Tag Archives: Testing

A Research Study on the Antimicrobial Properties of Cannabis

By Cindy Orser, PhD
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Inexpensive in vitro Methods to Evaluate the Impact of Cannabinoid-containing Products on Sentinel Lactobacillus spp. 

S. Lewin 1, A. Hilyard2, H. Piscatelli1, A. Hangman1, D. Petrik1, P. Miles2, and C. Orser2

1MatMaCorp Inc, Lincoln NE; 2Apothercare LLC, Boston MA 

Abstract

The public has readily embraced cannabidiol (CBD) in countless unregulated products that benefit from commercial promotion without FDA oversight, who recently concluded: “that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products w/ the regulatory oversight is needed to manage risks.”1 The reported antimicrobial properties of CBD combined with the recent proliferation of cannabinoid-containing products marketed to women for intimate care led us to explore the impact on the sentinel lactobacilli species associated with a healthy reproductive tract. Except for lubricants and tampons, the FDA regulates intimate care products as cosmetics. Even non-cannabis serums, washes, and suppositories are not required to be tested for their effect on the reproductive microbiota. We aimed to investigate the utility of easy-to-use, inexpensive in vitro assays for testing exogenous cannabis products on reproductive microbiota. In vitro assays can provide important evidence-based data to inform both manufacturers choosing both an active cannabinoid ingredient source as well as excipient chemicals and consumers in the absence of safety or quality data. In simple, straightforward exposure studies, we examined the antimicrobial activity of CBD and cannabigerol (CBG) on the most dominant vaginal lactobacilli species, L. crispatus, associated with good health.

Introduction

The testing of readily available products containing cannabinoids, predominately CBD following the widespread legalization of hemp by the 2018 US Farm Bill, is not required beyond ensuring THC content is below 0.3%. Therefore, basic information on safety, quality, antimicrobial activity, bioavailability, and dosing is unavailable and undocumented. The situation is further complicated by the complex chemoprofiles of cannabis extracts based on the cultivar, the extraction methods and subsequent cleanup, and other chemical excipients in the formulation. The FDA has finalized guidance on quality considerations for clinical research for the development of cannabis and cannabis-containing drugs intended for human use.

One approach to backfilling non-existent safety and quality data for cannabinoid active ingredients and those products made from them is to apply or devise assays that can provide relevant toxicity data in an in vitrosystem. Farha et al. (2020) reported that seven cannabinoids are potent antibiotics, including CBD and synthetic CBG. CBG inhibited the growth of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), but not gram-negative bacteria unless their outer membrane was permeabilized (Farha et al. 2020). In addition, several volatile terpenes, the main constituents of essential oils extracted from Cannabis sativa L., also have potent antibiotic activity against gram-positive bacteria (Iseppi et al. 2019). We have previously written about the risks associated with disrupting the healthy microbiome of gram-positive vaginal bacterial species leading to dysbiosis (Orser 2022) and its further health complications.

Several successful approaches to assessing the toxicity of CBD have already been reported including human cell culture work by Torres et al. (2022) who showed that pure CBD has a repeatable impact on cell viability, but that hemp-derived finished CBD products had variable impact. Cultured human cell viability experiments demonstrated similar potencies across three different hemp-derived CBD products in the microgram per milliliter [mg/mL] range with increased viability at lower doses [2-4 mg/mL] and decreasing cell viability above 6 mg/mL (Torres et al. 2022). In the same study, the authors demonstrated that the presence of terpenes, specifically b-caryophyllene, in hemp extraction matrices also impacted cell viability.

Neswell, a cannabis therapeutics company in Israel, demonstrated through the application of their in vitroneutrophil cell line that cannabis extracts have inherent immune response biodiversity, suggesting that the choice of a cannabis source should be based on its function rather than on its chemoprofile (https://www.neswell.net). Inflammatory cytokine levels in inflamed peripheral blood mononuclear cells (PB_MC) showed a 10-fold difference across hemp extract products containing unidentified terpenes in suppressing the inflammatory cytokine, TNFa (Torres et al. 2022). The influence of CBD concentration on inflammatory cytokine production was previously reported by Vuolo et al. (2015) and Jiang et al. (2022).

Materials & Methods

Chemicals and Products Tested

THC-free, 99% pure CBD and CBG isolates were purchased from Open Book extracts in North Carolina (openbookextracts.com). All other chemicals including erythromycin (EM), and growth media were obtained from Sigma-Aldrich (St. Louis MO). Specific reagents in the qPCR kits were assembled in-house at MatMaCorp Inc. (Lincoln NE).

Monitoring Cell Viability: OD600nm and plating

Individual frozen glycerin stocks of L. crispatus HM103 from BEI Resources Repository served as inoculum to streak on a sterile MRS agar plate and incubated anaerobically at 370C for 24-48 h until individual colony growth was observed. Single colonies were used to inoculate MRS broth and incubated for 24-48 h at 370C which served as the inoculum for exposure to test products. Exposed cultures and all control cultures were incubated at 370C for 48 h with OD600 readings taken at time zero, +24 h, and +48 h using disposable cuvettes in a standard spectrophotometer. The products were also plated onto MRS agar plates to evaluate inherent contaminants that could affect turbidity values.

Molecular Analysis by qPCR

DNA isolation from bacterial cultures was done using the MatMaCorp (Lincoln, NE) StickE Tissue DNA Isolation kit modified for bacteria as per manufacturer instructions. Briefly, a lysis buffer is applied to the sample followed by a heating step, and a binding buffer is added, thus allowing DNA from the solution to bind to the matrix of the StickE column. The column was washed prior to eluting the purified DNA. Per manufacturer instructions, 10 µL of isolated DNA was used as a template for genetic analysis in a Lacto-TM assay (MatMaCorp). The assay is a customized TaqMan-based detection assay that is conducted using a four-channel fluorescence detection platform, the Solas 8 (MatMaCorp). The assay was designed to detect the unique 16S-rRNA DNA sequence for L. crispatus. Briefly, the assay is a probe-based method that begins with hybridizing the custom-designed probes with their desired nucleic acid target found in the sample. Once hybridized, detection takes place from the fluorescently labeled primer. The target has been assigned a channelon the Solas 8 and is detected independently. 

Calling the Results

The calling algorithm uses first-order kinetics reaction properties (inflection point detection) in combinationwith a measure of the closeness of the signals associated with a specific target. Various indicators are tracked during the reactions to perform an on-the-fly analysis. The analysis is then consolidated by a measure of the similarity between the fluorescence signals at the end of the run. Aggregating values from the similarity measure, the end gain and the inflection point detection allow the Solas 8 software to make the call at the end of the run without having to compare a results library of known sample targets.

Figure 1: qPCR Findings

Results

Exposure of L. crispatus

Anaerobically grown cultures of L. crispatus were exposed to either CBD isolate or CBG isolate at each of two concentrations [5 mg/mL] and [10 mg/mL] with all appropriate controls. All treatment groups were evaluated by qPCR, turbidity at OD600, and plate counts.

Molecular Analysis via qPCR

These data show the specificity of the Solas8 testing for evaluating these products, as a molecular-level screening is not influenced by test product solubility, opacity, or non-specific contamination present in some of the tested products that can interfere with optical density measurements.

Growth Monitoring

Figure 2: Turbidity

Turbidity monitoring, albeit non-specific, confirmed the species-specific qPCR findings, that is no inhibition for the two cannabinoid isolates evaluated (Fig. 2).

Conclusions

In this limited in vitro study using a sentinel lactobacilli response, we have shown that 99% pure CBD and CBG isolates were not inhibitory at the two doses evaluated by complementary observations following turbidity, plating, and by qPCR. Limitations in this study prevent definitive conclusions regarding what individual or combination of cannabinoids or other cannabis secondary metabolites are inhibitory in vivo to dominant lactobacilli species in the reproductive tract. These limitations include commercial product testing without knowledge of excipients or impact on the bioavailability of any active cannabinoid ingredients. In addition, dose-response curves were not generated and exposure under micro-aerobic conditions was not carried out.

