Risk management is the process of identifying potential hazards, assessing the associated risk, then implementing controls to mitigate those risks. With Salmonella and Aspergillus being two of the leading causes of cannabis contamination that can occur throughout the supply chain, applying upstream risk management strategies can keep supplier contamination issues from impacting your products.
Salmonella enteritidis
In recent months cannabis products have been recalled for Salmonella and/or Aspergillus contamination in several states, including California, Arizona, Michigan, Florida, as well as Canada. While the recalls impacted retail products, in most cases, the contamination occurred farther back in the supply chain, as evidenced by recalls that impacted several dispensaries or other sales locations.
For example, the November 2021 Arizona recall caused multiple establishments and dispensaries to recall product due to possible contamination with Salmonella or Aspergillus; the Michigan recall of an estimated $229 million in cannabis products due to “inaccurate and/or unreliable results of products tested.” While a lab lawsuit against the recall released some of the product to market, the companies faced significant impact – in both removing and returning the product.
While microbial contamination can occur throughout the supply chain, Aspergillus is ubiquitous in soil and the flower, leaves, roots of the cannabis plant are all susceptible to such contamination. The mold also can colonize the bud both during growing and harvesting. Salmonella can be introduced during growing through, untreated manures, direct contact with animal feces, or contamination of surface water used for irrigation. However, the plant matter also can be compromised during drying, storage and processing from environmental contamination.
Aspergillus flavus
Supply chain risk management. To prevent a supplier’s contamination issues from becoming your problem to deal with, each facility at each step of the chain should develop a supply chain risk management program to assess and approve each of its upstream providers. Following are 5 key steps to assessing and managing risk in your supply chain:
Conduct a hazard analysis. A complete supply chain assessment should begin with a hazard assessment of all the ingredients, products or primary packaging you receive. There are two essential steps involved in conducting a hazard analysis: that is the identification of potential hazards – considering those related to the item itself, as well as the supplier environment and process as well as item – and an evaluation to determine if each hazard requires control based on its severity and likely occurrence.
Evaluate the risks. Based on the hazard analysis, the next step is to determine the associated risk. As defined by the European Food Information Council (EUFIC), “a hazard is something that has the potential to cause harm while risk is the likelihood of harm taking place, based on exposure to that hazard.” For example, the higher the exposure, the higher the risk.
Ensure risk control. Once risk is determined, it is critical to ensure that it is being controlled, who is controlling it and how it is being done. Depending on the risk, that control may need to be conducted by the supplier, by you or even by a downstream customer.
Require documentation. No matter which step in the chain is controlling the risk, it is essential that all be documented with records easily accessible – including the controls, any out-of-compliance events and corrective actions. The adage, “If it’s not documented, it didn’t happen,” is very applicable here, particularly should a problem arise and an inspector appear at your door.
Use only approved suppliers. Implementation of the above steps enable the development of a supplier approval program focused on quality, safety and regulatory compliance. Use of only suppliers who have been assessed and found to meet all your standards will help to protect your product and your brand.
Salmonella and Aspergillus contamination can occur throughout the supply chain, but implementing a supply chain risk assessment and management program will enable you to determine where the greatest risks lie among your ingredients and suppliers, allowing you to allocate resources based on that risk.
The United States Department of Agriculture (USDA) issued a Final Rule (FR) on hemp testing that went into effect on 22nd March 2021. Consequently, all hemp testing laboratories must familiarize themselves with what is stipulated in the FR and do all that is required to comply.
The 2014 Farm Bill put to an end to years of hemp prohibition, at least to some extent. It also paved the way for the 2018 Farm Bill that brought hemp at par with other agricultural crops. States, through their departments of agriculture and institutions of higher learning, were allowed to cultivate industrial hemp for research purposes, under what was called the hemp pilot programs. Some states also allowed individuals to cultivate hemp to investigate the economic and agronomic viability of the crop. This increased the acreage of industrial hemp from zero to about 90,000 by 2018 when the Agricultural Act that legalized hemp was passed. Some of the states that participated in this program included Colorado, Kentucky, Montana, and Oregon.
As expected of a new project, some challenges cropped up, including:
Inconsistency in the quality of hemp produced for research
Varying hemp laws between states
Maintaining regular supplies of inputs such as seeds and pest control
Lack of appropriate knowledge and technology
The 2018 Farm Bill addressed some of these challenges through the Hemp Farming Act that proposed to remove hemp from Schedule 1 of the Controlled Substances Act. Hemp, in this case, refers to cannabis sativa that contains less than 0.3% THC by “dry weight.” Proposals in the hemp act were incorporated into the 2018 U.S. Farm Bill and it became law in December 2018, thus making hemp legal at the federal level.
