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An Evaluation of Sample Preparation Techniques for Cannabis Potency Analysis

By Kelsey Cagle, Frank L. Dorman, Jessica Westland
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Sample preparation is an essential part of method development and is critical to successful analytical determinations. With cannabis and cannabis products, the analyst is faced with a very challenging matrix and targets that may range from trace level through percent level thus placing considerable demands on the sample preparation techniques.1 The optimal sample preparation, or “extraction”, method for potency analysis of cannabis flower was determined using a methanol extraction coupled with filtration using regenerated cellulose filters. 

In the United States (US), Canada, and other countries where medicinal and/or adult recreational cannabis has been legalized, regulatory entities require a panel of chemical tests to ensure quality and safety of the products prior to retail sales2. Cannabis testing can be divided into two different categories: Quality and Safety. Quality testing, which includes potency analysis (also known as cannabinoid testing or cannabinoid content), is performed to analyze the product in accordance with the producer/grower expectations and government regulations. Safety testing is conducted under regulatory guidelines to ensure that consumers are not exposed to toxicants such as pesticides, mycotoxins, heavy metals, residual solvents and microbial contaminates.

Potency testing evaluates the total amount of cannabinoid content, specifically focusing on tetrahydrocannabinol (THC) and cannabidiol (CBD). In the US, the biggest push for accurate total THC is to differentiate between hemp (legally grown for industrial or medicinal use), which is defined as cannabis sativa with a THC limit ≤ 0.3 %, and cannabis (Cannabis spp.), which is any cannabis plant with THC measured above 0.3 %3. Potency testing is typically performed by liquid chromatography (LC) with UV detection to determine the quantity of major cannabinoids.

In addition to reporting THC and CBD, their respective precursors are also important for reporting total potency. Tetrahydrocannabinolic acid (THCA) is the inactive precursor to THC while cannabidiolic acid (CBDA) is the precursor to CBD.4,5

Methods and Materials

Sample Preparation

All samples were homogenized using an immersion blender with a dry material grinder. The nominal sample amounts were 200 mg of flower, 500 mg of edibles, and 250 mg of candy samples.

Potency Extraction Method (1)

Twenty milliliters (mL) of methanol (MeOH) was added to each sample. The samples were mechanically shaken for 10 minutes and centrifuged for 5 minutes.

Potency Extraction Method (2)

Ten mL of water was added to each sample. The samples were mechanically shaken for 10 minutes. 20 mL of acetonitrile (ACN) was then added to each sample and vortexed. An EN QuEChERS extraction salt packet was added to the sample. The samples were placed on a mechanical shaker for 2 minutes and then centrifuged for 5 minutes.

Each extract was split and evaluated with two filtration/cleanup steps: (1) a regenerated cellulose (RC) syringe filter (Agilent Technologies, 4 mm, 0.45 µm); (2) a PFTE syringe filter (Agilent Technologies, 4 mm, 0.45 µm). The final filtered extracts were injected into the ultra-performance liquid chromatograph coupled with a photodiode array detector (UPLC-PDA) for analysis.

Figure 1: Calibration curve for THC potency

Calibration

Standards were obtained for the following cannabinoids at a concentration of 1 mg/mL: cannabidivarin (CBDV), tetrahydrocannabivarin (THCV), cannabidiol (CBD), cannabigerol (CBG), cannabidiolic acid (CBDA), cannabigerolic acid (CBGA), cannabinol (CBN), tetrahydrocannabinol (9-THC), cannabichromene (CBC), tetrahydrocannabinol acid (THCA). Equal volumes of each standard were mixed with MeOH to make a standard stock solution of 10 ug/mL. Serial dilutions were made from the stock to make concentrations of 5, 1, and 0.5 ug/mL for the calibration curve (Figure 1).

Instrumental Method

All instrument parameters were followed from Agilent Application Note 5991-9285EN.8 A UPLC with a PDA (Waters Corp, Milford, MA) detector was employed for potency analysis. An InfinityLab Poroshell 120 EC-C18, 3.0 x 50 mm, 2.7 um column (Agilent Technologies, Wilmington, DE) was utilized for compound separation. The organic mobile phase composition was 0.05 % (v/v) formic acid in HPLC grade MeOH and the aqueous mobile phase composition was 0.1 % (v/v) formic acid in HPLC grade water. The mobile phase gradient is shown in Table 1. The flow rate was 1 mL/min (9.5 minute total program), injection volume was 5 uL, and column temperature was 50 °C.

Table 1: LC mobile phase gradient for potency samples6

Discussion and Results

Table 2 summarizes the relative standard deviations (% RSD) were found for the THC calibrator (at 1 ug/mL) and one extract of a homogeneous sample (utilizing 7 replicates).

Table 2- %RSD values for the instrument response precision for THC in both the calibrations and the homogeneous extract.

The cannabinoid potency of various cannabis plant and cannabis product samples were determined for the various extraction techniques In the chromatograms THC was observed ~8.08 minutes and CBD was observed ~4.61 minutes (Figure 2).

Figure 2: Chromatogram of the 10ug/mL calibrator for potency/cannabinoid analysis

Total potency for THC & CBD were calculated for each sample using the equations below. Equation 1 was used because it accounts for the presence of THCA as well as the specific weight difference between THC and THCA (since THCA will eventually convert to THC, this needs to be accounted for in the calculations).