Cannabidiol’s potential as an antimicrobial agent may be limited by its extremely low solubility in water and a propensity to stick to spurious proteins limiting systemic distribution in the body as a therapeutic. Interpreting microbiome study findings to human health outcomes will require multi-disciplinary corresponding clinical data findings of disease diagnosis, processes, and treatment within populations. Nonetheless, this nascent translational research opportunity is vast with the promise of benefiting patient outcomes (Wensel et al. 2022).

Health Canada released a scientific review report on products containing cannabis, specifically containing 98% or greater CBD and less than 1% of THC (Health Canada 2022) while the FDA just concluded that there are no existing guidelines applicable for recommending safety and quality guidelines to manage risk for CBD products (U.S. FDA 2023). The Health Canada committee unanimously agreed that short-term use of CBD is safe at 20 mg per day up to a maximum dose of 200 mg per day and that packaging should include both dosing instructions and potential side effects. The Committee did not address the antimicrobial potential of CBD or CBG formulations or specifically vulvar or vaginally administered cannabinoids. There is clearly more basic physiological research needed on the impact of self-administration of CBD preparations based on the route of exposure.

References 

1. https://fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

Farha MA, El-Halfawy LM, Gale RT, MacNair CR, Carfrae LA, Zhang X, Jentsch NG, Magolan J, Brown ED (2020) Uncovering the hidden antibiotic potential of cannabis. ACS Infect Dis 6:338-346. 

Health Canada (2022). https://www.canada.ca/content/dam/hc-sc/documents/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis/report-cannabidiol-eng.pdf 

Hopkins AL (2008) Network pharmacology: the next paradigm in drug discovery. Nat Chem Biol 4(11):682-90.

Iseppi R, Brighenti V, Licata M, Lambertini A, Sabia C, Messi P, Pellati F, Benvenuti S (2019) Chemical characterization and evaluation of the antibacterial activity of essential oils from fibre-type Cannabis sativa L. (Hemp) Molecules 24:2302; doi:10.3390/molecules24122302.

Jiang Z, Jin S, Fan X, Cao K, Liu Y, Want X, Ma Y, Xiang L (2022) Cannabidiol inhibits inflammation induced by Cutibacterium acnes-derived extracellular vesicles via activation of CB2 receptor in keratinocytes. J Inflammation Res 15:4573-4583.

Orser CS (2022) Prevalence of Cannabinoid-containing Intimate Care Products Exposes Longstanding Unmet Need for Safety Data on Community Microbiota Exposure. https://cannabisindustryjournal.com/feature_article/intimate-care-products-with-cannabinoids-need-more-safety-data/

Torres AR, Caldwell VD, Morris S, Lyon R (2022) Human cells can be used to study cannabinoid dosage and inflammatory cytokine responses. Cannabis Sci & Tech 5(2) 38-45).

U.S. FDA (2023) https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

Vuolo F, Petronilho F, Sonai B, Ritter C, Hallak JE, Zuardi AW, Crippa JA, Dal-Pizzol F (2015) Mediators Inflamm 538670

Wensel CR, Salzberg SL, Sears CL (2022) Next-generation sequencing insights to advance clinical investigations of the microbiome. J Clin Invest 132(7):e154944. https://doi.org/10.1172/JCI154944.

Ask the Experts: Supply Chain Risks in Hemp & Cannabis

By Cannabis Industry Journal Staff
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There are a lot of risks throughout the entire supply chain in the cannabis and hemp markets. Legal and regulatory issues, quality control reliability, security problems, product safety, potency, and constantly changing supply and demand are just a few major risks cannabis operators must stay on top of. A lot of companies mitigate these risks by implementing programs to find the source and figure out what actions could alleviate it. Those actions can look like reviewing testing or certification reports, auditing supplier facilities, and much more.

Jennifer Lott, AMAS Service Delivery Director for the standards certification body, BSI, has over 25 years of experience in quality, safety, lab management, consulting, packaging, and systems development. She’s an expert in GMP, ISO 22716, 21 CFR 117, 21 CFR 111, 21 CFR 210-111, ICH Q7, WHO GDP, RSPO, food safety, GMP/HACCP and much more.

She is a panelist for an upcoming webinar, Supply Chain Risks in Hemp and Cannabis June 27, 2023. During that webinar, she’ll join other experts where they’ll discuss some of the supply chain risks cannabis companies face and what they can do to mitigate those risks.

Ahead of her webinar, where she’ll take a deep dive into supply chain risks, we sat down with Lott to get a preview for what she’ll talk about.

Q: What are the major supply chain issues faced by the cannabis and hemp markets currently?

Jennifer Lott: The U.S. market remains highly complicated for cannabis companies and investors. Fewer than half of U.S. states and territories have legalized recreational cannabis use as of Nov. 2022.

To this day, cannabis is still a Schedule one substance under the Controlled Substances Act, alongside drugs like heroin, LSD and ecstasy – an issue that has led to several regulatory and fiduciary challenges for growers, processors, and distributors of cannabis/hemp.

Legal concerns aside, cannabis companies operate much like other businesses and face almost the same exposures that most enterprises do. Here are the top risks cannabis businesses encounter, according to experts.

  • Distribution – Current regulations prevent products from one state to be transported to another state.
  • Natural disasters – including wildfires, storms, and flooding, can easily damage crops
  • Cybersecurity – Because of the type of information that cannabis companies handle, they can also become a prime target for hackers.

Despite the supply chain challenges mentioned above, the cannabis industry is growing, and its use is becoming more accepted in society, but still faces major challenges. These trends also will create a volatile and fast-changing environment cannabis companies in 2023. The big challenge will be deciding which of the scores of startups, IPOs and established cannabis companies can surmount the upheaval and succeed long term.

Q: How are companies mitigating risks and what tools are at its disposal?

Lott: Anyone involved in the cannabis/hemp business knows they need to manage their risk with a solid risk management plan.

The three biggest risks facing cannabis/hemp businesses aside from the supply chain issues mentioned above, include:

  • Employee theft – employees have easy access to the product, run cash registers at dispensaries, and generally know a lot about the inner workings of the company. Protecting against insider theft is critical for the business.
  • Product tampering – this can happen at any stage in the supply chain. Businesses whose products cause harm could be liable for injury and damages.
  • Compliance regulations – compliance varies from state to state and laws are frequently changing.

Thanks to regulatory uncertainty and limited access to tools other industries have access to, the cannabis industry likely will have an increased risk profile for the foreseeable future. This heightens the need for a structured, risk management approach. However, even with so many external factors out of its control, cannabis companies still can dramatically decrease risks by addressing internal strategies and processes.

Cannabis companies with effective, relevant, and well-documented risk management practices can better positioned to create and preserve capital, attract investment, and achieve long-term sustainable growth.

Jennifer Lott is speaking at the Supply Chain Risks in Hemp and Cannabis Webinar, taking place June 27 at 11:00 am EST. Click here to register.

About Jennifer Lott

Jennifer Lott is the AMAS Service Delivery Director for the internationally recognized standards certification body, BSI. Jennifer currently supports the quality and integrity of food and fast-moving consumer products. She is an accredited Lead Auditor and Trainer with over 25 years of experience in quality and safety, management system development, consulting, packaging, and laboratory management. Jennifer’s expertise includes GMP, ISO 22716, 21 CFR 117, 21 CFR 111, 21 CFR 210-111, ICH Q7, BRC GS Consumer Products, WHO GDP, EudraLex, BRC GS Storage & Distribution, BRC GS Packaging, BRC GS Agents & Brokers, RSPO, Food Safety, and GMP/HACCP.

Content Sponsored by BSI

Stemming the Tide: Strategies for Cannabis Testing Labs & Regulators to Address THC Inflation and Lab Shopping

By Arun Apte
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The cannabis industry in the United States is booming. In just a few years, it has gone from a small, underground market to a multi-billion-dollar industry. This growth is due in part to the legalization of cannabis in many states, as well as the growing public acceptance of its use for both medical and recreational purposes.

