DEA Archives - Green Market Report

StaffStaffSeptember 2, 2020
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6min6460

Editors note: This is a guest post by Robbert Dean.

In the middle of August, the US Drug Enforcement Administration (DEA) issued an interim rule which is a treat to the cannabinoid hemp market and could impact hemp pricing. Operators in this space including farmers, traders, and extractors are now racing to determine how this will impact their business and what they can do about it. Operators are facing risks and are not in a position to take the threat to their operations lightly. 

At issue is that some of the extracts that are produced can naturally exceed the legal level of hemp above 0.3%. As hemp flows through the process of becoming a final product, like CBD, is becomes compliant through dilution and blending. Despite this supply chain mechanism, there remain hundreds of thousands of kilos of crude CBD listed a schedule 1 narcotics in DEA possession. 

According to The Jacobsen, the destruction of a Willamette Valley Oregon business came at the hands of the DEA as they were forced to liquidate after spending hundreds of thousands of dollars in legal fees. The Oregon company Key Compounds used the extract from a Massachusetts company Phasex, which caught the attention of Albany police. The extraction facility was raided and charges were brought which cost the company 7-million dollars according to The Jacobsen. 

Are States Rights Federally Enforceable

The issue at hand is whether state rights enforceable. Can states forge their path with regards to CBD policy? The DEA appears to be willing to ignore how individual states are handling CBD laws and making their own interim decisions. If the DEA takes an antagonistic position, seeing hemp-derived or organic hemp cannabinoids as an illicit industry using health and wellness as a mask to distribute narcotics, they may see some political support erode due to an outdated, ideological, posture.  This could be the case as early as November if the White House and Senate flip.

The prospects for CBD for states may provide the backdrop for additional state legislation. Some might draw on other states which only have adult-use policies to protect the new industry. This leaves the issues to the DEA to determine enforcement priorities but also creates a fragmented hemp market. 

There are several ways to attack the current policy as in direct opposition to the intent of the 2018 Farm Bill, through nuanced positions on wet/dry content language in current hemp legislation.  If left in place though, the policy poses an existential threat to the cannabinoid segment, undoubtedly giving rise to the black market.  

Extractors are likely to prioritize remediation to mitigate risk.  Depending on the process, this can be costly and incredibly time-consuming, but dilution is another option. This would mean that extractors would attempt to mitigate the content they provide at the outset to comply with Federal law. Those with in-house remediation have a distinct advantage.  Biotech companies are working to produce proprietary hemp genetics, along the lines of their nicotine-free tobacco, maybe in the best position if the DEA’s strict interpretation stands.

The Bottom Line

The upshot is that the DEA and states across the US have a different interpretation of what is legal in the Hemp world. This scenario also plays out in the Marijuana industry where several states make weed recreationally legal, but it is not legal federally. The DEA is in a position to generate strife at the state level and politics will likely play a pivotal rose ahead of the 2020 election which could change the landscape for many farmers, traders, and extractors who are betting that the hemp industry has further upside and profitability in the years to come.


StaffStaffMarch 24, 2020
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3min5200

Late last week, the Drug Enforcement Administration (DEA) and the Department of Justice announced action to further expand opportunities for scientific and medical research on marijuana in the United States.

The Notice of Proposed Rulemaking was filed for public inspection on March 20.  The proposed rule was then published in the Federal Register on Monday, March 23.  The new approach will expand opportunities for marijuana growers who seek to grow marijuana for research purposes and outline the agency’s proposed process for administering the new program, consistent with applicable law.

“The Drug Enforcement Administration continues to support additional research into marijuana and its components, and we believe registering more growers will advance the scientific and medical research already being conducted,” said DEA Acting Administrator Dhillon.  “DEA is making progress to register additional marijuana growers for federally authorized research, and will continue to work with other relevant federal agencies to expedite the necessary next steps.”

This proposed rule will result in additional registered growers and a larger, more diverse variety of marijuana available for research. The new regulations will enable DEA to evaluate each of the 37 pending applications to grow marijuana for research under the applicable legal standard and conform the overall program to relevant laws.