Table 3 shows the % THC and the total THC potency values calculated for the same flower samples that went through all four various potency sample preparation techniques as described earlier. Figure 3 also provides LC chromatograms for flower sample 03281913A-2 and edible sample 03281912-1.

Table 3-THC and Total THC potency values for the same cannabis flower sample processed through the combination of extractions and cleanups.
Figure 3: Potency/Cannabinoid analysis chromatogram for flower sample 03281913A-2 (red trace) and edible sample 03281912-1 (green trace).

The results indicated that with the “Potency Extraction Method 2” (ACN/QuEChERS extraction) coupled with the RC filter provided a bias of 7.29 % greater for total THC % over the other extraction techniques. Since the other 3 techniques provided total THC values within 2% of each other, the total THC of the sample is more likely ~14%.

Since the sample dilution for the above data set reduced the CBD content, an undiluted sample was run and analyzed. This data is reported in Table 4.

Table 4- CBD and Total CBD potency values for the same cannabis flower sample processed through different sample preparation techniques.

The CBD results indicated that with the “Potency Extraction Method 1” (methanol extraction) coupled with RC filter, allowed for a greater CBD recovery. This may indicate the loss of CBD with an ACN/QuEChERS extraction.

With an average ~14% total THC and 0.06% total CBD for a homogenous cannabis flower sample, the optimal sample preparation extraction was determined to be a methanol extraction coupled with filtration using a regenerated cellulose filter. Since potency continues to remain at the forefront of cannabis regulatory testing it is important to utilize the right sample prep for your cannabis samples.

References

  1. Wang M, Wang YH, Avula B, Radwan MM, Wanas AS, Mehmedic Z, et al. Quantitative Determination of Cannabinoids in Cannabis and Cannabis Products Using Ultra-High-Performance Supercritical Fluid Chromatography and Diode Array/Mass Spectrometric Detection. Journal of Forensic Sciences 2016;62(3):602-11.
  2. Matthew Curtis, Eric Fausett, Wendi A. Hale, Ron Honnold, Jessica Westland, Peter J. Stone, Jeffery S. Hollis, Anthony Macherone. Cannabis Science and Technology, September/October 2019, Volume 2, Issue 5.
  3. Sian Ferguson. https://www.healthline.com/health/hemp-vs-marijuana. August 27, 2020.
  4. Taschwer M, Schmid MG. Determination of the relative percentage distribution of THCA and 9-THC in herbal cannabis seized in Austria- Impact of different storage temperatures on stability. Forensic Science International 2015; 254:167-71.
  5. Beadle A. CBDA Vs CBD: What are the differences? [Internet]. Analytical Cannabis. 2019 [cited 2020 Apr 22]; https://www.analyticalcannabis.com/articles/cbda-vs-cbd-what-are-the-differences-312019.
  6. Storm C, Zumwalt M, Macherone A. Dedicated Cannabinoid Potency Testing Using the Agilent 1220 Infinity II LC System. Agilent Technologies, Inc. Application Note 5991-9285EN
Milan Patel, PathogenDx
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The Need for More Stringent Testing in Cannabis

By Milan Patel
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Milan Patel, PathogenDx

As the demand for legal cannabis continues to rise and more states come online, it is imperative to enact more rigorous and comprehensive testing solutions to protect the health of consumers. People use cannabis products for wellness and to find relief; they should not be susceptible to consuming pathogens and falling ill. Especially for immunocompromised consumers, the consequences of consuming contaminated cannabis or hemp are dire. Of course, there should be federal standards for pathogen testing requirements like we have for the food industry. But right now, as cannabis is not yet federally legal, testing regulations vary between states and in many states, testing requirements are too loose and enforcement is minimal. It is up to state legislators, regulators and cannabis operators to protect the health of consumers through implementing more stringent testing.

From the outset, the environmental elements needed to grow cannabis – heat, light, humidity, soil – make cannabis ripe for pathogens to proliferate. Even when growers follow strict sanitation procedures through the supply chain from seed to sale, contaminations can still occur. Cannabis companies need to be hypervigilant and proactive about testing, not just reactive. The lack of regulations in some states is alarming, and as the cannabis industry is highly competitive and so many companies have emerged in a short time, there are unfortunately unscrupulous actors that have skated by in a loose regulatory landscape, just in the game to make a quick buck, even at the expense of consumer health. And there are notable instances where states do not have enforcement in place to deter harmful manufacturing practices. For instance, there are some states that don’t mandate moisture control and there have been incidents of companies watering down flower so it has more weight and thus can be sold at a higher cost – all the while that added moisture leads to mold, harming the consumer. This vicious circle driven by selfish human behavior needs to be broken by stricter regulations and enforcement.

While in the short term, looser testing regulations may save companies some money, in the long run these regulatory environments carry significant economic repercussions and damage the industry at large, most importantly injury or death to customers and patients. Recalls can tarnish a company’s brand and reputation and cause sales and stock prices to tank, and since cannabis legalization is such a hotly contested issue, the media gloms onto these recalls, which opponents to legalization then leverage to justify their stance. In order to win the hearts and minds of opponents and bring about federal legalization sooner, we need safer products so cannabis won’t be cast in such a dangerous, risky light.