The industry is still in its early stages, but it has the potential to be a major economic driver for the United States. However, the industry’s success has brought with it challenges, such as THC inflation. This is when growers inflate the THC levels of their products in order to sell them for a higher price. This practice has led to widespread lab shopping, as growers send their products to labs that promise to give them the highest THC readings.

THC Inflation and Lab Shopping: A Look Under the Hood

Among cannabis enthusiasts, a prevailing belief circulates, asserting that cannabis products with elevated THC levels inherently possess greater potency and induce more pronounced effects. Nevertheless, this belief rests upon a fallacy, for it erroneously assumes that THC levels alone dictate the overall potency of a cannabis product. Genuinely comprehending the potency and effects of cannabis products requires the consideration of an array of factors. These factors include the presence of other cannabinoids and terpenes, the method by which the substance is consumed, as well as an individual’s metabolic and tolerance peculiarities. For instance, a particular strain of cannabis with low THC content, but elevated levels of other cannabinoids and terpenes, may engender a more intense impact in contrast to a variety exhibiting higher THC levels but diminished quantities of other compounds.

This misguided notion that heightened THC levels correspond to augmented potency has contributed to a surge in the demand for high-THC products. Consequently, producers have resorted to offering incentives to labs that provide inflated THC numbers for their products. Thus, certain labs have engaged in a practice coined as “lab shopping,” whereby they furnish reports that align with the producers’ desired THC levels, rather than accurately reflecting the genuine levels present within the product.

The manipulation of THC levels and the deceitful practice of lab shopping inflict profound damage upon the cannabis industry, eroding the foundation of trust. The fact that growers selectively collaborate solely with labs that yield desired outcomes, generates a mirage of superiority surrounding their products, thus deceiving consumers. Consequently, unsuspecting customers find themselves in possession of goods that fall far short of the promised standards of potency or quality. Moreover, this predicament places labs that remain steadfast in their commitment to integrity and the provision of accurate test results at an unfair disadvantage.

Fighting Back to Eradicate THC Inflation and Lab Shopping in the Cannabis Industry

The relentless surge of THC inflation finds its origins in the glaring absence of standardized testing protocols within the cannabis industry. As each lab embraces diverse methodologies and tools, testing produces disparate outcomes. This dissonance becomes a fertile ground for unscrupulous labs, who seize the opportunity presented by this lack of uniformity to peddle false THC numbers. To compound matters, the scope for manual interference looms large. The solution to this problem is to create a set of standards that everyone in the cannabis industry must follow. It’s important for the industry to come together and establish a common set of rules for testing. This will ensure that all labs consistently follow the same procedures and produce accurate results. In addition, it is important to have different labs take part in proficiency testing to find outlier labs. States should also take quick action to punish labs that provide incorrect or exaggerated THC values in their reports.

A representation of various ways to arrest the budding trend of THC inflation and lab shopping (Figure courtesy CloudLIMS)

It is extremely important to prioritize transparency among labs in order to address the growing concerns regarding the inflation of THC potency. State regulatory bodies can achieve this by conducting frequent audits to detect and correct any inconsistencies or inaccuracies in the data. To make this possible, state agencies need to hire skilled data scientists who can thoroughly analyze the data produced by labs. If the industry collectively works towards addressing these issues, it will enhance consumer trust in the regulated market. By eliminating the incentives that drive THC potency inflation, a more trustworthy cannabis industry can take shape and flourish. 

Next, it is crucial to educate customers about the false notion that higher THC levels always result in stronger effects. Through effective communication and raising awareness, the industry can address the issue of THC potency and discourage the practice of selectively choosing labs with desired results.

Finally, labs should achieve accreditation to ISO/IEC 17025 as evidence of their competence in producing trustworthy results. This will help restore customer trust in the regulated cannabis industry and establish a stronger system for quality assurance.

The Importance of Deploying a Cannabis Lab Testing Software

Having a Laboratory Information Management System (LIMS) is essential to meet the challenging ISO/IEC 17025 requirements. This system plays a critical role in providing an extra level of assurance and trust in the accuracy of lab results. By automating processes, integrating analytical instruments, and adhering to rigorous quality standards, a cannabis lab testing software minimizes the possibility of manual manipulation of test results. 

Furthermore, a cannabis lab testing software maintains a sample chain-of-custody (CoC) through the sample life cycle and tracks samples using barcodes. Furthermore, it generates custom reports that include scannable QR codes, which can be instantly shared with customers. By configuring the QR code, it becomes possible to include a link to the original Certificate of Analysis (CoA) produced by a lab. This allows buyers to verify the reported composition on the product label by referring to the authentic test results on the CoA. This approach promotes transparency, trust, and accountability within the cannabis industry. 

Tackling THC Inflation & Lab Shopping with Cannabis Lab Testing Software
Cannabis lab testing software to manage and track samples through their lifecycle and maintain a CoC (Figure courtesy CloudLIMS)

A cannabis lab testing software carefully monitors and records all activities, such as staff logins, document modifications, sample records, and test results, with a date and time stamp along with the name of the person who performed those activities. This thorough record-keeping process eliminates any chance of manual tampering with lab data, thereby enhancing the reliability and defensibility of test results. Moreover, the system effectively manages the outcomes of various Quality Control (QC) samples to guarantee accurate test results. By comparing the test results of QC samples with the samples being tested, the system can identify any analytical errors and enable lab managers to fix them, enabling labs to uphold quality standards.

The cannabis industry has experienced swift expansion as a result of cannabis legalization in multiple states across the United States. This has brought about various advantages, such as increased demand for cannabis products and the creation of new employment opportunities and tax revenue. However, the industry has faced challenges such as the issues of THC inflation and lab shopping. Dishonest producers and labs take advantage of the lack of standardized industry practices to deceive regulators and consumers. To address this issue, it is crucial to establish industry-wide testing standards that ensure consistency and accuracy across all labs. State agencies must also take prompt action to penalize labs that provide false THC values. Additionally, educating consumers about the misconceptions surrounding high THC levels and potency is important to combat this detrimental trend in the industry. Implementing cannabis lab testing software can help reduce the potential for human error and guarantee the authenticity and reliability of lab data. 

This nascent but fast-growing industry holds remarkable promise for medicine and the economy, which can only be realized if proper safeguards are put in place and malpractices are stopped in their tracks.

Rise of the Machines: The Case for Automation in the Cannabis Industry

By Kyle Loucks
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The Case for Automation in the Cannabis Industry

History has shown that if companies fail to innovate when new technology emerges, even household name brands with enormous market share can squander their success if they are blind to anything that could ever unseat them from the top.

Kodak developed digital camera technology in the 1970s but didn’t envision a world where the film market wasn’t dominant. Toys R’ Us failed to adapt to the changing retail landscape, and Amazon became the chief source of online toy sales. Blockbuster famously laughed Netflix out of the room when the now-$149 billion behemoth sought to sell for a measly $50 million.

A “knockbox”-style unit for producing prerolls

Brands in the cannabis landscape can also fall victim to this same misstep. New technologies are driving the industry forward, yet many brands are still standing by sub-par processes. Whether due to misplaced beliefs around automation or an unwillingness to invest, cannabis brands could suffer the same fate as many of these bygone-era brands.

The Financial Argument: Automation Reduces Overhead 

The financial argument for automation is at the top of the list of motivators for most cannabis businesses. A great example of this is with pre-roll production. For cannabis brands still employing a “dexterous approach” to their pre-roll manufacturing, staying afloat to keep up with demand is a constant battle. Rebel Spirit, currently the number one pre-roll brand in Oregon, was burning through eye-welling amounts of money in labor costs to produce 300,000 pre-rolls per month. With a crew of 22 full-time pre-roll manufacturers, the team at Rebel Spirit quickly realized their process was unsustainable, and they were headed for an economic crisis if they didn’t cut costs.

