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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.

Digital Assets & Cryptocurrency in Cannabis

By Itali Heide
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As the cannabis industry experiences a significant shift toward general acceptance and mainstream adoption, new modes of operation are popping up everywhere. The evolution and expansion of the industry beg for constant innovation, and the integration of NFTs and cryptocurrencies as payment options is at the crossroads between tech and cannabis.

Crypto and NFTs have grown in popularity in recent years. Non-fungible tokens are an interesting asset in the art and collectibles world, while cryptocurrency has made a name for itself by providing a unique kind of financial independence. More and more payment processors are embracing these new payment methods, and the cannabis industry is also slowly welcoming them.

In order to fully understand the cannabis-crypto connection, Swaroop Suri, founder of Melee Dose, a cannabis brand that’s been embracing NFTs and crypto as payment options, shared some insights. Their innovative approach to creating unique cannabis experiences with technology and creative branding makes them a pioneer of this movement.

What’s Happening with Cannabis and NFTs?

NFTs and cryptocurrency are exciting developments in an industry that carries the reputation for having a rocky relationship with the banking industry. The legal gray area surrounding the connection between cannabis businesses and the banking industry has given way to an onslaught of challenges, with many banks shunning cannabis because of its federally illegal status. While traditional banking can limit cannabis companies’ access to basic financial services, the decentralization that’s characteristic of blockchain opens up many doors.

In recent years, different brands have tested the waters by using cryptocurrencies and NFTs to enhance marketing and offer alternate payment options. While it’s still early in the game, trends are starting to appear.

Bitcoin quickly became one of the more popular cryptocurrencies

One of these trends is using NFTs in marketing and branding, creating unique digital assets that can be collected. This gives an air of exclusivity, creates more immersive experiences, and helps forge a brand identity. NFTs are often a great tool to engage with customers and create a sense of community.

Melee Dose recently started integrating NFTs from Bored Ape Yacht Club (BAYC) into product packaging and branding. This has allowed the brand to offer unique experiences, foster community engagement, enhance storytelling and demonstrate adaptability to an ever-changing world.

“This collaboration merges the worlds of fashion, art and technology, providing our customers with exclusive “IRL” products incorporating digital assets and driving brand affinity”, says Swaroop Suri. “By embracing the digital revolution and connecting with the influential BAYC community, we aim to redefine consumer experiences and build lasting relationships with our audience.”

Crypto Payments Aren’t Futuristic Anymore

Payment is another trend to look out for. Cryptocurrencies are becoming more accepted in many big industries, including cannabis. With traditional banks limiting access to banking services, crypto allows cannabis companies to offer decentralized and secure payment options.

Cryptocurrency offers more enhanced privacy than traditional payment methods, which is great for those who want to stay under the radar. Lower transaction fees are another plus, as a decentralized system is more flexible. The speed of crypto payments is also an enticing feature, as payments are usually processed more quickly than traditional payment methods.

Swaroop Suri, Founder of Melee Dose

So, how are brands accepting crypto as payment? Is it safe? Melee Dose started accepting cryptocurrency payments on their e-commerce store by partnering with Coinbase Payments, a leader in the crypto industry with a strong reputation and ease of integration.

Cryptocurrency may seem perilous to those who don’t know much about it, but siding with the right company can help ease those fears. Addressing concerns about crypto volatility, Suri “opted for a feature provided by Coinbase Payments that allows for immediate conversion of cryptocurrency payments into our local currency, ensuring stable revenue despite market fluctuations.”

By working closely with reliable payment partners like Coinbase Payments and implementing necessary features, companies like his are able to successfully overcome crypto roadblocks, providing customers with increased flexibility and convenience.

The Future of Crypto, NFTs & Cannabis

The future of integration between cannabis, crypto and NFTs is exciting and always on the move, meaning there are opportunities constantly arising and challenges ahead we have yet to tackle. As cannabis legalization continues to evolve, we might expect changes in regulatory frameworks that impact how cryptocurrency is used in the industry. While we can’t say what those changes might be, the fact that NFTs and crypto have become mainstream indicates a clear adoption, as the industry finds ways to integrate them. From blockchain integration and creative marketing to payment options and immersive experiences, they are here to stay.

Swaroop Suri and his team might’ve gotten in on the game early, but they know the future is expansive: “It’s possible that NFTs could become a significant part of cannabis marketing strategies in the future,” He says. “The cannabis industry can use NFTs in various ways, such as tracking crops and using intellectual property to promote products through packaging artwork, which is what our team at Melee Dose has accomplished.”

NFTs won’t stop there. “There is a possibility to use NFTs for establishing VIP programs that offer exclusive discounts and access”, Suri says. “The ownership of an NFT could grant special privileges and perks to customers when shopping with an e-commerce company, fostering a deeper connection with the brand and community and leading to customer loyalty in the long run.” NFTs offer diverse possibilities for cannabis brands to improve their marketing techniques and get creative.

