In an unprecedented move, the U.S. Food & Drug Administration (FDA) has issued warning letters today to companies selling products containing delta-8 THC. In total, the FDA sent out five warning letters to companies for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Image from the FDA’s consumer update on Delta-8 THC
The violations include illegal marketing of unapproved delta-8 THC products as treatment for medical conditions, misbranding and adding delta-8 THC to food products. Back in September of last year, the FDA published a consumer update on their website, seeking to educate the public and offer a public health warning on delta-8 tetrahydrocannabinol, otherwise known as delta-8 THC.
Delta-8 THC is a cannabinoid that can be synthesized from cannabidiol (CBD) derived from hemp. It is an isomer of delta-9 THC, the more commonly known psychoactive cannabinoid found in cannabis. Delta-8 THC does produce psychoactive effects, though not quite as much as its better-known cousin, delta-9 THC. Many regulators and industry stakeholders are increasingly concerned about the rise in popularity of delta-8 products, namely because of the processing involved to produce it. Delta-8 THC is often synthesized using potentially harmful chemicals.
The FDA has a history of sending a lot of warning letters to companies marketing CBD products inaccurately and making drug claims. Earlier this year, they sent a number of letters to companies claiming that CBD can cure or prevent Covid-19.
According to Janet Woodcock, M.D., principal deputy commissioner at the FDA, they are getting more and more concerned about the popularity of delta-8 THC products sold online. “These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” says Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA sent warning letters to the following companies selling delta-8 THC products:
By Kelsey Cagle, Frank L. Dorman, Jessica Westland No Comments
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
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.
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.
Sian Ferguson. https://www.healthline.com/health/hemp-vs-marijuana. August 27, 2020.
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.
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
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.
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.
Cannabis 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.
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.
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.
Risk management is the process of identifying potential hazards, assessing the associated risk, then implementing controls to mitigate those risks. With Salmonella and Aspergillus being two of the leading causes of cannabis contamination that can occur throughout the supply chain, applying upstream risk management strategies can keep supplier contamination issues from impacting your products.
Salmonella enteritidis
In recent months cannabis products have been recalled for Salmonella and/or Aspergillus contamination in several states, including California, Arizona, Michigan, Florida, as well as Canada. While the recalls impacted retail products, in most cases, the contamination occurred farther back in the supply chain, as evidenced by recalls that impacted several dispensaries or other sales locations.
For example, the November 2021 Arizona recall caused multiple establishments and dispensaries to recall product due to possible contamination with Salmonella or Aspergillus; the Michigan recall of an estimated $229 million in cannabis products due to “inaccurate and/or unreliable results of products tested.” While a lab lawsuit against the recall released some of the product to market, the companies faced significant impact – in both removing and returning the product.
While microbial contamination can occur throughout the supply chain, Aspergillus is ubiquitous in soil and the flower, leaves, roots of the cannabis plant are all susceptible to such contamination. The mold also can colonize the bud both during growing and harvesting. Salmonella can be introduced during growing through, untreated manures, direct contact with animal feces, or contamination of surface water used for irrigation. However, the plant matter also can be compromised during drying, storage and processing from environmental contamination.
Aspergillus flavus
Supply chain risk management. To prevent a supplier’s contamination issues from becoming your problem to deal with, each facility at each step of the chain should develop a supply chain risk management program to assess and approve each of its upstream providers. Following are 5 key steps to assessing and managing risk in your supply chain:
Conduct a hazard analysis. A complete supply chain assessment should begin with a hazard assessment of all the ingredients, products or primary packaging you receive. There are two essential steps involved in conducting a hazard analysis: that is the identification of potential hazards – considering those related to the item itself, as well as the supplier environment and process as well as item – and an evaluation to determine if each hazard requires control based on its severity and likely occurrence.
Evaluate the risks. Based on the hazard analysis, the next step is to determine the associated risk. As defined by the European Food Information Council (EUFIC), “a hazard is something that has the potential to cause harm while risk is the likelihood of harm taking place, based on exposure to that hazard.” For example, the higher the exposure, the higher the risk.