The Blackbird atuomated system

They were using a knockbox-style unit which they had modified themselves in an attempt to force it to fit their needs. But this “semi-automated” solution simply wasn’t working. Rebel Spirit then turned to our team at RollPros to clean up and fully automate their production process, helping them to create quality pre-roll at scale with a fraction of the labor costs. (We are the Vancouver, WA-based designer and manufacturer of the Blackbird automated joint rolling system.) For them, it wasn’t a matter of greed, as some opponents of automation sometimes claim; it was simply a choice of going out of business or not. In competitive markets like the Beaver State, where every dollar counts, the case for automation was a no-brainer.

The Remote Argument: Automation Reduces Risk Of Human Error 

It’s a basic concept: the more human interaction in your processes, the more risk for error. We, as flawed humans, are simply not capable of being as precise or consistent in our work as a machine can be. Consider the cultivation process. Most experienced cultivators will tell you that growing cannabis is easy, but growing quality cannabis is very difficult, with a lot that can go wrong.

Enter one of the most valuable automation tools for cannabis cultivators – automated irrigation systems. With your irrigation systems and nutrients on autopilot, cultivators can ensure plants get the ideal mix of nutrients regardless of whether you are on-site, remote or facing a staffing crunch. Sensors can provide real-time data so that water, nutrients or even light can be adjusted as needed. In many cases, even these adjustments can be automated. (Think AI hasn’t entered the cannabis space yet? Think again!) Sure, there is always a potential for issues no matter how advanced a system you use. But when you compare this to a farmer using a manual watering and nutrient system, there are far fewer opportunities for mistakes. Does a human feel the difference between .94 gallons of water and 1 gallon of water? No. But a well-calibrated irrigation system can tell the difference and even alert you if it goes outside of whatever tolerance limits you set.

When the cost of flower is high, human errors that lead to damaged or inferior product are often overlooked. But when flower prices drop as markets mature, success versus failure can be balanced on a knife-edge, and cultivators can’t afford to make mistakes.

The Skynet Argument: Automation Increases Productivity Without Taking Your Job 

Whether AI is coming for our jobs or will destroy human creativity as we know it has been argued ad nauseum since the release of AI tools like ChatGPT and Midjourney. The good news? Automating your business doesn’t mean enlisting the T-1000 from Terminator 2 to terminate your 9-to-5. Think of automation as Arnold Schwarzenegger telling you to come with him if you want to live.

The Green Vault automated packaging system

The truth is that any task that needs to be completed frequently or on a set schedule is ripe for automation. Automation eliminates tethering your most talented employees to cog-in-the-machine work that wastes their time and abilities. Freeing them up to focus on more high-value tasks like customer service, marketing, or new product development will likely make your business more profitable long term, and make your employees happier with their work.

No industry has been spared from the impacts of industrial automation, says Amar Olgeirsson, CEO and founder of Green Vault Systems, but, “labor is typically not reduced as a result of automation.” Instead, “production is increased, and workers’ value increases because of higher production in terms of units produced per labor time. By increasing worker efficiency, companies and corporations are able to pay their workers a higher salary,” says Olgeirsson.

The Performance Argument: Automation Guarantees Consistent Quality Every Time 

Expansion across state lines means consumers know they can buy the same quality product whether they buy it on the East Coast or West Coast. You know that you can buy your favorite Red Blend wine whether you’re in Denver or Atlanta and expect to enjoy the same tasting glass (barring any unintended oxidization). If a customer purchases that same glass of wine, and it doesn’t meet their expectations of what it should be (it’s inconsistent with the last time they had it), a brand is essentially breaking a promise to that customer. When a customer doesn’t get what they want and expect out of a product, they’ll quickly move on to a competitor. Consistency builds loyalty… inconsistency destroys it.

A preroll infusion automated system

The cannabis industry is notorious for producing inconsistent products. It’s not surprising, considering the near-total ban on state-to-state commerce, (thanks federal government!) And, of course, the variation that can occur from crop to crop, batch to batch or facility to facility. There are so many variables to just the cultivation process; the amount of light a crop gets, the type and dosage of nutrients, the growing medium that’s used, the amount of air flow in the facility… The list goes on, and that’s just the first of many processes needed before a product ends up on shelves! It’s nearly impossible for humans to manually manage and ensure consistency of all these variables without the help of some level of automation.

Nohtal Partansky, ex-NASA-JPL engineer and CEO of Los Angeles-based Sorting Robotics, teamed up with fellow NASA Jet Propulsion Laboratory colleagues Cassio Santos and Sean Lawlor to found their firm that creates next-generation hardware and software for cannabis industry producers.

“Automation in the cannabis industry plays a crucial role in maintaining product consistency by reducing human error and standardizing processes across cultivation, extraction, and packaging,” says Partansky. “If brands are going to expand across states, consistency is a requirement if customer loyalty is ever going to be a market driver for sales.”

The Contamination Argument: Automation Limits Human Error & Contamination Risk and Improves Product Safety

Our industry demands very strict safety standards. Our customers deserve safe products, but beyond that, the testing requirements mandated by regulations in most markets are very, very strict. Each and every human touchpoint in your processes carries with it additional contamination risk. Even with stringent protocols, mold, mildew and other unwanted crits can more easily venture their way into final products as the human variable increases.

Automation minimizes these risks and improves the safety of the product for consumers, and reduces the risk of recalls or other regulatory issues. Consider that for many cannabis businesses in hyper-saturated, competitive markets, a significant product recall can be the end of the road. Automating production processes provides a reliable and consistent solution in an industry that demands the highest safety and quality standards.

“The new and burgeoning Cannabis industry and its consumers are no exception and possibly benefit it more than other industries.  The medicinal qualities of Cannabis products make consistency, quality, safety, and traceability paramount to the consumer.  Cannabis products are most often consumed by ingestion into the lungs which means product cleanliness and quality are essential to safety.  Chemically derived oils and extracts would not be possible without automation equipment. Again, industrial automation is a huge benefit to the Cannabis space, to the producers, their employees, and maybe most importantly to the consumer”.

Amar Olgeirsson, CEO & Founder, Green Vault Systems

Olgeirsson’s take on products created on specialized automation equipment? “Products produced on purpose-built machinery are more consistent and of a higher quality which lends itself to better oversight, enhanced traceability, and improved product safety.”

The Physical Argument: Automation Eliminates Tedious & Overhead-Heavy Tasks

In an increasingly competitive marketplace like cannabis, streamlining processes and reducing the liabilities that come with human labor – like being sidelined from Carpal Tunnel – is key. Let’s consider the trimming component of the post-harvest process. Manual trimming is monotonous, low-paying for workers, and an unrealistic way to harvest cannabis at scale. Also, it’s hard to be successful when team-wide prescriptions for night-time wrist splints are a threat.

The Mobius M108S Trimmer

Leaning into “hand-trimmed” as a differentiator for your brand? Many connoisseurs will argue that hand-trimmed bud is superior because buds stay aesthetic and trichomes aren’t lost. That may have been true in the early days of automated trimming machines, but with today’s crop of super-sophisticated trimming technology, it is now nothing more than a myth. (Yes, myths and misled traditions can be difficult to overcome in our industry, but I digress…)

The Mobius M108S Trimmer, for example, allows operators to reduce the staff required to process thousands of pounds of product every year without compromising quality. It’s next-gen tech not found on traditional trimmers can produce hand-trim quality buds with minimal trichome loss.

When flower prices are high, especially in the case of newly-legalized markets, it can be easy for operators to overlook the cost of trimming, and pay their employees higher wages to offset the physical risks to their bodies. But what about when product prices inevitably fall once the post-legalization honeymoon period wears off? It’s unrealistic (and unethical, I believe), to pay employees minimum wage while putting their health and safety at a significant risk. In the above example, at some point, your operations will grow to a point where hand-trimming will dig you further into a fiscal hole every time you harvest.

The Future Argument: Automation Isn’t Going Away (and Your Competitors Know It)

Automation could cause you to lose people, just not in the way you might think. Ultimately, competitors in any space will invest in new technology to streamline people, processes and tools to establish a competitive advantage. This investment puts them in a better position to attract talented employees that stick around for the long term.

