When people have to make important decisions, we often consult a third party to increase our knowledge and confidence in a product. For instance, when choosing a car, an individual may weigh heavily on safety ratings and other awards from organizations such as Consumer Reports. These awards are often boasted and a heavy focus in car commercials because it tells the consumer that a third party has deemed their car valuable to own. For more than 100 years, the Association of Official Agricultural Chemists (AOAC® International) has operated in this exact manner, and has set the bar and guidelines for testing in the cannabis industry through its special program called the Cannabis Analytical Science Program, also known as CASP.
The CASP program is designed to develop standards and validation guidance to evaluate testing methods, as well as the methods’ ability to detect the target organism or compound on the cannabis matrix. With the addition of new states permitting the legal sale of both medical and adult use cannabis and no federal governing body overseeing testing regulations, the value of AOAC cannot be understated, as these guidelines allow cannabis testing laboratories to have their own third-party reference to look to when choosing a compliant testing method to implement in their laboratory.
AOAC was founded in 1884 by the US government as the standard setting body in the country and, in 1991, became an independent association known as AOAC International, with a goal of building a reputation as an international, consensus-based standard-setting body and a conformity assessment organization in analytical sciences. As an independent third-party resource, AOAC has the Performance Tested Methods’ (PTM) and Official Methods of AnalysisSM (OMA) programs for certification of analytical testing methods in both biology and chemistry.
If analytical methods, including proprietary test kits, are deemed acceptable, AOAC provides approved certification, their seal of approval that the method works as designed. Though multiple factors are considered to determine if AOAC approval is given; accuracy and precision of the method are among the most important. For example, when validating a cannabis method for microbiology, AOAC will contract an independent testing facility to conduct a series of tests with known spiked samples to measure the recovery limit of the target microorganism. This allows the organization to determine if the method is sensitive enough to be named an AOAC-approved method through either the PTM or OMA conformity programs. Another way of ensuring the validity of results is by conducting an inclusivity and exclusivity study on a method. In this type of experiment, target organisms are tested while also spiking with non-target organisms to see if there will be a high rate of false positives.
In cannabis, discussions have grown surrounding testing of four strains of Aspergillus, which are A. terreus, A. flavus, A. fumigatus and A. niger. By spiking cannabis with one of the four Aspergillus strains and on a separate sample with a non-target Aspergillus strain such as A. clavatus, it ensures that only the target strains are being recognized and recorded on the method being tested.
This methodology limits the likelihood of unconfirmed positives occurring, ensuring the validity of the results. Of course, when a method is undergoing an actual AOAC evaluation for approval, the testing requirements for both the sensitivity and inclusivity/exclusivity experiments are much more thorough than the explanation above.
Regardless of which AOAC-approved method you select, you can feel confident that most of the “heavy-lifting” is done and that the method is accurate and precise enough to implement in a cannabis testing facility. In turn, the cannabis testing laboratory then only needs to complete their own internal method verification to ensure the method works with their processes, people, environment and product, but on a much smaller scale and aligns with state regulations.
On a consumer safety level, AOAC-approved methods are designed to keep cannabis consumers safe. Whether they are an adult using cannabis or medicinal cannabis patient, the product that is being sold should be held to the highest safety standards. By having a laboratory that is utilizing an independently approved AOAC method, an additional layer of confidence is achieved that the product being consumed is safe. This ultimately limits the number of costly recalls from dispensaries and minimizes risk to consumers. At the end of the day, cannabis testing laboratories want to keep the public safe and it is our job to do so. This means implementing these independently approved methods from agencies such as AOAC at various touch points in the seed to sale cycle to ensure the data is validated and reliable.
Overall, just as it is equally important to get a non-biased and reputable third-party approach to your automobile search, a scientist that is responsible for choosing methods in their cannabis compliance laboratory should also consider these third-party approvals. As a scientist, the goal every day is to report accurate data to help the client and the consumer equally. The cannabis compliance laboratories are the last line of defense in preventing harmful or contaminated products from getting into the marketplace and any extra assurance we have with our testing methodology is always encouraged. Ultimately, AOAC’s work is important and their standard of quality and safety is a must-have in the cannabis laboratory.
At first glance, the layout of a grow room and a factory production line might seem to have little in common. But whether a facility is producing plants or parts, adopting good manufacturing practices (GMP) can benefit plant quality, harvest consistency and production economics.
What is GMP?
Simply defined, GMP refers to a production system made up of processes, standards and safeguards designed to consistently meet a defined quality standard. In the grow house, establishing, documenting and implementing GMPs can help guard against problems ranging from plant contamination to inconsistent harvests. GMPs can be organized into five key categories, each which contribute to cultivation:
People: The people working in the grow house understand their responsibilities
Processes: Production processes are clearly documented and consistent across harvests
Procedures: Guidelines are documented and communicated to all employees
Premises: Grow rooms and equipment are clean and maintained
Products: Materials used in cultivation (fertilizers, lighting, growing media, etc.) are assessed
Optimizing each of these five P’s in production can help cultivators protect their business and their margins even as flower prices in both legacy and emerging states continue to trend downward. Below, we look at four GMP insights that can help cultivators coordinate the five Ps to achieve quality, consistency and economic objectives harvest after harvest, without massive investments in capital, even during turbulent market conditions.
#1 Know your numbers and their value
Avoid the temptation to lump production costs into very broad categories, i.e., “cost of goods.” Understanding the exact cost of all inputs that go into a grow is a precedent to cost-effective production. The price of the plant material, energy consumed, labor, nutrients, fertigation and other inputs involved in the grow should be calculated to determine the actual cost of a grow room. If rooms are set up consistently, you can multiply to get an aggregate production cost across the facility.
Growing media
Look beyond the price tag when calculating costs and consider the value each input brings to the grow. Nutrition is a good example. Understanding the concentration of specific nutrients in a product can be a better way of evaluating its value than simply looking at the cost of the goods. And consider whether added nutrients are actually adding value to the product produced. More isn’t always more. In most cases, simple salts will supply the plant with what it needs to grow.
Growing media is another opportunity to evaluate the cost/benefit of cultivation inputs. How much yield can be achieved with a particular medium compared to a different choice? For example, a bag of coco may initially appear to be the low-cost choice for cultivation. Upon a deeper evaluation, though, the cost per plant of coco is generally higher when you factor in the amount of media used for each plant (and that doesn’t even factor in the labor to fill the pots).
# 2 Reduce time waste
Among the various inputs in each growing cycle, labor represents a significant cost. Are labor hours being put to the best use and not wasted? American industrialist and innovator in mass production Henry Ford stated, “Time waste differs from material waste in that there can be no salvage. The easiest of all wastes and the hardest to correct is the waste of time, because wasted time does not litter the floor like wasted material.”
One way to see the cost of wasted labor dollars is to set up a camera and record a day of activity in the grow room during each step of a grow cycle. Or simply observe the responsibilities that are requiring workers’ time on a typical day. Watching employees’ work in the grow room may reveal how a room’s set-up is contributing to or hindering production. Are employees spending their time on tactics that add value or are they being slowed down by manual processes, such as filling containers, watering and relocating plants in the facility? Are there steps and process that could be automated, such as fertigation? Seeing how employees’ time is being used can identify opportunities to direct efforts toward functions that add value or cut costs. What would be the economic benefit of reducing a half-day of set-up time in the grow house or automating some processes?