Certainly, there’s a bit of irony at play here – the lack of federal regulations heightens the risk of contaminated cannabis reaching consumers, and on the flip side recalls are used by opponents to justify stigmatizing the plant and keeping it illegal. Nevertheless, someday in the not-too-distant future, cannabis will be legalized at the federal level. And when that day happens, federal agents will aggressively test and regulate cannabis; they’ll swab every area in facilities and demand thorough records of testing up and down the supply chain; current good manufacturing practices (cGMP) will be mandated. No longer will violations result just in a slap on the wrist – businesses will be shut down. To avoid a massive shock to the system, it makes sense for cannabis companies to pivot and adopt rigorous and wide-sweeping testing procedures today. Wait for federal legalization, and you’ll sink.

Frankly, the current landscape of cannabis regulation is scary and the consequences are largely yet to be seen. Just a few months ago, a Michigan state judge reversed part of a recall issued by the state’s Marijuana Regulatory Agency (MRA) on cannabis that exceeded legal limits of yeast, mold and aspergillus, bringing contaminated cannabis back to shelves without even slapping a warning label on the packaging to inform consumers of the potential contamination. This is a classic case of the power of the dollar prevailing over consumer safety and health. Even in well-established markets, the lack of regulations is jarring. For example, before this year in Colorado, testing for aspergillus wasn’t even required. (Aspergillus inhalation, which can cause Aspergillosis, can be deadly, especially for people who are immunocompromised). Many states still allow trace amounts of aspergillus and other pathogens to be present in cannabis samples. While traces may seem inconsequential in the short term, what will happen to frequent consumers who have been pinging their lungs with traces of pathogens for 30 years? Consistently inhaling trace amounts of pathogens can lead to lung issues and pulmonary disease down the road. Look what happened to people with breathing and lung issues during the last two years with COVID. What’s going to happen to these people when the next pandemic hits?

We need state regulators and MSOs to step up and implement more aggressive testing procedures. These regulators and companies can create a sea of change in the industry to better protect the health and well-being of consumers. Just complying with loose regulations isn’t good enough. We need to bring shortcomings around testing into the limelight and demand better and more efficient regulatory frameworks. And we should adopt the same standards for medical and adult use markets. Right now, several states follow cGMP for medical but not adult use – that’s ridiculous. Potentially harming consumers goes against what activists seeking legalization have been fighting for. Cannabis, untainted, provides therapeutic and clinical value not just to medical patients but to all consumers; cannabis companies should promote consumer health through their products, not jeopardize it.

For best practices, companies should conduct tests at every step in the supply chain, not just test end products. And testing solutions should be comprehensive. Most of the common tests used today are based on petri dishes, an archaic and inefficient technology dating back over a century, which require a separate dish to test for each pathogen of interest. If you’re waiting three to five days to see testing results against fifteen pathogens and a pathogen happens to be present, by the time you see results, the pathogen could have spread and destroyed half of your crops. So, not only do petri dishes overburden state-run labs, but due to their inherent inefficiencies, relying on these tests can significantly eat into cannabis companies’ revenues. At PathogenDx, we’ve created multiplexing solutions that can identify and detect up to 50 pathogens in a single test and yield accurate results in six hours. To save cannabis companies money in the long run and to make sure pathogens don’t slip through the cracks, more multiplexing tests like the ones we’ve created should be implemented in state labs.

Right now, while the regulatory landscape is falling short in terms of protecting consumer health, better solutions already exist. I urge state regulators and cannabis companies to take testing very seriously, be proactive and invest in creating better testing infrastructure today. Together, we can protect the health of consumers and create a stronger, more trustworthy and prosperous cannabis industry.

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How Fraud is Proliferating in the Cannabis Testing Market

By Cindy Orser, PhD
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With more and more states fully legalizing cannabis for medical and adult use, regulation has become a hot topic for the industry – and it won’t be going away anytime soon. The markets for virtually all cannabis uses (with the exception of industrial hemp, under the Farm Bill) have manifested at the state level without the benefit of federal oversight. One of the biggest consequences of state-based programs has been striking inconsistencies in assuring public safety through the establishment of testing requirements and the licensing of third-party, independent testing laboratories. Establishing legal cannabis programs on a state-by-state basis has been from the ground up. While some states have done a better job than others, it has not been an easy process; one that typically involves adjusting to yearly legislative changes. Third-party independent cannabis testing labs seem like a logical arrangement for public safety and defensibility at the state level given the illegal federal status of cannabis, and while this arrangement has undoubtedly prevented tainted cannabis flower, extracts and products from ending up on dispensary shelves, many caveats from this arrangement have emerged, including fraud.

While most states do require ISO 17025:2017 accreditation, no uniform testing methods nor uniform contaminant testing requirements exist, and they vary considerably. We see this in several examples including the list of pesticides required for screening varying from none to over 66, screening for microbial contaminants varies from a simple presence/absence test for two human pathogens to quantitative enumeration across several enteric and fungal categories and, finally, some states adhere to the American Herbal Pharmacopeia heavy metal limits for herbs, while other states have adopted the more appropriate US Pharmacopeia inhalation limits. Some states require rigorous demonstration of method validation before licensing, while other states hand out preliminary licenses prior to submission and review of validation data packages for each analyte category.

