The U.S. Drug Enforcement Administration (DEA) has once again pledged to take action to better facilitate clinical cannabis research.
According to the agency’s filing today in the Federal Register, the DEA “intends to promulgate regulations” to evaluate several dozen applications before it from private entities that wish to cultivate cannabis for FDA-approved research. However, this is not the first time the agency has made such a promise. In 2016, the DEA similarly announced the adoption of new rules to expand to supply of research-grade cannabis, but failed to take any further action.
“For the past three years, the DEA has failed to take any steps to follow through on its promise to facilitate clinical cannabis research, and today’s announcement makes it clear that this foot-dragging will continue,” NORML Executive Director Erik Altieri said. “According to the DEA’s filing, the agency has yet to even evaluate even one of the dozens of applications before it--many of which have been pending for more than two years, nor do they provide any timetable regarding when or if they ever will. In an era where public and scientific interest in the cannabis plant, particularly with regard to its therapeutic properties, has never been greater, and where patients in a majority of states are already using cannabis in compliance with state law, it is inexcusable that the DEA continues to take this ‘head-in-the-sand’ approach to this rapidly changing cultural and legal landscape.”
In June, one of the applicants seeking a DEA cultivation license--the Scottsdale Research Institute--filed a petition in the U.S. Court of Appeals for the District of Columbia seeking a writ of mandamus to order the DEA to comply with its 2016 policy, arguing that the agency has engaged in unreasonable delays. On July 29, the Appellate Court ordered the DEA to provide a written response to the filing within 30 days.
Since 1968, only the University of Mississippi has been federally licensed to engage in the growing of cannabis for FDA-approved clinical research. Scientists familiar with the product have consistently said that it is of inferior quality and fails to accurately reflect the types of marijuana varieties commercially available in legal states. Further, the University only provides scientists with the option to access herbal cigarette formulations of the plant, not concentrates, edibles, or extracts. Strains high in the compound cannabidiol (CBD)--a chemical of particular interest to many scientists--are also not currently available from the University.
Green Thumb Industries (GTI) Closes Transaction to Acquire Highly Coveted Vertically Integrated New York License
New York’s medical marijuana market has more than 105,000 registered patients as of August 20, almost doubling since January 2018.
CHICAGO and VANCOUVER, British Columbia, Aug. 26, 2019 (GLOBE NEWSWIRE) PRESS RELEASE -- Green Thumb Industries Inc. today announced it has closed on a transaction to acquire New York-based Fiorello Pharmaceuticals, one of only 10 companies approved to operate a medical marijuana company in the state. Assets include a manufacturing and cultivation facility in Schenectady County and a retail store in each of the following locations: Manhattan, Rochester, Halfmoon and Nassau County, three of which are open.
“As one of only 10 license holders in a state with a population of approximately 20 million, this acquisition is firmly in line with our strategic goal of entering highly regulated markets to manufacture and distribute cannabis brands at scale,” said GTI Founder and Chief Executive Officer Ben Kovler. “We believe entry into New York is an important milestone as we empower the right to wellness through responsible increased access to cannabis and are privileged to serve the people of New York seeking relief and an enhanced quality of life.”
New York’s medical marijuana market has more than 105,000 registered patients as of August 20, almost doubling since January 2018. The state’s program has 15 qualifying conditions including chronic pain, post-traumatic stress disorder (PTSD), and opioid replacement, and allows for home delivery.
“GTI is the clear industry leader and we have been very impressed with GTI’s leadership team and vision for the future,” said Fiorello Pharmaceuticals co-CEO Susan Yoss. “New York will benefit from GTI’s medical cannabis expertise and the high-quality care and products that they will bring to the many patients suffering from debilitating and life-threatening conditions.”
spiritofamerica | Adobe Stock
New Jersey Governor Vetoes Expungement Bill, Presents Ideas for Revised Legislation
Gov. Phil Murphy conditionally vetoed a bill that would have overhauled the state’s expungement process and immediately cleared some cannabis convictions.
New Jersey Gov. Phil Murphy conditionally vetoed a bill Aug. 23 that would have overhauled the state’s expungement system and allowed some individuals with cannabis convictions to have their records immediately cleared.
Murphy has instead offered his own recommendations on how to improve the state’s current expungement process, which has become outdated and tedious. Murphy’s vision includes the creation of a task force that would recommend how the state could implement a more technologically advanced, automatic expungement process for individuals who have not been convicted of any crimes for 10 years, NJ.com reported. Murphy’s conditional veto also calls for an electronic filing system to streamline the expungement process, the sealing of records related to the possession of small amounts of cannabis and paraphernalia and $15 million for the labor force required to process expungement petitions before the automated system is up and running, according to NJ.com.
