Article By: Shuki Greer
If you want to run FDA-approved clinical trials for cannabis, you need to source the cannabis from a federally authorized cultivator. For nearly 50 years, the U.S. has had only a single federally-authorized marijuana cultivator: the University of Mississippi’s National Center for Natural Products Research (National Center).
Since the Drug Enforcement Agency (DEA) was formed in 1973, the National Center has been the sole entity in the nation with a DEA license to cultivate marijuana for research purposes. Under the Controlled Substances Act (CSA), all persons who seek to manufacture a controlled substance must obtain a DEA registration.
The National Center cultivates its federally-authorized marijuana pursuant to a contract administered by the National Institute on Drug Abuse (NIDA). Under this contract, the National Center receives funding and is permitted to cultivate, produce, process, analyze, store and distribute standardized marijuana of varying THC potencies to support researchers.
But, according to a secret internal Department of Justice (DOJ) memo from 2018 that was just released to the public this week, the DOJ’s Office of Legal Counsel is of the opinion that the DEA’s marijuana licensing framework with the Research Center has been out of compliance with an international narcotics treaty for the past 47 years.
The memo reveals the Justice Department’s predetermined bias against cannabis research, and offers a glimpse into why marijuana research in the United States has hardly progressed. But before we dive into the details of this bombshell memo and its analysis of an archaic international treaty, first, we provide a bit of background on what prompted the release of the secret document:
DEA Announces In 2016 That It Will Approve Additional Marijuana Cultivation Licenses
In 2016, as legalization was spreading rapidly among states, the demand for cannabis research was increasing as a result of heightened public interest in cannabis’ medicinal benefits. As a result, the DEA announced a policy change that was “designed to foster research by expanding the number of DEA registered marijuana manufacturers” in the US.
Despite some initial reluctance and pushback from universities across the country, the DEA ultimately received 33 applications from pharmaceutical companies, universities, and a tribe to grow marijuana for research purposes.
But for the last four years, the DEA has been dragging its feet, and the agency has neither responded to nor processed any of the pending applications. As a result, the applicants have been left without knowing whether they would ever receive DEA approval.
Last year, the DEA’s delay led one of the applicants, the Scottsdale Research Institute (SRI), to file a lawsuit against the agency. The lawsuit alleged that the DEA unlawfully withheld and unreasonably delayed the processing of the applications, and asked the court to compel the DEA and Attorney General to act.
SRI also argued that Congress specifically passed legislation to allow for applicants like SRI to move forward, as Congress had just amended the CSA by passing the “Improving Regulatory Transparency for New Medical Therapies Act,” which requires the Attorney General to notice applications to manufacture Schedule I substances for clinical research not later than 90 days after the application is “accepted for filing.”
Meanwhile, problems were brewing with the Research Center’s marijuana program, as critics and lawmakers claimed that the marijuana produced by the Research Center is low in THC and more genetically similar to hemp, and therefore is not a representative sample of the commercial cannabis varieties available at dispensaries across the country.
These critics (correctly) point out that the unavailability of representative research-grade marijuana is counterproductive to the progress of important studies into the effects of medical marijuana, and raises concerns as to the accuracy of previous studies that relied on the Research Center’s poor-quality bud.
To that end, SRI’s lawsuit also alleged that the Research Center’s marijuana is inadequate for clinical studies, the NIDA’s monopoly over the supply chain stifles the progress of research, and additional manufacturers are needed to increase the genetic diversity of marijuana for research.
On July 30, 2019, the court ordered the DEA to respond to SRI’s legal challenge within 30 days. Accordingly, the DEA responded by announcing it had published a notice in the Federal Register explaining that the agency was busy developing new rules to approve the pending applications, but needed more time. The notice informed the applicants that the DEA would be proposing revised regulations in the near future that would govern registration to grow cannabis for clinical research.
The court found that the DEA’s status update afforded SRI the relief it requested, and dismissed the case in October 2019 on mootness grounds.
The DEA Continues To Stall Through 2020
Things have not progressed since last year’s dismissal of SRI’s lawsuit. To the frustration of many, the DEA has yet to approve a single application for a marijuana manufacturer.
In March, however, the DEA finally released proposed new rules that would allow the agency to approve additional applicants to grow marijuana for research purposes. The revised rules include structural changes that would give the DEA significantly more hands-on control by giving it the “exclusive right” of importing, exporting, wholesale trading, and maintaining stocks of marijuana, and requiring it to take legal title and possession of the crops soon after they are harvested.
These structural changes, which would give the DEA an effective monopoly over the possession and control of cultivated research-grade marijuana, would fundamentally change the existing policy, under which the DEA does not purchase, maintain ownership, or have physical possession over the Research Center’s marijuana.
The DEA has claimed that these rules were prerequisites for it to approve any additional cultivators, and claimed that its legal interpretation of certain international treaties required that it take such actions. However, the agency initially refused to release any of the details as to how it reached this legal interpretation.