Ensure risk control. Once risk is determined, it is critical to ensure that it is being controlled, who is controlling it and how it is being done. Depending on the risk, that control may need to be conducted by the supplier, by you or even by a downstream customer.
Require documentation. No matter which step in the chain is controlling the risk, it is essential that all be documented with records easily accessible – including the controls, any out-of-compliance events and corrective actions. The adage, “If it’s not documented, it didn’t happen,” is very applicable here, particularly should a problem arise and an inspector appear at your door.
Use only approved suppliers. Implementation of the above steps enable the development of a supplier approval program focused on quality, safety and regulatory compliance. Use of only suppliers who have been assessed and found to meet all your standards will help to protect your product and your brand.
Salmonella and Aspergillus contamination can occur throughout the supply chain, but implementing a supply chain risk assessment and management program will enable you to determine where the greatest risks lie among your ingredients and suppliers, allowing you to allocate resources based on that risk.
The United States Department of Agriculture (USDA) issued a Final Rule (FR) on hemp testing that went into effect on 22nd March 2021. Consequently, all hemp testing laboratories must familiarize themselves with what is stipulated in the FR and do all that is required to comply.
The 2014 Farm Bill put to an end to years of hemp prohibition, at least to some extent. It also paved the way for the 2018 Farm Bill that brought hemp at par with other agricultural crops. States, through their departments of agriculture and institutions of higher learning, were allowed to cultivate industrial hemp for research purposes, under what was called the hemp pilot programs. Some states also allowed individuals to cultivate hemp to investigate the economic and agronomic viability of the crop. This increased the acreage of industrial hemp from zero to about 90,000 by 2018 when the Agricultural Act that legalized hemp was passed. Some of the states that participated in this program included Colorado, Kentucky, Montana, and Oregon.
As expected of a new project, some challenges cropped up, including:
Inconsistency in the quality of hemp produced for research
Varying hemp laws between states
Maintaining regular supplies of inputs such as seeds and pest control
Lack of appropriate knowledge and technology
The 2018 Farm Bill addressed some of these challenges through the Hemp Farming Act that proposed to remove hemp from Schedule 1 of the Controlled Substances Act. Hemp, in this case, refers to cannabis sativa that contains less than 0.3% THC by “dry weight.” Proposals in the hemp act were incorporated into the 2018 U.S. Farm Bill and it became law in December 2018, thus making hemp legal at the federal level.
Unlike other agricultural commodities, hemp is a highly regulated crop because of its close association with cannabis which is still under Schedule 1 controlled substances. Once hemp exceeds the 0.3% THC threshold, it becomes classified as cannabis and is, therefore, governed under a different set of regulations.
The next step after the legalization of hemp was to roll out a nationwide hemp cultivation and distribution program. Consequently, the U.S. Food and Drug Administration (FDA) was instructed to develop a national framework to regulate the production of hemp in the U.S. An Interim Final Rule (IFR) was published in October 2019 to set the ball rolling. A final rule was published as an improvement of the IFR in January 2021. The Final Rule was created based on public comments received during the period as well as direct lessons learned in the 2020 growing season. The Final Rule took effect on 22nd March, 2021.
A schematic representation of the key federal rules for hemp testing laboratories (Figure courtesy of CloudLIMS)
The USDA requires that all hemp be tested by a third-party laboratory to ensure that quality is maintained and that the THC threshold is not exceeded. The Final Rule made significant changes tothe USDA’s hemp testing rules that will affect how laboratories carry out their operations. While the guidelines were issued on January 15, 2021, they went into effect on March 22 of the same year. If you are a hemp-testing laboratory, here are the most important changes that you should brace for.
Nine Changes Hemp Testing Labs Must Comply With
Changes in sampling
Previously, samples to be tested were restricted to the top third portion of the hemp plant. With the Final Rule, samples can be taken anywhere from 5-8 inches from the main stem (including the leaves and flowers). This provision offers greater flexibility and reduces the chances of “hot” hemp.