When it comes to crypto payments, brands will surely continue to add crypto as an option in addition to merchant processors. Highly-regulated industries like cannabis can find many benefits in crypto, as experienced by Suri: “Accepting cryptocurrency can mitigate some of these issues by providing an alternative payment option that is not subject to the same restrictions as traditional payment methods.”

Final Thoughts

The excitement surrounding crypto and NFTs is understandable, and as the cannabis industry introduces new opportunities for those who are at the intersection of these two global forces, companies everywhere are changing their relationship with technology.

There are other brands hopping onto the this train as well. Household cannabis brands and popular companies like Plain Jain, Highland Pharms, American Green and Pharma Hemp are just some of the many that have begun accepting crypto as payment.

As the industry continues to evolve and grow, staying ahead of the curve and embracing technology with critical thinking and environmental consciousness is key. As a new, dynamic and exciting space with as many opportunities as it is filled with challenges to tackle down the road surrounds us, the one thing we know for sure is that this is just the beginning.

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).

The Importance of Regulatory Compliance for Cannabis Delivery Providers

By Katherine Lehman
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Cannabis retail is becoming more and more commonplace in the United States. According to a consumer trends survey by North Hollywood-based cannabis brand Ganja Goddess Inc., 90% of respondents said they used online ordering and delivery services to purchase cannabis. Around 60% reported that online ordering and delivery would continue to be their preferred method of purchase post-pandemic. The pandemic hugely impacted the delivery market, pushing sales up 300% by the end of 2020. However, in a lot of states, brick-and-mortar stores remain illegal. Delivery services allow cannabis companies to reach customers in areas where dispensaries are not allowed. While cannabis delivery is an incredible opportunity for companies to reach new customers they would not otherwise be able to, following the law can be difficult in an environment with a patchwork of local laws and changing regulations. So, what do you need to know about regulatory adherence to stay ahead of the curve?

Delivery services allow cannabis companies to reach customers in areas where dispensaries are not allowed.

The short answer is it’s complicated. Each state has dramatically different laws regarding cannabis delivery, and laws can vary by jurisdiction. Some states allow full access to adult use cannabis, some only allow medical cannabis and some completely ban delivery, making it tricky to adhere to the law. There are currently 6 states that allow cannabis delivery: California, Colorado, Massachusetts, Michigan, Nevada and Oregon. Others like New York are taking the steps to allow delivery with careful regulation. With more states legalizing cannabis sales every year, delivery laws in existing delivery states are evolving and adapting to licensing changes. California introduced major changes to laws on January 1, 2023. These changes included allowing drivers to carry double the amount of product (up to $10,000 worth), no longer requiring vehicle inventory to be allocated or pre-purchased, and allowing curbside delivery for all licensed retailers. These changes to the largest cannabis market in the world showcase how much delivery is still changing and being regulated, and stresses the value of staying up to date on the latest laws and regulations.

Another aspect of delivery to consider is licensing specifically for delivery. Like regulations, licensing varies state to state and jurisdiction to jurisdiction. For example, in Massachusetts there are two types of licenses. Licensed providers must register as either a Marijuana Courier or as a Marijuana Delivery Operator. Couriers are allowed to earn a fee for delivering cannabis products from licensed retailers to consumers, and operators may buy and sell cannabis products wholesale, as well as deliver them. In Colorado, delivery requires two permits, however, a holder of both permits can still get in trouble if they deliver to an area or jurisdiction that has not affirmatively permitted delivery.

Although highly dependent on local, state and federal laws, the cannabis delivery space shows no signs of slowing down anytime soon.

A big win for delivery services came when Apple allowed cannabis delivery apps on iPhones in June 2021, with downloads restricted to states that allow adult use cannabis. Even then, a lot of individual counties or cities within adult use states still prohibit the delivery of cannabis. This patchwork of regulation makes adherence tricky, and makes certain software features like real-time driver tracking and proof-of-age verification crucial to delivery operations. With competition increasing it’s even more important for cannabis delivery operators to provide an outstanding experience for customers every time. One way they can achieve this is by improving their cannabis delivery software. According to cannabis last mile delivery management software provider Onfleet’s study, 72% of cannabis delivery operators said a delivery management tool was “critical to running delivery operations.” Delivery software also helps companies stay compliant with local regulations. Route planning allows your drivers to stay within legal zones. These platforms can also capture images of state-issued ID for age verification and record customer signatures so drivers can focus on ensuring customers are getting the best experience.

Although highly dependent on local, state and federal laws, the cannabis delivery space shows no signs of slowing down anytime soon. And if (or when) cannabis is legalized on a federal level, it would pave the way for major corporations like Uber and Amazon to enter the space – Uber is already taking steps in Canada. Whether that’s a good thing is up for debate, but delivery certainly isn’t going anywhere anytime soon. Depending on regulations and the market’s next moves, we will see a variety of delivery models and services in the coming years. Delivery services are the future of cannabis, providing customers with ease of access and personalized deliveries as well as benefiting retailers by lowering overhead costs and providing options for easy, quick customer service. Just make sure to check local laws before you confirm a delivery order, even in states where cannabis is legal.