State Sen. Sandra Cunningham (D-Hudson), who sponsored the original expungement bill, was disappointed with the veto, saying that Murphy’s version of the legislation would unfairly exclude some from participating in the process by capping the number of qualifying arrests, NJ.com reported.
The New Jersey Senate and Assembly passed Cunningham’s bill in June. The bill would have immediately expunged some cannabis convictions, and those guilty of non-cannabis-related offenses would have had their wait times reduced, according to NJ.com. Murphy has promised to expunge past cannabis convictions as part of his adult-use legalization efforts, but expungement legislation stalled in the legislature earlier this year. Now, both houses of the legislature would have to pass an amended version of the legislation that incorporates Murphy’s suggestions in order to have the bill signed into law.
PhotoSpirit/Adobe Stock
Jamaica Planning Medical Cannabis Research Center
The country is looking to Dr. Wilfred Ngwa's work at Harvard Medical School for inspiration and vision.
With cannabis-based medicinal research picking up global interest from governments and universities—and with cannabis reform legislation sweeping the planet—Jamaica is developing a plan to serve as a hub for international markets’ scientific innovation and health care policy.
The Jamaican government is courting Dr. Wilfred Ngwa, director of the Global Health Catalyst at Brigham and Women’s Hospital’s Dana-Farber Cancer Institute at Harvard Medical School. Ngwa is joined in Jamaica’s plans by Dr. Henry Lowe and Dr. Julius Garvey (son of Marcus Garvey).
Earlier this summer, Ngwa hosted a plant medicine conference that caught the attention of Industry, Commerce, Agriculture and Fisheries Minister Audley Shaw. At the time, Ngwa was announcing the launch of Harvard Medical School’s International Phytomedicines Institute. “I am excited about the launch of the IPI to dramatically increase access to evidence-based medicinal products from plants," Ngwa said.
Shaw told the Jamaica Observer that Ngwa would be visiting the country soon to learn more about its climate and cannabis growing conditions.
Jamaica legalized medical cannabis in 2017, but the industry has been slow to develop. (Regulators have issued 54 cannabis business licenses. Export licenses are forthcoming.) The country decriminalized cannabis use in 2015, honoring Rastafarian traditions while also nurturing a rise in tourism; an illicit market has thrived, even as law enforcement cracks down on illegal cannabis cultivation. Add to those developments the usual restrictions on banking and the still-stringent regulation of international drug treaties, and Jamaica’s cannabis businesses remain in a bind. The idea of a medical cannabis research institution, however, strikes at the heart of the plant’s significance in Jamaican history and culture;
“We must also not forget that Dr. Lowe and others have developed plant-based medicines in Jamaica that are now world-renowned, and are presently submitting more applications for further development of additional plant-based medicines to the Food and Drug Administration of the United States Government,” Shaw told the Observer.
The timing is fortuitous, as Shaw’s department hopes to synchronize the work of Lowe and Garvey with Ngwa’s ongoing medical cannabis research. Earlier in August, Ngwa’s Harvard research team announced that it had discovered a flavonoid derivative in the cannabis plant with “significant therapy potential” in the treatment of pancreatic cancer. (In the U.S., approximately 57,000 adults will be diagnosed with pancreatic cancer in 2019, according to the American Society of Clinical Oncology.)
“In this study, we investigate a new non-cannabinoid, non-psychoactive derivative of cannabis, called FBL-03G, to assess its potential for the treatment of pancreatic cancer,” the study’s authors wrote in Frontiers in Oncology. “We hypothesize that the use of FBL-03G will have therapeutic potential and can enhance radiotherapy during the treatment of pancreatic cancer.”
With Shaw’s plan in motion, Jamaica may be situated geographically and climatically to support research like the flavonoid derivative study—with the scope of the International Phytomedicines Institute.
Photos courtesy of Seed & Smith
How Seed & Smith Navigates Facility Tours in Colorado
The vertically integrated cannabis company offers public tours of its cultivation, extraction and packaging facilities to provide transparency and customer education.
Seed & Smith’s vertically integrated cannabis facility has cultivation, extraction, packaging and retail facilities on-site at its Denver, Colo. location, and each component is showcased through the company’s complimentary facility tours, which offer transparency and customer education, according to Director of Logistics Mike Lempert.
The tours, which run Thursday through Sunday and draw 1,000-1,500 people per month, begin in the dispensary, where guests sign up in the waiting room area. A tour guide then meets the customers and takes them first to the loading dock, where guests can view a vegetative grow room through glass windows while a video explains the company’s cloning process.
“Essentially, we just give them some back story, fill them in and educate them on how exactly the plants get from point A to what they’re about to see when we open up the blinds for that room,” Lempert says. “We had a production company come in and do all the video and editing … so [there are] no actors—it’s all Seed & Smith employees on the video.”
From there, the tour progresses to what Seed & Smith calls the bloom hallway, where one of the company’s 14 bloom rooms is enclosed on two sides with glass. Guests can peek into the 1,500-square-foot-room at different angles to see flowering plants.