Beyond better allocation of human capital, understanding how time is used in the growing operation can suggest changes to materials used in the grow. For example, selecting a growing media that comes in plugs and blocks with pre-drilled holes for efficiently dropping in new plants can reduce time spent filling pots or configuring containers. Automating functions like fertigation and watering can not only reduce labor time but increase the precision of delivery when it comes to water and nutrients.
#3 Introduce incremental improvements
Many manufacturers rely on pilot plants to mitigate risk before process scale-up takes place across an enterprise. The same approach can benefit the grow house. Resist the temptation to overhaul the system and instead focus on introducing one change at a time. This disciplined approach will allow you to evaluate if a change is actually delivering value and should be applied more broadly. The wisdom of a cautious approach to improvements is reflected in a quote by innovation magnate Steve Jobs, co-founder of Apple. Observing that not every innovation will be a win, Jobs stated, “Sometimes when you innovate you make mistakes. It is best to admit them quickly and get on with improving your other innovations.”
When introducing a new element into the grow, pilot it in one “sample” area before adding it to the entire operation. Then give the innovation time to be evaluated before deploying it more widely. This measured approach can help reduce the risk that accompanies making a change to processes and will allow you to evaluate the relative benefit of any change or innovation. And as changes are introduced one at a time, it is easier to determine which changes are contributing value.
#4 Satisfy the market, not just the spec
Regulatory bodies set the compliance criteria for purity or quality standards in manufacturing, but the ultimate mark of approval is awarded by customers in the marketplace. A harvest may meet all of the quality specs, but if customers don’t want to buy it, achieving GMP metrics is a moot effort. The marketplace will always have the final say on a product’s commercial viability.
Understand what the market wants and be able to replicate it consistently harvest after harvest. Manufacturing a product that meets the market’s desired performance attributes is essential to sustaining and growing operations. Production quality is only as good as the last harvest and any degradation in product quality will diminish buyers’ trust. History shows that the challenge of achieving consistent production quality and reliability isn’t just a problem for cultivators. Among several factors that doomed the short-lived Edsel sedan introduced in 1957 were problems arising from assembly workers having to use different tools and techniques. A lack of consistency in producing cars or cultivars can turn off customers and profitability.
A tension exists between achieving production consistency and the opportunity to introduce changes that improve the grow. By integrating improvements into the production system one measured change at a time, cultivators can assess which improvements to continue and what needs to be tweaked. But as manufacturing has long demonstrated, continuous improvement is an ongoing journey.
As cultivators consider the 5 Ps of people, processes, procedures, premises and products, applying these four GMP insights can help growers in emerging and legacy markets navigate changing market conditions and drive continuous improvement.
Despite the US making cannabis regulations challenging to navigate, the industry is snowballing toward profitability. New Jersey legalized adult use cannabis on April 21 this year. One month earlier, The Garden State began accepting applications for Class 5: Retailers, Dispensing and Delivery.
Although New Jersey isn’t shy about its licensing requirements and standards, many people want to know how retailers can stay in the game for the long run. So, let’s talk about risk management considerations New Jersey retailers need to know.
Top Risks Cannabis Retailers Face in New Jersey
Regardless of what kind of retailer you operate —medical or adult use — it’s critical to know what you’re up against. The following are the most common risks we’ve watched cannabis retailers face daily in New Jersey, making a customized risk management strategy necessary.
Theft
Like other retailers, New Jersey cannabis retailers are vulnerable to theft. Unfortunately, theft can come from various angles, such as in-store, in-transit and insider crime. Besides cannabis retailers typically having a well-stocked inventory, it’s not uncommon for them to have more cash on hand than most other businesses.
Although the SAFE Banking Act could positively impact the cannabis industry, it’s in a notorious stall yet again. Briefly, the SAFE Banking Act would no longer allow financial institutions, such as banks and credit card companies, to refuse to do business with cannabis companies. However, cannabis retailers must operate in a cash-only environment, for now, forcing them to make bank runs multiple times a day. We probably don’t have to explain how enticing a significant inventory and fat bank bags look to criminals.
Cybersecurity
Since the onset of the global health crisis, the cyber liability landscape has nearly spun into a death spiral. In other words, cybercriminals sat on the edge of their seats during the pandemic, waiting to pounce on anything that looked slightly vulnerable. Remote workers, small businesses, and emerging industries were hard-hit.
It’s no surprise that New Jersey cannabis retailers face many cybersecurity risks through their point of sale (POS) systems. Additionally, retailers often gather and store personal information, such as email addresses, credit card numbers, shipping addresses, etc. Hackers and cybercriminals gravitate to this vital data rapidly.
Property Damage
In addition to the risk of theft, as mentioned above, cannabis retailers must protect their property from losses. Without adequate protection, damage to equipment or buildings could add up to high out-of-pocket costs. Consider the damage a weekend office fire or late-night vandalism would cause. If property damage occurs, retailers must figure out how to sustain business operations while recovering from the loss simultaneously. As a result, New Jersey retailers must protect their property and maintain business continuity.
How to Customize a Risk Management Strategy
Watch or listen to any news reports and there’s a decent chance that you’ll feel some slight sense of doom and gloom. And sure, a lot is going wrong in our world; however, that doesn’t need to impact how you perceive your businesses. Instead of casting a massive net over every possible risk that you can imagine, we recommend trying the following 5-step approach. Here’s the gist:
Identify: Pinpoint high-level risks that are specific to the cannabis industry. Then, let the process trickle down to focus on company-specific exposures.
Analyze: Determine how badly a particular risk could harm your retail company. How much will this hurt should the “what-ifs” play out?
Evaluate: Categorize risks according to how risk tolerant your company is. Will you avoid, transfer, mitigate or accept the risk?
Track: Use your history or the stats from a similar retailer to map out how you’ve handled the risk over time. Older retailers have an advantage over younger retailers, of course, but you can still get a feel for your risk management style.
Treat: Make good on your evaluation promises by avoiding, transferring, mitigating, or accepting the various risks you identified.
Recommended Insurance for New Jersey Retailers
Sales totals in the first month of New Jersey’s adult use market
The New Jersey Cannabis Regulatory Commission issued detailed requirements for new cannabis businesses. That said, part of the application requirements considered is the plan for companies to obtain liability insurance. Many new retailers opted for a “letter of commitment” as opposed to a certificate of insurance (COI), stating their plans for obtaining the following coverages:
Commercial general liability: Protects cannabis companies against basic business risks.
Product liability: Protects against claims alleging your product or service caused injury or damage.
Property: Reimburses cannabis companies for direct property losses.
Workers’ compensation: Covers employees if they are injured on the job and can no longer work.
In addition to the required insurance coverages, we recommend New Jersey retailers customize their risk management package with these policies:
Crime: Protects your cannabis company against specific money theft crimes.
Cyber: Protects your cannabis company against damages from specific electronic activities.
Directors & officers: Protects corporate directors’ and officers’ personal assets if they are sued.
Employment practices liability: Protects cannabis companies against employment-related lawsuits.
Professional liability: Protects cannabis companies against lawsuits of inferior work or service.