From Seed to Storefront: Why Cannabis Retailers Should Know How to Cultivate

By Itali Heide
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There isn’t one simple formula that holds the secrets of success in cannabis branding, but there are some things that might give you an advantage. The possibilities of cannabis are endless and understanding the cultivation process can be incredibly advantageous to brands who want to become involved every step of the way and build a trustworthy brand from seed to storefront.

Some of the most successful brands in the cannabis industry have built their name on quality and the best way to ensure that is to know exactly where your bud is coming from.

The Advantages of Understanding the Cultivation Side of Cannabis

Understanding the cultivation side of the cannabis industry can be quite valuable for many reasons. If you’re in commercial cannabis, getting up close and personal with the cultivation process can lend cultivation expertise to your brand name and help connect you with the process from the very start so you can offer your customers a guarantee of high-quality products with a hands-on approach. Being close to the process allows you to develop the highest standards when it comes to better yields, stronger plants and more potent cannabis. In short, it gives you complete control of your brand and its reputation.

Radiant Huoang, CEO of Delta Munchies, shares how a deeper knowledge of the brand’s cultivation has affected and given Delta Munchies an advantage. “The years of experience on the cultivating side of cannabis, gave me an appreciation for the craftsmanship and the hard work that is essential to creating a great product,” says Huong. “In a crowded market, it’s impossible to build a lasting brand without a product of undoubtable quality, and that starts with the flower we use, thanks to our cultivators.”

Essentially, when you have control of the cultivation side of the business, you are able to craft strains, edibles and other products that are unique to your company. It gives you control over the quality of your product and gives you a consistent edge over the competition.

Being close to the process allows you to develop the highest standards when it comes to better yields, stronger plants and more potent cannabis.

“This level of craftsmanship bled over [to the retail side] when creating our brand and what we choose to offer to our consumers,” says Hoang. “Always trying to craft and improve the best products possible that deliver a similar effect to your traditional cannabis is our goal.”

Anyone buying a cannabis product wants to know that what they’re consuming is cultivated with passion and a careful eye for the details. As a retailer, cultivating their own crop allows Delta Munchies to ensure the integrity of the final product and deliver a true plant-centered experience to their clients.

Beyond retail, growing is an excellent place to start in the cannabis industry. It sets up a solid foundation for you to understand cannabis and allows you to bring the highest quality products to the market. Especially since a rise in the use of cannabis calls for more growers and cultivation-centered businesses.

Understanding the Headwinds of Cannabis Cultivation and Cannabis Retail

Not everything in the cannabis cultivation and retail world is perfect, as with any other industry. Making it can be challenging, especially as local regulations fluctuate while nationwide legalization remains in limbo.

The first challenge is legalization: as of now, hemp is federally legal and hemp-derived products containing less than 0.3% delta 9 THC are technically legal in all states. It can be difficult to keep up with new laws and constant changes. Right now, cannabis businesses can still struggle with access to banking services and insurance.

It’s important to follow general federal regulations for your product, such as the nutrition facts section

Growers are also faced with the bureaucracy and costs of regulations, testing conditions, label requirements and other additional investments that come with constant change. Still, change is a part of any budding industry, so it’s important to keep this in mind and remain adaptable.

Some states place a limit on the number of licenses they’re allowed to issue to cannabis businesses and growers, which can make it challenging for new players to join and results in the market being dominated by the top dogs, but this isn’t unlike any other industry. Making sure you can commit to a business of this type is another thing to consider deeply before endeavoring into the world of cannabis.

What About the Future of Cannabis Cultivation and Retail?

The future of cultivation and retail is bright, although not without speedbumps along the way. The good: we can expect more consistency and structure after regulation becomes the norm, advances in technology are being used to make exciting, creative products and growing interest and preferences make for a promising future of growth.

On the other hand, regulation could go a bit too far. When asked about the future of the industry Huong believes brands need to be given the freedom to innovate. “We think that cannabis cultivation will always be a beautiful art, but with so much saturation and over-regulation it makes it extremely difficult to operate,” says Hoang. This is an important factor to consider, although regulation can have its advantages, states need to consider whether their regulations are truly aimed at improving quality and safety, or just acting as barriers to entry.

Technology will surely play a role in the future of cannabis cultivation and retail. Advances in the agricultural sector grow exponentially, with systems that are developed and optimized to grow hemp and cannabis with a variety of top-of-the-line technologies that help ensure high-quality raw materials.

The future of the cannabis industry will be shaped by many things, but nothing can influence the market as much as its consumers. Customer preference, brand trustworthiness and effectiveness, and legality will ultimately lead the way for cannabis trends.

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Getting involved with the cultivation process can be important for overall quality.

One way to do this is to be in complete control of your product, from seed to storefront. Being able to cultivate the product you sell allows you to pivot more easily when the market demands it. Rather than seeking out new suppliers, a nimble cannabis brand will be set up to shift its cultivation operations as consumers switch from high THC strains to CBD or any other novel cannabinoid to hit the market.