Automation is like a boat motor in the 21st century, and companies that don’t use it are paddling against the current. Sure, you can use a wooden oar, but your competitors know paddling is too much work and will strap a motor to theirs. The truth is that companies that drag their feet out of stubbornness or inability to see how the current situation could ever change will often find their employees jumping ship to go elsewhere.

An automated vape cart filling system

“I strongly believe that automation not only propels our industry forward but also sets the stage for a more profitable future in cannabis production for those that embrace technology rather than fight it,” says Ryan Hoitt, CEO, developer & founder of Vape Jet in Portland. “I can confidently say that it enables businesses to fine-tune operations, improve product quality, and achieve unmatched consistency.”

Saying that you will eventually be forced to automate sounds harsh, but it’s largely true. As soon as your competitors deploy automated processes, they gain an advantage. If you don’t do the same, it will become more difficult to compete, stay profitable and stay in business.

The Consumer Argument: Automation Provides Consumers More Options

Automation isn’t going away, and it’s certainly not a fad like pogs or planking. Automation drives lower production costs, which means lower-priced products for consumers. This process has been behind the dramatic increases in global living standards and population growth since the birth of the Industrial Revolution and is not likely to change anytime soon.

Automation allows producers to manufacture a broader range of products and focus on providing the consumer with more options. Consumers want to be in control of their purchasing decisions, and companies that deliver variety will be the ones to reap the rewards.

Embrace the Future with Automation

History has shown us time and again that failure to innovate can lead even the most prominent brands to fall victim to their inability, or unbelief, in the necessity to evolve. Automation is a no-brainer in crowded and competitive markets.

No doubt, the future of the cannabis industry will trend toward automation. Businesses embracing it will have a significant advantage over those that do not. Companies that drag their feet in the face of disruptive automation risk resigning to the same fate as those brands that underestimated technology at the expense of their own existence. No industry is immune from disruption, and there will be dynamic entrepreneurs who will come along and see to it. Embrace the change, embrace automation and technology, and you’ll increase your chances of winning in the cannabis industry!

New Jersey Market Grows, Regulators Make Licensing Progress

By Cannabis Industry Journal Staff
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2023 has so far been a productive year for the New Jersey Cannabis Regulatory Commission (CRC), the government body tasked with overseeing the state’s medical and adult use cannabis markets. The licensing process since New Jersey first launched its adult use cannabis market has been slow, but intentional and systematic.

When the state first launched adult use sales in April of last year, only thirteen dispensaries in the Garden State had their doors open for customers. A little more than a year has passed and now 27 dispensaries at this time have opened their doors for adult use customers.

Holistic Solutions, a dispensary based in southern NJ

The CRC has been a busy body this year, issuing hundreds of conditional licenses to microbusinesses and standard licensees (temporary licenses awarded to applicants giving them the green light to obtain local approval, find real estate and apply for a conversion to an annual license). Of the annual licenses they have awarded in 2023 so far, 18 have gone to cultivators, 12 to manufacturers, 35 to retailers and one laboratory. That’s an additional 65 cannabis businesses given approval to start operations.

Just last week, Holistic Solutions, based in Waterford, New Jersey, announced that they started serving adult use customers. Holistic is New Jersey’s first Black woman-owned cannabis licensee, with Suzan Nickelson at the helm. “We are thrilled to have the opportunity to serve adult-use customers at Holistic Solutions,” says Nickelson. “Our mission has always been to provide education and access to natural healing solutions, and we are excited to continue that mission for all of our customers.”

The Cannabis Quality Conference takes place in New Jersey this year, October 16-18, 2023. Click here to learn more.Valley Wellness, the first independently owned dispensary to open in the state, also opened its doors to adult use customers last week in Somerset County. “While the market is expanding, it takes cannabis companies months, if not years, to open,” Sarah Trent, owner of Valley Wellness, told reporters. “So we expect our product selection will remain stable and similar over the next year or so. That said we are anxious to add new products made from local New Jersey growers and manufacturers.”

With all these new licensees and a larger marketplace comes tax revenue the state is eager to see. Back in March, legislators in the state approved a bill that would allow cannabis businesses to deduct ordinary business expenses on their state tax return that they are prohibited from deducting on their federal tax return, the dreaded 280E tax code that cannabis stakeholders know as a painful thorn in their side. Governor Murphy signed that bill into law yesterday, which should lessen the massive tax bills that cannabis businesses in the state are accustomed to seeing.

As the state’s cannabis market continues to blossom, a large number of those new licensees are expected to come online before the end of the year.

Cannabis Quality Conference & Expo logo

Registration Opens for 2023 Cannabis Quality Conference

By Cannabis Industry Journal Staff
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Cannabis Quality Conference & Expo logo

May 4, 2022 – Registration for the Cannabis Quality Conference & Expo (CQC), taking place October 16-18 at the Hilton Parsippany in New Jersey, is now open.

The agenda will feature breakout sessions, keynotes and panel discussions that will help attendees better understand the cannabis markets in the region and provide insights on best practices and business strategies. The conference will begin with a number of pre-conference workshops on Monday, October 16:

  • The Seed to Sale Safety Workshop
  • Food Safety Auditor Training
  • CP-FS Credential Review Course
  • The Food Safety Culture Design Workshop

The conferences will run all day Tuesday, October 17 and throughout Wednesday, October 18. The full agenda is expected to be announced in the coming weeks. Notable speakers include:

  • Tahir Johnson, Founder, Simply Pure
  • Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
  • Jay Czarkowski, Founding Partner, Canna Advisors
  • Michael Kramer, Quality Assurance Director, Wana Brands
  • Casey Leaver, Director of Regulatory Compliance, Vicente LLP
  • Sumer Thomas, Director of Regulatory Affairs
  • Rachel Wright, Managing Partner, ABFinWright
  • Ernest Toney, Founder, BIPOCann
  • Victor Guadagnio Jr., Co-Founder, Canna Remedies NJ

The Cannabis Quality Conference and the Food Safety Consortium are co-located this year, taking place in the same venue and at the same time. Registered attendees get full access to both conferences.

Registration options are available for full conference passes for both the Cannabis Quality Conference and the Food Safety Consortium as well as all pre-conference workshops.

Event Hours

  • Monday, October 16: Pre-conference workshops, 8 am – 6:30 pm (ET)
  • Tuesday, October 17: 8 am – 6:30 pm (ET)
  • Wednesday, October 18: 8 am – 3 pm (ET)

Tabletop exhibits and custom sponsorship packages are available. For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales, and Chelsea Patterson, Account Executive.

About Cannabis Industry Journal 

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.

SC Labs Expands, Acquires C4 Laboratories

By Cannabis Industry Journal Staff
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According to a press release published on Monday, SC Labs has acquired C4 Laboratories, a cannabis testing lab located in Scottsdale, Arizona. The acquisition means SC Labs has expanded their footprint into five states total. Originally based in California, the cannabis testing company now has locations in Arizona, California, Colorado, Michigan and Oregon.

Ryan Tracy, Founder/CEO of C4 Labs.

Ryan Treacy founded C4 Laboratories and has been a vocal advocate for product safety testing since 2016. As CEO of the company, he led the laboratory through regulatory upheaval and a lot of changes the state has seen since legalization.  He also co-founded the Arizona Cannabis Laboratory Association and led lobbying efforts on behalf of patients and stakeholders to require lab testing.

He says they are excited to join forces, becoming the largest cannabis testing platform in the US. “Our combined leverage of top scientists with specialized cannabis testing knowledge and a leadership team of industry experts will allow us to do everything from harmonizing R&D efforts to improving the data experience to pushing for positive regulatory change,” says Treacy. All current employees of the C4 team will stay on, joining the new SC Labs team.

Jeff Journey, CEO of SC Labs

This acquisition represents another important milestone for the SC Labs expansion plan. Last year, they hired a new CEO, Jeff Journey, and launched their national hemp testing partnership based in Colorado. That, coupled with the expansion through Can-Lab into Michigan last year along with the C4 acquisition, SC Labs has expanded into three new states within the last twelve months.