Unlike other agricultural commodities, hemp is a highly regulated crop because of its close association with cannabis which is still under Schedule 1 controlled substances. Once hemp exceeds the 0.3% THC threshold, it becomes classified as cannabis and is, therefore, governed under a different set of regulations.
The next step after the legalization of hemp was to roll out a nationwide hemp cultivation and distribution program. Consequently, the U.S. Food and Drug Administration (FDA) was instructed to develop a national framework to regulate the production of hemp in the U.S. An Interim Final Rule (IFR) was published in October 2019 to set the ball rolling. A final rule was published as an improvement of the IFR in January 2021. The Final Rule was created based on public comments received during the period as well as direct lessons learned in the 2020 growing season. The Final Rule took effect on 22nd March, 2021.
A schematic representation of the key federal rules for hemp testing laboratories (Figure courtesy of CloudLIMS)
The USDA requires that all hemp be tested by a third-party laboratory to ensure that quality is maintained and that the THC threshold is not exceeded. The Final Rule made significant changes tothe USDA’s hemp testing rules that will affect how laboratories carry out their operations. While the guidelines were issued on January 15, 2021, they went into effect on March 22 of the same year. If you are a hemp-testing laboratory, here are the most important changes that you should brace for.
Nine Changes Hemp Testing Labs Must Comply With
Changes in sampling
Previously, samples to be tested were restricted to the top third portion of the hemp plant. With the Final Rule, samples can be taken anywhere from 5-8 inches from the main stem (including the leaves and flowers). This provision offers greater flexibility and reduces the chances of “hot” hemp.
Laboratories shall use specific testing methods
According to the Final Rule, hemp-testing laboratories must use reliable methods to test for THC concentration. This includes methods such as post-decarboxylation; they take into consideration the conversion of THCA to THC after decarboxylation. Currently, methods that meet these requirements include gas chromatography and liquid chromatography.
The USDA also expects that laboratories demonstrate consistent testing reliability and validity. The test methods used must have high specificity for THC and other tested compounds.
Negligence limit raised to 1% THC
Negligence limit refers to the extra wiggle room that is advanced to hemp farmers in regards to THC testing. In the IFR, hemp that tested above 0.3% THC but lower than 0.5% was considered negligence and not a violation of federal laws. This limit for negligence has now been pushed from 0.5% to 1%. As much as the Final Rule has maintained the THC limit for hemp at 0.3%, growers now have a wider margin of error to work with.
For hemp-testing laboratories, all samples that test above 0.3% THC are still considered hot hemp and must be destroyed or remediated. However, samples testing below 1% THC are considered a negligent violation and not a criminal offense.
All hemp testing laboratories need to be DEA registered
The Final Rule made it mandatory for all hemp-testing laboratories to be registered with the Drug Enforcement Agency (DEA). Getting this registration is time intensive and the number of registered laboratories is few. With this in mind, the USDA had extended the registration deadline to the last day of 2022. After the expiry of this period, laboratories that are not registered with the DEA will be barred from conducting hemp testing.
Laboratories to calculate Measure of Uncertainty (MU)
With the Final Rule, laboratories are expected to calculate and include the MU when reporting test results. The Guide to the Expression of Uncertainty in Measurement (GUM) defines MU as “a parameter, associated with the result of a measurement, which characterizes the dispersion of the values that could reasonably be attributed to the measurand.”
While there is no upper or lower limit for the MU, it is controlled using performance standards such as AOAC Standard Method Performance Requirements. Organizations such as ISO and Eurachem also provide guidelines for calculating MU. Hemp testing laboratories can refer to those guidelines as well.
Adherence to the ISO 17025 standards
While this is not an enforceable rule, the USDA strongly recommends all hemp testing laboratories be ISO 17025 compliant.
Laboratory SOPs
Testing laboratories must have an internal SOP for testing and retesting hemp. This SOP should be available upon request by state sampling agents or other responsible agents. Laboratory managers should ensure that all staff members follow the SOPs.
Reporting of THC
Once a laboratory has completed the test, whether failed or passed, they should share the results with all stakeholders:
The licensed producer
The appropriate State Department of Agriculture or Tribe
The USDA using AMS Form 22.