Laboratories shall use specific testing methods
According to the Final Rule, hemp-testing laboratories must use reliable methods to test for THC concentration. This includes methods such as post-decarboxylation; they take into consideration the conversion of THCA to THC after decarboxylation. Currently, methods that meet these requirements include gas chromatography and liquid chromatography.
The USDA also expects that laboratories demonstrate consistent testing reliability and validity. The test methods used must have high specificity for THC and other tested compounds.
Negligence limit raised to 1% THC
Negligence limit refers to the extra wiggle room that is advanced to hemp farmers in regards to THC testing. In the IFR, hemp that tested above 0.3% THC but lower than 0.5% was considered negligence and not a violation of federal laws. This limit for negligence has now been pushed from 0.5% to 1%. As much as the Final Rule has maintained the THC limit for hemp at 0.3%, growers now have a wider margin of error to work with.
For hemp-testing laboratories, all samples that test above 0.3% THC are still considered hot hemp and must be destroyed or remediated. However, samples testing below 1% THC are considered a negligent violation and not a criminal offense.
All hemp testing laboratories need to be DEA registered
The Final Rule made it mandatory for all hemp-testing laboratories to be registered with the Drug Enforcement Agency (DEA). Getting this registration is time intensive and the number of registered laboratories is few. With this in mind, the USDA had extended the registration deadline to the last day of 2022. After the expiry of this period, laboratories that are not registered with the DEA will be barred from conducting hemp testing.
Laboratories to calculate Measure of Uncertainty (MU)
With the Final Rule, laboratories are expected to calculate and include the MU when reporting test results. The Guide to the Expression of Uncertainty in Measurement (GUM) defines MU as “a parameter, associated with the result of a measurement, which characterizes the dispersion of the values that could reasonably be attributed to the measurand.”
While there is no upper or lower limit for the MU, it is controlled using performance standards such as AOAC Standard Method Performance Requirements. Organizations such as ISO and Eurachem also provide guidelines for calculating MU. Hemp testing laboratories can refer to those guidelines as well.
Adherence to the ISO 17025 standards
While this is not an enforceable rule, the USDA strongly recommends all hemp testing laboratories be ISO 17025 compliant.
Laboratory SOPs
Testing laboratories must have an internal SOP for testing and retesting hemp. This SOP should be available upon request by state sampling agents or other responsible agents. Laboratory managers should ensure that all staff members follow the SOPs.
Reporting of THC
Once a laboratory has completed the test, whether failed or passed, they should share the results with all stakeholders:
The licensed producer
The appropriate State Department of Agriculture or Tribe
The USDA using AMS Form 22.
The THC should be reported on a “dry weight” basis.
Remediating and retestingof hot hemp
Once a laboratory finds a sample that has tested above 0.3% THC, it has to flag it as “hot” hemp. Previously, all hot hemp had to be destroyed but with the FR, parts of the hemp (excluding the flowers) can be salvaged.
A Laboratory Information Management System (LIMS) to manage multi-analyte test results and flag hot hemp (Figure courtesy of CloudLIMS)
The licensed producers (LP) are required to shred the hemp into biomass and send a sample back to the laboratory for retesting. The laboratory shall use the same procedure to retest the biomass and report the results back to the LP and the USDA.
The hemp final rule took full effect on the last day of 2021. The only extended deadline is the one requiring that all hemp-testing laboratories be registered with the DEA that still has a few more months to go.
Fast Track Your Laboratory’s Preparedness with a LIMS
Becoming compliant with USDA’s hemp testing rules can be quite challenging for a laboratory simply because there’s too much to keep up with. A laboratory must monitor samples, analyze and report test results, and at the same time maintain internal quality protocols.