Journey says they’re thrilled to acquire the C4 team and that they have shared values, a proven track record and good expertise. “With this acquisition, we can continue to expand best-in-market cannabis testing services and the opportunity to service multi-state growers and manufacturers,” says Journey. “It is truly an exciting time for growth, and we know that the C4 team will be an invaluable addition to our team, culture and operations.”

2023 Infused Products Virtual Conference

By Cannabis Industry Journal Staff
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2023 Infused Products Virtual Conference

Click here to watch the recording

Agenda

Beyond GMPs: Assessing Hazards at Your Facility

  • Dr. Kathy Knutson, Principal, Kathy Knutson Food Safety Consulting LLC

Have you implemented GMPS? Do you have a quality management system headed by a dedicated Quality Manager? Yes! Great! Then you know that quality management is never done, and you desire continuous improvement. The cannabis industry will always have Good Manufacturing Practices (GMPs) along with Good Agricultural Practices, Good Laboratory Practices, and Good Distribution Practices from seed to sale. Beyond GMPs is the writing and implementing of a hazard analysis, preventive controls, and a recall plan for the manufacture of edibles. It’s what the food industry does in writing a food safety plan, and the cannabis-infused edibles industry is expected to do the same with an edible safety plan. As the cannabis industry continues to lead ahead of federal regulation, assessing hazards at your facility is the next step. This presentation will introduce you to the importance of a hazard analysis and prepare you to perform a hazard analysis of processing steps.

How to Create a Bulletproof Food Safety Plan: Supplier Controls & Other Preventative Strategies

  • Matt Regusci, Technical Director, CSQ

Food safety is the bare minimum in a quality and safety program for plant touching businesses in cannabis, and yet it is constantly being overlooked. One important element of a food safety plan in this industry is implementing proper supplier controls, considering whether your suppliers and/or Contract Manufacturers are including a 2nd or 3rd party auditing program in their standardization of processes. This is a crucial step for MSOs, because although brands aim to do everything they can to ensure the product remains consistent across borders, there’s no guarantee that each manufacturing facility will adhere to the same Good Manufacturing Practices (GMPs) as in your own facility. Why does this matter? At the end of the day, if your company has to undergo a recall due to a mishap in one of the partner facilities, this reflects badly on the entire brand, not the individual facility.  According to long-time food safety expert Matt Regusci, when it comes to navigating safety & quality- quality is a mere strategy, but food safety is a requirement. During this discussion, Regusci will share insights to help brands craft a food safety plan, while keeping the entire supply chain in mind.

Mitigating Potency Loss in Cannabis Infused Beverages

  • Dr. Harold Han, Chief Science Officer & Co-Founder, Vertosa

THC and CBD are prone to losing potency when infused into beverages, leading to unknown cannabinoid concentrations and thus unpredictable effects for the end user — in other words, a brands’ worst nightmare. In this session, Harold will discuss the drivers behind scalping through packaging and oxidation reactions in the manufacturing process for cannabis-infused beverages. He will reference Vertosa’s studies on how antioxidants and the materials used to fabricate can liners affect cannabinoid potency over time, outlining the materials and additives most effective at mitigating cannabinoid potency loss holistically for longer shelf-life. Harold will end the session by explaining why consistent, stable products are vital in ensuring consumer safety and building a responsible cannabis industry.

Click here to watch the recording

Product Liability in the Cannabis Industry: Insights From 2022 & Looking Forward

By Andrew Solow, David Kerschner, Alessandra Lopez
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In 2022, product liability lawsuits in the cannabis/cannabidiol (CBD) industry continued to focus on levels of THC and the psychoactive ingredient in cannabis, while federal agencies continued issuing warning letters for CBD products (including CBD-infused food and dietary supplements) that made misleading medical claims. Against this backdrop of ongoing litigation and regulatory enforcement, 2022 showed that at the Federal level, there is more recognition that marijuana is becoming increasingly normalized. For example, President Biden pardoned federal offenses of simple marijuana possession and requested a reassessment of marijuana’s classification as a Schedule I drug under federal law. Additionally, Congress passed its first standalone piece of cannabis reform with the Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) which, among other things, will ease restrictions on cannabis research and allow for more clinical trials. And even though the Food and Drug Administration (FDA) declined to act on CBD products, the agency announced that it will work with Congress to create a new regulatory framework for CBD products (2023 FDA Announcement).

These events of the past year provide a glimpse into what the future may hold for cannabis and CBD companies when it comes to product liability risks. This article looks at the types of product liability actions that the cannabis and CBD industry faced in 2022 and may encounter in the future, and provides some basic guidance on how to best mitigate, and if necessary, defend these potentially costly litigations.

Focus on Cannabis and CBD Risks

FDAlogoA central part of any product liability lawsuit—regardless of whether brought under a design defect and/or adequate warning theory—is that a product caused or was a substantial contributing factor to a Plaintiff’s injury or illness. Thus, any potential safety concerns over cannabis/CBD could end up as the subject of litigation in the future. In the 2023 FDA Announcement, the FDA recognized that “the use of CBD raises various safety concerns, especially with long-term use,” including potential harm to the liver and negative interactions with certain medications. The agency also noted that questions still exist on how much CBD can be consumed, and for how long, before causing harm. Furthermore, on December 2, 2022, President Biden signed the MMCREA into law, which is intended to advance research on the potential risks and medical benefits of cannabis and cannabis products.1 This additional funding will not only help researchers learn more about possible safety risks that may lead to future product liability claims, but will also allow for better exploration of the benefits of these products to possibly expand product indications and help reach new customers.

Given the FDA’s statements and the increased funding for new research, CBD and cannabis companies should ensure that they are properly monitoring both regulatory communications and new research regarding risks that may be associated with their products. As new information is released, companies should evaluate how their product labels and marketing messages should be altered. Announcements like this one by the FDA can be seen as providing industry participants with knowledge about certain risks, and how companies react could be analyzed, post hoc, in any litigation down the road.

2022 Product Liability Actions  

Over the last year, misbranding/mislabeling issues presented some of the most prevalent litigation risks for industry participants.

An example of a warning letter the FDA sent to a CBD products company making health claims

For example, at the Federal level in 2022, the FDA issued thirty-three warning letters to CBD companies, a nearly 400% increase from 2021. These letters generally focused on CBD products that made medical claims. Some of these warning letters addressed misbranding, where the product labels provided inadequate directions for consumer use. In one letter, the FDA noted that because the CBD products were “offered for conditions that are not amendable to self-diagnosis and treatment by individuals who are not medical practitioners,” ranging from cancer to diabetes, labeling compliance was only possible if the product was an FDA-approved prescription drug with FDA-approved labeling. Other companies received warning letters in March of 2022 for making misleading representations that their CBD products were safe and/or effective to prevent or treat COVID-19. Many of these representations were made via companies’ websites and social media platforms. The warning letters—often triggers for product liability actions, as well as consumer protection/fraud actions—serve as a reminder that companies cannot make medical claims on non-FDA approved drug products and must otherwise present accurate information to consumers not only on product packaging, but any form of marketing or advertising, including company websites and social media platforms.

Turning to state-level regulatory actions, Oregon’s Liquor and Cannabis Commission fined a cannabis company $130,000 and suspended the company’s license for 23 days over an alleged label mix-up between its CBD and THC products. According to the state’s investigative report, a company employee allegedly confused two product buckets with similar identification numbers, one that contained THC and the other CBD, and accidentally switched the labels of the two products. In addition to the fine and license-suspension, the state agency also issued a mandatory recall on the CBD drops based on the alleged undisclosed levels of THC.