The release of this Notice of Proposed Rulemaking is the latest and most significant action taken to expand the number of registered marijuana growers in the United States and underscores the federal government’s support for scientific and medical research with marijuana and its chemical constituents.

Since the beginning of this Administration, there has been a 58 percent increase in the number of active researchers registered with DEA to conduct research with marijuana, marijuana extracts, and marijuana derivatives – from 377 in January 2017 to 595 in March 2020. At present, more researchers are registered to conduct research on marijuana, marijuana extracts, and marijuana derivatives than on any other schedule I substance in the United States. More than 70 percent of DEA’s total schedule I research registrant population is registered to conduct research on these substances.  To accommodate this growth in research, DEA has increased the annual production quota for marijuana by 575 percent – from 472 kilograms in 2017 to 3,200 kilograms in 2020.


Debra BorchardtDebra BorchardtSeptember 27, 2018
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5min13240

The Acting Administrator of the Drug Enforcement Administration has placed FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols  (THC) in schedule V. GW Pharmaceutical’s (GWPH) Epidiolex had been a schedule I controlled substance, with this new directive Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance.

Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

The order made it clear that other cannabis products would remain in the schedule 1 category. The statement said, “As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” The document is scheduled to be published on September 28, 2018.

The order also said, “Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in
treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”

The order went on to stress that CBD material, “which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.”

Dr. George E. Anastassov, Chief Executive Officer of AXIM Biotechnologies remarked, “Today’s news is an important step for the pharmaceutical cannabinoid industry. It signifies an understanding on behalf of the regulatory agencies in the United States, such as the FDA and DEA, that cannabidiol (CBD) has therapeutic potential and a very low potential for abuse and misuse. However, this applies ONLY to Epidiolex, i.e. to the molecule contained within this particular formulation. Otherwise, CBD still remains as a Schedule I controlled substance and the current classification is non-applicable to the rest of the products available on the market.”

Thoma Kikis, Chief Communications Officer of Kannalife Sciences said, “The DEA’s rescheduling of Epidiolex from a Schedule I to a Schedule V controlled substance gives cannabidiol (CBD) more credibility and recognition as a treatment in the U.S. that does, in fact, have medical value. This is a watershed moment for the cannabinoid industry, and very encouraging for Kannalife Sciences and the work we have done to research and develop our own CBD-derived molecule (KLS-13019) for the treatment of diseases with unmet medical needs, such as Chemotherapy-Induced Neuropathic Pain (CINP), Hepatic Encephalopathy (HE), and Chronic Traumatic Encephalopathy (CTE). However, there is still more work to be done.”

GW Pharmaceutical stock jumped over 8% on the news to lately trade at $176.


Debra BorchardtDebra BorchardtSeptember 20, 2018
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8min11800

Tilray Inc. (TLRY) has been somewhat a source of pride in the cannabis community, listing on the NASDAQ (NDAQ) with a successful Initial Public Offering (IPO). It’s a well-run respectable company with strong sales and an enviable portfolio of brands.

Two things have happened this week with Tilray. The stock went on a ridiculously crazy ride that even seasoned stock traders shook their heads at. A stock does not run up a chart like that without some sort of downside response. The second thing that happened was the Drug Enforcement Agency approval for Tilray to bring in medical marijuana for a scientific study.

Stock Moves

Cowen & Co. initiated coverage on Tilray’s stock with an outperform rating on August 13 and a target price of $34. This week the stock hit $300 at one point. Cowen analyst Vivien Azer defended her $34 price target at the time, assuming readers would question how she arrived at that number. No doubt Azer is probably wondering if she has to downgrade purely based on valuation.

Tilray began the week at $117, which was already a fairly rich valuation. It closed at $154 on Tuesday and then all hell broke loose. It opened at $233 on Wednesday, shot up to $300 at one point, dropped to $151 and then the trading was halted during the day. It eventually reopened and the stock closed at $214.

The wild gyrations had short sellers screaming now was the time to sell. Cannabis stocks were being compared to bitcoins and predictions of a dot-com bust were all over the internet. This is the part that hurts all cannabis stocks. According to S3 Partners, short sellers have lost $626 million since the start of August betting against cannabis stocks.