Fraud in laboratory testing facilities is well known in the clinical setting, especially where lucrative Medicare or commercial insurance claims tempt less than honest laboratory managers to falsify results or add tests that were not ordered by a physician costing taxpayers billions of dollars annually. Fraud within cannabis testing labs is not instigated by large insurance payouts but rather by survival within individual markets where competition for clients can be fierce. Cannabis testing fraud ranges from outright collusion of testing labs with growers and producers demanding certificates of analysis (CoAs) with specific, inflated THC numbers to a testing lab handing out sweeping passing marks for contaminants in an attempt to keep clients or steal clients away from a reputable lab not willing to inflate cannabinoid values or pass on the presence of, say, chlorpyrifos, a highly toxic organophosphate pesticide, in extracts or lead in outdoor-grown hemp.

labsphotoCannabis testing labs have had little power to influence state legislators or regulators to improve industry oversight and combat fraud. From the outset of a state cannabis program, the growers and producers are placed in the driver seat. They generate the products that end up in dispensaries and generate sales that create the tax revenue that propels the industry forward. A consequence of this hierarchical arrangement has let the growers decide that the concentration of THC equates with value. This translates to the higher the THC concentration, the higher the price both wholesale and retail. Sadly, this also has been taken to mean better products yet with zero medical justification since we know virtually nothing about THC dosing, save for how our endocannabinoid system functions, which is at the nanomolar range. Now the entire cannabis industry is stuck with this unsubstantiated marketing ploy around THC that no one can now seem to escape. It is as if cigarette makers had decided early on to market their brands by how much nicotine each cigarette contained. You can see how this would have quickly led to toxic levels of nicotine.

Where do we go from here? Placing THC content as the primary valuation of cannabis is not an easy problem to solve, as there is little incentive for change. Fraudulent labs provide higher THC numbers, which increases dollars to the growers/producers and state tax coffers fill up. It’s a multi-point problem that will require a multi-point solution:

  • State regulators could move the focus away from THC by placing limits on the concentration of THC in products, increasing oversight of cannabis testing labs, and requiring unscheduled round-robin testing and annual review of validation data packages.
  • Growers and producers could place a higher emphasis on public safety and education.
  • Ultimately, the solution lies with the cannabis consumer through education and awareness. Cannabis end-users need to familiarize themselves with the testing regulations in their state and understand that higher THC numbers does not mean a better or more effective product. Cannabis consumers also need to understand the product on the market may or may not be tested for microbiological contaminants protecting them from pathogens. In many instances, they are paying for higher THC numbers that are not reflected in the product they just purchased.

Until cannabis is federally legalized and therefore given federal oversight, piecemeal, state-by-state regulation is going to continue. How that regulation protects the American consumer is up to the work of the industry and what we continue to prioritize.

New York Launches Conditional Licensing Program

By Kristin Kowalski, CPA
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Progress and history are being made in New York for adult use cannabis. Recently, Governor Hochul signed an amendment to New York State Cannabis Law which permits the Office of Cannabis Management (OCM) to award conditional licenses to certain adult use cultivators and processors, allowing hemp farmers in New York to grow cannabis in the 2022 growing season. And now, the application period to obtain a conditional license is officially open and available for qualified candidates. New York is moving full speed ahead in the hopes of creating one of the most inclusive adult-use cannabis industries in the nation.

What Does a Conditional License Mean?

With this legislation, New York State is creating a new conditional adult use cannabis cultivator license, allowing hemp farmers to grow cannabis in the 2022 growing season – helping to fast-track the state’s adult-use cannabis program. Under the law, conditionally licensed cannabis farmers must meet certain requirements, including safe, sustainable and environmentally friendly cultivation practices.

Highlights of the Bill & Legislation

Industrial Hemp First

To qualify for an adult use cannabis conditional cultivator license, only companies and individuals currently licensed with the state for cultivation or processing of industrial hemp can apply for the conditional licenses. Applicants must have been an authorized industrial hemp research partner for the Department of Agriculture and Markets, and industrial hemp cultivators must have grown and harvested the crop during at least two of the past four years.

Growing Locations

Licensed cultivators will be authorized to grow indoors, outdoors, or a combination of both, subject to space and lighting limitations in the law. With a conditional adult use cannabis cultivation license, farmers can grow outdoors or in a greenhouse for up to two years from the issuance of the license. It also allows them to manufacture and distribute cannabis flower products without holding an adult use processor or distributor license, until June 1, 2023.

Expanding Abilities with License

Conditional licensees will have temporary authority to conduct additional activities not included in their license. Cultivators are allowed to both minimally process and distribute flower, and processors can distribute their products.

Requirements of Conditional License

Hemp farmers in New York could be licensed to grow cannabis for the 2022 growing season.

As listed in the bill, conditional licensees must abide by all regulations, including those issued after receipt of the license. Applicants must also participate in a soon to-be-developed mentoring program for individuals interested in joining the industry through the social equity component of the Marijuana Regulation & Taxation Act, as well as actively participate in an environmental sustainability program. And lastly, applicants must begin operations within six months of receiving their license, and grant OCM employees’ access to the premises for inspections to ensure all rules are being followed.

Future Outlook on Cannabis Industry in New York

With the opening of the application portal for conditional licenses, this advances the Governor’s first-in-the-nation Seeding Opportunity Initiative, which positions individuals with prior cannabis-related criminal offenses to make the first adult use cannabis sales with products grown by New York hemp farmers. While this news is a positive step, there remain many unknowns about how the conditional licensing process will unfold. Applications can be filed with the OCM for Conditional Cultivator Licenses through June 30, 2022, with a $2,000 non-refundable application and licensing fee. For hopeful applicants, gathering a team of professional advisors to plan for the application process and operating an adult-use business is essential. Consulting with an accounting team or financial advisors from a tax standpoint, will be critical to establish systems and controls to maintain separate accounting records for your industrial hemp and adult use activities.

