity in the US Cannabis Industry

To help mend the harms of the War on Drugs and reduce the institutional challenges faced by marginalized individuals, some states have instituted social equity programs that prioritize cannabis business licenses to those previously incarcerated on cannabis-related convictions and/or those who live in zip codes with high incarceration rates for drug crimes. Some states broaden the social equity lens and include women- and veteran-owned businesses in social equity programs.

The National Association of Cannabis Businesses explains:

The goal of social equity laws is to ensure that people from communities disproportionately harmed by marijuana prohibition and discriminatory law enforcement are included in the new legal marijuana industry. Policymakers are working to address criticisms that outsiders are setting up legal cannabis businesses and profiting by doing the same things their less fortunate neighbors were arrested and given jail time for just a few years ago.

By prioritizing social equity applicants, our industry is starting to bridge the access gap and improve the odds that previously marginalized individuals will make it into the C-suite and other influential positions. But is it enough? Many argue that social equity programs won’t make a real difference until more programs include low-interest loans and/or provide access to capital sources and ongoing support after licensure.

Although social equity programs vary, many require applicants to live in a zip code with a high incarceration rate for drug crimes or have a state residency requirement, meaning that social equity applicants must have lived in the state for an established number of years before they can qualify for social equity status. In some states, municipalities are tasked with creating these programs as is the case in Los Angeles and Oakland, California.

While some states offer social equity applicants priority consideration for their licensing applications, others offer reduced application and licensing fees, technical assistance, entry into an incubator program specifically designed for social equity applicants and/or apprenticeship opportunities.

Although social equity programs focus on developing business leaders with marginalized racial and socioeconomic backgrounds, other components of these programs often include criminal justice reform, such as revising resentencing guidelines and expungement requirements for those with cannabis-related convictions. The MORE Act, for example, not only calls for federal legalization, but also for reassessing the legal status of cannabis-related convictions, arrests, and prison sentences.

US States with Cannabis Social Equity Programs

When Colorado and Washington voted in favor of adult-use cannabis legalization nearly a decade ago, lawmakers were tasked with drafting regulations for what a legal marketplace would look like in their respective states. Although legalization efforts focused on the inequities of prohibition, the War on Drugs, and the legal cannabis industry, social justice initiatives were not initially included.

Today, there are 37 states and municipalities, including Washington D.C., that have legalized medical cannabis. Nineteen of those states have also legalized adult-use cannabis. Recent data shows that one in four Americans consumes cannabis, suggesting that legalization efforts have started to normalize cannabis use among the US population.

Out of the 19 states with adult-use cannabis, 13 have developed social equity programs to help marginalized people become cannabis leaders in their markets. States that incorporated social equity programs into initial adult-use cannabis legislation include Massachusetts, California, New Jersey, New York, New Mexico, Michigan, Vermont, Illinois, Connecticut, Arizona and Virginia. Although Colorado and Washington’s laws initially did not include social equity programs, both states are now in the process of implementing them.

It’s important to note that not all US states with legal cannabis programs take the social equity approach. States with legal adult-use programs but without social equity programs include Montana, South Dakota, Maine, Nevada, Oregon and Alaska.

After Social Equity Licensure

For those social equity applicants who receive operational licensure, there is the ongoing issue of compliance. As if there were not enough pressure on social equity applicants and license holders, maintaining state-compliant businesses and developing internal policies and procedures that drive brand awareness and loyalty can be a challenge. The hard reality is that admission into a social equity program and even obtaining licensure does not ensure a business leader’s success. Besides increased access to capital, expanding social equity programs to include post-licensure support, at least for the first year or two, would improve the odds of long-term success.

All in all, social equity programs in the US cannabis industry have begun to make a difference and right some of the wrongs of the War on Drugs, but there is still work to be done. To build an industry that improves lives not only with cannabis products but also with financial opportunity, we must continue to prioritize and expand current social equity programs and fight for new social equity programs in all legal cannabis states.

Think Your Cannabis Business Complies with Temp and Part-Time Employment Regulations? You Might Be Surprised

By Stacy Bryant
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As a fast-growing cannabis company, ensuring your business stays compliant with regulatory agencies of all kinds—planning departments, the U.S. Department of Agriculture (USDA), Occupational Health and Safety Administration (OSHA) and so on—is critical for survival. But is your business also compliant with temporary and part-time employment regulations? Violating these often-overlooked regulations can land your company in hot water at best and force you to shut your doors at worst. Here’s what you need to know about risks, regulations, compliance issues and more.

The 30,000-Foot View: Part-Time and Temporary Employees 

Cannabis has proven itself to be a high-turnover industry. But in the ever-shifting, post-COVID landscape, many cannabis employers are seeing the financial and logistical benefits of hiring part-time and temporary workers.

Though the terms “part-time” and “temporary” are sometimes used interchangeably, the fact is, there are legal differences in the definitions of part-time versus temporary work. For starters, temporary employees must work for less than a year at a specific organization, and their work must have a defined end date. Temporary employees, or “temps,” often fill vacant roles in a temporary capacity, such as roles previously occupied by someone on parental leave.

Many full-time employees in the cultivation space are defined as “agricultural workers”

Part-time employees, on the other hand, can work indefinitely for a company—but they must work less than 40 hours per week. And, side note, if a part-time employee works more than 1,000 hours in a calendar year, they could be eligible for retirement benefits—so hiring managers, bear that in mind.

For employers, there are some tangible benefits in hiring part-time or temporary workers. For starters, there are often fewer upfront costs associated with hiring part-time workers (like workers’ compensation and healthcare). Establishing a strong part-time and temp employment strategy also allows for employers to quickly scale up or down based on market tendencies or shifts.

Understanding the Risks of Hiring Part-Time or Temporary Workers

While hiring part-time and temporary workers can help businesses stay agile and responsive to market demands or fill vacancies created by recent resignations, many businesses hire these types of employees without a full understanding of associated regulations. And it can get even trickier: many full-time cannabis industry workers in the cultivation space aren’t considered “employees” at all—they’re defined by the federal government as “agricultural workers.”