The company wrote, “Short sellers have been very active in the cannabis sector this year, with short interest climbing to $1.5 billion spread over 33 stocks and ETFs. This is a $458 million increase in short interest, +44%, since the end of the second quarter. Most of this increase was centered on increased short activity in Canopy Growth (CGC) and Tilray, which were up $514 million in just over three months.”

The cannabis industry tends to trade in lockstep. When one stock does well, they all tend to move higher. Similarly, when one struggles, they trade down in sympathy. Tilray’s seesaw moves hurt the industry as all of the companies get lumped into one. Comparing an industry with real product and real revenue to a digital cryptocurrency that doesn’t exist except in a computer is just well, dumb. It is making the comparison purely based on a percentage of increase in value. It makes a good headline for the short seller but is based on one metric alone.

There is no argument that the valuations have gotten ahead of themselves. Market values at 150x revenue? That’s not sustainable. Most of the industry insiders agree with this unless of course, their company stocks have stayed low. Then they stare wistfully at those unrealized gains.

Market stability is something everyone would prefer. Wild rides aren’t good for cannabis stocks.

DEA Just Says Yes
Tilray Inc. announced on Tuesday that the U.S. Drug Enforcement Administration (DEA) granted approval to import a cannabinoid study drug into the U.S. from Canada for a clinical trial at the University of California San Diego Center for Medicinal Cannabis Research. The agreement had been in the works for two years and plans on examining the safety, tolerability, and efficacy for a condition known as Essential Tremor.

According to the statement, “Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol (CBD) and tetrahydrocannabinol (THC).  It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation.”

At first glance, this seems like a huge positive for the cannabis industry. Cross-border cannabis would make life so much easier for the companies that have operations in both countries. However, one wonders how this makes all the medical marijuana companies in the U.S. feel?

Rep. Matt Gaetz tweeted, “Unbelievable… gives approval to import compounds from Canada, while AG Sessions is sitting on 2 dozen+ applications from domestic manufacturers. What happened to “buy American, hire American”? The Florida Republican authored a bill that would require the granting of more cannabis cultivation licenses.  The licenses would be for more cannabis to be grown for research. The bill was approved but not voted on.

Considering the amount of cannabis that is grown in California and that the state has legalized medical marijuana for the last twenty years, UC San Diego couldn’t find a company in its home state to provide product for this study?

The Justice Department is handing out lifetime bans to people in Canada that work in the cannabis industry at the border, but then the DEA (which is housed under the DOJ) approves a cross-border transfer of cannabis? The same DEA that also considers cannabis to have no medicinal benefit?

Stability

The standard line in the investment community is that the market hates uncertainty. Roller coaster moves and short seller attacks hurt all cannabis companies. Even the big moves higher.

Stability in rules and regulations is also a plus. The industry has accepted that it can’t cross state lines, much less country borders. Then the DEA throws a wrench into this machine. It’s a like a kid yelling, “new rule, new rule.” Only, who does the new rule benefit? Will the Canadians similarly offer a U.S. cannabis company a chance to export its product for testing? Would the DEA allow that?

One thing can be certain in the cannabis industry, just when it thinks the rules are set – they change.


Video StaffVideo StaffMay 4, 2018

3min13300

May the fourth be with you!

The DEA won the case regarding Cannabidiol or CBD from the Hemp Industries Association. The Ninth Circuit appeals court ruled in favor of the DEA that wants to classify CBD as a schedule 1 controlled substance. The DEA has long believed that CBD is a marijuana extract and since marijuana is schedule 1 then so is CBD. The agency made a rule change in 2016 that worried CBD makers at the time, which the DEA talked down. Now it looks as if the DEA is setting itself up to go after CBD makers.

The Green Organic Dutchman went public this week as its shares began trading on the Toronto Exchange using the ticker TGOD. The company’s shares which were priced at $3.65 jumped almost 10% in the first three hours of trading as the company raised $115 million. The stock was lately trading at $4.06.

Earnings continue to roll out this week.

