An official determination from the DEA could draw the cannabis genetics market into the mainstream—if that’s what breeders and growers want.
In January 2022, an official at the U.S. Drug Enforcement Administration (DEA) quietly confirmed that, yes, cannabis seeds fall under the legal definition of hemp and, yes, they can be sold openly and without criminal liability.
Breeders and growers haven’t exactly taken the administration up on that suggestion yet, however.
“Marihuana seed that has a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis meets the definition of ‘hemp’ and thus is not controlled under the CSA,” wrote Terrence Boos, chief of the Drug and Chemical Evaluation Section of the Diversion Control Division of the DEA. The official determination invoked the regulatory language of the 2018 Farm Bill. Read Boos’s full letter below.
Boos was responding to a letter from Vicente Sederberg attorney Shane Pennington, who sought clarity on this matter.
“This is one of the areas that I get a lot of questions about,” Pennington told Cannabis Business Times, referencing the vagaries of seed and genetics sourcing in the industry. He felt that the 2018 Farm Bill, with its definition of hemp as any aspect of the plant containing less than 0.3% THC, should give licensed business buying and selling cannabis seeds some degree of cover—“and nobody believed me.”
So, he wrote a letter and sent it straight to the top brass at the DEA. He knew the DEA was under no obligation to answer him, but on Jan. 6 Boos penned his response. Marijuana Moment first reported on the news.
While the cannabis seed market has generally operated outside the limelight of the legal, licensed business landscape, the DEA’s official determination suggests that more transparency may be possible for breeders and growers. But is that what the industry wants?
Cannabis breeder Rick Mosca of Mosca Seeds said that, at the very least, the acknowledgment from the DEA was “very comforting for a lot of folks.” He pointed out that this official determination may pave the way for brick-and-mortar seed sales in the future, something that is not yet widespread in practice. Mosca has no plans to open such a store (Mosca Seeds sells online and through distributors), but the principle of the matter could very well be a boon for the industry.
In Chicago, MoneyTree Genetics is opening a new genetics bank that will sell seeds and clones to cannabis growers—including those working in state-legal markets that allow THC-rich cultivars. Business owners told Cannabis Business Times that they’re operating under 2018 Farm Bill guidance, and that the 2022 DEA official determination provided even more support for their work.
Elsewhere, breeders are eager to embrace a rare federal decision that actually serves the benefit of the industry.
“We’re very interested in the new DEA [determination],” California-based Dark Heart Nursery CEO Daniel Grace said. “This seems to be a green light from the feds that genetics can start moving across state lines. Many breeders are already taking advantage of this. However, most, if not all, state regulatory programs still require closed-loop seed to sale systems. As a result, state regulations and regulators still pose a problem here. Ironically, in this case, the feds are saying ‘yes,’ but the state is still saying ‘no.’ Hopefully states will act promptly to clear up this discrepancy and allow the interstate and international genetics space to flourish.”
In Michigan, for instance, licensed cultivators may only purchase seeds from other licensed cultivators or from licensed caregivers serving medical patients. Those caregivers, however, may purchase seeds from out of state, effectively bringing them through the back door into the licensed adult-use cannabis market in Michigan.
In Massachusetts, licensed growers are given 90 days from the point of earning a certificate of occupancy to obtain seeds. Cultivation businesses may source genetics from seed banks or fellow growers—but only in that 90-day window. This is known colloquially as the “immaculate conception” principle. After that 90-day window, the sources of all genetics must be cited in the state’s METRC-based tracking system (e.g., via METRC-tagged mother plant cuttings or METRC-tagged seed purchases within the state).
That tight timeline puts the onus on newly licensed cultivation businesses to identify helpful, transparent seed vendors from the jump. “It’s best to work with companies that are proven,” Mosca said, “companies that have been in the business and deliver quality and consistency among their genetics. A lot of that is shared information through social media and magazines.” Word of mouth prevails in this mostly furtive sector of the market. But that does not mean it’s a clear-cut solution for cultivation teams.
Off the record, growers in Michigan, Massachusetts and elsewhere have confirmed to Cannabis Business Times that the seed sourcing question is effectively a “don’t ask, don’t tell” situation.