Cresco Labs To Acquire Columbia Care

By Cannabis Industry Journal Staff
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According to a press release published last week, Cresco Labs has come to an agreement with Columbia Care Inc. to acquire the company. The $2 billion deal, expected to close in the fourth quarter of 2022, will create the largest multi-state operator (MSO) in the country by pro-forma revenue.

Cresco Labs is already one of the country’s largest MSOs with roots in Illinois. With a footprint covering a lot of the United States, their brands include Cresco, High Supply, Mindy’s Edibles, Good News, Remedi, Wonder Wellness Co. and FloraCal Farms.

Columbia Care is also one of the largest cannabis companies in the US, with licenses in 18 jurisdictions and the EU. They currently operate 99 dispensaries and 32 cultivation and manufacturing facilities. Their brands include Seed & Strain, Triple Seven, gLeaf, Classix, Press, Amber and Platinum Label CBD.

Under the agreement, shareholders with Columbia Care will receive 0.5579 of subordinate voting share in Cresco for each common share they hold. Columbia Care shareholders will hold approximately 35% of the pro forma Cresco Labs Shares once the deal goes into effect.

Coming out of the deal, Cresco’s total revenue will hit $1.4 billion, making it the largest MSO in the country. Their footprint will reach 130 retail dispensaries across 18 different markets. The companies already have the largest market share in Illinois, Pennsylvania, Colorado and Virginia and are of the top three market shares in New York, New Jersey and Florida, which gives them unique opportunities to capitalize on emerging adult use markets.

Charles Bachtell, CEO of Cresco Labs, says the deal is very complementary and they are excited about long-term growth and diversification. “This acquisition brings together two of the leading operators in the industry, pairing a leading footprint with proven operational, brand and competitive excellence,” says Bachtell. “The combination of Cresco Labs and Columbia Care accelerates our journey to become the leader in cannabis in a way no other potential transaction could. We look forward to welcoming the incredible Columbia Care team to the Cresco Labs family. I couldn’t be more excited about this enhanced platform and how it furthers the Cresco Labs Vision – to be the most important and impactful company in cannabis.”

Registration Open for 2022 Cannabis Quality Conference & Expo

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EDGARTOWN, MA, March 23, 2022 – Registration for the Cannabis Quality Conference & Expo, taking place October 17-19 at the Hilton Parsippany in New Jersey, is now open.

The agenda features 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 keynote presentation, then a panel on The Future of East Coast Cannabis: Social Equity, Justice & Legalization. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.

The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:

  • The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
  • Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
  • Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
  • Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
  • A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
  • Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific

Registration options are available for in-person, virtual and hybrid attendance.

Event Hours

  • Monday, October 17: 12 pm – 6:30 pm (ET)
  • Tuesday, October 18: 8 am – 5:45 pm (ET)
  • Wednesday, October 19: 8 am – 12 pm (ET)

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

Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21. The program features panel discussions and breakout sessions that encourage dialogue among mid-to-senior-level food safety professionals. The Food Safety Consortium kicks off with an FDA Keynote and Town Hall, followed by a panel on the State of the Food Safety Industry and where it is going, led by Darin Detwiler of Northeastern University.

About Cannabis Industry Journal 

Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.

About the Cannabis Quality Conference & Expo

The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.

ASTM Launches Standard for International Intoxicating Cannabinoid Symbol

By Cannabis Industry Journal Staff
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A new ASTM International standard seeks to create an internationally recognized symbol that indicates a product contains intoxicating cannabinoids. The cannabis technical committee at ASTM, D37, developed the standard for the International Intoxicating Cannabinoid Product Symbol (IICPS).

The International Intoxicating Cannabinoid Product Symbol (IICPS)

The standard is labeled D8441/D8441M and is supposed to be used with all finished consumer use products, including topical use, ingestion and inhalation. ASTM International members David L. Nathan, M.D. and Eli Nathan designed the symbol with a group of volunteers from the D37 led by Martha Bajec, PhD of HCD Research. The symbol was concurrently developed by Doctors for Cannabis Regulation (DFCR) and Subcommittee D37.04 on Cannabis Processing and Handling. The symbol is designed “to create a truly universal cannabinoid product symbol, mindful of its importance as a means to communicating to adults and children the need for caution with products containing cannabinoids,” says Dr. Nathan. “The symbol has the potential to facilitate a spirit of collaboration among experts, regulators, and all other stakeholders in the cannabis industry.”

Darwin Millard, subcommittee vicechair for ASTM D37.04 and subcommittee co-chair for ASTM D37.07, says this is perhaps one of the most important standards to come out of the committee. “It serves to establish a harmonized warning symbol that is truly international,” says Millard. “It is not intended to replace symbols that have already been established, rather it is intended to be used by marketplaces that have yet to establish a symbol.” As more and more marketplaces adopt the symbol, the hope is that markets with their own symbol will harmonize with the ASTM symbol over time.

Millard says the symbol uses the ISO standard warning triangle, the ANSI standard warning orange/yellow and defines a standardized icon for cannabinoids, the leaf. “There are a number of cannabinoids that are intoxicating, not just delta-9-THC, therefore the symbol is designed to be used to identify any cannabinoid that can be classified as intoxicating,” says Millard. “The symbol doesn’t care if the cannabinoid is naturally derived, isolated and purified, synthesized by yeast or created in a lab; if it is ‘intoxicating’ and a ‘cannabinoid’ the symbol can be used to identify a consumer product containing it. ‘Intoxicating’ was used over ‘inebriating’ or ‘psychoactive’ since neither term is correct. Impairing was recently used by Washington State and might be worth considering down the road.”