Cronos Group (CRON) reported fourth-quarter sales of $1.6 million and annual sales of $4.1 million. The company also delivered a gross profit for 2017 of $7.2 million versus last year’s gross profit of $1.9 million. The Nasdaq listed company has really turned a corner with net profits for 2017 of $2.4 million over last year’s loss of $1.1 million.

Namaste Technologies (NXTTF) reported sales for the fourth quarter were $5.6 million and gross profits of $1.9 million. The company also announced this week that it was acquiring Findify, an A.I. powered e-commerce platform. The idea is that the product will help Namaste recommend the right products for its clients.

Sunniva (SNNVF)  reported $16.1 million in annual revenue for 2017, but still delivered a net loss of $18.5 million. The losses stemmed from C$14.3 million in selling, general and administrative expenses and then the company also incurred costs of goods sold of C$9.4 million due to the contract physician compensation in NHS and product manufacturing costs in FSD.

 

 

 


Debra BorchardtDebra BorchardtMay 3, 2018
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5min11680

It’s time for your Daily Hit of cannabis news for May 3 2018:

On The Site:

DEA Wins One

A panel of judges for the 9th U.S. Circuit Court of Appeals rejected a challenge filed by cannabidiol (CBD) producers against a Drug Enforcement Agency rule that classifies CBD as a Schedule I drug. The rule originated in 2016 when the DEA created a new Administration Controlled Substances Code Number for the term “marijuana extract,” which defined a marijuana extract as “an extract containing one or more cannabinoids that have been derived from any plant of the genus Cannabis…” This meant that CBD, regardless of whether it was extracted from hemp or cannabis, was now effectively a Schedule I substance.

Firing back at the DEA, the Hemp Industries Association filed a challenge against the rule, arguing that the agency overstepped its authority by scheduling substances that were not included in the Controlled Substances Act and that hemp-based CBD extracts were protected under state laws and Farm Bill provisions.  The HIA’s case hinged on whether or not the DEA rule violated agricultural laws, which the justices determined it did not and consequently ruled in favor of the DEA.

ABcann Global Corporation

ABcann Global Corporation (ABCCF) reported net sales of C$922,030 in 2017 versus C$525,940 in 2016.  The annual report or business update did not provide much in the way of standard financial reporting with regards to profits or losses. ABcann’s 2017 audited annual financial statements showed a cash balance on December 31, 2017, of $70.8 million and operating expenses totaling C$27.5 million.

Namaste Technologies

After posting an impressive second quarter financial earnings, the cannabis-tech company Namaste Technologies (NXTTF) has started makings moves in the world of artificial intelligence.

Today the company announced that they have executed a definitive agreement to acquire Findify AB, a Swedish corporation on the forefront of A.I. powered e-commerce personalization, delivering solutions such as personalized search, recommendations, and advanced data analytics.

In Other News

Medicine Man Technologies Inc.

Medicine Man Technologies Inc. (MDCL) reported financial results for the quarter ended March 31, 2018. Medicine Man generated revenues of $1,211,037 as compared with the three months ending March 31, 2017, where it generated revenues of $541,136. Overall revenue increased during this three-month period over that of the prior year by $669, 901, or 124%, making this the fifth consecutive quarter on quarter revenue growth period achieved.

Harvest One Cannabis Inc. 

Harvest One Cannabis Inc. (TSXV: HVT)  is acquiring all the outstanding shares of Dream Water Products Canada Inc. and Sarpes Beverages, LLC in exchange for a combination of US$12.5 million in cash and C$18.5 million in shares at a deemed price of C$1.00 per share, representing total consideration of approximately C$34.5 million. After closing, Harvest One will continue to hold a substantial cash position of approximately C$62 million and zero debt. As part of this Transaction, the combination of Dream Water Canada and Dream Water USA will become Dream Water Global (“Dream Water”) and own the worldwide rights and all intellectual property to and for Dream Water.

CannaRoyalty Corp.

CannaRoyalty Corp. (CNNRF) announced that it has received renewed licenses for Kaya Management Inc., Alta Supply Inc., Vista Distribution Inc., and Zenco Manufacturing Inc. Kaya and Alta are wholly-owned subsidiaries of CannaRoyalty, and the company’s active cannabis operations in California are exclusively carried out through these two entities. The company intends to apply for permanent licenses in both the adult use and medical categories in due course during 2018, and a further update will be provided on receipt of such permanent licenses.