It’s essential that businesses classify part-time workers and independent contractors correctly. Attempting to claim a worker is part-time when they’re really a full-time employee (a practice known as “misclassification”) can save a business tax dollars in the short-term but lead to sanctions and hefty penalties down the line. For example, if a worker is misclassified and the Department of Industrial Relations finds out, they can sue the former employer for unpaid wages.

Potential fallout from noncompliance with classification or wage and hour issues includes massive fines, potential litigation and more. Federal agencies are extremely sensitive to cannabis business regulatory violations, it’s vital to adhere to proper staffing regulations and compliance. The wrong kind of attention can tank your business’s reputation and halt your operations altogether. I’ve personally worked with numerous cannabis businesses in their hiring and payroll initiatives, and I’ll say this: It may seem like a headache to cross all the “Ts” and dot all the “Is” in the beginning, but it will make a massive difference down the line.

Understanding the Regulations for Hiring Part-Time or Temporary Workers 

All employers must adhere to the regulations set forth by the Fair Labor Standards Act, which mandates that part-time employees must be treated the same as full-time employees. That means they must be paid minimum wage, be paid overtime should they exceed their determined hours, have the opportunity to take job-protected unpaid leave, and so on. I really want to stress how essential it is that employers classify their workers appropriately.

It’s also worth noting that many states have specific regulatory structures for employment, both full- and part-time.

In the heavily regulated cannabis industry, employers must exercise strict due diligence to meet all OSHA standards. Additionally, they must identify all occupational hazards and account for employees’ overtime and double time. Grow operations must also adhere to the Field Sanitation Provisions of the Occupational Safety and Health Act, which includes providing toilets, drinking water, hand sanitation facilities and hygiene information.

Avoiding Compliance Problems with Planning and Diligence 

There’s a lot more to hiring workers than businesses realize, especially in cannabis. Most companies don’t intend to be noncompliant with regulations—they simply don’t know the regulations, or they’re overwhelmed by hiring and growing so quickly. To make sure you’re compliant, you might consider building out your HR team, educating yourself as the business leader and reaching out to staffing and HR professionals in the space who can answer your questions. In this rapidly growing industry, which seems to shift and change every day, planting your feet firmly on solid regulatory ground will serve to benefit you in the event of federal legalization, massive business growth or initiatives you may want to undertake in the future.

Recent Developments in Cannabis Vaping Product Safety – A Q&A with Corey Mangold, CEO of PurTec Delivery Systems

By Aaron Green
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Vaping is a multi-billion dollar cannabis product category representing more than 20% category share in the US, according to a recent Headset.io report. The 2019 vaping crisis, whereby lung injury and several deaths were caused by the adulteration of vapor pen cartridges with vitamin E acetate, highlighted the importance of safety and emissions testing for vapor pen products. In addition to volatile organic compounds, metals and ceramics contained in the heating elements of cartridges are also a concern. While the FDA has a robust program for emissions testing in nicotine products, they do not currently regulate cannabis. Cannabis vaping is currently regulated at the state level in the United States.

Cannabis vaping is popular among minors owing to its discrete nature. In a recent study published in the Journal of the American Medical Association (JAMA), 14.7% of teens reported vaping cannabis in 2018. In a separate research study, University of Michigan researchers found that teens vaping cannabis were two times more likely to experience respiratory issues than teens who smoked e-cigarettes.

We spoke with Corey Mangold, CEO and founder of PurTec Delivery Systems, to learn more about cannabis vaping safety and their PurGuard technology. Prior to entering the cannabis space, Corey founded a software company in 1998. He also founded the advertising agency Gigasavvy in 2008, which he recently exited from in March 2021.

Aaron Green: How did you get started in the cannabis industry?

Corey Mangold: I got started in the cannabis industry in 2016. My daughter was away at college in San Luis Obispo and got pregnant and was going to have a baby, which obviously I was excited about. I decided to have her come down to Southern California and start a company together, as I’ve done multiple times in my career successfully. I wanted to show her the ropes, and teach her everything from finance to HR, to business development, marketing – everything it takes to be successful – and give her the tools that she would need to be successful for her life.

Green: What kind of things were you into before 2016?

Mangold: I founded my first company in 1998 in the software industry and had that company up until 2005. In 2008 I started another company called Gigasavvy, a nationally recognized advertising agency out of Irvine, California, which I successfully exited in March of 2021.

Corey Mangold, CEO and founder of PurTec Delivery Systems

When deciding to start a company with my daughter, we were interested in the cannabis industry – I think everybody was back in 2016. In 2016, I had started using cannabis again after probably about a 16- or 17-year hiatus. I was using a vape because I had children in the house. I went to literally anywhere I could and bought every type of cartridge on the market. What I found was that their user experience was not like what it was on the nicotine side of vaping. I reached out to associates of mine who had been manufacturing vapes since 2011, starting with the blue e-cigarette, and we engineered a unique device that was proprietary and completely unlike anything on the market. It was incredible, and still to this day, I think it’s probably the best 510 thread cart on the market. We launched that under the Orchid Essentials (CNSX: ORCD, OTC:ORVRF) brand in California and Oregon.

Green: Is that cart something that you sell to other brands as well, or is it purely for the Orchid brand?

Mangold: Yes, purely for the Orchid brand, but it’s what inspired me to start PurTec Delivery Systems. After a few years of struggling in this industry because we didn’t have the access to capital needed – Orchid is a US company traded on the Canadian Stock Exchange (CSE:ORCD, OTC:ORVRF) – and dealing in a substance that’s federally illegal, there was no access to any traditional financing, be it factoring or inventory financing. We were literally creating as much product as we could every month and then selling out almost instantly, and then waiting till the next month to get money in from all our accounts to make more. We had to slug it out. We did get into a little over 500 stores in California and Oregon, but it was just a battle, and I didn’t really want to be touching cannabis.