The IICPS became the official symbol for the state of Montana as of January 1st. New Jersey and Vermont have also incorporated the IICPS design into their state symbols, already making it the most widely adopted cannabis product symbol in fully legalized states. Alaska and other states are currently discussing use of the symbol as well.

If you are interested in contributing to the development of this and other D37 standards, you are encouraged to join the committee. In addition, they will be hosting a free webinar on June 1 to discuss the development of the international symbol, how to use it and how the marketplace and consumers will benefit from it.

Petri dish containing the fungus Aspergillus flavus

Salmonella & Aspergillus: Controlling Risk in Your Supply Chain

By Cameron Prince
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Petri dish containing the fungus Aspergillus flavus

Risk management is the process of identifying potential hazards, assessing the associated risk, then implementing controls to mitigate those risks. With Salmonella and Aspergillus being two of the leading causes of cannabis contamination that can occur throughout the supply chain, applying upstream risk management strategies can keep supplier contamination issues from impacting your products.

Salmonella enteritidis

In recent months cannabis products have been recalled for Salmonella and/or Aspergillus contamination in several states, including California, Arizona, Michigan, Florida, as well as Canada. While the recalls impacted retail products, in most cases, the contamination occurred farther back in the supply chain, as evidenced by recalls that impacted several dispensaries or other sales locations.

For example, the November 2021 Arizona recall caused multiple establishments and dispensaries to recall product due to possible contamination with Salmonella or Aspergillus; the Michigan recall of an estimated $229 million in cannabis products due to “inaccurate and/or unreliable results of products tested.” While a lab lawsuit against the recall released some of the product to market, the companies faced significant impact – in both removing and returning the product.

While microbial contamination can occur throughout the supply chain, Aspergillus is ubiquitous in soil and the flower, leaves, roots of the cannabis plant are all susceptible to such contamination. The mold also can colonize the bud both during growing and harvesting. Salmonella can be introduced during growing through, untreated manures, direct contact with animal feces, or contamination of surface water used for irrigation. However, the plant matter also can be compromised during drying, storage and processing from environmental contamination.

Petri dish containing the fungus Aspergillus flavus
Aspergillus flavus

Supply chain risk management. To prevent a supplier’s contamination issues from becoming your problem to deal with, each facility at each step of the chain should develop a supply chain risk management program to assess and approve each of its upstream providers. Following are 5 key steps to assessing and managing risk in your supply chain:

  1. Conduct a hazard analysis. A complete supply chain assessment should begin with a hazard assessment of all the ingredients, products or primary packaging you receive. There are two essential steps involved in conducting a hazard analysis: that is the identification of potential hazards – considering those related to the item itself, as well as the supplier environment and process as well as item – and an evaluation to determine if each hazard requires control based on its severity and likely occurrence.
  2. Evaluate the risks. Based on the hazard analysis, the next step is to determine the associated risk. As defined by the European Food Information Council (EUFIC), “a hazard is something that has the potential to cause harm while risk is the likelihood of harm taking place, based on exposure to that hazard.” For example, the higher the exposure, the higher the risk.
  3. Ensure risk control. Once risk is determined, it is critical to ensure that it is being controlled, who is controlling it and how it is being done. Depending on the risk, that control may need to be conducted by the supplier, by you or even by a downstream customer.
  4. Require documentation. No matter which step in the chain is controlling the risk, it is essential that all be documented with records easily accessible – including the controls, any out-of-compliance events and corrective actions. The adage, “If it’s not documented, it didn’t happen,” is very applicable here, particularly should a problem arise and an inspector appear at your door.
  5. Use only approved suppliers. Implementation of the above steps enable the development of a supplier approval program focused on quality, safety and regulatory compliance. Use of only suppliers who have been assessed and found to meet all your standards will help to protect your product and your brand.

Salmonella and Aspergillus contamination can occur throughout the supply chain, but implementing a supply chain risk assessment and management program will enable you to determine where the greatest risks lie among your ingredients and suppliers, allowing you to allocate resources based on that risk.

USDA’s Hemp Testing Rules: Fast Track Your Lab’s Preparedness with Digitization

By Martha Hernández
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The United States Department of Agriculture (USDA) issued a Final Rule (FR) on hemp testing that went into effect on 22nd March 2021. Consequently, all hemp testing laboratories must familiarize themselves with what is stipulated in the FR and do all that is required to comply.

The 2014 Farm Bill put to an end to years of hemp prohibition, at least to some extent. It also paved the way for the 2018 Farm Bill that brought hemp at par with other agricultural crops. States, through their departments of agriculture and institutions of higher learning, were allowed to cultivate industrial hemp for research purposes, under what was called the hemp pilot programs. Some states also allowed individuals to cultivate hemp to investigate the economic and agronomic viability of the crop. This increased the acreage of industrial hemp from zero to about 90,000 by 2018 when the Agricultural Act that legalized hemp was passed. Some of the states that participated in this program included Colorado, Kentucky, Montana, and Oregon.