This same incident also spurred a string of civil lawsuits, resulting in several settlements by the company in 2022.2 Numerous customers reported experiencing “paranoia,” “mind fog,” and feeling “extremely high,” with at least five people going to the emergency room with serious health issues due to use of the CBD drops. One lawsuit, which was publicly settled for $50,000 in January of 2022, alleged that the company failed to warn the plaintiff that the CBD drops contained THC or that the product may have been contaminated with foreign substances like THC, and that the company failed to exercise quality control standards that would have detected the THC.3 Nine other lawsuits made similar failure to warn allegations based on the same batch of CBD drops and were settled by January of 2022, although those settlements were not disclosed.4 In October of 2022, the company agreed to pay a settlement of $100,000 in a class action suit, which alleged that the company failed to disclose that the CBD product contained substantial amounts of THC.5 The class action focused on unlawful trade practices claims, including that the company falsely represented that the product had the characteristics, uses, and benefits of a CBD product that did not contain THC.6 Also in October 2022, the company settled a wrongful death lawsuit—alleging that the company failed to warn the plaintiff that the drops contained THC and had negligent quality control standards—stemming from the same CBD drops,7 where the plaintiff suffered stroke-like-symptoms, allegedly due to the tainted CBD product, and ultimately died.8

Other recent lawsuits have also focused on mislabeled cannabis products, alleging that companies failed to inform customers that products contained THC. For example, in Kentucky, a man who drove into a bus after using a CBD vape sued both the CBD manufacturer and retailer on December 14, 2022, claiming that he was not warned that the vape contained a substance that would make him intoxicated.9 According to the complaint, the store employees told the man that the vape was “all natural” but made no mention that the product contained THC.10 The man alleged that the vape actually contained Delta-8 THC and brought negligence, failure to warn, and state consumer protection law claims.11

As noted above, in addition to traditional product liability actions, companies are likely to face increased consumer fraud and false advertising actions in the absence of personal injuries. Two class actions brought in December of 2020 against a hemp tea maker alleged that the company’s website and the product’s packaging fraudulently stated that a tea contained zero THC.12 Plaintiffs claimed that they tested positive for THC after drinking the tea and that product testing similarly revealed that the tea contained some THC.13

Potency inflation marketing communications from a laboratory

Last year also saw a rise in cases focused on potency inflation, alleging that cannabis companies knowingly overstated the amount of THC in their products to charge higher prices.14 Again, while these actions focused on consumer fraud allegations rather than product liability claims, these cases underscore the importance of accurate labeling. Due to potency inflation concerns, states have started investigating licensed cannabis testing labs within their respective jurisdictions, resulting in product recalls and fines. Some states have also updated their regulations, requiring cannabis companies to test their products through two separate labs.

Finally, contamination and the existence of impurities and other byproducts has been a recent focus of several product liability lawsuits across the life sciences space, and this trend is something that cannabis and CBD companies should be aware of and take steps to mitigate.

For example, a Canadian cannabis producer reached a $2.31 million settlement over a class action brought in March of 2017 regarding pesticide-contaminated medical marijuana. The marijuana was recalled due to the presence of myclobutanil and bifenazate pesticides, neither of which were authorized for use on cannabis plants in Canada. The lead plaintiff experienced nausea and vomiting, allegedly from consuming the medical cannabis, and brought numerous claims on behalf of the class, including negligent design, development, testing, manufacturing, distribution, marketing, and sales.15 In the United States, California’s Department of Cannabis Control issued a mandatory recall on January 26, 2022 for a batch of cannabis flower that was contaminated with mold. On March 25, 2022, the New Mexico Cannabis Control Division recalled cannabis products sold by a local medical cannabis company because the product contained impermissibly high levels of mold. New Mexico’s Cannabis Control Division also required the company to immediately cease and desist operations at its production and manufacturing site.

A Look at the Future and What Companies Can do to Mitigate Product Liability Risks  

The FDA’s 2023 announcement means that the industry will have to wait for Congressional action for the development of a regulatory scheme that can help standardize requirements and provide industry players additional defenses when facing product liability actions. Many of the proposed risk management tools in the FDA Announcement could help companies mitigate future litigation risks if implemented. These risk management tools may include “clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.” Although the FDA has had regulatory oversight over CBD and other hemp-derived products for nearly four years, the agency has not developed a regulatory framework for these products aside from issuing warning letters, leaving manufacturers and distributors without much guidance. The FDA has also left the states to fill the void, resulting in a patchwork of differing—and sometimes conflicting—state laws. Additional guidance and regulation on labeling at the federal level for cannabis and cannabis-derived products will make compliance a more straightforward proposition and may provide avenues for industry participants to explore preemption defenses in the face of future mislabeling claims.

Just some of the many CBD products on the market today

In addition to following the changing regulatory landscape and understanding how regulatory changes can impact litigation defenses, cannabis and CBD companies can continue to take various steps to help mitigate future litigation risks.

Quality Control: Adequate testing procedures and effective quality control procedures can help avoid contamination issues and situations where products are mixed up during the manufacturing process. For example, the company whose license was suspended in Oregon due to the alleged mix up between CBD and THC subsequently implemented new ingredient tracking protocols, adopted a policy to retain samples from each batch of product, and now sends additional samples to an independent lab to ensure product compliance before anything is sold.

Proper documentation of testing and quality control procedures, as well as maintaining records of compliance checks, can also help companies put together a defense to state regulatory actions or lawsuits relating to contamination or manufacturing defects. Indeed, in February of 2022, an Arizona marijuana testing lab was fined $500,000 for various incomplete records and documentation as well as improperly calibrated machines for contamination testing, with an inspector also noting that one of the employees was trained to use a technique that produced inflated potency results.

Ongoing Safety & Regulatory Review: Keeping up to date with regulations and science will play a key role in making sure labels are accurate and defendable. Working directly with regulators and seeking guidance from regulators on labeling can help potential defendants present a clear and compelling labeling defense. Moreover, the 2023 FDA Announcement made clear that the agency will not pursue rulemaking on CBD’s potential use in foods and dietary substances. Thus, industry players should monitor agency announcements and engage with the FDA’s Cannabis Product Committee (CPC) and Congress to better understand the potential structure of this new regulatory pathway.

Stay on Top of the Science: A boost in cannabis research is on the horizon, as the Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) will advance research on the potential risks and benefits of cannabis products and promote the development of FDA-approved drugs derived from marijuana and CBD. On the litigation front, causation is an essential element in most causes of action, and plaintiffs will have to prove that the cannabis caused their injury. Thus, industry players should be aware of the current science, including potential side effects.

Litigation Monitoring: Finally, companies will also be well served by following court decisions involving CBD and cannabis products. For example, courts in 2022 were split over the legality of Delta-8 THC, a substance typically manufactured from hemp-derived CBD. The Ninth Circuit held in AK Futures v. Boyd Street Distro that Delta-8 THC found in e-cigarettes and vape products is legal under the 2018 Farm Act, at least in the intellectual property context.16 But in Kansas, a federal judge ruled that the 2018 Farm Act does not make selling hemp-derived products such as Delta-8 THC legal.17 In Texas, litigation initiated in 2021 is ongoing over the legality of Delta-8 THC.18 There, a hemp company sued the Texas Department of State Health Services for its classification of Delta-8 THC as a Schedule I drug, making the sale of this substance a felony offense. A temporary injunction was granted on November 8, 2021—temporarily lifting the ban on sales of Delta-8 THC products—but the plaintiff’s request for a permanent injunction remains pending.19 As these lawsuits show, the legality of different products may vary by jurisdiction, whether by regulation or a judicial decision.