In 2020, I had a breakthrough in my strategy. I was watching the TV show Gold Rush and I watched one of the guys go and have to buy a new wash plant. He pulls up to this dealer’s yard that sells wash plants and tractors. I saw this dealer had a lot of inventory and clearly a lot of money, and I realized the place to make money was selling the shovels, not really digging for gold. I said to myself if I have the best shovel out there, why am I digging? I should just be innovating new shovels and selling shovels. Hence, I started PurTec Delivery Systems and now for the last year and a half have been 100% focused on developing advanced vaporizer technologies.

Green: Tell me more about PurTec.

Mangold: I founded PurTec with the sole intention of creating safe vaporizers for consumers. We conducted an 18-month safety study in Switzerland with our partners, on vaping devices in the market. I learned a lot of things that I already knew but wanted to see it proven by independent laboratories and by PhDs and MDs, and really see what was so concerning to me. For the last year and a half, we have sought to develop a safe line of vaporizers. I’m very cognizant about what’s going on in my body and want to know what’s going on internally with these products. I don’t think anyone would be using them if they knew what was really going into their lungs.

Green: What are some of the things that consumers should be thinking about when it comes to vape safety?

Mangold: Consumers should be thinking about all the different aspects from inhaling vaporized heavy metals to ceramics. Ceramic particle inhalation is one of my biggest concerns. I think it’s been ignored. I think all the manufacturers know about it and I think it’s been swept under the rug. I think it’s one of the threats that we have. There should be regulatory bodies that are out there protecting consumers like the FDA, hence why I believe federal legalization is so important, because if the FDA was involved not even one of these products would be on the market because the first thing the FDA would do would be very extensive emissions testing to find out what compounds and potential toxins are entering into your body.

Green: There’s clearly a need for safety and regulation in the space, but from where you’re sitting, is there a demand? When consumers go into a store, one of their main focuses is: what’s the THC content? How do you see consumer demand for safety and how do you think about building that awareness?

Mangold: I don’t think there is consumer demand yet. The consumer demand right now is for getting medicated and having fun or getting whatever relief or primary reason you use cannabis. I can point to a direct correlation with the opioid epidemic. No one knew they were as horrible as they are, and doctors were prescribing them left and right, and everyone thought it was okay. People think these cannabis products are okay because they’re on the shelf in every licensed dispensary, and the California Department of Health and the Department of Health in every other state and country has been involved to some degree. So, consumers think that they’re safe. The problem is they’re likely not just like we weren’t with opioids.

I don’t think the consumer demand will be there for quite some time until we start seeing a lot of long-term health impacts where we start seeing people getting lung disease, we start seeing people getting iron lung, different potential brain issues from inhaling adhesives and heavy metals. I think once the health impacts are seen clinically – just like we saw with the opioid crisis – once that was really in the forefront, everybody saw with their own eyes, and then they were aware that there was a problem. So, I think that it’s important to become aware of the potential health impacts, but I think it will take quite some time before that happens.

Green: It sounds to me like you want to get ahead of the industry on this because if it does go federally legal, there will be more stringent requirements. How do you think about that from a product design and development perspective to get ahead of a problem that exists but isn’t reflected in current regulations?

Mangold: The best thing we can do right now in the cannabis vape industry is to look at what the nicotine vape industry is doing. It is controlled by the FDA and there are standards for vaporizers in other parts of the world that are very stringent, like the AFNOR standards, which are in the European Union regulations for vaporizer safety.

What we do is we find the most stringent standards in the world, and we test our products to those standards. If the standards get stricter, we can develop our products and re-engineer them to meet those new requirements. Right now, all our products are emissions tested at AFNOR standards and over-engineered even for those standards. We also are constantly working on reduction of potentially hazardous materials: reductions of heavy metals; only using proven safe and effective materials and FDA approved materials like SAE 316L surgical stainless steel; and using improved ceramics that are not as brittle as the ceramics being used by almost every single manufacturer out there. There’s a lot of things that can be done. It takes supply chain management, understanding the technology and having strong solid teams of scientists and doctors that know this stuff much better than anyone else in the industry does, and leveraging their expertise.

Green: You recently launched a safety feature for minors. Can you tell me more about that?

Mangold: Yes. Two weeks ago, we launched a new software application called PurGuard. PurGuard is a massive innovation and is the first of its kind that we’re aware of. It’s a piece of software that pairs with any device, whether it’s a disposable pod system or a 510 cartridge. You then pair it to your phone and take a picture of your government ID. Then the camera looks at your face, runs quick facial recognition and runs an age check through the largest age-checking platform API in the world. Then based on location and legal age of the user’s location – some states are 18 and different countries have different rules – it validates your ability in your market to be consuming that product. This technology works in 180 different countries.

Once that occurs and the device is ready for you to use, we have another feature that we’ve developed. There is an auto-lock feature that we have where if you’re a parent, like me, and you have kids in the house, you can turn your device to auto-lock right from your phone. When you walk away from your phone and are 10 feet away, your Bluetooth connection will break, and it will automatically lock the device and so your child can’t walk into your bedroom and take your device.

This technology is important to us. Consuming cannabis is horrible for the health of minors. There are serious mental effects on brain growth that occur from using cannabis at a young age because the brain is still developing up until about the age of 23 to 25. So, it’s not safe for them to be using. Of course, I’m sure we all smoked when we were in high school, but the ease of use of vape and the discretion, I think allows minors to use significantly more cannabis than previous generations did 20, 30, 40 years ago. It’s a massive problem right now and I think it’s just a matter of time before the FDA requires such protections. This industry can only survive if we protect minors. So, we’re getting ahead of the curve and setting the standard.

Green: What kind of hardware does PurGuard work with?

