Cannabis brands are facing a proverbial fork in the road: determining whether their product evolves into a luxury consumable or affordable agricultural commodity. While it is reasonable to assume the cannabis market space will organically grow into a luxury goods industry such as wine and spirits, the luxury brands that serve as the foundation of these markets were built over years of engagement between consumers, connoisseurs and producers. If cannabis companies want to successfully market their products as luxury items, a concerted effort towards well-defined, consumer-accessible branding is required.
The first step towards evolving a cannabis brand towards luxury is overcoming the fixation on cultivar identity. Unregulated cultivar naming currently impedes creativity and craftsmanship, disrupting brands and salespersons’ abilities to clearly communicate strain aesthetics.
The good news is the alcohol, coffee and consumer packaged food (CPG) industries have done most of the heavy lifting, paving the way with robust sensory science and analytical approaches to product characterization. Cannabis stakeholders need only adapt their tools and apply them to cannabis with similar intention.
Research suggests that aroma is one of the strongest predictors of positive consumption experience. As adult use consumers become familiar with current product offerings and increasingly legal availability, they will seek products that consistently yield the best experience. The most successful brands will be those that most effectively communicate that experience and then deliver it. The status quo – describing aroma using strain names, top terpenes or THC content – is not effective at harmonizing a brand’s promise with consumer experience.
Figure 1: Illustration of both the conventional branding approach (top) and the sensory-based branding opportunity (bottom).
The conventional cannabis product branding approach leaves to be desired a tremendous opportunity to characterize cultivars (Figure 1). Sensory science, the discipline used to evoke, measure, analyze and interpret reactions to materials through human perception, has been used for decades to characterize CPGs from skin lotion to washing machines. Adapting these well-established techniques for use in cannabis can be challenging, but it is certainly worth the investment.
These shifts in the cannabis industry have already begun to occur. I recently was the principle investigator on a white paper that presented a novel cannabis aroma wheel derived from aroma descriptors and a panel of trained sensory experts. In the study, sensory scientists evaluated randomly sampled cannabis flower over a period of several months. The researchers combined qualitative focus panels, literature review and formal blinded sensory tests to develop a comprehensive lexicon that served as a tool for trained evaluators to characterize cannabis aroma. This novel and robust tool (Figure 2) was designed to be used by trained panels to characterize cannabis aroma, is freely available and is just the beginning of a collective development of a data-driven cannabis lexicon.
Much like the World Coffee Research Lexicon referenced here, the Cannabis Aroma Lexicon is a tool with a specific purpose: collecting an objective description of the product aroma. It is a living document that will grow along with the industry. In the future, we may have lexicons to describe more than just aroma. Tactile and appearance sensory attributes of cannabis will gradually be defined by sensory scientists, presenting more opportunities for deep craftsmanship in the cannabis industry.
Figure 2: Expert-derived aroma wheel tool for cannabis aroma characterization.
The role that dispensaries play in adoption of standardized quality metrics is critical. The product features that position cannabis to be a craft product warrant the presence of a third-party expert to translate and guide consumers during the purchasing process. It’s intuitive to ask a waiter to recommend a pairing (i.e., a dry red wine to pair with a seafood dish), given the trust that consumers put in the restaurant to understand the properties of the food they are serving. Dispensaries have thus far filled the service structure role for cannabis, but the vast amount of unknowns regarding the physiological and sensorial effects of cannabis have resulted in inconsistent experiences that leave something to be desired in terms of consumer trust.
Application of sensory science in cannabis is an unparalleled opportunity for brands to build consumer trust and differentiate their products in a sea of strain names and high potency flower. Cultivars that can be established as measurably aromatic in a specific character can leverage that aroma profile to add significant value to the product. For example:
Cultivar name can be aligned with the perceived aroma (e.g., garlic is not bad, but expecting tropical and getting garlic can harm consumer trust).
Product catalog can be consolidated and optimized to avoid sales cannibalization by growing specific products to meet consumer group’s needs.
Guesswork is removed from breeding by measuring when a product is meeting sensory goals and ensuring it doesn’t drift over time.
Demonstrating transparency will win over ethical consumers. Utilizing controlled, blinded studies to profile aromas will add value to ethics-minded consumers.
Becoming a leader in connoisseurship. In the forefront of this shift in branding, one can position a brand to be ahead of the competition.
Elevating the dispensary experience. By utilizing aroma profiling, products can be more easily sold by budtenders and salespeople.
Opening doors to new application types (e.g., seasonal, occasion centered or geographically unique cultivars).