With more states in the US entering the marketplace soon, New Jersey is doing its fair share of the heavy lifting by spearheading the onboarding process. Remember, doing your due diligence at the start pays off in the long run — New Jersey retailers are proving that. Consider teaming with a commercial insurance broker calibrated to the cannabis industry, so you get the most out of your broker, marketplace and the cannabis industry as a whole.
In every industry, there’s an underlying threat and worry that as AI advances, jobs will be at risk. This programming is deeply instilled in labor workers who have grown accustomed to income security to maintain their expenses or quality of life. But what if we’re looking at robots all wrong?
Instead of seeing a robot job apocalypse, what if they’re the machines to lift us to our highest degree? Robots are already proving to improve efficiency and cut company costs, so it’s inevitable they’ll come to a job near you soon.
For the budding cannabis industry, everything is fresh and new as the market is in its infancy. That means new systems and new workers have the opportunity to implement robotics to get ahead of the competition and boost morale earlier than most.
So, here, let’s de-program the way we think about robots today and cover the top three ways robots can help, not hurt, the cannabis industry—and the livelihoods of its workers too!
#1 Labor Shortage Gaps Need To Be Filled
Let’s get real—the cannabis industry is feeling the labor shortage just as much as anyone. Even more, it’s extremely difficult in this day and age to only pay a minimum wage to workers. This is true from coast to coast, but especially in lucrative cannabis markets like California, which have a higher cost of living for workers to meet.
“Robots aren’t here to hurt the cannabis industry, they’re here to help”Another predicament for facility owners? You can’t pay more for low-level repetitive tasks without significantly decreasing margins for your company while remaining competitive in such a bustling market. Moreover, humans just aren’t built to sit in closed, highly regulated areas, repeating the same motions over and over, to fill pre-rolls, vape carts, package jars and beyond.
By implementing robotics and automation tools, cannabis industry owners can not only fill labor shortage gaps but also alleviate labor costs for an improved bottom line. In addition, this will allow executives to better leverage labor costs towards more valuable positions that are more rewarding for employees too.
#2 Human Productivity Declines Over Extended Periods of Time
You know how you move with speed and precision when you first begin a repetitive task? Think exercising. When you first start your set of mountain climbers, your body moves mechanically, hitting the steps on point, repeatedly. But by the end, you’re struggling to get 1 or 2 last pushes in to hit your reps.
An automated pre-roll infusion robot
Manual labor and repetitive tasks are no different. In fact, there are companies in the world that hire workers to pack cases for just one hour a day. Why? Because their analytics have shown that after just one hour of work, the employees zone out and lose focus, which decreases productivity over time and increases the chance of human error.
In cannabis, someone has to fill the pre-rolls, and someone has to pack the jars into boxes. But, scheduling one worker for one hour shifts all day every day is a logistical nightmare to get the most productivity from the time you have. With no creative minds of their own (sorry, not sorry), robots are quite literally built for this type of labor and produce accurate results, too.
This allows cannabis owners to pay one up-front investment for the ’employee’ and can rest assured, financially and operationally, that the position will always be filled with no wage raises to consider.
#3 – More Robots Allows For More Rewarding Roles
Last but not least, there are few people in the world who actually desire or dream of the manual labor that’s required to keep the cannabis industry’s momentum moving upward for good reason. The human mind is meant to explore, create and evolve by putting it to use day in, and day out.
Hence, the uptick in investments towards upskilling in the cannabis industry and the passion for retraining employees for more technical roles. For employees, they’re more fulfilling and hold higher value. For employers, you have more human minds at work towards what matters versus the tasks that just need to get done.
Implementing robots in cannabis facilities for these mundane, repetitive, and low-level tasks help open the doors for more fulfilling roles for employees that share an interest in the plant. In the end, allowing them to put that passion and their unique skills, ideas and creativity towards helping your company prosper.
The Bottom Line – Cannabis Robots Are Here to Stay
With any new trend or shift in the labor and job landscape, it’s natural to be cautious of how it may affect you or your workers, both personally and professionally. However, as you can see, robots aren’t here to hurt the cannabis industry, they’re here to help.
As cultivators and other manufacturers struggle to turn a profit, now is the time for the overwhelmingly cottage industry to go big or go home. Because, whether you like it or not, there’s one thing we can all agree on: robots are the future of manufacturing, the cannabis industry included.
Cannabis sativa contains over 500 different bioactive compounds that can be separated through an extraction process. This is carried out in an extraction lab and the end result is the production of cannabis extracts with a high concentration of specific cannabinoids (such as THC or CBD) with up to 99% purity levels. Cannabis can get easily contaminated with pesticides, heavy metals, residual solvents or other contaminants and thereby pose a risk to the health and safety of consumers. In-house testing allows manufacturers to ensure that the cannabis products they put out to the market are not only potent but also are free of all sorts of contaminants.
The cannabis extraction market worldwide was valued at $9.7 billion in 2020. According to data from Grandview Research, the market size is expected to hit $23.7 billion by 2027, growing at a CAGR of 16.6%. While setting up a cannabis extraction facility can be cost-intensive at the start, the running costs are minimal, making this a profitable venture in the long run. However, you will need to consider these 7 important factors.
1. Location
A schematic representation of the 7 important factors to consider when setting up a cannabis extraction facility (Figure courtesy of CloudLIMS)
Cannabis is a highly regulated industry, regardless of the country. In the U.S, it is illegal at the federal level, and therefore there’s a need for judicious selection of location to avoid run-ins with the federal government. If you are in the U.S, you will need to check the specific laws in your state. These rules dictate how close an extraction facility can be to a daycare facility, children’s park, school, residential areas, etc. The rules may also spell out how many cannabis facilities can be located in one area and how close to each other they can be. At the end of the day, you also want to ensure that the location that you settle for is readily accessible, secure and close to resources.
2. Regulatory Compliance
A cannabis extraction facility needs to meet regulations that apply to the manufacturing and production of consumable goods to ensure that the safety of workers and end consumers is guaranteed. Here are a few that are of priority:
current Good Manufacturing Practices (cGMP): The CGMP is a regulatory standard enforced by the FDA. It defines the creation, implementation and monitoring of manufacturing processes to meet the quality and safety threshold. It requires manufacturers to use technology and have systems in place to ensure product safety and effectiveness. Cannabis extraction facilities should be GMP certified for operational standardization and for performing transnational business.
National Fire Protection Association (NFPA): Extraction labs use flammable materials which can easily trigger fires. NFPA, which is a non-profit organization, has created standards and codes to minimize injuries, death, and economic losses attributable to fire accidents. The standard describes how labs should be set up and how flammable liquids should be stored and transported to prevent accidental fires.
Local Fire Codes: These are a set of codes/requirements that must be adhered to in all commercial and industrial buildings to prevent fires. They include the availability and proper use of the following:
Fire extinguishers
Extension cords
Smoke detectors
Fire exits
Fire signage
Fire assembly points
Sprinkler heads and pipes
Fire alarms
Here are some important fire codes that should be followed in a cannabis extraction facility:
NFPA 1: The Fire Code Handbook
NFPA 30: The National Code for Flammable and Combustible Liquids
NFPA 45: Fire Protection for Labs Using Chemicals
NFPA 70: The National Electrical Code
NFPA 58: The Liquid Petroleum Gas Code
Occupational Standards for Health and Safety (OSHA): Cannabis extraction facilities are compelled by federal law to comply with OSHA requirements for occupational health and safety, and specifically regarding biological and chemical compounds that lab staff may come into contact with during their work. OSHA standard 29CFR1910.1200 requires labs to have a written hazard safety standard for all chemicals, and the standard should be accessible to all employees at all times. Labs are required to have an inventory of all hazardous chemicals with associated details recorded in a Safety Data Sheet (SDS).