Final Thoughts

Getting involved with the cultivation process can be important for overall quality. If you own a cannabis brand, having a close relationship with your grower or growing your own cannabis can lead to a product that’s higher in quality, as you can achieve a deeper understanding of the unique effects that you want your product to have and the quality necessary to achieve them. At the end of the day, what customers care for most is the product inside the packaging that you’ve designed to catch their eye. This is what will keep them coming back. It’s that quality that will imprint the packaging in their minds on their next trip to the dispensary.

Knowing more about cannabis from the ground up can be beneficial when it comes to innovation opportunities. Being able to apply your own knowledge or that of your trusted growers to a new product can help you grow your brand in a way that’s uniquely yours.

Hoang says harmony between the grower and the brand is important: “Seeing something you grew yourself come to life bleeds into the brand.” Becoming involved in the cultivation process of cannabis allows you to gain perspective that can be beneficial for your brand.

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FDA Punts on CBD Rules

By Cannabis Industry Journal Staff
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On December 20, 2018, Former President Trump signed the Farm Bill into law, which removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, stripped the DEA’s authority from hemp and gave states the ability to regulate hemp markets of their own, with approval from the USDA.

FDAlogoWhen that Farm Bill became law, it paved the way for state-sanctioned hemp and CBD product markets and it seemed as if the floodgates were opening for legal CBD, but some caveats and gray areas remained. The same day the Farm Bill became law, the FDA released a statement asserting their authority, threatening enforcement actions for things like unsubstantiated drug marketing claims.

Over the past four years, the FDA has dealt with dozens of enforcement actions involving CBD products. The agency said they were “working quickly to further clarify our regulatory approach,” but that seems categorically false given how long it took them to tell the public they don’t know what to do. Finally, after four years and change of comment periods, industry frustration, warning letters and state-sanctioned gray markets, the FDA announced they need help from Congress.

Janet Woodcock, M.D., principal deputy commissioner at the FDA

Last week, the FDA published a statement from Janet Woodcock, M.D., principal deputy commissioner, that says, to paraphrase, they’ve given up. Industry stakeholders have long agreed that the food and dietary supplements regulatory framework is adequate for CBD products, citing minimal public health risk and a pre-existing framework that CBD could fit into easily. “The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,” says Dr. Woodcock. “Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.”

The reasoning behind the agency’s unwillingness to regulate it as a dietary supplement is because of safety concerns, like potential liver damage, possible drug interactions and reproductive harm. Scientific data available to the FDA shows that they cannot say that CBD is generally recognized as safe (GRAS). “Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” says Dr. Woodcock. “The agency is prepared to work with Congress on this matter.”

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3 Benefits of Conducting Genetic Tests on Your Plants

By Angel Fernandez
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Many growers may wonder why it’s important to get their plants genetically tested, but the truth is that genetic testing can make growing a lot easier. Genetic analysis in plants can give a wide range of results that can help scientists solve everyday problems in plant cultivation, such as detecting diseases and identifying important traits in plant species.

Currently, three of the most important benefits that genetic testing can give growers are the ability to detect diseases, identify the gender of their plants and control the quality of their crops.

Pathogen detection

Pathogen infections can be difficult to detect and by the time symptoms are obvious, it may be too late and the rest of the crop is already contaminated. This is why DNA tests are a valuable tool for the early detection of diseases in plants. Even though plants reproduce through cloning, it’s crucial to make sure the mother plant is healthy before proceeding, as 100% of the genetic material will be transferred to the clone, including any diseases the mother plant may have, such as a virus.

There are a few ways to detect pathogens in plants, including detection and symptomatology, serological techniques for viruses and microbiological techniques for fungi and bacteria. However, another effective method is detection tests using genetic material, also known as molecular methods. These tests involve screening the plant’s genetic material for any alterations, such as the presence of the pathogen’s genetic material. These tests are particularly useful as they provide accurate results when at least part of the pathogen’s genome sequence is known. This is important as many of these genomes have yet to be fully studied and there may be new unknown variants.

Tobacco Mosaic Virus symptoms can include tip curling, blotching of leaf mosaic patterning, and stunting

The reliability and effectiveness of genetic and molecular tests are due to the use of DNA as the starting material for pathogen detection. DNA is a stable molecule that can withstand adverse conditions, such as high temperatures or low humidity. Additionally, this technique can still be effective even when the samples used are very damaged or necrotic. Due to these qualities, genetic testing is considered one of the best methods for pathogen detection.

In summary, genetic testing is the most effective technique for pathogen detection as it is highly specific, requires a small sample and provides accurate results in a short period of time.

Plant gender detection

In the case of the cannabis plant, it is naturally diploid and dioecious, meaning that it has separate male and female reproductive structures, and each one contributes a chromosome during reproduction. However, there may be mutations that result in hermaphrodite plants, which have both male and female reproductive structures.