Fortunately, digitization can help streamline processes and accelerate the preparedness of laboratories for the new federal rules. A cloud-based Laboratory Management Information System (LIMS) takes the hard work out of compliance by keeping track of compliance processes seamlessly and in real-time.
A LIMS enables laboratories to:
Track samples through their lifecycle
Automatically share results with stakeholders
Flag hot hemp samples
Generate certificates of analysis (COAs) in prescribed formats
Meet regulatory compliances
Manage SOPs, staff training, and QA/QC protocols
Hemp that tests above the 0.3% THC mark is considered cannabis and is therefore illegal under federal law. Consequently, hemp testing is a highly sensitive process that is strictly regulated. Hemp-testing laboratories must optimize their processes to ensure efficiency at all times and assure the validity of their test results. This can be made possible with a LIMS.
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.
Medicinal Genomics announced today that they have received AOAC International certification for their PathoSEEK® Salmonella and STEC E. coli multiplex assay. In combination with their SenSATIVAx® extraction kits, labs can simultaneously detect Salmonella spp. and STEC E. coli with a single qPCR reaction for flower, concentrates and infused chocolates using the Agilent AriaMx and the BioRad CFx-96 instruments.
The certification came after the multiplex assay was validated according to the AOAC Performance Tested Method Program. According to the press release, the PathoSEEK platform now has more cannabis matrices accredited for Aspergillus, Salmonella, and STEC E. coli than any other product out on the market, according to their press release.
The PathoSEEK microbiological testing platform uses a qPCR assay and internal plant DNA controls for reactions. The two-step protocol verifies performance while detecting microbes, which allegedly helps minimize false negative results from human error or failing conditions.
“AOAC’s validation of our Salmonella/STEC E. coli assay across the various cannabis matrices is further proof of our platform’s robustness and versatility,” says Dr. Sherman Hom, director of regulatory affairs at Medicinal Genomics. “We are excited that our PathoSEEK® platform is moving in concert with the FDA’s new blueprint to improve food safety by modernizing the regulatory framework, while leveraging the use of proven molecular tools to accelerate predictive capabilities, enhance prevention, and enhance our ability to swiftly adapt to pathogen outbreaks that could impact consumer safety.”
The 2022 Emerald Cup Awards will look a little different this year. The competition is adopting a new classification system for different strains of flower, going well beyond the conventional and outdated sativa and indica categories.
Developed by Napro Research in 2013 and supplemented with more than 250,000 terpene tests by SC Laboratories, the PhytoFacts® classification system uses the chemometrics of cultivars to categorize different strains of cannabis, largely based on terpenes, flavor and effects.
The classification system puts different cultivars into six different umbrella categories: Jacks and Hazes; Tropical and Floral; OGs and Gas; Sweets and Dreams; Dessert; and Exotics. “Terpenes, however, with their unfamiliar names and mysterious effects, have mostly added another layer of consumer confusion already complicated by overly broad Indica/Sativa/Hybrid terminology, whimsical strain names, irrelevant THC/CBD percentages, and other ambiguous factors that make the process of selecting the best or correct strain, a less-than-satisfying ordeal for even the most experienced cannabis connoisseurs,” reads the press release.
The names for the six different categories were decided on using current industry-standard terminology, expanded upon with tasting notes, effects common strains, and of course, the primary terpenes. The Emerald Cup believes this will help the industry move forward with a more accurate classification system, revolutionizing how we think about cannabis.
“Together we hope to empower a better way for consumers to understand the range of flavors, aromas and effects within Cannabis, and bridge the gap between what legacy has always known with regards to terpene content defining quality,” says Alec Dixon, co-founder of SC Laboratories. “We need to move away from this fixation that dispensary buyers and consumers have on delta-9 THC, which is currently blurring the lines between craft and corporate cannabis, and is homogenizing cannabis genetics and leading to the loss of biological diversity within Cannabis.”
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According to Janet Woodcock, M.D., principal deputy commissioner at the FDA, they are getting more and more concerned about the popularity of delta-8 THC products sold online. “These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” says Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