“The tour guide gives [a] talk about how the plant progresses in the next two weeks and turns into what they’re about to see there, and that is a room that is usually in full bloom,” Lempert says. “These plants are flowering [and] there are nugs all over the place, up against the window.”
The guests are also briefed on how Seed & Smith cares for its flowering plants, from the different light spectrum and intensities required to the HVAC, humidity control, nutrients and irrigation that are used.
“We want to be as transparent as possible when educating people,” Lempert says. “We get people who grow at home, so they know just about everything—or they think they do—and we get people who have never touched weed in their entire lives. We try to make this tour accessible for everybody, and the narrative we give is applicable to everybody.”
The second half of the tour kicks off at Seed & Smith’s packaging department, where guests can hold a pound of cannabis flower. Next up is the extraction facility, where guests can see where all the company’s concentrates are made.
Seed & Smith has recently become one of three cannabis operators in Colorado to launch a limited vaporizer device in partnership with CCELL, and the tours now work to spotlight the product, allowing guests to handle it and learn how it works.
“Part of the tour is kind of a launchpad for our products that we want to push,” Lempert says. “Let’s say we have a new strain that we want people to be aware of. We’ll focus on that on the tour. … We’ll make sure those plants are in the windows. We’ll put out some of those terpenes for people to smell. So, it allows us to focus on one specific strain or one specific product or whatever it is that we want to show to the world.”
Photo courtesy of Seed & Smith
The tour wraps up in Seed & Smith's dispensary.
Certain regulations come into play when bringing outside parties into a cannabis facility, and in Colorado, Seed & Smith has several rules it must follow to keep its tours compliant with state law.
For example, tours are limited to five guests per tour per tour guide, Lempert says. If a group of 10 or 15 sign up for a tour, Seed & Smith will send two or three tour guides, and the company can accommodate tours of up to 25 people. Beyond that, the hallways get too crowded and guests have trouble hearing and seeing parts of the tour, Lempert says.
Another common compliance issue, he adds, is that state law prohibits customers from bringing cannabis products into the facility, whether it is products purchased from Seed & Smith’s dispensary or elsewhere.
“A lot of people that come on these tours are coming through a larger tour company or they were at another dispensary and maybe they have a pack of joints on them, or a vape cartridge,” Lempert says. “We have to advise them prior to the tour that they can’t bring anything that has THC in it. They have to go back to the bus, back to the car, and leave it outside this building. That’s a big thing we focus on.”
And while social consumption laws have been approved in Colorado, the issue is still in a regulatory gray area, Lempert says. Seed & Smith is in the process of trying to obtain a social consumption license, but licensing has so far proven difficult to obtain, Lempert says.
“Let’s say we have a new strain that we want people to be aware of. We’ll focus on that on the tour."
-Mike Lempert, Director of Logistics, Seed & Smith
Overall, the tours aim to provide insight into the cannabis industry and its processes, much like a brewery tour that allows customers to see how beer is made, Lempert says. Seed & Smith has based its facility design around the tours, he adds, building it around transparency and education.
“Cannabis has been a secretive world where nobody wants to give up best practices and nobody wants to show behind the scenes,” he says. “We don’t want to be like that. We think [part of] progressing the industry … is allowing people to understand the processes that go into making this product. At the end of the day, this is something you’re putting into your body, and we want people to feel comfortable doing that.”
Customers have been very receptive of the tours, Lempert adds. “When people come in and they see the magnitude and the thought and the design that have gone into this, they’re blown away. It’s really unlike anything that’s out there right now that’s open to the public.”
The tours have also helped boost Seed & Smith’s sales; 30 percent of total sales come from customers who have taken the tour, Lempert says.
The success of Seed & Smith’s tours can largely be attributed to its employees, he adds. “They’re the driving force behind this—the tour guides, the dispensary staff that checks in these guests when they get here, and then, eventually, once the tour ends … in the dispensary, … they’re the ones who are doing their best and really being the face of the company at that point. So, [we are] making sure that our employees understand the company values and understand exactly how Seed & Smith wants to be portrayed—they’re that driving force.”
The company’s tours have also played an important role in Seed & Smith’s wholesale business, Lempert says. The company’s products are sold in other dispensaries across Colorado, and Seed & Smith invites companies that sell its offerings to visit the facility and take advantage of the tours to learn more about the brand.
“There are a lot of edibles companies … that every dispensary carries them, but they don’t know anything about them other than what the sales pitch is,” Lempert says. “They don’t get to go to the factory, see how it’s made—they don’t know what goes into it. So, that has been a huge competitive advantage for us."
Legislative Map
Cannabis Business Times’ interactive legislative map is another tool to help cultivators quickly navigate state cannabis laws and find news relevant to their markets. View More