With that in mind, Dark Heart hasn’t yet begun selling seed directly to licensed cultivators—“due to the state-federal disconnect,” Grace said. The company presently sells retail-packaged seeds through licensed dispensaries.
That disconnect between the federal stance (vis-à-vis the 2018 Farm Bill and the 2022 DEA official determination) and the state-by-state stances (a spectrum of policies that serves as a good reminder to know your local statutes when getting into this business) is a stumbling block that any startup cultivation business will need to confront.
Matt Simmons of Elev8 Seeds said that this undermines otherwise good-faith attempts to stock a genetics library when launching a cultivation business.
“While [the DEA official determination] does make a big difference federally, many of the states include ‘seeds’ when they define what cannabis is,” he said. “Because of the definition on a state level, this does not give the producers within that state a clear path as to how they can acquire fresh genetics. In the state’s attempt to exert total control over anything that is related to the plant, they are directly limiting the quality of the product which they depend on for tax revenue without any clear benefit in their goal to keep THC out of the hands of underage people.”
He proposed a simple fix, one that takes the clear guidance of the DEA and hands it to state regulators as an action item: “What we would like to see is for more legal states to remove the word ‘seed’ from the definition of cannabis. This would allow legal growers in that state access to wider variety of genetics.”
Until then, one of the most important functions of the state-legal cannabis space remains handcuffed by regulatory language.
The result is a de-facto policy that underscores the prohibition-era culture of cannabis, even in the newly licensed landscape from coast to coast.
“Everybody knows that the cannabis marketplace is illegal,” Pennington said. “Not might be illegal. It is illegal. It’s quite profoundly unjust and outrageous that we’re in this state of affairs. Nobody really wants to talk about that, because that’s a really uncomfortable reality. State markets are premised on discrimination against interstate commerce.”
Will the DEA’s stance prod the industry to move toward a more open genetics market?
“It could, if people wanted transparency,” Pennington said.
At CannaCon’s B2B events this year, exhibitors, including Elev8 Seeds, reportedly sold seeds on the expo floor at locations like the Greater Richmond Convention Center in Richmond, Va.—openly and under the aegis of the event itself. Those in-person events provide a platform for more detailed conversations about the product being sold. This is especially helpful in a nuanced transaction, as in the case of sourcing genetics that will form the backbone of a new company’s cultivation operation. Breeders can share practical information about the seeds and dial in a better understanding of what’s important to the grower.
But, as of late 2022, months after the DEA’s official determination was made public, those in-person examples are few and far between.
“The seed space is still fairly clandestine and cloak-and-dagger,” Grace said. “Some breeders in these spaces are doing great work, but it can be hard to distinguish the geniuses from the charlatans. Because there is still ambiguity in the state-federal legality, many breeders are still not professionalizing. Most, for example, are still not obtaining formal intellectual property protections on the genetics they produce. This has some benefits to other growers in the industry, but it also means that these breeders must constantly release new varieties. That means they can’t spend a lot of time or money improving a single variety. That’s why you see so much ‘pollen chucking’ activity in the space. With the DEA memo and hopefully future action from the states, I expect to see some breeders really step up their work and introduce higher quality seed. I’m especially bullish on high-quality stable hybrid seed. Over the next five years or so, I believe you will see some strong offerings in this category. I believe those offerings will revolutionize cannabis cultivation.”
Intellectual property protections on cannabis genetics remain in their infancy (due, again, in part, to the mixed federal positions on the legality of cannabis).
The 2023 Farm Bill may also provide more specific guidance on seed sales. While that federal legislation is aimed at honing agricultural policies, the bill is expected to fine-tune language around hemp cultivation—including the definition of what hemp is.
And that’s where this all began: with a procedural acknowledgement that cannabis seeds (whether they sprout into industrial hemp plants or THC-rich phenotypes of your cultivation team’s latest Sour Diesel crosses) ultimately fall under the definition of hemp. They are legal to distribute in the eyes of the federal government.
But the word “infancy” is important here. Commercial trends have not yet matured into any definitive statement on how the above-board cannabis seed market operates.
“I would say at this point that clones are still the bread and butter, but our retail seedling line has grown every year,” Grace said. “Commercially, seeds and seedlings are growing among outdoor cultivators, especially those growing for extract.”