Growers who propagate their crops through seeds must wait several weeks to identify the sex of their plants, as their dioecious nature makes it difficult to recognize the plant’s sex in the early stages of growth. This can be time-consuming and resource-intensive. However, thanks to genetic testing, it is possible to determine the sex of a plant long before it reaches the flowering stage.

The sex organs on a Cannabis plant identified.

The determination of the gender of a dioecious plant is influenced by a sex chromosome system. Male plants have an XY sex chromosome system, known as heterogametic, while female plants have the XX sex chromosome system, known as homogametic.

To identify the sex of a plant through genetic studies, DNA or RNA-based molecular markers are used with a tissue sample. These markers typically look for the male trait “Y” in the plant, as the trait “X” is present in both male and female plants. In this way, the presence of the Y chromosome can be used to confirm the plant is male, and its absence can be used to confirm that it is female.

Crop quality control

The same species can often present one or more varieties, and although they may have physical features that distinguish them, it is not always possible to identify them with the naked eye. Beyond physical characteristics, genetic traits can have considerable differences.

Molecular identification is a very accurate tool for identifying varieties

Different varieties of cannabis have been widely cultivated and crossbred, making it possible for plants to have very similar physical traits, making it difficult to identify the variety being cultivated. This is why molecular identification is a very accurate tool for identifying varieties in cases where there is uncertainty about their identity.

Additionally, some plants can produce lower or higher amounts of cannabinoids due to their genetic nature or small mutations that occurred during growth. This is how there are plants with the advantage of having genes that code for high production of THC or CBD. These outstanding traits can be detected through the selection of characteristics using analysis of molecular markers that indicate the presence of these genes in the plant, or that detect the genes responsible for synthesizing these substances and determine their respective quality.

These procedures are performed using a tissue sample from the plant and using DNA as a starting material for testing, which provides information on the genetic traits of interest and validates their function.

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Attracting Investment: How Cannabis Companies Can Best Position Themselves

By Joe Madigan
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Remember those heady days of the Green Rush a decade ago, when markets were small and it seemed everyone had a chance? Now it’s more of a mad rush to get some green in the form of investment capital.

The majority of states in the country now have some type of legal cannabis market. Businesses in those states operate in spite of regulations that are restrictive, confusing and make it very difficult to make a profit. Meanwhile, heavy tax burdens, differences in enforcement techniques and varying degrees of oversight are other factors that influence bottom lines in the cannabis industry.

Saturated markets are giving businesses trouble when it comes to their bottom line

Inflation also continues to be a prominent force across world markets. Sales of cannabis products have fallen as consumers adjust to inflation and post-COVID supply chain issues that are causing higher prices on necessary staples like food and gas. An oversaturation of cannabis flower is becoming a perennial problem in some states and another factor causing industry distress.

When cash flow slows to a trickle, companies of all sizes seek out investment funding to keep their momentum. But catching the eye of an investor group requires more than just sticking your hand out.

What Attracts Potential Investors?

A company is best positioned to attract those interested in cannabis investment opportunities when it appears serious about its growth plans. That means being well positioned with a solid upper-management foundation and so much the better if there’s an advisory board in place too. A company built with a diverse group of talent—ideally from consumer packaged goods companies—presents an attractive opportunity for investors.

Talent from the CPG space can help attract investors

Top-quality and industry savvy finance employees who maintain sound financial books and establish a solid banking arrangement are also important. If the company’s financial scenario is robust enough to provide confidence in case of an audit and the books are in good shape with auditable METRC logs investors will be far more inclined to put money on the line.

A cannabis company with full inclusion (or seed to sale) is often a smart choice for investment. The vertical integration of cultivation, processing/manufacturing and retail allows them to sell their own products while also stocking other brands’ products on the floors of their dispensaries. If their products are respected and the brand is held in high regard, even better. Similarly, a cultivation enterprise that can grow crops for multiple brands can also be very attractive. The ability to pivot and adjust production to reflect the market and consumer demands indicates a strong business foundation.

Despite the current headwinds and saturated markets, other chances for growth exist. When a local municipality finally decides to “opt-in” to adult-use cannabis sales, there’s opportunity for both established brands and startups. It’s a matter of being ready for those opportunities and having a plan to leap in whenever new licenses become available.

What Businesses Will Struggle to Attract Investment?

Culture is key here. Poor employee relations and weak cohesion across departments are indicative of deeper problems. Do people actually want to work for the business? Do they feel supported by human resources? A company with underdeveloped or non-existent workers’ compensation policies and a management team that is not respected by its employees is not going to look good in the eyes of potential investors.

Non-diversified cannabis businesses are also at a major disadvantage when seeking investors. Cultivators of one type of product or service are locked into a single operation geared to do one thing. Any changes to market whims or problems with the supply chain can wreak havoc on a business based around a single product.

Stick to Business Basics

The cannabis industry is unique, but the basics of running a business well enough for success still apply. Strictly adhering to the traditional methods that any successful organization follows is extra important in cannabis. Businesses that are active in their community and make a real effort to be involved will be held in higher regard by investors. They want to see cannabis businesses that are not just setting up shop to make a quick buck, but are dedicated to bettering their community. That indicates a relationship with customers that involves mutual respect and promotes business longevity and financial stability.