Mangold: PurGuard works with every single type of device that we manufacture: 510 thread cartridges, disposables, and pods. If it’s a 510-thread cartridge, the battery has to be a PurTec battery, and the cartridge has to be a PurTec cartridge. They communicate to each other through certain technologies, and it can even recognize what oils are in the cartridge or the pod or the disposable. Moreover, we can tell what strain it is, when it was manufactured, what the potency levels are and more. It records all the usage statistics. We’ve also proven with our hardware, the actual milligram contents being consumed per hit, or draw based on volume, and draw duration. We can track and report to people and say, “Hey, you’re consuming 100 milligrams of THC a day, that’s too high, you need to slow down and maybe go down to 50 milligrams a day.” That will be what is required as it is being required in the nicotine industry under the FDA pre-market tobacco applications (PMTA). When the FDA comes into cannabis, they’re going to want to see the same thing. They’re going to want to know that cannabis products are not promoting people to use more, and they are trying to get people to use less. It doesn’t mean stop using it, but use it in moderation, like everything in life. You shouldn’t be drinking a bottle of whiskey a day. You probably shouldn’t be smoking a pound of weed a day either. Everything in life is moderation and this application not only protects minors but also teaches us about our consumption habits.

Green: A theme here is “skating where the puck is going to be.” What kind of trends are you looking at right now in the industry?

Mangold: The biggest trend I see right now in the industry is disposables. We’ve seen that the trends in cannabis consumption trail behind the nicotine industry by 2-4 years. We see a lot of our customers and potential customers shifting into disposables and are now seeing a very large spike in sales of disposables. I think that’s a big trend, but with that comes another major issue: we now have lithium-ion batteries being thrown away at astonishing rates and going into landfills. PurTec has an answer for that that we’ll be launching here in the next four to six months That will be I think the biggest innovation in regards to eco-friendliness within the vape industry. That’s where I see things going right now.

Green: What are you most interested in learning about?

Mangold: The thing that interests me most, and what I’m most interested in learning about is regulations. Not the regulations themselves, but how regulations are drafted. I’ve sat in several meetings with rules committees for different regulatory bodies throughout the United States and it is laughable. I was recently in a state I’m not going to mention. I asked them what scientists and what doctors they have consulted with and they said none. I just found that dumbfounding. The state regulatory bodies are making decisions without doing due diligence and without bringing in subject matter experts in some cases.

I’m very interested in learning about how we can change our regulatory bodies. Taxpayers pay these salaries and their job at the end of the day is to protect consumers. I think that these cannabis regulatory bodies need to be way more involved with their state’s Department of Health, as well as with the FDA, and National Institute of Health and looking at this as a holistic approach. How do we protect consumers? This is a drug. It’s like anything else out there. If you’re selling tomatoes that were sprayed with a certain pesticide, you must do the research and you have to know what’s in that product before you start putting it in people’s hands. Otherwise, you may have people dying left and right. So, I’m very interested in learning more about regulatory bodies and how they need to evolve and hopefully I can help push them into evolving sooner rather than later.

Green: Great, that concludes the interview, Corey.

Mangold: Thanks, Aaron.

Cannabis Manufacturing Considerations: From Raw Materials to Finished Goods

By David Vaillencourt, Kathleen May
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Facility layout and design are important components of overall operations, both in terms of maximizing the effectiveness and efficiency of the process(es) executed in a facility, and in meeting the needs of personnel. Prior to the purchase of an existing building or investing in new construction, the activities and processes that will be conducted in a facility must be mapped out and evaluated to determine the appropriate infrastructure and flow of processes and materials. In cannabis markets where vertical integration is the required business model, multiple product and process flows must be incorporated into the design and construction. Materials of construction and critical utilities are essential considerations if there is the desire to meet Good Manufacturing Practice (GMP) compliance or to process in an ISO certified cleanroom. Regardless of what type of facility is needed or desired, applicable local, federal and international regulations and standards must be reviewed to ensure proper design, construction and operation, as well as to guarantee safety of employees.

Materials of Construction

The materials of construction for interior work surfaces, walls, floors and ceilings should be fabricated of non-porous, smooth and corrosive resistant surfaces that are easily cleanable to prevent harboring of microorganisms and damage from chemical residues. Flooring should also provide wear resistance, stain and chemical resistance for high traffic applications. ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces22 provides a method for evaluating the antibacterial activity of antibacterial-treated plastics, and other non-porous, surfaces of products (including intermediate products). Interior and exterior (including the roof) materials of construction should meet the requirements of ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Covering7, UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings 8, the International Building Code (IBC) 9, the National Fire Protection Association (NFPA) 11, Occupational Safety and Health Administration (OSHA) and other applicable building and safety standards, particularly when the use, storage, filling, and handling of hazardous materials occurs in the facility. 

Utilities

Critical and non-critical utilities need to be considered in the initial planning phase of a facility build out. Critical utilities are the utilities that when used have the potential to impact product quality. These utilities include water systems, heating, ventilation and air conditioning (HVAC), compressed air and pure steam. Non-critical utilities may not present a direct risk to product quality, but are necessary to support the successful, compliant and safe operations of a facility. These utilities include electrical infrastructure, lighting, fire detection and suppression systems, gas detection and sewage.

  1. Water
Microbial monitoring methods can include frequent/consistent testing

Water quality, both chemical and microbial, is a fundamental and often overlooked critical parameter in the design phase of cannabis operations. Water is used to irrigate plants, for personnel handwashing, potentially as a component in compounding/formulation of finished goods and for cleaning activities. The United States Pharmacopeia (USP) Chapter 1231, Water for Pharmaceutical Purposes 2, provides extensive guidance on the design, operation, and monitoring of water systems. Water quality should be tested and monitored to ensure compliance to microbiological and chemical specifications based on the chosen water type, the intended use of the water, and the environment in which the water is used. Microbial monitoring methods are described in USP Chapter 61, Testing: Microbial Enumeration Tests 3and Chapter 62, Testing: Tests for Specified Microorganisms 4, and chemical monitoring methods are described in USP Chapter 643, Total Organic Carbon 5, and Chapter 645, Water Conductivity 6.Overall water usage must be considered during the facility design phase. In addition to utilizing water for irrigation, cleaning, product processing, and personal hygiene, water is used for heating and cooling of the HVAC system, fogging in pest control procedures and in wastewater treatment procedures  A facility’s water system must be capable of managing the amount of water required for the entire operation. Water usage and drainage must meet environmental protection standards. State and local municipalities may have water usage limits, capture and reuse requirements and regulations regarding runoff and erosion control that must also be considered as part of the water system design.