3. Staff Management
Lab staff need to train on all hazards in the facility and be given first aid measures in case of an accident. The staff will need to sign that they have received training on the same.
4. Waste Management
Cannabis waste in an extraction facility includes plant trimmings, leftover extraction chemicals, disposed of samples and other debris left behind. Waste needs to be segregated according to hazardous or non-hazardous categories and disposed of accordingly. The lab needs to put measures in place for proper waste segregation so that the waste does not get mixed.
5. Worker Safety
Worker safety in an extraction facility is of paramount importance and should be based on the kinds of risks that each staff gets exposed to in the line of duty. This makes it necessary to have a Job Hazard Analysis (JHA) to assess hazards and put measures in place to avert accidents and injuries.
A laboratory software for CBD/THC laboratories to schedule staff training and manage staff competency (Figure courtesy of CloudLIMS)
6. Equipment Selection and Management
Cannabis extraction equipment can cost anywhere between $5,000 to $100,000, depending on the type and scale of extraction. When choosing the equipment, you need to factor in the cost efficiency, output, and the final product. All equipment used in an extraction lab should be Underwriters Laboratories Listed (UL-Listed). The equipment also needs to undergo regular maintenance to ensure maximum efficiency and productivity, and to prevent accidents and minimize wear and tear. National Recognized Testing Laboratory (NRTL) certification is necessary to achieve this.
7. Supply Chain Management
Supply chain management refers to the strict monitoring of the entire workflow to ensure effectiveness, eliminate wastage, and boost productivity and profitability. This means tracking raw materials from the time they are received by the extraction facility to when they are released as cannabis extracts. A Laboratory Information Management System (LIMS) comes in handy to support supply chain management in an extraction facility.
Role of a LIMS in Setting Up a Cannabis Extraction Facility
A laboratory software for CBD/THC laboratories, also known as a Laboratory Information Management System (LIMS), helps automate workflows, and thereby improve efficiency and productivity in an extraction facility. A laboratory software for CBD/THC laboratories streamlines in-house testing processes and guarantees that the final extracts produced are potent and free of impurities. A LIMS also comes in handy in managing Standard Operating Procedures (SOPs) and human resources, tracking samples and lab inventory, scheduling equipment calibration and maintenance, and ensuring compliance with the necessary regulations.
When setting up a cannabis extraction facility, sufficient time needs to be allocated to the planning to ensure all-important considerations are in place. This starts with finding an ideal and compliant location, ensuring regulatory compliance, ensuring worker safety, efficiently managing staff, inventory, and waste, and the careful selection of equipment. A laboratory software for CBD/THC laboratories ties these factors together to ensure a smooth workflow and maximum productivity of the facility.
Coda Signature is a leading cannabis edibles company that has won countless awards for their creations. Founded in 2015 in Trinidad, Colorado, a small town just north of the New Mexico border, the women-led company has since become a fixture of the infused products market. Coda Signature prides itself on its innovative lens, focusing on what consumers want and framing their products around a luxury experience.
Lauren Gockley co-founded the brand in 2015 after a 20-year culinary career that started with professional training in France, working in Michelin-starred restaurants and Parisian pastry shops. They launched their first line of products in March of 2016 and three weeks later, the awards started coming in. Today, the company is a leader in the cannabis industry and constantly raising the bar. Last year they rolled out products with nanoemulsions, offering fast-acting edibles with a shortened onset time. In May of this year, Coda Signature debuted their low dose Fruit Notes, their foray into microdose formulations.
We caught up with Lauren Gockley to see what inspires her, hear the story of how the business came to be and get some insights on what’s next for the cannabis space.
Cannabis Industry Journal: I saw that you have a culinary background. Can you tell me about your background and how you got involved in the cannabis industry?
Lauren Gockley, Co-Founder and Chief Innovation Officer, Coda Signature
Lauren Gockley: I have been working in the culinary world for almost 20 years. I have been blessed to have a wealth of different experiences from my professional training in France at Valrhona’s L’Ecole Du Grand Chocolat and the Parisian pastry shops of Pierre Hermé, to the fine dining restaurants of Jean-Georges Vongerichten and Thomas Keller. I also spent several years as a raw vegan chocolatier where I gained a totally new understanding of chocolate and flavor creation using unconventional ingredients.
The transition into cannabis was an unexpected turn in my culinary career, especially considering the level of acceptance of cannabis in its early legalization period. I had been living in New York for almost eight years. I was working two jobs and trying to start a chocolate business. One night, my partner (and fellow co-founder), Brien Sauchelli, brought over a cannabis chocolate bar. At the time, I was not terribly familiar with cannabis edibles, but I sure was familiar with chocolate! I tasted the chocolate bar, and thought, “this tastes pretty good, but what if I could do it better?” The idea of elevating the cannabis edibles experience to the same caliber of excellence that we revere food made so much sense.
CIJ: Tell us how you co-founded and started Coda Signature. I’d like to hear the origin story
Lauren: Well, like so many cannapreneurs, I started in my kitchen with a crockpot, a Ziploc bag of trim and a massive amount of research. Fast-forward a few months to March 2015, and my partner and I are traveling across the country to Trinidad, Colorado—the new home of Coda Signature. Once unpacked, we dedicated almost a full year to product development, raw material sourcing, packaging design, facility construction, and most importantly we defined the mission, vision and core values of Coda Signature. One of our most significant core values is legacy. This was not meant to be an aspirational statement about the impact we hoped to have many years into the future, but rather an opportunity for us in every moment to ask, “What will my legacy be today?” We launched our first products in March of 2016. Three weeks later, we won the High Times Cannabis Cup for Best Edible with our Crescendo truffle collection.
CIJ: Your job title is Chief Innovation Officer – How is your company innovating the cannabis product space? What does your day-to-day look like?
Lauren: When it comes to innovation, we have identified four key areas of focus for Coda Signature products:
1) Flavor. We are leaning into our brand legacy of bold flavors and aromas, quality ingredients and impeccable craftsmanship. This legacy is reinforced by industry data. According to BDSA Trending Consumer Insights, flavor is the No. 1 driver of consumer purchase decisions, and second is brand loyalty.
2) Microdosing. According to BDSA Consumer Research, 73% of adults nationwide are now “bought in” to consuming cannabis. Understanding that much of this population is still getting acquainted with cannabis-infused products, we believe strongly that microdosed products are an essential factor for safe and customized experiences. We are one of the few infused products companies to defy the industry “standard serving size” with our new 1mg THC Fruit Notes.
3) Minor cannabinoids. We define the Coda experience through the integration of minor cannabinoids such as CBN, CBG, CBC and most recently THCV. This is no longer a market solely driven by milligrams of THC per dollar. Products innovating with minor cannabinoids are rapidly taking top-selling positions in both brand share and the market as a whole.