Grace also offered words of advice for growers—both licensed rookie and licensed veteran alike.
“Assume nothing,” he said. “Know your source as well as you can, and try to work with reputable partners. Don’t put all your eggs in one basket. Get a number of genetics from different partners and trial them against each other.”
U.S. DEA Official Determination on the Legality of Cannabis Seeds by sandydocs on Scribd
As published in the journal Food and Chemical Toxicology, the biopharmaceutical drug development firm's sponsored research used co-cultured human, primary immune cells as a model to evaluate the ability of selected cannabis constituents to decrease inflammation.
LAS VEGAS, Nov. 01, 2022 (GLOBE NEWSWIRE) — PRESS RELEASE — Gb Sciences, Inc., a plant-inspired, biopharmaceutical research and drug development company, has co-published a study in the journal Food and Chemical Toxicology that demonstrates the potential of selected cannabinoids and terpenes to reduce inflammation. Finding cannabis compounds with anti-inflammatory properties may be useful in decreasing inflammation associated with a wide range of serious human disorders, and these cannabis compounds potentially have more favorable side effect profiles than NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), which currently lead the anti-inflammatory market based on sales. Largely because of the increasing prevalence of chronic and auto-immune inflammatory disorders, the market for anti-inflammatory therapies is expected to grow to $191.42 billion by 2027.
“We believe that this is the first demonstration of the anti-inflammatory potential of some very potent minor cannabinoids and terpenes derived from cannabis,” said Dr. Andrea Small-Howard, President, Chief Science Officer, and Director of Gb Sciences. “The identification of cell type-specific immune modulating effects by different individual cannabinoids and terpenes was an important first step in designing our novel anti-inflammatory therapies. The results from our second study on the anti-inflammatory effects of proprietary mixtures of these ingredients will be published subsequently with our collaborators at Michigan State University and Chaminade University.”
Gb Sciences selected the specific cannabis constituents for this study based on their prior activity within chemovar studies. To determine whether these cannabinoids and terpenes could reduce inflammation, Gb Sciences’ colleagues at Michigan State University tested the individual cannabis constituents over a wide range of concentrations in human, primary immune cells in a co-culture system that mimics the complex interactions that regulate the human immune system. Three immune cell types were chosen as representatives within these native human immune cell mixtures based on their important roles in modulating the inflammatory cascade.
This study demonstrated that delta-9 tetrahydrocannabinol (THC) had the greatest effect on reducing inflammatory biomarkers and processes in all three immune cell types. Following THC, the greatest immune activity modulation was measured by cannabidivarin (CBDV), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), and lastly, cannabidiol (CBD) in decreasing order based on the number of statistically significant changes measured in inflammatory bioassays relative to the control. Some of these minor cannabinoids and the terpenes tested had very ‘selective’ anti-inflammatory effects, which targeted a single cell type and/or caused a change in only a single inflammatory bioassay.
This study entitled “Evaluation of the anti-inflammatory effects of selected cannabinoids and terpenes from Cannabis Sativa employing human primary leukocytes” was co-authored by Gb Sciences’ own President and Chief Science Officer, Andrea Small-Howard, and her collaborators Lance K. Blevins, Anthony P. Bach, Robert B. Crawford, Jiajun Zhou, Joseph E. Henriquez, Michael D. Rizzo, Sera Sermet, D.M. Isha Olive Khan, and Norbert Kaminski from Michigan State University (East Lansing, Michigan, USA) and Helen Turner from Chaminade University of Honolulu (Honolulu, Hawai’i, USA). The second part of this study measured the effects of proprietary mixtures of cannabinoids and terpenes on inflammation within this human, primary immune cell model, and this second study will be published next in collaboration with our colleagues at Michigan State University and Chaminade University.
To learn more about Gb Sciences, visit www.gbsciences.com.
The multistate operator now has 52 locations in the state with its water-soluble cannabis tinctures now on its retail menus.
MIAMI, Nov. 1, 2022 – PRESS RELEASE – Ayr Wellness Inc., a leading vertically integrated multistate cannabis operator, announced the opening of two new retail stores in Florida, located in Daytona Beach and Lake Worth, as well as the expansion of LEVIA water-soluble cannabis tinctures to its Florida retail menus.