These are just some of the ways that aroma characterization will differentiate products and simultaneously contribute to cannabis brands’ ability to communicate craftsmanship and the maturity of the industry as whole. Not only will adoption of robust sensory-based branding improve the consumer experience by providing a means to compare products to one another, it will promote adoption of good manufacturing practices that simultaneously improve the quality and safety of cannabis products. Without consumer-accessible quality metrics, brands have little incentive to produce products of elevated quality and are conversely incentivized to prioritize quantity and meet minimum regulatory requirements.
Importantly, cannabis businesses will use this tool to adapt to an inevitable industry-wide shift towards connoisseurship and application of robust sensory science. While it may be challenging to shake off the “bad habits” that currently plague many brands, cannabis has significant potential as a luxury good. Consumers are eager for a better cannabis experience from purchase to consumption. How will your brand use sensory profiling to expand or evolve product offerings to succeed in a cannabis market full of luxury brands and what steps will you take now to prepare?
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.”
ASTM International has announced the approval of a new standard in development that could have potentially wide-reaching influence on the cannabis industry throughout the world. ASTM’s cannabis committee (D37) has approved the new standard (D8449) for development that aims to develop internationally aligned label specifications for all products containing cannabinoids.
According to the press release, The new labeling standard is the first of its kind, attempting to harmonize regulations throughout the cannabis industry with universally recognized labels that could be adopted by regulators anywhere in the world. ASTM member Darwin Millard has spearheaded the development of this new standard and believes it will have countless practical applications.
“Having the same information presented in the same manner across jurisdictions means consumers of products containing cannabinoids will have consistent information conveyed to them in a way they are familiar with,” says Millard. “This ensures consumers have the information they need to make an informed purchase decision, and will ultimately lead to increased consumer safety and confidence.”
ASTM International is a nonprofit, voluntary consensus-based standards development group. They are inviting feedback and input as they refine the standard and work on presenting it to the international cannabis community. “We welcome regulators, producers, and consumers from around the world to give us feedback,” says Millard. “This is intended to be a living document to remain relevant throughout this ever-changing landscape.”
By Andrew Solow, David Kerschner, Alessandra Lopez No Comments
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
A 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 receivedwarning 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 investigatinglicensedcannabis 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
Medical Marijuana and Cannabidiol Research Expansion Act, Pub. L. 117–215, 136 Stat. 2257 (2022).
Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, (D. Or. Jan. 5, 2022).
Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, ECF 1, 6 (D. Or.).
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);
Williamson v. Curaleaf, Inc., No. 3:22-cv-782, ECF 1, 8 (D. Or.).
Williamson v. Curaleaf, Inc., No. 3:22-cv-782 (D. Or. May 30, 2022).
Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001, 19 (D. Or. Oct. 18, 2022).
Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001 1 (D. Or. Jan. 1, 2022).
Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
Complaint at ¶ 11, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
Complaint at ¶¶ 15-33, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
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).
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).
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).
Downton v. Organigram Holdings Inc., Hfx No. 460984 (Sup. Ct. Nova Scotia Mar. 3, 2017).
AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682 (9th Cir. 2022).
Dines v. Kelly, No. 2:22-cv-02248, 2022 WL 16762903 (D. Kan. Nov. 8, 2022).
Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Oct. 20, 2021).
Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Nov. 8, 2021).
When it comes to microbial diagnostics, there are many different methods to choose from. How do you know which ones to choose for each application? If you know how and why the different methods do what do it makes it much easier to look for and identify your target microbe of interest. Additionally learn why not all methods are created equal, and not all methods can be used for every test or target.
Hop Latent Viroid – The Pandemic of the Grow Room: Fact, Fiction & Management
Dr. Tassa Saldi, Chief Science Officer, TUMI Genomics
In this talk Dr. Saldi will provide a laymen overview of viroid biology including how viroids differ from more familiar pathogens such as viruses, bacteria and fungus. Dr. Saldi will discuss the various HLVd testing options and what a cultivator should look for when choosing a testing lab. Finally, recommendations regarding sample collection, ideal HLVd testing schedules and how to mitigate losses from HLVd when it is found in a facility will be reviewed.
Christopher Fox-Strauss, Accreditation Manager, ANAB
Most cannabis laboratories are familiar with accreditation as required by state regulations, but many labs still have questions about how to conform to the requirements. During this session we will focus on some of the recurring challenges and questions we are seeing in ISO 17025-accredited cannabis laboratories. We will also highlight some supplemental resources and programs to elevate laboratory performance and compliance.
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