As expected of a new project, some challenges cropped up, including:

  • Inconsistency in the quality of hemp produced for research
  • Varying hemp laws between states
  • Maintaining regular supplies of inputs such as seeds and pest control
  • Lack of appropriate knowledge and technology

The 2018 Farm Bill addressed some of these challenges through the Hemp Farming Act that proposed to remove hemp from Schedule 1 of the Controlled Substances Act. Hemp, in this case, refers to cannabis sativa that contains less than 0.3% THC by “dry weight.” Proposals in the hemp act were incorporated into the 2018 U.S. Farm Bill and it became law in December 2018, thus making hemp legal at the federal level.

Unlike other agricultural commodities, hemp is a highly regulated crop because of its close association with cannabis which is still under Schedule 1 controlled substances. Once hemp exceeds the 0.3% THC threshold, it becomes classified as cannabis and is, therefore, governed under a different set of regulations.

The next step after the legalization of hemp was to roll out a nationwide hemp cultivation and distribution program. Consequently, the U.S. Food and Drug Administration (FDA) was instructed to develop a national framework to regulate the production of hemp in the U.S. An Interim Final Rule (IFR) was published in October 2019 to set the ball rolling. A final rule was published as an improvement of the IFR in January 2021. The Final Rule was created based on public comments received during the period as well as direct lessons learned in the 2020 growing season. The Final Rule took effect on 22nd March, 2021.

A schematic representation of the key federal rules for hemp testing laboratories (Figure courtesy of CloudLIMS)

The USDA requires that all hemp be tested by a third-party laboratory to ensure that quality is maintained and that the THC threshold is not exceeded. The Final Rule made significant changes to the USDA’s hemp testing rules that will affect how laboratories carry out their operations. While the guidelines were issued on January 15, 2021, they went into effect on March 22 of the same year. If you are a hemp-testing laboratory, here are the most important changes that you should brace for.

Nine Changes Hemp Testing Labs Must Comply With

  1. Changes in sampling 

Previously, samples to be tested were restricted to the top third portion of the hemp plant. With the Final Rule, samples can be taken anywhere from 5-8 inches from the main stem (including the leaves and flowers). This provision offers greater flexibility and reduces the chances of “hot” hemp.

  1. Laboratories shall use specific testing methods

According to the Final Rule, hemp-testing laboratories must use reliable methods to test for THC concentration. This includes methods such as post-decarboxylation; they take into consideration the conversion of THCA to THC after decarboxylation. Currently, methods that meet these requirements include gas chromatography and liquid chromatography.

The USDA also expects that laboratories demonstrate consistent testing reliability and validity. The test methods used must have high specificity for THC and other tested compounds.

  1. Negligence limit raised to 1% THC

Negligence limit refers to the extra wiggle room that is advanced to hemp farmers in regards to THC testing. In the IFR, hemp that tested above 0.3% THC but lower than 0.5% was considered negligence and not a violation of federal laws. This limit for negligence has now been pushed from 0.5% to 1%. As much as the Final Rule has maintained the THC limit for hemp at 0.3%, growers now have a wider margin of error to work with.

For hemp-testing laboratories, all samples that test above 0.3% THC are still considered hot hemp and must be destroyed or remediated. However, samples testing below 1% THC are considered a negligent violation and not a criminal offense.

  1. All hemp testing laboratories need to be DEA registered

The Final Rule made it mandatory for all hemp-testing laboratories to be registered with the Drug Enforcement Agency (DEA). Getting this registration is time intensive and the number of registered laboratories is few. With this in mind, the USDA had extended the registration deadline to the last day of 2022. After the expiry of this period, laboratories that are not registered with the DEA will be barred from conducting hemp testing.

  1. Laboratories to calculate Measure of Uncertainty (MU)

With the Final Rule, laboratories are expected to calculate and include the MU when reporting test results. The Guide to the Expression of Uncertainty in Measurement (GUM) defines MU as “a parameter, associated with the result of a measurement, which characterizes the dispersion of the values that could reasonably be attributed to the measurand.”

While there is no upper or lower limit for the MU, it is controlled using performance standards such as AOAC Standard Method Performance Requirements. Organizations such as ISO and Eurachem also provide guidelines for calculating MU. Hemp testing laboratories can refer to those guidelines as well.

  1. Adherence to the ISO 17025 standards

While this is not an enforceable rule, the USDA strongly recommends all hemp testing laboratories be ISO 17025 compliant.

  1. Laboratory SOPs

Testing laboratories must have an internal SOP for testing and retesting hemp. This SOP should be available upon request by state sampling agents or other responsible agents. Laboratory managers should ensure that all staff members follow the SOPs.

  1. Reporting of THC

Once a laboratory has completed the test, whether failed or passed, they should share the results with all stakeholders:

  • The licensed producer
  • The appropriate State Department of Agriculture or Tribe
  • The USDA using AMS Form 22.
  • The THC should be reported on a “dry weight” basis.
  1. Remediating and retestingof hot hemp

Once a laboratory finds a sample that has tested above 0.3% THC, it has to flag it as “hot” hemp. Previously, all hot hemp had to be destroyed but with the FR, parts of the hemp (excluding the flowers) can be salvaged.

A Laboratory Information Management System (LIMS) to manage multi-analyte test results and flag hot hemp (Figure courtesy of CloudLIMS)

The licensed producers (LP) are required to shred the hemp into biomass and send a sample back to the laboratory for retesting. The laboratory shall use the same procedure to retest the biomass and report the results back to the LP and the USDA.

The hemp final rule took full effect on the last day of 2021. The only extended deadline is the one requiring that all hemp-testing laboratories be registered with the DEA that still has a few more months to go.