The THC should be reported on a “dry weight” basis.
Remediating and retestingof hot hemp
Once a laboratory finds a sample that has tested above 0.3% THC, it has to flag it as “hot” hemp. Previously, all hot hemp had to be destroyed but with the FR, parts of the hemp (excluding the flowers) can be salvaged.
A Laboratory Information Management System (LIMS) to manage multi-analyte test results and flag hot hemp (Figure courtesy of CloudLIMS)
The licensed producers (LP) are required to shred the hemp into biomass and send a sample back to the laboratory for retesting. The laboratory shall use the same procedure to retest the biomass and report the results back to the LP and the USDA.
The hemp final rule took full effect on the last day of 2021. The only extended deadline is the one requiring that all hemp-testing laboratories be registered with the DEA that still has a few more months to go.
Fast Track Your Laboratory’s Preparedness with a LIMS
Becoming compliant with USDA’s hemp testing rules can be quite challenging for a laboratory simply because there’s too much to keep up with. A laboratory must monitor samples, analyze and report test results, and at the same time maintain internal quality protocols.
Fortunately, digitization can help streamline processes and accelerate the preparedness of laboratories for the new federal rules. A cloud-based Laboratory Management Information System (LIMS) takes the hard work out of compliance by keeping track of compliance processes seamlessly and in real-time.
A LIMS enables laboratories to:
Track samples through their lifecycle
Automatically share results with stakeholders
Flag hot hemp samples
Generate certificates of analysis (COAs) in prescribed formats
Meet regulatory compliances
Manage SOPs, staff training, and QA/QC protocols
Hemp that tests above the 0.3% THC mark is considered cannabis and is therefore illegal under federal law. Consequently, hemp testing is a highly sensitive process that is strictly regulated. Hemp-testing laboratories must optimize their processes to ensure efficiency at all times and assure the validity of their test results. This can be made possible with a LIMS.
People today are more eco-conscious than ever. The last several years have seen a growing awareness of the impact of human behavior on the environment, and COVID-19 brought real-life context to the catastrophic effects of a global crisis. Lifestyle changes during the pandemic empowered people to make choices with a positive impact for the collective good. In a June 2021 PricewaterhouseCoopers survey , half of global consumers said they’ve become more eco-friendly since the COVID-19 pandemic. Consumers are changing their behaviors, educating themselves about the businesses they support, and evaluating the products they buy through a “green” lens. Terms like circular economy, zero-waste, ESG and carbon footprint are now part of the common vernacular, and sustainability is no longer a nice-to-have but a business imperative.
Cannabis consumers, in particular, value sustainability. They are conscientious of what they’re putting into their bodies and the planet. There is increased interest in brands and businesses that use responsible growing practices, eco-efficient manufacturing, and sustainable packaging. In a nationwide survey conducted by Canivate Growing Systems, 79% of U.S. cannabis consumers said they support establishing environmental standards. And in 2021, the Sustainable Cannabis Coalition (SCC) was formed to promote sustainability best practices.
Sustainable packaging is an important way that brands can show a commitment to the environment. Packaging is a highly visible and tangible representation of your brand and one that matters to consumers. A July 2021 Adweek/Morning Consult poll found that 77% of consumers believe it is the brand owners’ responsibility to make sure their packaging is recyclable. According to Nielsen, of the top five sustainability attributes consumers are willing to pay more for, three are packaging-focused: Recycled packaging, reduced packaging and reusable packaging. While cannabis packaging has unique regulatory requirements and safety guidelines, it can still be eco-friendly. Sustainable cannabis packaging has the necessary properties to protect against moisture and maintain freshness and smell. It can also be child-resistant and include other unique cannabis functionalities.
Image: Nielsen, 2019
When it comes to sustainable cannabis packaging, that which you may believe to be the “greenest” option may not be sustainable at all. Many factors go into this determination, including packaging material, weight, distance traveled from supplier to manufacturer, water and energy usage and more. At Berlin Packaging , we take a comprehensive and integrated approach to sustainability to ensure our solutions meet customer objectives and consumer expectations. We use life-cycle analysis to quantify a product’s environmental impact throughout its entire life cycle, including sourcing/raw materials extraction, manufacturing, distribution and end-of-life. This analysis ensures that the solutions we provide are effective, impactful, and don’t contribute to greenwashing.