A Guide to Dispensary Insurance

By Itali Heide
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As a business owner, insurance is always a must. If you are interested in entering into the cannabis industry or you already have, it’s important to know what to expect when it comes to insuring your cannabis-related business.

That’s why we’ll be exploring what dispensary insurance is, different options for business owners and general advice regarding dispensary and other CRB insurance.

What is Dispensary Insurance?

Insurance for cannabis-related businesses refers to policies that protect the business against risk. This can include dispensaries, cultivation centers and testing labs – all of which require different levels of coverage and liability.

We spoke to Alexander Marenco, an insurance broker from Marenco Insurance, who explained what dispensary owners should know before seeking out insurance. Marenco says it’s similar to shopping for insurance for other businesess. “You need to have full details of the business and location to receive a quote.” He adds. “The applications will ask questions such as location, renovations, or improvements to the location, ownership information, payroll details, and sales or projected annual sales.”

How is Dispensary Insurance Different From Other Forms of Business Insurance?

Because non-hemp-derived cannabis is still considered a schedule one controlled substance under the Controlled Substance Act, cannabis insurance can be more expensive than regular insurance for non-cannabis businesses. Because of the risks associated with being considered a potential retailer of a controlled substance, liability policies and other options can cost a pretty penny.

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The cash-only nature of the business makes insuring dispensaries more costly

Additionally, when asking Marenco about how dispensary insurance differs from other brick-and-mortar retail insurance, he says: “With more states increasingly legalizing medicinal and recreational marijuana, insurance carriers have started to open risk acceptability. However, since marijuana is still federally illegal, businesses will find it difficult to find multiple quotes from different carriers.”

Types of Insurance Available for Cannabis-Related Businesses

What kind of insurance is available for cannabis-related businesses? Let’s find out.

First off, it’s important to keep in mind that CRBs are at risk for a lot of things: workplace accidents, damage to property, theft, general liability and product liability. Plus, the fact that most dispensaries work on a cash-only business model until the Secure and Fair Enforcement (SAFE) Banking Act is approved by Congress, CRBs tend to handle big amounts of cash, further putting them at risk of theft and liability. CRB insurance can be as low as $350 and as high as $7,500 depending on the type of business and policy.

Here are some of the most common types of insurance for CRBs and what they cover:

  • General liability: third-party claims for bodily injury, property damage and reputational harm.
  • Commercial property: damage to a business-owned property.
  • Professional liability: third-party accusations of negligence and mistakes.
  • Workers’ compensation: employees’ medical bills and lost wages due to injury or illness.
  • Inland marine: damage or theft of business-owned property in transit.
  • Crop: costs from damage to seeds and plants.

With so many things to watch out for, insurance for cannabis businesses and dispensaries isn’t cheap. Here, Marenco says what CRB owners can do to keep their premiums as low as possible:

A smart safe like this one can help secure cash handling

“Premiums are primarily based on sales (actual or projected). After the term expires, the insurance carrier will conduct an audit for the prior term to confirm the information from the application. The audited discrepancy will adjust the next term’s sales figures. Dispensary insurance will typically be placed through an excess & surplus market which do not provide traditional discounts.”

So, in essence, the best thing a dispensary owner can do is be honest about their projections.

Navigating premiums can be a detailed process, as we learned when speaking to Jesse Giffith, an owner of Smokeless CBD and Vape: a chain of retail shops across the twin cities Minneapolis–Saint Paul, Minnesota:

“Our shops carry insurance that has been offered with a modified rate for vape retailers. This route was not as straightforward as some traditional retail insurance options, but may offer benefits, and a better fit for coverage than other dispensary insurance options.”

A Growing Number of Dispensaries Across America

With the growing legalization and normalization of adult use, medical and hemp-derived cannabis across the nation, it should come as no surprise that the number of dispensaries across the country grows exponentially.

In 2021, the cannabis market in the U.S. was valued at 10.8 billion dollars, with an expected annual growth of 14.9% annually. This is a sign of what’s to come. Cannabis may be an industry that’s been considered taboo for decades, but the growth shows the growing acceptance of the plant for medical and adult use reasons.

Insurance providers remain cautious as cannabis laws are still in flux.

With that growth comes a greater need for insurance providers, opening the door to the possibility that these two industries will grow in tandem. The future may bring a greater variety of options for coverage at cheaper prices. But for the time being, insurance providers remain cautious as the fate of federal and local cannabis laws are still in flux.

Are There Limited Carriers that Issue Dispensary Insurance?

Every CRB needs insurance, just like any other type of establishment, business or company. The issue within the cannabis industry is that there is still a limited insurance market, with insurers willing to provide insurance constantly exiting and entering the market. Plus, the overall capacity and variety of policies that cover different types of risks are limited. Lastly, it can be difficult to use CRB insurance when you read between the lines of the policy. Because cannabis with THC is still federally illegal (excluding hemp-derived cannabis products containing less than 0.3% THC), insurers can negate coverage when a loss or claim occurs.