Fast Track Your Laboratory’s Preparedness with a LIMS

Becoming compliant with USDA’s hemp testing rules can be quite challenging for a laboratory simply because there’s too much to keep up with. A laboratory must monitor samples, analyze and report test results, and at the same time maintain internal quality protocols.

Fortunately, digitization can help streamline processes and accelerate the preparedness of laboratories for the new federal rules. A cloud-based Laboratory Management Information System (LIMS) takes the hard work out of compliance by keeping track of compliance processes seamlessly and in real-time.

A LIMS enables laboratories to:

  • Track samples through their lifecycle
  • Automatically share results with stakeholders
  • Flag hot hemp samples
  • Generate certificates of analysis (COAs) in prescribed formats
  • Meet regulatory compliances
  • Manage SOPs, staff training, and QA/QC protocols

Hemp that tests above the 0.3% THC mark is considered cannabis and is therefore illegal under federal law. Consequently, hemp testing is a highly sensitive process that is strictly regulated. Hemp-testing laboratories must optimize their processes to ensure efficiency at all times and assure the validity of their test results. This can be made possible with a LIMS.

Busting the THC Myth: When it Comes to the Best User Experience, Terpenes Reign Supreme

By Mark Lange, PhD
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The scent of pine from your Christmas tree. The fragrance of a ripe summer peach at the farmer’s market. The whiff of eucalyptus and lavender that greets you when you enter a spa.

Aroma is a keystone in how we experience the world. In any given environment, aroma can help shape your mood, solidify memories and instantly transport you to another place or time.

I have focused my career on studying the fascinating compounds that are often behind these powerful aromas: terpenes. They form the largest class of natural products (compounds produced by living organisms), found in nearly all living beings. There are around 50,000 currently known terpenes in nature — with potentially thousands yet to be discovered.

Terpene-rich plants you might be most familiar with are lavender, mint, oranges (in the peel), and yes, cannabis. In recent years, terpenes have rightfully become a central discussion in the recreational cannabis world. This is because terpenes — not THC level, not “Indica-Sativa” classification — are a key determinant of cannabis’s effect, both psychoactive and non-psychoactive. But the current lack of prioritization and understanding of the crucial role terpenes play may put the collective quality of U.S. cannabis at risk.

At this crucial inflection point for legal cannabis, on its path to becoming a $70 billion dollar global industry by 2028, we need to ensure that everyone across the cannabis space, from breeders to testers, growers and consumers, understands which traits to prioritize for a cannabis world brimming with diversity and predictable effects.

What the cannabis industry has to lose 

What do we lose if the cannabis industry continues to scale without a clear understanding of the compounds that define the uniqueness of each variety?

There is a ripple effect across the ecosystem. For cannabis testing labs, focusing on only twenty of the most dominant terpenes means we are missing out on tapping into potentially over a hundred of less common terpenes in cannabis. For the cannabis consumer, lack of understanding on the breeding and testing side may make it difficult to find cannabis that delivers on its promised effect time and time again. And, most detrimentally for breeders, not understanding the direct correlation between genetics and the formation of terpenes means we will have increasingly fewer terpene profiles and combinations to work with, especially when the industry-dominant focus has been on cannabinoid potency.

Let’s explore some misconceptions related to potency. In recent years, many breeders have prioritized high THC levels over genetic diversity. Consumers often associate high THC levels and that telltale strong “skunky” aroma with a strain’s quality and effect, when in reality, these are poor indicators of potency. (In fact, recent research indicates that this specific cannabis aroma is caused by a family of sulfur compounds.) Terpene profiling is a much more accurate way to determine a variety’s given effect. In focusing too much on increasing THC, breeders miss out on the true potency powerhouse: tapping into the terpene diversity that’s out there.

Terpenes are responsible for giving flowers (including cannabis), fruits and spices their distinctive flavors and aromas. Common terpenes include limonene, linalool, pinene and myrcene.

To illustrate the impact of breeding practices that prioritize crop yield over product quality, I first have a question for you: When was the last time you enjoyed a really good tomato?

If you’re lucky enough to have a great farmer’s market nearby, maybe you purchased an heirloom tomato at peak freshness last August. It was likely fragrant, flavorful and didn’t need much preparation to be enjoyable.

Or maybe you can’t remember the last time you’ve eaten a good tomato, as the last standard grocery store tomato you purchased was watery, tasteless and essentially scentless.

Tomatoes are a prime example of what is unfortunately true for a whole host of traditional crop plants in the U.S. When yield is the goal, flavor and aroma profiles often suffer. The culprit: lack of genetic diversity in the breeding process. The tragedy of the tomato serves as a harbinger for the cannabis industry — and we can draw parallels to what we’ve seen happen to cannabis.

What the cannabis industry should do: Tap into the diversity that’s out there

An important aspect of preventing cannabis from going the way of the tomato is to better understand the genes that generate these different terpene profiles. Different cultivars with varying aromas will hold different collections of genes. We as an industry must learn more about which terpenes correlate with desirable aromas, and then access already existing genetic diversity.

We have just begun to scratch the surface of the potential of terpenes in cannabis. With the right alignment across the industry and a stronger focus on genetics in breeding, we will see the rise of completely unique cannabis varieties. They will smell like lavender, lilac, orange peel or even brand-new aromas that have yet to be discovered. To ensure this future, we need to prioritize the right traits and the right genetics.