One key pillar of sustainable cannabis packaging is material circulation – using recycled and recyclable plastics and alternative materials. It’s important to understand that not all plastics are created equal. HDPE and PET are fully recyclable and have a ~30% recyclability rate. Polypropylene, on the other hand, while recyclable, only has roughly a 3% recyclability rate. Color can also play a role. PET is valued for its transparency, so colored and opaque plastics are not considered recyclable.
Continuous innovation and technological improvements have contributed to several eco-friendlier plastic packaging solutions. One popular choice for many of today’s brands is post-consumer recycled (PCR) materials. Using recycled plastic reduces single-use plastic waste that fills our landfills and threatens our waterways. Bio-plastics, made using renewable plant-based materials, are another sustainable option. Berlin Packaging has partnered with numerous premium packaging manufacturers to provide sustainable solutions for our customers. Many of our offerings – suitable for flower, pre-rolls, edibles, concentrates and more – can be produced using PCR or bio-plastics.
Material circulation means using recycled and recyclable plastics and alternative materials.
We’re also seeing brands embrace new compostable, biodegradable and paper packaging options. Berlin Packaging offers pre-roll tubes that are 100% compostable in industrial or municipal facilities and are better for the environment while also protecting the product inside. With zero migration, zero odor, and zero visibility, these air-tight tubes maintain freshness and meet regulatory requirements. We also offer a variety of paper tubes for pre-rolls, vape carts, and flower that are reusable, recyclable, and biodegradable.
Other sustainable packaging strategies include refill & reuse systems, which have gained popularity over the past several years, especially among personal care categories. Other tactics to consider when evaluating your package’s sustainability scorecard are eliminating unneeded packaging components like outer wraps and neck seals, ensuring labels are recyclable, and lightweighting (reducing the weight of your package). Berlin Packaging evaluates all of these avenues when developing sustainable packaging solutions.
Beyond the packaging itself, we encourage our customers to consider aligning their branding design and on-pack messaging to tell their sustainability story. We’re seeing many brands elevate their packaging sustainability benefits on their packaging’s primary display panel. The How2Recycle labeling program is another tool that helps educate consumers about how to dispose of packaging to ensure it gets recycled properly. Berlin Packaging’s sustainability specialists assist companies with comprehensive messaging strategies. Given the rise of greenwashing and consumer confusion and skepticism, effective and impactful messaging is a critical part of a sustainable packaging strategy.
Working with packaging suppliers and design partners who understand the cannabis market and have sustainability expertise is key to a brand’s success. A holistic approach that considers consumer insights, design functionality, aesthetics, manufacturability, regulatory requirements and sustainability results in packaging solutions that grow sales and build brand loyalty.
Medicinal Genomics announced today that they have received AOAC International certification for their PathoSEEK® Salmonella and STEC E. coli multiplex assay. In combination with their SenSATIVAx® extraction kits, labs can simultaneously detect Salmonella spp. and STEC E. coli with a single qPCR reaction for flower, concentrates and infused chocolates using the Agilent AriaMx and the BioRad CFx-96 instruments.
The certification came after the multiplex assay was validated according to the AOAC Performance Tested Method Program. According to the press release, the PathoSEEK platform now has more cannabis matrices accredited for Aspergillus, Salmonella, and STEC E. coli than any other product out on the market, according to their press release.
The PathoSEEK microbiological testing platform uses a qPCR assay and internal plant DNA controls for reactions. The two-step protocol verifies performance while detecting microbes, which allegedly helps minimize false negative results from human error or failing conditions.
“AOAC’s validation of our Salmonella/STEC E. coli assay across the various cannabis matrices is further proof of our platform’s robustness and versatility,” says Dr. Sherman Hom, director of regulatory affairs at Medicinal Genomics. “We are excited that our PathoSEEK® platform is moving in concert with the FDA’s new blueprint to improve food safety by modernizing the regulatory framework, while leveraging the use of proven molecular tools to accelerate predictive capabilities, enhance prevention, and enhance our ability to swiftly adapt to pathogen outbreaks that could impact consumer safety.”
EDGARTOWN, MA, Feb. 21, 2022 – Innovative Publishing Company, Inc., the publisher of Cannabis Industry Journal, has announced the return to in-person events with the Cannabis Quality Conference & Expo (CQC), taking place October 17-19, 2022 at the Hilton in Parsippany, New Jersey. Presented by Cannabis Industry Journal, the CQC is a business-to-business conference and expo where cannabis industry leaders and stakeholders meet to build the future of the cannabis marketplace.