Because of the complications that may arise even if you do have insurance, Marenco offers some advice for dispensary owners that are searching for the right insurance option for them: “Before shopping for insurance make sure you have all your licenses and are in full compliance with all regulations. Insurance carrier’s requirements from the state. Additionally, consider different coverage options.” He continues. “At a minimum, a business needs general liability insurance. Insurance companies can also consider covering business property including inventory, betterments, and improvements to a rented space, among others. When shopping for insurance make sure your agent reviews different coverage options.”

Cannabis in 2023: Here to Stay, but Major Challenges Remain

By Joshua Weiss, Osiris Morel
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2022 brought more change and visibility to the cannabis industry than nearly any year before. Two of five legalization ballot measures passed, bringing the total number of states with legal medical or medical and recreational laws to 39. President Biden issued an executive order pardoning nonviolent offenders and directing a review into rescheduling cannabis. The Medical Marijuana and Cannabidiol Research Expansion Act was enacted. Cannabis arose prominently in legislatures across the country, with over 50 federal bills and hundreds of state-level measures introduced.

We’ve yet to see the full impact from Biden’s October 6 announcement

But as 2022 came to a close, only a handful of actions are being carried into the new year, and the industry faces more hardship and turmoil than it has since the inception of legalization. Legal cannabis retailers and cultivators in markets across the country continue to struggle with onerous regulations and competition from the illicit market, and oversupply in these markets is driving down prices as West Coast growers and manufacturers anxiously await interstate commerce.

Looking ahead to the coming year, industry watchers can anticipate certain issues and legislation: further investigation into cannabis’ classification on the Controlled Substances Act (CSA) from federal agencies, federal cannabis pardons coming to fruition, a follow-up from the Department of Justice’s technical report, and the reintroduction of high-profile federal legislation, like the Cannabis Opportunity Act (CAOA), the States Reform Act, Marijuana Opportunity Reinvestment and Expungement (MORE) Act, Harnessing Opportunities by Pursuing Expungement (HOPE) Act and the Secure and Fair (SAFE) Banking Act.

Below, we recap some of the big moments of 2022 and what to expect in 2023.

A Presidential Pardon for Simple Possession

On Oct. 6, President Biden made a historic announcement to “grant a full, complete, and unconditional pardon to all current United States citizens and lawful permanent residents who committed the offense of simple possession of marijuana in violation of the Controlled Substances Act” and “all current United States citizens and lawful permanent residents who have been convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act.” His executive order also encouraged governors to follow suit for cases regarding state offenses and requested that the secretary of Health and Human Services and the attorney general “expeditiously” review how cannabis is scheduled under federal law.

Biden signing his executive order back in October of 2022

The president’s strategic plan attempts to at least partly address some of the adverse impacts of the United States’ war on drugs on certain populations like low-income and Black and Latinx Americans. While an admirable and important effort, certain portions of his executive order will take much longer than others to yield tangible impact. A federal pardoning can take anywhere between two to five years, and the laws and duration of state-level pardoning vary—depending on the state and its governing practices. Additionally, since governors are not required to pardon individuals following the president’s executive order, some convicted persons may never see or be able to seek justice. And the most uncertain timeline relates to the review of cannabis’ classification on the CSA. Rescheduling or descheduling a substance under the CSA can be tedious and grueling, and, as seen with other substances, the process can range from four to ten years. However, the exercise is ongoing, and although results may not be shared in time for the 118th Congress, it is to be expected that the issue will be discussed at length in 2023 and beyond.

Descheduling, Decriminalizing & Banking Legislative Efforts  

1. CAOA.

When it comes to legislation, there is no question that Majority Leader Chuck Schumer (D-NY) and Sens. Ron Wyden (D-OR) and Cory Booker (D-NJ) will reintroduce the CAOA in 2023. The comprehensive legislation aims to decriminalize cannabis by removing the drug from the CSA and tackles issues related to research, public safety, restorative justice and equity, taxation and regulation, public health and industry practices.

2. States Reform Act.

Sen. Schumer unveiling the Cannabis Administration and Opportunity Act

Another piece of legislation we anticipate seeing in the 118th Congress is Rep. Nancy Mace’s (R-SC) States Reform Act. Coming from a state without any cannabis laws, the freshman congresswoman introduced a measure that would federally decriminalize cannabis by fully deferring to state powers over prohibition and commercial regulation and regulate cannabis products like alcohol. In 2022, the bill received positive feedback from the industry and dominated the discussions during the Developments in State Cannabis Laws and Bipartisan Cannabis Reforms congressional hearing. With its bold cannabis sponsor, who will now serve as the House Oversight Subcommittee on Civil Rights and Civil Liberties chair, the States Reform Act will undoubtedly take center stage in 2023.