4) Fast-acting. After two years of intense R&D, Coda launched our first “Fast Acting” products in Q3 of 2021. “Fast Acting” decreases not only the onset time from 1-2 hours to 15-20 minutes, but also shortens the overall duration. This technology is a strong example of the incredible innovation redefining the cannabis edibles experience.
To answer your second question: My day-to-day is a blend of hands-on product creation; ongoing research into industry trends and new technologies; working with my colleagues in operations, quality and compliance to ensure our systems and procedures continue to deliver safe and consistent products; brand development and expansion; and of course, eating a lot of chocolate! The past few weeks have been particularly exciting for me as I have been back in the kitchen revitalizing our signature truffles that will be returning this holiday season.
CIJ: Where do you think cannabis will innovate next? What excites you about the future of product innovation in this market?
Lauren: Innovation in the cannabis industry can be particularly challenging due to the ongoing legalization limitations. However, like most life forms in nature, it is through limitations that we adapt, grow stronger and defy expectations. The fact that 73% of adults nationwide are open to the idea of cannabis means that we are just scratching the surface of innovation with this incredibly powerful plant.
Post-pandemic, I think a lot about our social habits. As a chef, there is a level of social intimacy I identify with food that I feel is not fully present in cannabis. I get very excited about the opportunities for more open cannabis consumption and how that will elevate and inspire the Coda product experience.
Hangovers are one of the aftereffects often experienced with spirits. Who doesn’t love a good martini or a refreshing margarita? One company is on a mission bring the flavor profile and buzz of spirited drinks without the negative consequences.
Like this article and want to see more? Subscribe to our free newsletter hereMXXN is a California-based cannabis infused beverage manufacturer specializing in 1:1 non-alcoholic replacements for everyone’s favorite spirits, enhanced with a touch of cannabis. By combining new technology in cannabis oil nano emulsions and alt-alcohol, MXXN is able to create flavor matching spirits sold by the 750 mL bottle. MXXN recently launched with three product SKUs including London Dry (gin), Jalisco Agave (tequila) and Kentucky Oak (bourbon) with a rum replacement due to launch soon.
We caught up with Darnell Smith, founder & CEO of MXXN, to ask about the technology going into infused non-alcoholic spirits, regulatory challenges and more. Prior to MXXN, Darnell was a spirits industry veteran, having worked with companies including Diageo, Pernod-Ricard and Bacardi.
Aaron Green: Darnell, nice to meet you. How did you get involved in the cannabis industry?
Darnell Smith: For me, it wasn’t something that was premeditated, in a sense. I had always been a cannabis user in my adult life. I played Division I sports. Cannabis replaced a lot of painkillers and medications that I probably would have had to take just to cope with athletic injuries. That’s how I got introduced to cannabis. And there is the recreational use of it as well.
Darnell Smith, Founder & CEO of MXXN
To get to the origin story of MXXN, I spent a large part of my career working in spirits, namely, on the innovation and commercialization side of bringing new products to market under very well-known trademarks for large multinational companies. A few years into it, my liver was kind of at a point where it was like, “It’s gonna be you or me here, buddy.” So, I made the decision to start making – this is 15 years ago, in New York – a tincture where I would just heat up flower and decarb it and soak it in a high proof spirit. I would cover it for 30 days then strain it and have my tincture.
I’d be the guy in the bar, that would say “Hey, can I get a tonic and lime?” and I would put three drops of my tincture in there, and I would session cocktails along with everyone else. Next day at work, I’m the guy that’s bright-eyed and bushy-tailed and everyone else is kind of feeling a little bit weathered by that alcohol.
Innovation is usually born out of a personal need and that’s the same way here. So, fast forward 15 years and the technology has finally caught up. The rise of non-alcoholic spirits, the rise of cannabis and water-soluble emulsification, those two things combined really made the light bulb go off and say now is the time to offer this product. I feel like MXXN has a very specific place in our consumption of beverages and can fill a unique need that I think is rising.
Green: I’m interested in learning about the technology and the product. We can start with the technology that went into the product development process. I’ll go on to product next.
Smith: From a technical standpoint, up until a few years ago, the way that edibles were made was basically like raw extraction. There was very little ability to be precise about dosage. It was like trying to throw softballs through a chain-link fence. Non-uniformity made it very hard to say, “Here’s how this is going to affect you.” Fast forward and companies like Vertosa and Source have perfected this kind of nano-emulsion technology, which is basically water-suspended cannabis that can uniformly be used in food, beverage and cosmetic applications. And it’s akin to trying to throw sand through a chain-link fence. It’s just much smaller. It can remain more uniform, and thereby be more predictable in terms of dosage and effect.
The MXXN London Dry
So, that technology made it possible for us to then combine it with another wave that’s happening, which in the spirits industry is called alt-alcohol. What we do is distill all the flavor essences of well-known spirits and skip the alcohol. We then add the emulsified cannabis in place of the alcohol. And so with that, we offer a new kind of experience which is basically all the buzz but none of the booze. That’s really where technology-wise things have evolved. The rise of the non-alcoholic spirits and then the rise of being able to do water-soluble compatible cannabinoid emulsions.
Green: Are you selling this then as packaged goods or are you selling it as bladders similar to Coca-Cola in a bar setting?
Smith: This is a CPG packaged product and it really is analogous to a 750 ML spirits bottle similar to Tito’s or Grey Goose. The form factor is the same as spirits bottles, same 750 ML bottle. It doses just like a spirit would. Standard spirit pour is an ounce and a half. For us, an ounce and a half shot has six milligrams of THC.
For the average consumer, you can session cocktails and we give you the option to dose between two and six milligrams between a half ounce and an ounce and a half pour. So, it’s very analogous to what people are experienced in when it comes to spirits from the bottle to the dosage and to the actual recipes. We pride ourselves on being able to demystify something that has been a little bit complex in terms of making cannabis-infused cocktails. We are sticking close to what people are familiar with. People have a lot of experience with tequila or gin or bourbon and so we wanted to stay very familiar but also give people a chance to make the same recipes but sans alcohol.
Green: What kind of flavor profiles are you launching with?
Smith: We’re launching with three SKUs. Our first is London Dry, which is our take on a gin and that one has cucumber, juniper, coriander, and a nice peppery finish. We have Jalisco Agave, which is our take on a tequila or Mezcal. You have notes of agave, flint, salt, oak, and vanilla. And then the last one is Kentucky Oak, which is our version of a bourbon or whiskey. There you have charred oak, vanilla, and other flavor components that make up what bourbon is.
The MXXN Kentucky Oak
Now we have a rum in development that’s nearing the end of a robust R&D pipeline. We have some other options like ready-to-drink cocktails made with MXXN to more high-dose products for what we consider the “legacy consumer” who is maybe more medically inclined in the hopes of being able to give people more options when it comes to consumption of flavored spirits.
Green: On the cannabis side, with the infusions that you’re doing, is it pure THC or are you doing full spectrum?
Smith: Yes, full-spectrum cannabinoid. You’ll notice some beverage brands have what we consider a hybrid, some THC and some CBD. For us, and for the effects that we wanted to have the product to have we stuck with a THC-forward blend. There is a trace of CBD in there, but we don’t even claim it. It’s not something that we go forward with. Our emulsion is THC-based.