References

  1. Medical Marijuana and Cannabidiol Research Expansion Act, Pub. L. 117–215, 136 Stat. 2257 (2022).
  2. Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, (D. Or. Jan. 5, 2022).
  3. Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, ECF 1, 6 (D. Or.).
  4. See Crawforth v. Curaleaf, Inc., No. 3:21-cv-1432 (D. Or. Sept. 29, 2021); Lopez v. Curaleaf, Inc., No. 3:21-cv-1465 (D. Or. Oct. 6, 2021);
  5. Williamson v. Curaleaf, Inc., No. 3:22-cv-782, ECF 1, 8 (D. Or.).
  6. Williamson v. Curaleaf, Inc., No. 3:22-cv-782 (D. Or. May 30, 2022).
  7. Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001, 19 (D. Or. Oct. 18, 2022).
  8. Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001 1 (D. Or. Jan. 1, 2022).
  9. Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  10. Complaint at ¶ 11, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  11. Complaint at ¶¶ 15-33, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  12. Williams v. Total Life Changes, LLC, No. 0:20-cv-02463 (D. Minn. Dec. 3, 2020); Santiago v. Total Life Changes LLC, No. 2:20-cv-18581 (D.N.J. Dec. 9, 2020).
  13. Complaint at ¶¶ 54-59, Williams v. Total Life Changes, LLC, No. 0:20-cv-02463 (D. Minn. Dec. 3, 2020); Complaint at ¶¶ 21-25, Santiago v. Total Life Changes LLC, No. 2:20-cv-18581 (D.N.J. Dec. 9, 2020).
  14. See Centeno v. Dreamfields Brands Inc., No. 22STCV33980 (Cal. Superior Ct. L.A. Cnty. Oct. 20, 2022); Shanti Gallard v. Ironworks Collective Inc., No. 22STCV38021 (Cal. Superior Ct. L.A. Cnty. Dec. 6, 2022).
  15. Downton v. Organigram Holdings Inc., Hfx No. 460984 (Sup. Ct. Nova Scotia Mar. 3, 2017).
  16. AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682 (9th Cir. 2022).
  17. Dines v. Kelly, No. 2:22-cv-02248, 2022 WL 16762903 (D. Kan. Nov. 8, 2022).
  18. Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Oct. 20, 2021).
  19. Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Nov. 8, 2021).
A greenhouse grow facility

The Science of Cultivating Cannabis: Tips for a Thriving Grow Operation

By Nathan Johnson, Ph.D.
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A greenhouse grow facility

Creating a healthy cannabis growing environment based on the science behind growing top-notch, medical-grade cannabis is essential for producing consistent results, assuming you start with quality genetics. Before speaking about the environment, it is necessary to highlight that quality and consistency has to first start with quality plant material. In this article, we will explore six key factors that make for a healthy cannabis growing environment and how regular testing allows growers to achieve consistency and quality. Keep in mind, optimizing these factors to the cannabis strains and environment they are grown in is a must.

Lighting

Lighting is the most important factor in creating a good cannabis growing environment. Cannabis plants require specific types, wavelength and exposure times to grow and produce high-quality flower. The two main types of light that are essential for cannabis growth are blue and red spectrum light where blue is primarily dedicated to vegetative growing and red for flowering. The exposure time is necessary for non-autoflower cannabis to maintain a vegetative or a flowering plant.

lightwavesincTo ensure that the plants are receiving the right type and amount of light, growers can use specialized grow lights that provide both blue and red spectrum light. They can also monitor the intensity and duration of light using light meters and timers. Regular testing of the light spectrum and intensity can help growers fine-tune their lighting setup for optimal plant growth and flower development.

Temperature

Temperature always needs to be considered when creating a strong, healthy cannabis growing environment. Cannabis plants prefer a warm, humid environment, but temperatures that are too high or too low can negatively affect plant growth and flower development. The ideal temperature range for cannabis growth is between 70-85°F (21-29°C) during the day and between 58-70°F (14-21°C) at night.

To maintain a consistent temperature in the growing environment, growers can use temperature-controlled grow rooms or HVAC systems. They can also monitor the temperature using digital thermometers and adjust the temperature as needed. Regular testing of the temperature can help growers identify and address any temperature fluctuations that may affect plant growth and flower development.

Humidity

Like other factors that require precision, humidity needs to be carefully dialed in when creating an optimal cannabis growing environment. Cannabis plants prefer a humid environment, but too much humidity can promote the growth of mold and mildew. On the other hand, low humidity can cause the plants to dry out and become stressed.

A humidity sensor mounted in a weatherproof enclosure
A humidity sensor mounted in a weatherproof enclosure

To maintain a consistent humidity level, growers can use humidifiers and dehumidifiers in the growing environment. They can also monitor the humidity level using a hygrometer and adjust the humidity as needed. Regular testing of the humidity level can help growers identify and address any issues that may affect plant growth and flower development.

Airflow and Ventilation

Proper ventilation helps regulate temperature and humidity and prevents the buildup of carbon dioxide, which can be harmful to the plants. It also helps prevent the growth of mold and mildew. To ensure proper airflow and ventilation, growers can use fans and air ducts in the growing environment. They can also use carbon filters to remove odors and other contaminants from the air. Regular testing of the air quality can help growers identify and address any issues that may affect plant growth and flower development.

Nutrients

Nutrients are a non-negotiable for cannabis growth and flower development. Cannabis plants require a balanced supply of macronutrients such as nitrogen, phosphorus and potassium, as well as micronutrients such as calcium, magnesium and iron.

To ensure that the plants receive the right amount of nutrients, growers can use nutrient-rich soils or hydroponic systems. They can also supplement with fertilizers and other nutrients. Regular testing of the nutrient levels in the soil or growing medium can help growers adjust their nutrient regimen for optimal plant growth and flower development.

Pest and Disease Management

Cannabis plants are susceptible to over 90+ pests and diseases, including insects, mold, mildew, viruses and viroids commonly infected through the environment by touch, air, water and nutrients. The most common are spider mites, aphids, powdery mildew, botrytis, fusarium and hop latent viroid. It is estimated by the United Nations that 20% to 40% of total global crop loss is due to improper pest and disease management. The cannabis growing environment is no different.

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

While lighting, humidity, air flow and nutrients are key aspects for a cannabis growth environment, the most common overlooked aspect of growing is proper pest and disease management. Cannabis plants are susceptible to a variety of pests and diseases, which can have a significant impact on plant health and crop yields. To take optimizing a cannabis growing environment one step further, here are five essentials for developing an effective pest and disease management setup.

  1. Prevention

Prevention is the first and most important step in pest and disease management. Growers should always take steps to prevent pests and diseases from entering or infesting the growing environment in the first place. This can be done by quarantining new plants or clones, using clean equipment, sterilizing the growing area, and monitoring plants for signs of pests and diseases through both visual inspection as well as testing.

Some diseases such as those caused by viruses and viroids, require molecular based testing to identify. Growers should quarantine and test any new plants or clones before introducing them to the growing area. This can help prevent the spread of pests and diseases from infected plants to healthy ones. Growers can also use biological controls, such as beneficial insects, to help prevent pests from infesting the plants. These insects can help control pest populations by preying on them or interfering with their reproduction.

  1. Early Detection

Early detection is key to preventing an entire crop from being infected and scrapped. Growers need to regularly inspect their plants for signs of pests and diseases, including yellowing leaves, discoloration, spots and unusual growth patterns. Early detection can help prevent the spread of pests and diseases and limit the damage they cause, not to mention saving a business’s bottom line!

  1. Integrated Pest Management

Integrated Pest Management (IPM) is an approach to pest and disease management that involves a combination of preventative measures, biological controls and chemical treatments. IPM aims to reduce the use of chemical pesticides, which can be harmful to the environment and human health.

IPM involves regular monitoring of plants for signs of pests and diseases, using biological controls to prevent and control infestations, and only using chemical treatments as a last resort. Chemical treatments should be used sparingly and only when necessary, and growers should follow all safety precautions when using them.

  1. Sanitation

Taking the necessary precautions to ensure all equipment used throughout a cultivation is properly sterilized will save growers from countless headaches. Growers should keep the growing area clean and free of debris, which can provide a breeding ground for pests and diseases. They should also regularly sterilize equipment and growing containers to prevent the spread of pathogens.

  1. Record Keeping

Record keeping is essential for effective pest and disease management in the growing environment. Keep detailed records of all pest and disease issues, including the type of pest or disease, the severity of the infestation, and the treatments used. Cultivators, you will thank yourselves later! This will help identify recurring issues and develop effective pest and disease management strategies.

While there are key aspects of creating a healthy cannabis growing environment, the most common overlooked aspect of growing is on proper pest and disease management, which involves prevention, early detection, integrated pest management, sanitation, quarantine, and record keeping. By taking these steps, growers can help ensure the health and vitality of their plants, produce high-quality cannabis that consumers want and preserve their business’s bottom lines.