 


William SumnerWilliam SumnerMay 3, 2018
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3min29123

If you think that the wave of legalized cannabis in recent years has turned the tide of reefer madness, think again. On May 2, 2018, a panel of judges for the 9th U.S. Circuit Court of Appeals rejected a challenge filed by cannabidiol (CBD) producers against a Drug Enforcement Agency rule that classifies CBD as a Schedule I drug.

The rule originated in 2016 when the DEA created a new Administration Controlled Substances Code Number for the term “marijuana extract,” which defined a marijuana extract as “an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis…” This meant that CBD, regardless of whether it was extracted from hemp or cannabis, was now effectively a Schedule I substance.

Firing back at the DEA, the Hemp Industries Association filed a challenge against the rule, arguing that the agency overstepped its authority by scheduling substances that were not included in the Controlled Substances Act and that hemp-based CBD extracts were protected under state laws and Farm Bill provisions.

However, because of the vagaries of the federal law, their arguments mattered little. Under federal law, a party can petition a Court of Appeals for a review of final DEA decision. However, if the petitioner fails “to make an argument before the administrative agency in comments on a proposed rule,” they are prevented from raising that argument on judicial review.

Without its strongest argument, the HIA’s case hinged on whether or not the DEA rule violated agricultural laws, which the justices determined it did not and consequently ruled in favor of the DEA. Although the case is currently being appealed, the results of this case could have a chilling effect on the U.S. CBD market.

In 2016, the U.S. hemp industry generated approximately $688 million in product sales, with $130 million alone coming from Hemp-based CBD. According to the Hemp Business Journal, the CBD market will grow to a $1.8 billion in consumer sales by 2020 with $450 million of those sales coming from hemp-based sources.

Now those projections are cast into doubt because of this recent ruling. At the moment, hemp-based CBD products are still available for purchase online from online retailers like Amazon, but the question is for how long?


StaffStaffSeptember 27, 2017
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3min16700

The acting chief of the U.S. Drug Enforcement Administration (DEA) Chuck Rosenberg is stepping down according to reports from The Associated Press. Rosenberg is said to have notified employees on Tuesday in an email that he was leaving and thanked them for their hard work.

Rosenberg has been in the position temporarily since 2015 and garnered attention when he distanced himself from President Trump after comments that the police shouldn’t be nice to suspects when putting them in squad cars. At that time he told employees that he did not condone police misconduct. The AP also said that New Jersey State Police Col. Rick Fuentes is a front-runner for the role.

Just last week, he named the President an honorary state trooper bestowing badge number 45 on him. “The New Jersey State Police ‘Roll Call’ roster will forever reflect badge number 45 being honorably issued to President Donald J. Trump,” Fuentes wrote in an order that authorized the ceremonial designation. Fuentes is known for taking a stance against racial profiling. He also holds masters and doctoral degrees in criminal justice from the City University of New York.

Rosenberg is known for being a close associate of fired FBI Director James Comey. According to the New York Times, Rosenberg was asked whether he wanted to be a permanent administrator for the DEA and he said he did not. It was also said that he believed the President had little respect for the law.

This follows a report earlier this week from the FBI that stated that 653,249 arrests were made for marijuana in 2016. “Arresting and citing over half a million people a year for a substance that is objectively safer than alcohol is a travesty,” said Morgan Fox, director of communications for the Marijuana Policy Project. “Despite a steady shift in public opinion away from marijuana prohibition and the growing number of states that are regulating marijuana like alcohol, marijuana consumers continue to be treated like criminals throughout the country. This is a shameful waste of resources and can create lifelong consequences for the people arrested.”

Tom Angell of Marijuana Majority crunched the numbers and found that marijuana drug arrests were rising – up 5.6% from 2015. He said that it is an average of one drug arrest for every 20 seconds. While industry insiders have operated with an attitude of business as usual, it may be that some prefer the devil you know.



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The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


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