Ayr’s newest stores in Daytona Beach and Lake Worth join more than 50 other retail locations throughout the state. Through this robust retail footprint, Florida’s rapidly growing community of more than 761,000 qualified patients have access to Ayr’s growing menu of cannabis products.
“We are excited to see the results from the progress we’ve made in Florida since acquiring Liberty Health Sciences in 2021. We’ve opened more than 20 new locations, with our store count now at 52, and have introduced several brands from our national portfolio to the market,” Ayr founder and CEO Jonathan Sandelman said. “On our mission to produce the highest quality cannabis at scale, Florida has been instrumental in bringing that vision to life.”
At all Liberty Health Sciences locations, patients can now enjoy LEVIA water-soluble cannabis tinctures, the latest addition to its menus following the recent introduction of hydrocarbon-extracted concentrates brand HAZE, as well as the award-winning premium whole flower brand, Lost in Translation (LIT).
LEVIA tinctures come in three unique offerings: the indica Dream, the hybrid Celebrate, and the sativa Achieve. Featuring high bioavailability and 300 milligrams of THC per bottle, LEVIA tinctures are water-soluble, allowing for flexible dosing and easy mixing with water and other beverages based on consumers’ preference. The tinctures are fast-acting, providing a unique intended effect for the consumer within minutes.
Now operating in eight states throughout the country, Ayr continues to reaffirm its commitment to the state of Florida, employing more than 800 people across its headquarters office in Miami, 52 retail locations throughout the state, a 745,000-square-foot cultivation facility in Gainesville and other field and corporate positions.
For more information about Ayr Wellness or to locate your nearest dispensary, visit https://ayrwellness.com.
The Libra MF and HF LED modules are engineered for indoor and greenhouse farming environments where dust, water, chemicals, and workers are present, and are now certified to the latest UL 8800 standard for horticulture lighting equipment and systems.
AUSTIN, Texas, Oct. 31, 2022 – PRESS RELEASE – Libra Design, LLC (Libra) announced the official launch of its horticulture lighting design services and Mid-Flux (MF) and High-Flux (HF) LED Modules for the Controlled-Environment Agriculture (CEA) industry, specifically for commercial indoor and greenhouse farming. Based on a customizable platform and a transparent, function-based pricing model, the new LED systems are designed and priced to ensure farmer cultivation and financial success.
“LED technology has taken greenhouse growing to new levels of production and transformed vertical farming from science fiction to a modern reality,” said Travis Williams, Libra co-founder & CEO. “Yet today’s LED systems are still cost-prohibitive and inadequately designed for most crop producers. Our goal with the launch of the Libra Design Mid-Flux and High-Flux LED Modules is to remove the financial barrier to CEA by providing indoor and greenhouse growers access to premium LED technology without the premium price tag.”
Designed for CEA and Certified to the Latest Safety Standards
The Libra MF and HF LED modules are specifically engineered for indoor and greenhouse farming environments where dust, water, chemicals, and workers are present, and are now certified to the latest UL 8800 standard for horticulture lighting equipment and systems. With an all-metal construction, passive cooling, and a wet-location IP66 rating, the LED modules are designed for years of efficient, maintenance-free operation reinforced by passing the construction and testing requirements for the Supplement SA to UL 8800.
“Decades of experience in LED systems, optics, and horticulture lighting went into the development of our Mid-Flux and High-Flux LED systems,” said Dung Duong, Libra co-founder and CTO. “Being certified to the UL 8800 standard and having passed the requirements set forth in the new Supplement SA, affirms our commitment to developing a no-compromise lighting platform which delivers the exact performance, reliability and affordability growers need to succeed in today’s challenging industry.”
A Unique Approach to Horticulture Lighting
Libra provides a collaborative and client-focused design process that replaces conventional off-the-shelf products. Instead of taking a “one-size-fits-all” approach, Libra works with each client to customize the MF and HF LED Modules based on their cultivation, operations, and business goals to develop a lighting solution as unique as their farm. The Libra MF and HF LED modules are specifically developed for vertical farms and greenhouse cultivation facilities where performance, affordability and reliability are paramount to success.