“Cannabis markets in New Jersey, New York, Connecticut, Pennsylvania and Massachusetts are all beginning to get off the ground,” says Aaron Biros, editor of Cannabis Industry Journal and director of the Cannabis Quality Conference. “Taking place in a pivotal year for the cannabis industry and in a location surrounded by new market opportunities, the CQC will deliver hands-on education, networking and business discussions. The venue setting, just a short train ride from New York City and Newark International Airport, coupled with highly focused content, creates a unique business meeting environment.”
The 2022 program will have three separate tracks of educational presentations and panel discussions, focused on Regulations & Policy, Safety & Quality and Business & Operations.
Due to safety protocols and venue restrictions, limited space is available for sponsors and attendees. The CQC is a hybrid event, meaning attendees will have the option to either attend in-person in New Jersey, or attend remotely via the virtual platform. Registration is now open. Click here to stay up to date on lodging, early bird pricing, keynote announcements and more.
Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.
About the Cannabis Quality Conference & Expo
The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.
This week, three companies in the cannabis testing space announced a partnership: Agricor Laboratories, its sister company Botanacor Laboratories and SC Laboratories will join forces to work together on comprehensive cannabis and hemp testing throughout the United States. The press release says that this partnership creates the foundation for a national testing network, offering comprehensive cannabis and hemp lab testing.
Agricor and Botanacor laboratories, founded in 2014, are sister companies headquartered in Denver, Colorado. SC Labs, founded in 2010, is based out of Santa Cruz, California. They say the partnership will bring value to cannabis and hemp industry stakeholders by offering a broader range of testing resources, better data collection and delivery, instrument redundancy, increased testing capacity and improved turnaround times.
“Agricor, Botanacor, and SC Laboratories have well-earned reputations for delivering high-efficacy results, through a ‘science-first’ approach to product quality, safety, and compliance,” says Dr. Carl Craig, CEO of Agricor and Botanacor. “With operations in Colorado, California, and Oregon, the newly combined operation is uniquely positioned to support multi-state cannabis operators, as well as hemp producers within the U.S. and throughout the world.”
Each lab is ISO 17025 accredited and have become known as leaders in the hemp testing market, offering a wide range of tests to meet state regulations in every corner of the United States. Last year, SC Labs debuted their comprehensive hemp testing panel, claiming they could meet testing standards in every state in the country.
“This combination creates the largest specialized resource in North America that is committed to delivering exceptional testing results that empower smarter growing, manufacturing, and consumer decision making,” says Jeff Gray, CEO of SC Labs. “By combining these reputable science organizations, we’ve taken major steps toward creating a laboratory network that is dedicated to improving the safety of cannabis products for all consumers, globally.”
According to Gray and the press release, the team is setting their sights on the global market, beyond just the United States. “The organization is focused on continued expansion via acquisition and organic entry to new markets – all with the focus on best serving customers’ needs across North America and supporting a growth market where testing can help deliver confidence to consumers,” reads the press release.
In the cannabis industry, it’s crucial to be able to predict the future, to adapt and survive in a competitive industry that is arguably regulated more closely than any other.
From licensing to buildout, there are a growing number of barriers to entering the cannabis industry as a cultivator. Those who are lucky to successfully establish a grow operation are well aware that one of the crucial hurdles is managing space to maximize facility efficiency and capacity.
To stay profitable, the more plants you can grow and harvest at a time in a continuous cycle, the better. From an economic and environmental perspective, managing cost, space and time comes down to automation and efficiencies. One of the most efficient ways we optimize is through the practice of vertical farming.
Vertical farming maximizes canopy square footage while minimizing Cost of Goods Sold (COGs) to produce high-quality cannabis at scale year-round, and the industry is slowly finding that this method is an incredibly efficient and profitable way to maximize cannabis output.
Yellow Dream Farm is our family-owned cannabis cultivation, manufacturing and distribution company based in San Bernardino County, California, often known as the Silicon Valley of cannabis. Our craft, boutique-style cannabis is grown from floor to ceiling in the 30,000-square-foot facility. We’re using cutting-edge technology that’s only come to market in the last five years and using a variety of sustainable practices. With environmental and feeding efficiencies, we’re able to harvest 300 pounds per week when compared to 150 pounds per week from a facility of the same size.