3. MORE Act.

Sponsored by Rep. Jerry Nadler (D-NY), the MORE Act will also be reintroduced in 2023; however, it remains to be seen how much attention the bill will receive. The MORE Act aims to decriminalize cannabis by removing the drug from the CSA and eliminating criminal penalties for anyone who manufactures, distributes or possesses cannabis. In the 117th Congress, Rep. Nadler served as the chair to the House Judiciary Committee and was able to advance his measure through the chamber with ease. But since the House majority has flipped, and Rep. Jim Jordan (R-OH) is likely to serve as the chair, getting the MORE Act to the floor for a vote may be challenging—especially given Rep. Jordan’s opposition to the cannabis sector.

The House passing the MORE Act back in 2020

4. HOPE Act.

The HOPE Act often flies under the radar, but this Republican-sponsored bill made headlines during the 117th Congress. Sponsored by Co-Chair of the Congressional Cannabis Caucus (CCC), Rep. Dave Joyce (OH), the bipartisan legislation aims to help states with expunging cannabis offenses by reducing the financial and administrative burden of such efforts through federal grants. Although it was not considered in the House, the language of the bill was heavily debated by the Senate, particularly toward the end of the year when the chamber was negotiating the final text for end-of-year must-pass packages, like the National Defense Authorization Act (NDAA), the Omnibus and the Continuing Resolution (CR). Alongside the SAFE Banking Act, the HOPE Act was one of the only cannabis bills that had a realistic chance of advancing as part of a larger legislative vehicle, so there is no question that the congressman will reintroduce the measure in the upcoming congressional session.

5. SAFE Banking Act.

And last, but certainly not least, is the most discussed cannabis bill this year: the SAFE Banking Act. The legislation aims to create a safe harbor for financial institutions to provide traditional banking services to cannabis businesses in states that have legalized the drug. It also allows cannabis businesses to access lines of credit, loans and wealth management. It has now passed in the House seven times, with bipartisan support. And although the SAFE Banking Act was debated by the House several times throughout the year, the Senate did not tackle the bill until November. By the time discussions for the bill’s language had taken off, Sen. Booker remained firm that he would only support a cannabis bill if it included criminal justice and social equity reform language. In an attempt to satisfy the senator’s demands, Majority Leader Schumer considered marrying the SAFE Banking Act and the HOPE Act as part of a larger package.

However, and much to the cannabis industry’s detriment, not only was the timeline for those bills a little too late, but Democrats were, unfortunately, unable to fix the money laundering and cash legacy concerns of Sen. Chuck Grassley (R-IA) and other Republicans.

Sen. Cory Booker (D-NJ)
Photo: Nick Fisher, Flickr

After attempting to attach the SAFE Banking Act to multiple vehicles, retiring Congressman Ed Perlmutter (D-CO), sponsor of the legislation, and Sen. Schumer were unsuccessful in getting the bill over the finish line. In a final Hail Mary, Sen. Schumer attempted to include the language to the Omnibus, but compounded with the technical assistance report from the Department of Justice (DOJ) and ongoing media flurry, he and the Democratic party yet again came up empty-handed.

The question now is: who will carry the SAFE Banking Act and Rep. Perlmutter’s legacy in 2023? Many will look toward cannabis industry champions like Reps. Joyce, Mace, Earl Blumenauer (D-OR) and Brian Mast (R-FL). However, it would be worth considering other members of the CCC and some of the incoming freshmen, particularly those from a state with legal cannabis laws. It is also entirely possible that Sen. Jeff Merkley (D-OR) finds his own sponsor to carry his companion bill in the House since he has already announced that he looks forward to working on the legislation in the upcoming year. Regardless, it is highly likely that the SAFE Banking Act will be reintroduced in 2023 and considered throughout the year.

6. Other Measures

Other measures that are likely to reappear in 2023 are the Capital Lending and Investment for Marijuana Businesses (CLIMB) Act, Veterans Equal Access Act, the GRAM Act, Common Sense Cannabis Reform for Veterans, Small Businesses and Medical Professionals Act, VA Medicinal Cannabis Research Act and the Homegrown Act. Additionally, the passage of the Medical Marijuana and Cannabidiol Research Expansion Act and the advancement of many of these federal bills have opened the gates for new legislation related to medical and recreational cannabis, research, veterans’ access, financial services, criminal justice reform and social equity, and public health and safety to emerge.

For states with legal cannabis laws, bills related to enhancing the state’s medical or medical and recreational programs, preventing industry oversaturation and price gouging, expanding licensing opportunities, criminal justice reform, youth and advertising protections and impaired driving are likely to be introduced. States where cannabis ballot measures failed will likely see those measures resurface.

The continued growth of legalization across the country is all but inevitable. In the nearer term, the industry will focus on how to remain viable in the face of high taxes and oversupply in 2023. New Congressional leadership could lead to bipartisan cannabis legalization if enough members are willing to rally behind their colleagues who are pushing for cannabis legislation. While the road is long before we will see the full impact from President Biden’s Oct. 6 announcement, the action proves those in power cannot ignore the ever-growing numbers of Americans across party lines and demographics who agree that cannabis use should be legal and regulated.