• Performance: Libra provides a minimum photosynthetic photon efficacy (PPE) of 2.7 µmol/J for all product designs and works with each client to customize functionality from flux, spectrum and power density to efficacy, form factor and additional key features.
• Affordability: A transparent, function-based pricing model ensures Libra clients pay only for what they need, resulting is a horticulture lighting system with significant cost savings compared to conventional LED systems.
• Reliability: The MF and HF LED Modules are designed for manufacturing and assembly (DFMA) best practices to ensure high-quality, low-cost and efficient production. This includes reducing the number of discrete components and connection points to achieve an anticipated failure rate below 1% with every order backed by a five-year manufacturer’s warranty.
The center’s work has so far largely focused on identifying and quantifying various cannabinoids.
Colorado State University’s (CSU) Cannabinoid Research Center (CRC) has been operating for a full year, with its work so far largely focused on identifying and quantifying various cannabinoids, laying the foundation to support clinical studies.
CSU received a $1.5 million donation in early 2020 from an alumna who wanted to create a research center dedicated to studying the chemical compounds in hemp. The CRC was born and now operates in collaboration with Panacea Life Sciences, a Colorado-based cannabinoid research and certified GMP manufacturing company.
RELATED: Inside Colorado State University’s Plans for a Cannabinoid Research Center
The CRC aims to solve industry-wide issues and gain a better understanding of how cannabinoids work in the body. In the past year, researchers have discovered how to remove common contaminants from hemp products and purify cannabinoids that are present in low concentrations in the hemp plant, as well as created the foundation for future clinical studies.
“You see people who say such-and-such a cannabinoid has this effect, and then there’s no data,” CRC Director Melissa Reynolds says. “You don’t know how much, you don’t know which cannabinoid [and] you don’t know which applications. So, that’s what we’re really working on, is getting the science right.”
Panacea Life Sciences Chief Science Officer James Baumgartner says the CRC’s overall mission is to deliver reliable information about cannabinoids to scientists, physicians, veterinarians and consumers.
“We want the center to actually serve as the foundation to support clinical studies, both within animals as well as within humans,” Baumgartner says. “That’s going to be a really important aspect moving forward.”
Baumgartner and Reynolds welcome other researchers to collaborate with the center to help drive the science forward in the CRC’s second year of operation.
The first order of business for the research center was developing methods to separate out various cannabinoids to determine which cannabinoids—and how much of each—the researchers had at their disposal.
“We have very reproducible protocols that we can do that over a range of cannabinoids,” Reynolds says. “That measurement science, the notion that we can accurately know what we have and how much we have, was an important aspect of really laying the groundwork for the center.”
Reynolds and her team have also been working on measuring the bioavailability of the cannabinoids by measuring blood and saliva samples.
The past year of work at the CRC has also allowed researchers to detect various pesticides and separate them from hemp samples.
“The pesticide research is extraordinarily important,” Baumgartner says. “Hemp is a notoriously difficult plant from the standpoint of it absorbs everything that’s in the soil. So, if you have a hemp farmer that’s next to a corn farmer and the corn farmer crop dusts with a pesticide on their crop, it’s going to drift over and … the hemp will absorb everything that comes into contact with it.”
Remediating these contaminated crops using the methods developed by the CRC will ultimately save hemp farmers from destroying their crops, Baumgartner says.
“Having a safe method to remediate those contaminated hemp oils is extremely important to the industry,” he says.
While many of the CRC’s clinical trials are yet to come, researchers have launched an irritable bowel syndrome study with a collaborator in New York, as well as a study that will take place within CSU on how cannabinoids impact Alzheimer’s disease.
Reynolds and Baumgartner are in the process of launching six total studies in the coming year with the hope of eventually gleaning some results on how cannabinoids affect different disease states.
“It’s really important to understand, what is the dosage that these [cannabinoids] need to be at in order to affect a medical condition?” Baumgartner says. “[The Cannabinoid Research Center is] a platform to be able to support clinical studies that will allow us to better understand how cannabinoids, terpenes and other compounds of the plant actually contribute towards novel medications or novel supplements for health and well-being.”
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