Vertical Farming for Space Optimization
Like any medical field, cannabis has seen large numbers of outside investments into the space, bringing ideologies and efficiencies from other time-tested industries. One such efficiency is vertical farming – a practice already seen in large-scale agriculture.
The Yellow Dream Farm vertical cultivation facility
We choose vertical farming to maximize our canopy square footage and minimize COGs to produce high-quality cannabis at scale. The barrier to entry into the cannabis industry is expensive, and you must utilize every square inch to stay profitable. We believe vertical farming is the most efficient and most profitable way to maximize output and our numbers can back that up; for example, we can produce double the amount of flower than the average single-tier room with the same square footage, without doubling the cost.
Our rooms contain double stacks to double room capacity by using ceiling heights instead of square footage. Even though vertical farming has larger start-up costs, we can maximize square footage and output, allowing us to get a better and faster ROI. Vertical farming can be done in many different ways but the way we built our facility was always with a sustainable outlook. We also look to improve and remove human error; with full irrigation control and crop steering technologies, we can recalibrate sensors, irrigation media and environmental sensors when needed based on successes, challenges or environmental constraints. Additionally, we have a few other sustainable practices that make a difference.
Water Conservation, Lighting and Automation
Being a California-based grower, water conservation is a key part of our operations. With San Bernardino County being located in the heart of the high desert, conserving water is not only a requirement but a competitive advantage. Our practices provide cost savings which we then pass along to our customers. Each cannabis plant on average requires between a half gallon and one gallon of water per day, which we then recirculate through condensate water from our A/C and dehumidifiers. All runoff nutrient water is re-filtered and reused to get the most out of our nutrients before discarding waste. Our freezer panel walls hold temperatures at consistent rates, and we have a fully automated system to dial in specific needs at any given time.
LED lights above a crop at Yellow Dream Farm
Lighting is another major environmental and capital cost. Our primary lighting system is LED technology, and we use LED spectrums to find which spectrum benefits the plant most. With LEDs, our energy consumption is 30 percent less.
Vertical Farming Is the Future of Cannabis and Agriculture
Vertical farming has been hailed as the future of many agricultural industries and cannabis is no different. We already see large vertical farms in most legal states, but surprisingly it’s still not a common style of growing. As the price per pound steadily declines in California, being able to keep COGs down will allow vertical farmers to sustain and thrive in this volatile industry.
In order to adapt, grow and leave a positive mark on the industry, we must pave the way for new styles of growing and utilizing new technology and science that was not available to growers in the past. We can use these advanced new technologies to make real-time changes to each sector of our facility and optimize both people power, and energy efficiency. And most importantly, we’ll be able to produce top-quality cannabis for adults to enjoy at affordable prices.
According to projections, counterfeiting and piracy could reach $2.3 trillion in the US alone, bringing the economic cost to $4.2 trillion globally by 2022. The pandemic made the billion-dollar problem even worse. Products that you directly ingest or place in contact with your body have become a target for counterfeiters introducing some serious side effects.
More than 70% of the CBD products purchased at unlicensed CBD shops in the Los Angeles area failed after-market laboratory testing according to the SC Labs report brought by the United Cannabis Business Association (UCBA). More than half of the tested samples labeled as hemp or hemp-based did not qualify as hemp. Perhaps the biggest concern is the level of contamination which in some cases, were several hundred times the allowed limit.
With the rise of synthetic cannabinoid agonists, some of them having a structure similar to THC, it is hard to keep track of the complete list. The majority of these chemicals are produced in Asia without standards or regulations. The most extreme case has been a version of synthetic cannabis laced with rat poison that led to several deaths.
Last year in Florida, synthetic THC was to blame for daily emergency calls to Poison Control. Poisoning cases linked to counterfeit cannabis edibles tripled between 2019 and 2020.
Vaping is growing rapidly in popularity. An illicit market has emerged and with it a rise in Vaping-Associated Pulmonary Illness (VAPI). Over a hundred cases have been reported in California contributing to over a thousand reported cases nationwide.
Consumers pay a harsh and unnecessary price with their health, risking long-term damage or even death. If you don’t know the source, it is very difficult to identify counterfeit cannabis products. Still, some telling points can help you identify the fakes:
Authentic-looking products available at dubious prices perhaps bought at a gas station or a convenience store.
Packaging that matches a reputable brand, without the brand’s logo and missing required details such as an amount of CBD and THC per serving.
Missing laboratory testing information
Authentic-looking counterfeits can have labeling that mimics a brand’s look, but could be missing key information.