Green: Where are you at today in terms of the launch and presence?
Smith: We just finished a pilot test here in California. We started late-January, early-February and we’ve been selling direct-to-consumer. Just order and you can have it at your door in 24 hours for about 85% of the state. We’ve blown through our entire pilot run. Now we are entering into what we consider our launch phase which will be available in select retailers late-July. We are gearing up for our next big production run here in mid-July. We are basically all systems go.
At the same time, we’re exploring multi-state expansion. We have a lot of interest in states like Colorado, Nevada, Arizona and we’re having constant conversations with partners in those states to help bring the product to market.
Green: Have you looked at lounges?
Smith: Lounges have been our biggest traction as we start the retail rollout. We literally just started the dispensary piece of what we’re doing last month. And this is by design. First, we wanted to go direct-to-consumers for proof of concept to make sure we weren’t, you know, saying the story to ourselves. I think just by the performance of the pilot run and direct-to-consumer sales, we proved okay, this is a viable concept.
MXXN’s Jalisco Agave
So as we go out, our number one targets are obviously establishments that also are connected to or have connections with a consumption lounge. There aren’t a ton at this point. They’re still kind of proliferating. But I will tell you the moment we walk into one of these accounts is like a no-brainer because it allows this account to offer a whole new experience. When it comes to consumption lounges in terms of great cocktails you already know: gin and tonics, margaritas, paloma, with no real education required on the part of who’s ever going to be serving. We basically take 20 retailers a month in chunks and so far of the 15-20 that we’ve done, four or five of them have consumption lounges and you’ll see it in those very soon.
Green: Are there any challenges there with dosing in a lounge where the onus is on the operator to dose? How do the regulations work there?
Smith: It’s similar to alcohol, right? As an establishment, you have a responsibility to kind of pay attention to what’s happening as the consumer is consuming. Typically, most of the legislation that was written is for an inhaled consumption lounge. Ingestibles weren’t necessarily considered heavily when it came to legislation. What we tell folks is you have the same responsibilities you would if you were a bartender. Our recommended pour in consumption lounges is a lighter dose. This way, the customer has a chance to start low and go slow, and really recognize how it’s going to affect them.
Legally, there is no firm guidance on what overconsumption looks like for the typical consumer. So, we tell folks you have to kind of get a feel for who the consumer is. If they’re curious person who doesn’t have a lot of experience with cannabis, we typically recommend not to exceed a five-milligram serve per sitting until you figure out how it’s going to affect them. However, if you have very high dose legacy consumers, who buy and drink these 100-milligram single-serve bottles it’s a different story. You kind of need to gauge that from consumer to consumer, and what their tolerance level is. A lot of onus is on the consumption lounge. And I think that’s why they’ve kind of been slow to really roll out how they deal with beverages, because it’s just a different beast. It’s absorbed differently by the body from inhalable products
Green: What trends are you looking at in the industry?
Smith: I love seeing more food-based options. Edibles to this point have been mostly candies and gummies and I see the trend going to more high-end, curated food selections. I think that’s super interesting. The condiments that go into cooking is a category that I’m keeping an eye on. I came across a THC and CBD-infused Siracha sauce the other day and I was like, “wow, this is fantastic!”
MXXN logo
In the beverage space, there continues to be innovation, which we are on the forefront of. There’s a point of saturation that’s going to come for how many seltzers can exist in the market at the same time. And I think we’re kind of reaching that point. So, it’s going to be incumbent upon the beverage space to continue to innovate.
I’m also watching where things go with hemp-derived THC, the Delta-8s and those things and how is that going to be dealt with when it comes to the legal market. I think you see varying ways that it’s being dealt with across states. That’s a trend I’m certainly keeping an eye on as things continue to roll out across the country.
Green: What, in your personal life or in cannabis are you most interested in learning about?
Smith: Given where the world is today, I feel like we all live in this “OR” mindset. It’s either you OR me, it’s either this OR that. And I think you can see with some of the more recent political things that have happened, it’s this ideology of like, trying to force your beliefs on someone else. For me, it’s more about like, how can we learn to live more in the “AND” right? You can have this AND this and they can coexist, and they don’t have to be in competition. In my personal life, that’s where a lot of my energy is going. How do I spread that thought of getting out of this living in OR. We must move to this kind of mindset of AND. How can we be accommodating for a bunch of different beliefs, a bunch of different approaches? It causes so much friction when we try to impose beliefs on others that may not share the same beliefs.
I am thinking about how I can apply that to the cannabis industry as well. In terms of federal legalization versus state, where can we find that the happy ground? If we think about going across state lines, that’s effectively building a whole other business in the state, and in virtually no other industry does that exist. I can tell you economically this country could use infusion of cannabis to be more freely available. So those are the types of things that keep me moving these days. I’ve had a lot of success in my past and so for me, it’s less about financial achievements, and it’s more about how we can help move folks to this is AND mentality and not everything has to be OR.
In a growing number of communities around the U.S., new cannabis lounges are offering a social setting where guests can openly use cannabis products. Colorado and New Mexico both saw their first cannabis lounges open in April, Michigan’s first cannabis lounge is set to open this summer, and officials in Nevada are currently discussing how the recently approved class of businesses should be regulated. In West Hollywood, California, where the state’s first cannabis lounge opened in 2019, multiple new lounges are now in the works after two years of slowdown due to the pandemic.
The bar-like establishments add a new dimension of potential revenue — and risk — to an industry that is expected to add almost $100 billion to the U.S. economy this year. This new and emerging segment within cannabis isn’t happening in every legal state, but more are starting to enact regulations to provide for some type of on-site consumption.
These new ventures need insurance policies tailored to address the risks of serving cannabis products, which could be looked at similarly to liquor liability for bars and restaurants.
Whether it’s alcohol or cannabis, these products impair people’s judgment, meaning everyone reacts differently to them. But how do you know when to cut someone off?
Cannabis lounges could be held liable & run risk of being sued for overserving
If a cannabis lounge faced a lawsuit alleging that it overserved a patron, leading to a third-party bodily injury, the business’ Commercial General Liability (CGL) Insurance and Products Liability Insurance could potentially cover costs such as legal defense, medical expenses and settlement amounts. Until such a case occurs, it is not yet known how exactly these lawsuits would be covered by insurance.
Because of the short history of cannabis lounges in the U.S., something like this is largely untested, making it hard to speak to exactly how a scenario would play out. Many of the existing cannabis insurance policies are highly exclusionary, meaning it could exclude a loss that is deemed to have arisen out of the use of cannabis.
Recent liquor liability lawsuits have shown the potential for a significant loss is clear. In early April 2022, a $20 million lawsuit was filed against a nightclub in Houston, Texas, alleging it overserved customers and allowed underage drinking, contributing to a drunk driving crash that killed a teenager.
In December 2021, a jury in Texas awarded the family of two drunk driving victims over $301 billion after a lawsuit alleged the driver was overserved at a bar before the accident; though largely symbolic, the settlement marked the largest personal injury award in U.S. history.
The Barbary Coast lounge in San Francisco
With these cannabis lounge establishments more or less encouraging intoxication of patrons on their premises, it’s very similar to a liquor liability type situation. If someone overindulges at a lounge, leaves and causes a crash resulting in injury or death, that could come back to the establishment.