  1. Lighting

Lighting considerations for a cultivation facility are a balance between energy efficiency and what is optimal for plant growth. The preferred lighting choice has typically been High Intensity Discharge (HID) lighting, which includes metal halide (MH) and high-pressure sodium (HPS) bulbs. However, as of late, light-emitting diodes (LED) systems are gaining popularity due to increased energy saving possibilities and innovative technologies. Adequate lighting is critical for ensuring employees can effectively and safely perform their job functions. Many tasks performed on the production floor or in the laboratory require great attention to detail. Therefore, proper lighting is a significant consideration when designing a facility.

  1. HVAC
urban-gro
Proper lighting is a significant consideration when designing a facility.

Environmental factors, such as temperature, relative humidity (RH), airflow and air quality play a significant role in maintaining and controlling cannabis operations. A facility’s HVAC system has a direct impact on cultivation and manufacturing environments, and HVAC performance may make or break the success of an operation. Sensible heat ratios (SHRs) may be impacted by lighting usage and RH levels may be impacted by the water usage/irrigation schedule in a cultivation facility. Dehumidification considerations as described in the National Cannabis Industry Association (NCIA) Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification 26 are critical to support plant growth and vitality, minimize microbial proliferation in the work environment and to sustain product shelf-life/stability. All of these factors must be evaluated when commissioning an HVAC system. HVAC systems with monitoring sensors (temperature, RH and pressure) should be considered. Proper placement of sensors allows for real-time monitoring and a proactive approach to addressing excursions that could negatively impact the work environment.

  1. Compressed Air

Compressed air is another, often overlooked, critical component in cannabis operations. Compressed air may be used for a number of applications, including blowing off and drying work surfaces and bottles/containers prior to filling operations, and providing air for pneumatically controlled valves and cylinders. Common contaminants in compressed air are nonviable particles, water, oil, and viable microorganisms. Contaminants should be controlled with the use appropriate in-line filtration. Compressed air application that could impact final product quality and safety requires routine monitoring and testing. ISO 8573:2010, Compressed Air Specifications 21, separates air quality levels into classes to help differentiate air requirements based on facility type.

  1. Electrical Infrastructure

Facilities should be designed to meet the electrical demands of equipment operation, lighting, and accurate functionality of HVAC systems. Processes and procedures should be designed according to the requirements outlined in the National Electrical Code (NEC) 12, Institute of Electrical and Electronics Engineers (IEEE) 13, National Electrical Safety Code (NESC) 14, International Building Code (IBC) 9, International Energy Conservation Code (IECC) 15 and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ).

  1. Fire Detection and Suppression

“Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs.”Proper fire detection and suppression systems should be installed and maintained per the guidelines of the National Fire Protection Association (NFPA) 11, International Building Code (IBC) 9, International Fire Code (IFC) 10, and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ). Facilities should provide standard symbols to communicate fire safety, emergency and associated hazards information as defined in NFPA 170, Standard for Fire Safety and Emergency Symbols 27.

  1. Gas detection

Processes that utilize flammable gasses and solvents should have a continuous gas detection system as required per the IBC, Chapter 39, Section 3905 9. The gas detection should not be greater than 25 percent of the lower explosive limit/lower flammability limit (LEL/LFL) of the materials. Gas detection systems should be listed and labeled in accordance with UL 864, Standard for Control Units and Accessories for Fire Alarm Systems 16 and/or UL 2017, Standard for General-Purpose Signaling Devices and Systems 17 and UL 2075, Standard for Gas and Vapor Detectors and Sensors 18.

Product and Process Flow

Product and process flow considerations include flow of materials as well as personnel. The classic product and process flow of a facility is unidirectional where raw materials enter on one end and finished goods exit at the other. This design minimizes the risk of commingling unapproved and approved raw materials, components and finished goods. Facility space utilization is optimized by providing a more streamlined, efficient and effective process from batch production to final product release with minimal risk of errors. Additionally, efficient flow reduces safety risks to employees and an overall financial risk to the organization as a result of costly injuries. A continuous flow of raw materials and components ensures that supplies are available when needed and they are assessable with no obstructions that could present a potential safety hazard to employees. Proper training and education of personnel on general safety principles, defined work practices, equipment and controls can help reduce workplace accidents involving the moving, handling, and storing of materials. 

Facilities Management

Facilities management includes the processes and procedures required for the overall maintenance and security of a cannabis operation. Facilities management considerations during the design phase include pest control, preventative maintenance of critical utilities, and security.

Damage from whiteflies, thrips and powdery mildew could be prevented with an appropriate PCP

A Pest Control Program (PCP) ensures that pest and vermin control is carried out to eliminate health risks from pests and vermin, and to maintain the standards of hygiene necessary for the operation. Shipping and receiving areas are common entryways for pests. The type of dock and dock lever used could be a welcome mat or a blockade for rodents, birds, insects, and other vermin. Standard Operating Procedures (SOPs) should define the procedure and responsibility for PCP planning, implementation and monitoring.

Routine preventative maintenance (PM) on critical utilities should be conducted to maintain optimal performance and prevent microbial and/or particulate ingress into the work environment. Scheduled PMs may include filter replacement, leak and velocity testing, cleaning and sanitization, adjustment of airflow, the inspection of the air intake, fans, bearings and belts and the calibration of monitoring sensors.