Legitimate product manufacturers and brand owners suffer financial losses, as well as something even more precious – trust and reputation.
Essential elements of a brand protection program
Are you running a business in the cannabis industry? It is your top-quality product the customers want and not some third-rate knockoff. How can you provide your customers with the means to verify that their product is genuine? Let’s weigh several methods.
1. Provide images and videos of an authentic item on your website
Pros:
Customers can visually compare the details of the product.
Cons:
Customers need to know your website and navigate to a specific page with product details. You need to capture several details of the product.
2. Label each item with a unique product code. Optionally use a hologram image as an additional anti-forgery
measure
Pros:
Customers can verify a single product code instead of several visual details.
Cons:
You must be able to generate unique product codes and maintain a database of these codes for later verification.
You need to implement a solution for customers to authenticate their product codes.
3. Use a product number authority like ProdNum to issue and validate unique QR product codes for you
Validating a product using QR Code
Pros:
Customers don’t need to retype an alphanumeric product code, merely scan a QR code with a camera to get instant verification.
The manufacturer doesn’t need to implement and maintain a custom solution.
Cons”
You need to arrange printing of the QR codes on the package or stickers you will attach to each product.
The inevitable drawback of a profitable cannabis business is the fact it attracts counterfeiters. Businesses and customers joining forces in the never-ending battle against counterfeiting is a winning scenario for both.
Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.
This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.
In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.
Oral Cannabinoid Delivery
Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.
Some of the many infused products on the market today.
Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.
Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.
Cannabinoid capsules
Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.
To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.
Fast-Acting Absorption
Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.
A drink additive, made by Splash Nano, that uses nano emulsion technology
Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.
As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.
Microencapsulation to boost cannabinoid absorption
Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.
Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.
Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.
This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.
Metered Dose Inhalers
So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.
A metered dose inhaler by MÜV
Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.
Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.
Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.
Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.
Now entering its sixth year of medical cannabis legalization, the Empire State is well on its way to expanding the market considerably. When New York first legalized medical cannabis, it had some of the strictest rules in the country. Dispensaries needed to have pharmacists and doctors with special training on staff, they couldn’t sell flower and there was a very small list of qualifying conditions for getting a cannabis prescription.
While New York legalized adult use cannabis back in March of 2021, the actual market is still probably about a year away from launching. The bill immediately decriminalized possession up to certain amounts and set up the Office of Cannabis Management (OCM), New York’s regulatory body now overseeing the medical, adult use and hemp markets.
Over the past six years since the state legalized medical cannabis, the rules have eased incrementally, with more licenses awarded, more doctors participating, more qualifying conditions approved and a larger variety of products on dispensary shelves. Back in 2017, they added chronic pain to the list of qualifying conditions, which was seen as a big effort at the time for expanding patient access.
Just a few weeks ago on January 24, 2022, the Office of Cannabis Management, dropped all qualifying conditions. That means patients with more common ailments and really any type of condition, like anxiety or sleep disorders, can get a prescription for cannabis.
“Launching the new patient certification and registration system and expanding eligibility for the Medical Cannabis Program are significant steps forward for our program,” says Chris Alexander, executive director of the OCM. “We will continue to implement the MRTA and ensure that all New Yorkers who can benefit from medical cannabis have the access they need to do so. It’s important for New Yorkers to know that even as we shift the medical program to the OCM, your access will not be disrupted and the program will continue to expand.”
New York City Image: Rodrigo Paredes, Flickr
In addition to dropping qualifying conditions, the state took a number of other measures to increase access and allow the market to expand further. For example, dispensaries can now sell flower, more physicians like dentists, podiatrists and midwives can participate, the OCM removed the patient registration fee and they increased the amount of cannabis patients can purchase at a time.
Beyond the medical market, New York is making strides in launching their hemp program as well as preparing for the eventual launch of the adult use market. Back in November, the state’s Cannabis Control Board approved new regulations for the hemp program, establishing standards for manufacturing, lab testing, packaging and labeling.
On the adult use front, delays are the name of the game. According to a publication called The City, delays to launch the new market have been made worse by former Governor Andrew Cuomo’s resignation following sexual harassment allegations. They say the state might not see the launch of the adult use market until early 2023 at best. Decisions on licensing, standards and rules are to be made by the Cannabis Control Board, a five-member commission tasked with overseeing the OCM. So far, the Board has not addressed a timeframe for when they will begin adult use sales.
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