While it remains to be seen how cannabis overserving lawsuits could play out in American courts, it’s worth noting Canada forbids on-site consumption of cannabis products and any loss or damage will not be covered by their insurance policies – despite it being legal country-wide.
Lawsuits possible over product issues, budtender advice
Even cannabis operations that do not allow on-site consumption can face liability related to the products they sell, making Products Liability Insurance and Product Recall Insurance necessary for growers and retailers. They should also consider Employment Practices Liability (EPL) Insurance to cover staffing-related allegations such as discrimination and ask their insurance broker whether budtender liability is included in their CGL Insurance policy.
Budtenders must walk a fine line between giving advice versus general information on products.
Budtenders, or individuals who work at cannabis retailers, are not allowed to offer medical advice to consumers. They must walk a fine line between giving advice versus general information on products. Although we are not aware of lawsuits that have been filed over a budtender’s advice, it would ultimately be up to the courts and lawyers as to how those proceedings would play out.
Budtender liability is not very different from professional liability insurance, and it’s more like an incidental coverage based off the budtender’s informal advice. There are, indeed, insurance carrier partners today that offer that service.
CGL Insurance can also cover in-store slip-and-falls and other third-party injuries and property damage. Because most cannabis retail stores are fairly small, these incidents have been rare, but GCL cannot be overlooked. Businesses must be prepared for anything to happen – and need to know that no risk is too small.
Theft, vandalism among top threats to cannabis businesses
Whether or not a cannabis business includes a lounge for cannabis use, any business in this industry may be more vulnerable to certain risks, including theft and vandalism.
In the U.S., where many cannabis companies operate on a cash-only basis because of banking difficulties tied to recreational products being federally illegal, a recent surge in cannabis shop robberies has led to calls for a new banking bill. Some of these incidents have even turned deadly, including an April 30 dispensary robbery in Los Angeles, California, during which one man was reportedly shot and killed.
Many insurance carriers require retailers to install alarm systems, video monitoring equipment or safes
Large amounts of cash are on-hand daily at these premises, and workers might have to make multiple bank runs throughout the day, leaving a heightened exposure and risk for robberies.
From robberies and vandalism to fires and flooding, Commercial Property Insurance is a key protection for cannabis retailers. Equipment Breakdown Insurance may also be needed, particularly when the stores contain expensive refrigeration equipment. The potential loss is large in this industry, especially at growing facilities, and there’s a lot at stake with such high-value equipment.
Security systems, employee training can help reduce risks
Many insurance carriers require business owners to install alarm systems, video monitoring equipment or safes to help reduce potential property losses, and employees should be trained to use the alarm systems consistently. Policyholders and business owners should also know there is a lot they can do to curb some of the risks, such as businesses doing background checks on every hire and taking steps to ensure they are hiring individuals they can trust.
Installing bars on glass windows and doors is another loss prevention measure that is strongly encouraged because it adds an additional layer of security to get through – it won’t be an easy or quick process to break-in and will trigger the alarm system.
The importance of working with an insurance broker
Working with an insurance broker who is specialized in the cannabis industry can help business owners better explore available coverage options. With cannabis or any type of risk, you should always work with someone who has knowledge and expertise in that area. When you work with someone who knows the ins-and-outs of the regulations, you can have more peace of mind.
You might have a risk warranty that always requires two drivers in that vehicle, or GPS monitoring on the vehicle.
Understanding your policy in its entirety is also essential, as these policies have any number of different limitations and exclusionary forms that could preclude you from collecting if you had not understood and followed the language of the policy.
In a transportation situation, for example, you might have a risk warranty that always requires two drivers in that vehicle, or GPS monitoring on the vehicle. In the event of a claim, if the investigation determines the business did not have those items present at the time of loss, that claim will not be covered.
In a rapidly growing and changing industry, business owners should not underestimate the value of working with a team of insurance experts who keep a close pulse on the quickly evolving industry. Brokers are aware of the different legal environments in each state or even each city or county. Cities and counties can add different levels of compliance matters, so as a buyer, you can be confident that you have the most recent information and are in compliance with state law and any insurance requirements that may be present. Being able to explain the differences between the markets and the coverage options is beneficial to any business owner in this ever-changing industry.
Despite the popularity of cannabidiol (CBD) infused edibles among consumers there are storm clouds on the horizon for this market. The potential threat stems from continuing uncertainty about the regulatory status of CBD in the United States (US) and the European Union (EU). Recent statements by government agencies in both areas are reminders that regulators could make decisions or take actions that would suddenly end the viability of this market. Any company that sells, or is planning to sell, CBD infused edibles such as bakery items, candy and beverages needs to understand what the regulators are thinking now and what might happen in the future.
in the US, the 2018 Farm Bill created a category of products called hemp that are derived from the Cannabis sativaplant and contain less than 0.3% tetrahydrocannabinol (THC). This law also explicitly confirmed the authority of the US Food and Drug Administration (FDA) to regulate the safety of hemp-derived infused edibles. This means CBD needs to navigate the New Dietary Ingredient pathway for dietary supplements, and either the food additive petition process or the Generally Recognized as Safe (GRAS) pathway for foods before it can be used as an ingredient in a food. All three of these processes require that someone (an individual, a company or a group) acting as a petitioner or notifier must submit safety data to the agency or arrange for a safety evaluation by independent experts.
Just some of the many hemp-derived CBD products on the market today
In the EU, CBD is regulated as a Novel Food in a process that is triggered by a submission to the European Commission. The submission must include safety data that is evaluated by the European Food Safety Authority (EFSA). In England and Scotland, CBD products are also novel foods and are evaluated using a process like that in the EU. As in the US, it is the responsibility of an applicant to provide the safety data.
The standard used by the FDA to judge the safety of new food substances in all three pathways is that there should be a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” The standard used by EFSA for novel foods is, “the food does not, on the basis of the scientific evidence available, pose a safety risk to human health.”
It is important to realize that both in the US and the EU the safety standard for evaluating new food substances only considers the safety of that substance. The laws or regulations that define agency authority do not allow for consideration of any potential benefits. Approval (or rejection) must be based solely on the safety of the substance. Further, safety is evaluated in the context of the intended use of the substance, the planned level of use and the resulting consumer exposure to that substance.
What do we know about FDA’s and EFSA’s current thinking about CBD safety?
Unfortunately, both the FDA and EFSA have made it abundantly clear that they believe the available scientific data does not meet the required safety standards. FDA has issued multiple warning letters to companies that sell CBD products and has rejected two NDI notifications for CBD. Although these actions were primarily based on non-safety issues (illegal health claims and the drug exclusion provision in the FD&C Act, respectively), in each case the FDA also raised safety concerns. This was done by saying that the agency is not aware of any data that would support a GRAS determination or that the products raise “concerns about the adequacy of the safety evidence.” This doubt echoes statements from the agency in public meetings and advisories. These doubts were expressed as recently as June 2022 during a meeting of the FDA Science Advisory Board.
Similarly, EFSA has stated that they feel that there are critical gaps in the existing CBD safety data. In April 2022, they published a statement with a detailed analysis of the relevant scientific literature and explicitly identified critical data gaps. EFSA said that these data gaps prevented them from evaluating CBD as a novel food.