In most medical cannabis markets, an established Security Program is a requirement as part of the licensing process. ASTM International standards: D8205 Guide for Video Surveillance System 23, D8217 Guide for Access Control System[24], and D8218 Guide for Intrusion Detection System (IDS) 25 provide guidance on how to set up a suitable facility security system and program. Facilities should be equipped with security cameras. The number and location of the security cameras should be based on the size, design and layout of the facility. Additional cameras may be required for larger facilities to ensure all “blind spots” are addressed. The facility security system should be monitored by an alarm system with 24/7 tracking. Retention of surveillance data should be defined in an SOP per the AHJ. Motion detectors, if utilized, should be linked to the alarm system, automatic lighting, and automatic notification reporting. The roof area should be monitored by motion sensors to prevent cut-and-drop intrusion. Daily and annual checks should be conducted on the alarm system to ensure proper operation. Physical barriers such as fencing, locked gates, secure doors, window protection, automatic access systems should be used to prevent unauthorized access to the facility. Security barriers must comply with local security, fire safety and zoning regulations. High security locks should be installed on all doors and gates. Facility access should be controlled via Radio Frequency Identification (RFID) access cards, biometric entry systems, keys, locks or codes. All areas where cannabis raw material or cannabis-derived products are processed or stored should be controlled, locked and access restricted to authorized personnel. These areas should be properly designated “Restricted Area – Authorized Personnel Only”.

Future Expansion

The thought of expansion in the beginning stages of facility design is probably the last thing on the mind of the business owner(s) as they are trying to get the operation up and running, but it is likely the first thing on the mind of investors, if they happen to be involved in the business venture. Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs. Thought must be given to how critical systems and product and process flows may be impacted if future expansion is anticipated. The goal should be to minimize down time while maximizing space and production output. Therefore, proper up-front planning regarding future growth is imperative for the operation to be successful and maintain productivity while navigating through those changes.

References:

  1. United States Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA).
  2. United States Pharmacopeia (USP) Chapter <1231>, Water for Pharmaceutical Purposes.
  3. United States Pharmacopeia (USP) Chapter <61>, Testing: Microbial Enumeration Tests.
  4. United States Pharmacopeia (USP) Chapter <62>, Testing: Tests for Specified Microorganisms.
  5. United States Pharmacopeia (USP) Chapter <643>, Total Organic Carbon.
  6. United States Pharmacopeia (USP) Chapter <645>, Water Conductivity.
  7. ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Coverings.
  8. UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings.
  9. International Building Code (IBC).
  10. International Fire Code (IFC).
  11. National Fire Protection Association (NFPA).
  12. National Electrical Code (NEC).
  13. Institute of Electrical and Electronics Engineers (IEEE).
  14. National Electrical Safety Code (NESC).
  15. International Energy Conservation Code (IECC).
  16. UL 864, Standard for Control Units and Accessories for Fire Alarm Systems.
  17. UL 2017, Standard for General-Purpose Signaling Devices and Systems.
  18. UL 2075, Standard for Gas and Vapor Detectors and Sensors.
  19. International Society for Pharmaceutical Engineers (ISPE) Good Practice Guide.
  20. International Society for Pharmaceutical Engineers (ISPE) Guide Water and Steam Systems.
  21. ISO 8573:2010, Compressed Air Specifications.
  22. ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces.
  23. D8205 Guide for Video Surveillance System.
  24. D8217 Guide for Access Control Syst
  25. D8218 Guide for Intrusion Detection System (IDS).
  26. National Cannabis Industry Association (NCIA): Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification.
  27. NFPA 170, Standard for Fire Safety and Emergency Symbols.

Leaders in Cannabis Formulations: Part 4 – LifeTonic

By Aaron Green
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Russell is the CEO of NES Technology Holdings, a technology development and marketing company that operates Vapor Distilled and LifeTonic Brands. NES Technology Holdings has invented a technology portfolio of more than 160 granted and pending patents that cover inventions across several high-value industries, including cannabis, beverage, fragrance and nutraceuticals. The company is currently in license acquisition diligence processes with 7 of world’s 10 largest fragrance companies and has received a joint venture offer from a $3 billion fragrance company to produce perfumes with its extraction technology. It is also launching ionized cannabis beverage products that provide effects as quickly as alcohol in Nevada and Colorado this fall.

Vapor Distilled invented and commercialized an evaporative extraction process with 40 international patents granted and pending that, along with CO2 extraction, is one of only two fundamentally new extraction processes invented in the last 50 years. Instead of using solvents or hydrocarbons to extract oils from plants, evaporative extraction directly evaporates essential oils from plants and condenses the evaporated compounds into an extract. The process takes less than two seconds to complete and extracts higher levels of volatile terpenes than existing extraction methods. Vapor Distilled has built a fleet of commercial-scale extraction machines and has supplied some of the cannabis industry’s largest brands. The company is currently licensing its evaporative extraction technology within the perfume industry and is marketing an aroma hop extract to replace the dry hopping step when making beer.

LifeTonic invented a drug delivery technology with 56 patents pending and granted, that turns oil-based plant compounds like CBD and THC into electrically charged cannabinoid ions that dissolve completely in water without emulsifiers or additives. When cannabinoids are ionized, absorption is significantly enhanced and their effects can be felt in minutes. The effects of a LifeTonic ionized CBD beverage can be felt by most people in less than 5 minutes, whereas the effects of a LifeTonic ionized THC beverage can be felt by most people in less than 8 minutes. For reference, typical onset times for cannabis beverages are 30 minutes or longer. LifeTonic beverage technology will allow cannabis beverages to work as quickly as alcohol, enabling cannabis to become a social drink.

Russell Thomas, CEO of Vapor Distilled and LifeTonic

We spoke with Russell Thomas, CEO of Vapor Distilled and LifeTonic about his cannabinoid evaporation process and rapid onset beverage technologies. Thomas is a career entrepreneur and inventor with 21 years of experience inventing and protecting intellectual property. Russell’s team has generated more than 160 granted and pending patents. Prior to entering the cannabis industry, Thomas worked in the cleantech industry.

Aaron Green: How did you get involved in the cannabis industry?

Russell Thomas: I came to the cannabis industry from the cleantech industry where I worked on technologies that improved the fuel economy of vehicles. I saw opportunities in the cannabis industry to improve cannabis extraction, which was one of the most important supply chain verticals in cannabis. Every product, from edibles to beverages and vape products, requires a cannabis extract. Any product that needs to be accurately dosed requires an extract. The old way of making edible products with cannabis butter was simply not viable as the industry matured, and most people were rapidly moving away from smoking cannabis and embracing vape products. Even with the entire industry almost completely dependent on extraction, no fundamental innovation was occurring. The primary ways that cannabis was being extracted were chemically intensive. The cleaner methods, such as CO2 extraction, were slow and expensive for terpene recovery. I saw this as a great opportunity to provide a better solution within a primary funnel of the cannabis supply chain.

We commercialized an extraction technology that evaporates cannabinoids directly from plant material in the form of vapor, and then recondenses that vapor back into an essential oil. The entire process takes less than two seconds to complete and preserves fragile terpenes. That technology, called Evaporative Extraction, is the foundation of Vapor Distilled.

Green: What timeframe was that roughly?

Thomas: We capitalized our company in 2015 and began selling wholesale extracts in 2017.

Green: Can you talk more about the evaporative extraction process?

Thomas: Our process works in a similar way to a cannabis vaporizer, but on a massive scale. Our extract is literally recondensed cannabis vapor. In one step, we extract, refine, and activate cannabinoids. On one end, plant material goes in the machine, and on the other end, extract and depleted plant material comes out. Our total extraction time is less than two seconds if you measure the time from when the plant material goes into the extractor and when the extract is condensed.

The LifeTonic logo

A continuous feed of dry plant material is introduced into a heated air stream. The air stream pneumatically conveys the plant material through a series of turbulent, heated evaporation chambers. Upon entering the evaporation chambers, volatile plant compounds are instantaneously distilled from the plant material. A centrifugal separator removes the depleted plant material from the air stream. The air stream is rapidly cooled, causing the volatile plant compounds to condense into an essential oil.

We achieve nearly total activation of THCA to THC simultaneously during extraction and, on average, we extract approximately two to four times more terpenes than a conventional extraction process. The cannabis industry is rampant with exaggeration about terpenes, but we are the only cannabis company negotiating a joint venture with a $3 billion fragrance company to produce perfumes, and I think that says a lot about our process.

Green: Is the extract coming out then as an oil?

Thomas: Our extract comes out of our machines as a fully-activated, high-terpene content, full spectrum oil. Unlike the THC crude that emerges from other processes, our extract requires no further distillation, activation or refinement. You can put it straight into a product.

Green: How about terpene recovery?

Thomas: This is by far what we do best. We excel with the recovery terpenes and volatile compounds from plant material. From day one, we noticed that our evaporative extraction process yields about two to four times more terpenes by mass compared to traditional extraction methods.

While we started as a cannabis company, we recently received a compelling joint venture offer from a $3 billion fragrance company to produce perfume products with our technology. We are also under NDA with 7 of the world’s 10 largest fragrance companies to complete diligence processes to license our extraction technology.

As part of our licensing diligence process, we are performing paid fragrance extraction research for three multi-billion-dollar fragrance companies. Our evaporative extracted fragrance extracts are presenting a broader and more complete range of volatile compounds compared reference samples. We are also seeing substantially improved yield of volatile fragrance compounds. Combined, this gives us the advantage of being able to produce more extract at a lower cost, while also producing a superior product. This combination is how licensees can take market share away from any fragrance company that does not have access to our technology, and it is why we are seeing so much rapid traction in this area.

We have also extracted hops with our technology. If you’ve ever smelled a traditional hops resin, it smells good, but the smell doesn’t fill the room. If you put just a drop of our hops extract on any surface, the entire room will smell strongly of a premium IPA beer. It’s so potent you don’t want to get it on your hands or clothes because you will smell like beer for hours. It’s powerful and wonderful stuff!

Green: What is your business model?

Thomas: At our core, we are a technology development and licensing company. We first identify what we believe to be critical verticals and bottlenecks in high-value industries, then we develop and patent highly differentiated and disruptive technology solutions that we believe exist nowhere else. We then demonstrate both market fit and viability at scale through proof-of-concept sales of branded and high-profile, white-labeled products produced with our unique technologies. Finally, we systematically license and exit the various portions our IP portfolio though the orchestration of highly competitive bidding processes that promote both defensive and strategic acquisitions of our technologies. We are currently at the final phase of our model with licensing our extraction technology, and we are receiving offers as part of a competitive bidding process.

Green: Okay, let’s change gears here and start talking more about LifeTonic and your cannabinoid ionization technology. Can you talk high level about the onset times of cannabinoids in different matrices and media?

Thomas: Through LifeTonic, we invented 56 international patents granted and pending cannabinoid ionization technology that compresses the normal onset time of cannabis beverages from 30 minutes down to just a few minutes. Our cannabinoid ionization technology can also be used as a rapid onset vape alternative when sold in a breath spray format. We are currently selling hemp-based versions of these products through LifeTonic.com, and we are bringing THC versions of these products to market in Nevada and Colorado this fall and winter under the brand name LifeTonic.

All conventional and even nano-emulsified cannabis edibles and beverages take a long time to work. A cannabis chocolate can take 45 minutes to two hours before the effects kick in. Cannabis gummies are faster, but it still takes half an hour to 45 minutes to feel the effects. The very best nano-emulsified cannabis beverages take about a half an hour to work on average, if you are lucky. That long of a time delay effectively eliminates the social aspect of consuming cannabis, so most people instead choose to vaporize or smoke cannabis.

If you look at the largest investments that have been made across cannabis, some of the most prominent have been made by alcohol companies. Constellation Brands invested nearly $4 billion into Canopy Growth, with a mission to find an alternative to alcohol in cannabis. Molson Coors has partnered with Hexo and AB InBev has partnered with Tilray, both with that same mission. Even after all this effort and investment, cannabis beverages represent just a sliver of the market because current cannabis-based beverages take too long to work. The fastest ones on the market, on average, take around a half hour to kick in.