What do the regulators see as data gaps?
Although the details of each of the data gaps are technically complex, for both the FDA and EFSA they fall into few broad categories.
The first is that the agencies feel that they need better information on how CBD behaves in the human body. This is described as understanding the absorption, distribution, metabolism and excretion (ADMA) of CBD. The agencies also would like to see data on whether repeated use of CBD might cause damage to specific organs that does not occur from single exposures.
The second need is for more data related to the negative effects that have been observed in some previous work. This includes effects on the liver and reproductive system. In particular, the agencies would like to know whether it is possible to identify a level of exposure that is low enough to not cause any negative effects. This is termed the No Observed Adverse Effect Level (NOAEL). In an ingredient safety assessment, the NOAEL is used to establish a safe intake level, called the Acceptable Daily Intake (ADI). Comparing the ADI to the expected exposure for the intended use allows the regulators to assess overall safety for a substance. If the expected exposure is below the ADI, the substance is considered safe. Both agencies feel that the existing data do not allow them to identify a NOAEL for CBD.
The third data need relates to the composition of the CBD products used in safety studies. Food safety determinations are based on the total composition of an ingredient that is produced using a fully defined process. Even if the potential ingredient is 95% or 99% pure, a safety evaluation needs to know what is in that other 5% or 1%, and that this is the same from batch to batch. For example, the presence or absence of residual processing chemicals (such as extraction solvents) and the nature and concentration of substances such as other cannabinoids and terpenes will differ between manufacturers and processes. These differences could affect the overall safety profile for each CBD product. Therefore, it is considered important that studies supporting a safety determination for a new substance be carried out with the actual article of commerce.
Unfortunately, many different CBD preparations have been used in past studies, and in most cases these preparations were poorly characterized. This makes it difficult or impossible to combine the safety data obtained using one product with data obtained with a different product. For example, data obtained using CBD isolates from two different sources cannot be combined unless it can be shown that they were made using the same process and have the same overall composition.
What does this mean for the future?
Neither the FDA nor EFSA is likely to take any positive action on CBD until they receive safety data that fill the gaps that they have identified.
Given these data problems, it is likely that there will be little or no movement on regulatory approvals for CBD in edibles (or dietary supplements in the US) for at least several years. In the US, these products will remain in legal limbo, with state regulations playing the leading role in determining what is allowed on the market. Products with health claims will continue to be particularly vulnerable to FDA action. The situation in the EU will be at least as confusing because, in the absence of action from EFSA, the regulatory and market status of CBD edibles will be determined by each member country independently.
In view of this uncertainty and business confusion, that are three ways that companies making CBD and CBD edibles can respond. First, in the short term, they can develop and implement manufacturing processes that ensure that their products are consistent from batch to batch and that they have the intended dose of CBD per serving or per product unit. This includes working with the analytical community and organizations such as AOAC and ASTM to ensure that there are validated testing methods available for the CBD and for the final edible products.
In the medium term, business risk management plans for companies that make CBD and CBD infused edibles should consider the possibility that new scientific data will push food safety authorities to actively conclude the CBD does not meet the current regulatory safety standards. In that case, the regulators might start to act against all CBD-containing products.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Businesses should also be aware that the agencies could make a positive safety determination but that they would use the available data to establish a low maximum allowed dose per serving or set very low limits on the presence of specific contaminants such as other cannabinoids.
In the longer term, the CBD industry as a whole might consider advocating for legislative changes. The best statutory fix is likely to be one that that regulates all cannabis-derived products in a system or agency that is separate from the food safety system. This approach is being used in Canada under the Cannabis Act. It is also similar to the way that alcoholic beverages are regulated in the US. This approach, if appropriately designed, could avoid the need for safety determinations but might also limit market access. While this approach could bring clarity and certainty to the market, it is important to remember that it will take time and effort to create a functionally system under this scenario.
There are many market reports that forecast on-going high rates of growth for the CBD market. However, the regulatory and scientific developments that are likely to occur of the next couple of years will determine whether those projections can become reality.
Companies making these products need to monitor changes and prepare to respond to either positive or negative events.
These companies should also remember that edible products are mostly made from food ingredients using standard food product processes. It is critical that these products be made under a system that prevents food-borne hazards.
According to a press release published last week, SC Labs is in the midst of a multi-state expansion under new leadership. The company hired Jeff Journey as their new CEO, coming from a VP position at Thermo Fisher Scientific.
Jeff Journey, the new CEO of SC Labs
Last year, in what seemed like an initial move to establish the lab on a coast-to-coast level, SC Labs developed a hemp testing panel that covers a number of contaminants on a national regulatory level. The hemp testing panel they developed purportedly meets testing standards in states that require contaminant levels below a certain action limit.
Then in February of this year, the company announced a partnership with Colorado-based Agricor and Botanacor Laboratories, with the goal of establishing a national testing network, offering comprehensive cannabis and hemp lab testing. All three of those organizations are certified by the Colorado Department of Public Health and Environment (CDPHE) for compliance testing required for hemp products.
In the press release that was published last week, they hinted at another announcement coming soon: a new partnership with Michigan-based Can-Lab. This, coupled with hints at further expansion and their current presence in California, Colorado and Oregon, means Journey will have his hands full and his sights set on nationwide cannabis testing.
“We’re looking forward to partnering with cannabis and hemp brands at every stage of the supply chain to share our innovative and forward-thinking scientific expertise so they can deliver safe products to the marketplace,” says Journey. “As cannabis legalization expands across the country, the testing industry is rapidly shifting and scaling to meet both market and regulatory demands.”
The leadership team will still have a few familiar faces, such as Jeff Gray as chief innovation officer and Josh Wurzer as chief operating officer. “The most important assets we can offer as a multi-state operator are scientific expertise, financial stability, and unquestionable integrity, the principles on which SC Labs has long stood for and will continue to provide to our valued customers,” says Journey.
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AOAC was founded in 1884 by the US government as the standard setting body in the country and, in 1991, became an independent association known as AOAC International, with a goal of building a reputation as an international, consensus-based standard-setting body and a conformity assessment organization in analytical sciences. As an independent third-party resource, AOAC has the Performance Tested Methods’ (PTM) and Official Methods of AnalysisSM (OMA) programs for certification of analytical testing methods in both biology and chemistry.
In cannabis, discussions have grown surrounding testing of four strains of Aspergillus, which are A. terreus, A. flavus, A. fumigatus and A. niger. By spiking cannabis with one of the four Aspergillus strains and on a separate sample with a non-target Aspergillus strain such as A. clavatus, it ensures that only the target strains are being recognized and recorded on the method being tested.
On a consumer safety level, AOAC-approved methods are designed to keep cannabis consumers safe. Whether they are an adult using cannabis or medicinal cannabis patient, the product that is being sold should be held to the highest safety standards. By having a laboratory that is utilizing an independently approved AOAC method, an additional layer of confidence is achieved that the product being consumed is safe. This ultimately limits the number of costly recalls from dispensaries and minimizes risk to consumers. At the end of the day, cannabis testing laboratories want to keep the public safe and it is our job to do so. This means implementing these independently approved methods from agencies such as AOAC at various touch points in the seed to sale cycle to ensure the data is validated and reliable.