Imagine going to a bar and knowing that every time you got a shot of tequila or a shot of whiskey it’s going to take thirty minutes or more for the effects to even begin to kick in. That would be terrible. That would be the end of social drinking. Unfortunately, that is how a conventional cannabis beverage works.

You can’t really get a social drinking experience with cannabis yet, so most people vape it because it’s fast. But a lot of people don’t want to smoke something; in fact, they don’t want to inhale at all. So, we saw beverages as a huge opportunity. How do we make cannabis beverages work as fast as alcohol? That’s what our ionization technology delivers. From all the people we’ve surveyed – hundreds of people – they say that they reliably feel an onset within about seven to eight minutes with our technology. That is just about as fast as a shot of tequila or whiskey.

“With our partners, we will be featuring LifeTonic beverage products on tap in a cannabis cocktail lounge right off the Las Vegas strip, where social consumption rules are welcoming.”What we’ve done is very different from available nanoemulsion technologies. All those technologies try to mix oil and water, and oil and water don’t mix. In a nanoemulsion, you mix cannabis, a carrier oil, an edible detergent and water, and then you run it all through an ultrasonic homogenizer that breaks the cannabinoids and oil into microscopic droplets suspended in water. There are a lot of styles of nanoemulsions, from spray-dried nanoemulsions to liquid liposomal encapsulations, and they all confer certain absorption benefits when compared to straight-up oil absorption. But still, even the microscopic oil droplets suspended in water are quite large compared to what we have done, and still take quite a long time to digest.

We looked at the cannabis molecule and we said, “You know what? If we can put a strong negative charge on it, if we can ionize it, then we can make it behave more like a dissolvable salt instead of an oil.” When we treat it this way, the cannabis molecule dissolves completely in the water without emulsifiers or additives. When something is dissolved, there is no nano-emulsion droplet size. It is single molecules dissolved water. A single ionized cannabinoid molecule is about 1,000 times smaller than an average nano-emulsion droplet – and this greatly enhances absorption. The onset speed of ionized cannabinoids compared to nanoemulsions is measurable as just a few minutes instead of a half hour or more.

We have 56 granted and pending patents on LifeTonic’s ionization technology. We can ionize THC, CBD, CBG and CBD – most cannabinoids are compatible. There are also several herbal products that are compatible with our ionization technology, like the curcuminoids in turmeric, which are normally very hard to get into water. We can also ionize the eugenol that is in cloves. Ionized eugenol is an intoxicant, so we have big plans for alcohol alternatives outside of cannabis.

We’re using this technology to enter the Nevada cannabis market with one of the largest dispensary chains and cannabis product manufacturers in Nevada. With our partners, we will be featuring LifeTonic beverage products on tap in a cannabis cocktail lounge right off the Las Vegas strip, where social consumption rules are welcoming. We’ll craft every kind of cocktail you can imagine, only without alcohol. All these beverages will work in a matter of minutes to provide the first true social drinking experience with cannabis. After you enjoy a beverage, you may purchase a package of ionized THC beverage powder sachets in the cannabis cocktail lounge or at any of the dispensaries within our distribution network. You can pour the powder into any beverage, and it becomes a friendly, fast-acting THC beverage that will get you high, but not leave you with a hangover. We will also be selling a breath-spray format that works almost as quickly as vaping.

Green: What kind of validation studies have you done?

Thomas: We have conducted several broad market studies for our ionized products and almost all people report a profound onset within a few minutes. We have not completed a formalized clinical trial, but we are closing a major funding round that will allow us to do so. We plan to begin controlled pre-clinical trials focused mainly on ionized CBD because it’s far easier to get FDA approval for clinical trials on CBD than for THC. Our studies will monitor a couple dozen volunteers with a functional MRI and watch the change in the brain using our oral spray and beverage products compared against a standard CBD tincture control. We know that we’re going to see fast action because everybody who uses it says that a feeling develops in minutes.

Green: What geographies are you active in and exploring?

Thomas: CBD and hemp products from our extraction technology have been sold in every US state and parts of Europe. Additionally, hemp-based CBD and CBG versions of our ionized products and ionized turmeric products have been sold in several states through our LifeTonic.com, our ecommerce site. We have also sold white labeled versions of our ionized products through partner brands. We will be launching THC versions of our ionized products with our partners Nevada this fall. We expect THC versions to also be available in Colorado this winter.

Green: So, you are creating the powders on site?

Thomas: Yes. We manufacture ionized CBD, CBG, eugenol and turmeric beverage powders on site. We also manufacture and fast acting ionized sprays. These products are sold through our own retail site and we white label for other brands. Per our long-term licensing strategy, these sales establish market viability through sales. Selling products and establishing market viability prior to licensing significantly increases the value of our licenses and exits. It’s very important to answer the question: Do people buy it and do people love it? So far, we like the feedback!

On the THC side, we manufacture ionized products through partners in each cannabis state that we enter. We manufacture the ionizing base here in Colorado, then we ship it to other states where our partners add the THC and package it in LifeTonic-branded packaging. The analogy is that we sell a proprietary Coca-Cola formula without the caffeine, then our partners add the caffeine and bottle it in Coca-Cola branded bottles. In this way, we ensure that the hardest part of our process is controlled house to ensure consistency and quality across all states. It also allows us to be a non-plant touching business, since we only sold upstream base products that did not contain THC. We pick the best manufacturing and distribution partner in each cannabis state and grow from there.

Green: What’s the one thing you’re most interested in learning about?

Thomas: Increasing the bioavailability of cannabis. I have been most passionate about making cannabis work as quickly as alcohol and giving people an alternative to inhaling it through smoking or vaping. That’s definitely what we’ve been most excited about as a company.

Green: Okay, great. That concludes the interview!

Thomas: Thank you Aaron!