SRI Strikes Again
Frustrated that the agency wouldn’t release those details, SRI took the DEA to court again. This time, the lawsuit included a Freedom Of Information Act (FOIA) claim demanding that the DEA release its legal arguments supporting the need for the rule change. FOIA, under 5 U.S.C. § 552(a)(2), requires the government to make publicly available all non-sensitive government documents–which certainly includes any documents supporting the DEA’s analysis in this matter.
The court agreed with SRI, and ordered the DEA to release the document supporting its claim. The agency acquiesced to the court’s order, and on April 29, 2020, released a “secret” internal DOJ legal memo from 2018. This memo appears to have been used internally by the DEA for the last four years to justify its delay tactics.
The Secret Memo
The 25-page memo, titled “Licensing Marijuana Cultivation in Compliance with the Single Convention on Narcotic Drugs” describes why the current arrangement with the University of Mississippi, as well as the DEA’s pledge in 2016 to approve additional applicants, do not comply with an international treaty called the Single Convention on Narcotic Drugs (“Single Convention”), 18 U.S.T. 1407, which went into effect in 1961.
In short, the memo explains that under the Single Convention, signatory nations (which includes the US) that permit marijuana cultivation must meet the following requirements:
“First, the division of responsibilities between DEA and NIDA, a component of the Department of Health and Human Services (“HHS”), contravenes [the Single Convention’s requirement that all] functions be carried out by a single government agency. Second, neither of the two government agencies “take[s] physical possession” of the marijuana grown by the National Center, as required by [the Single Convention]. Third, no federal agency exercises a monopoly over the wholesale trade in marijuana, as required by [the Single Convention].”
In other words, because the Research Center’s contract is administered by the NIDA, which falls under the Department of Health and Human Services, there is not a single government agency overseeing the Research Center’s marijuana cultivation. Further, the DEA presently neither purchases nor takes physical possession of the marijuana at any point in the distribution process. Rather, the Research Center distributes the marijuana to researchers itself pursuant to the NIDA contract and NIDA oversight.
The memo also explains that the National Center does not step into the shoes of the federal government for purposes of satisfying the monopoly requirement, and that any conclusion to the contrary would create constitutional concerns:
“If the National Center were viewed as exercising significant authority in establishing a federal government monopoly over the lawful distribution of marijuana, in conformity with the international obligations of the United States, its officials might be viewed as officers of the United States, who would need to be appointed consistent with the appointments clause.”
The memo also outlines the recommended changes to the current licensing framework, and explains how those changes must be made in order to bring the United States into compliance.
At first glance, the memo reads quite well. It cites relevant authority, is persuasively written, and walks the reader through a variety of reasoned legal steps to reach its conclusion.
However, taking a step back, we believe the memo reveals bias and a predetermined conclusion. In 2016, the Obama-led DOJ announced its policy change that the DEA would accept additional applications for marijuana manufacturing. That was just before the DOJ was handed over to Jeff Sessions, whose extreme anti-cannabis policies included trying to go after fully state-legal operations, increasing asset forfeitures, and doing everything he could to increase criminal penalties for even minor drug offenses.
Faced with the prospect of expanding the government’s cannabis cultivation regime, Sessions was surely coming up with ideas to stymie any progress in that regard. We suspect that coming up with a legal memo that he could use to justify his delay tactics certainly gave Sessions some sly satisfaction.
When taken with that large grain of salt, the memo was clearly created with the intent of delaying any progress in this area.
Tellingly, the memo concedes that there are arguments that could be used to support the conclusion that the United States’s licensing framework actually is in compliance with the Single Convention. Indeed, the document lists several arguments in support of that conclusion, but dismisses them one by one.
For example, the memo acknowledges that the UK, Canada, Israel and Australia–which have similar licensing frameworks to the US–are also violating the treaty for the very same reasons as the US. But rather than accepting the consistent interpretation of the treaty amongst these multiple nations as an indication of treaty compliance, the memo asserts that “the practices of a handful of the 186 parties to the treaty are entitled to comparatively little weight.”
This is shockingly incorrect. First, these nations are some of the most influential and powerful countries in the world. To merely disregard them as “a handful of the 186 parties” is to ignore the fact that these are some of the countries most likely to respect the treaty. If all of these countries are independently interpreting the treaty in the same way, the DEA is erroneous in overlooking their interpretations.
Clearly, the memo is a complete 180 from the views of the DEA in its 2016 policy statement. This is a conspicuous example of a predetermined conclusion by the federal government that is post-hoc supported by legal authority.
The memo also sees no problem in declaring that the US has been violating the treaty for decades. By stating that the US licensing practices require numerous changes in order to comply with the treaty, it is calling into question the determination of every prior DEA attorney who did not feel any need to make these changes. Such a drastic and sudden change in the legal stance of the DEA is indicative of after-the-fact reasoning that is created for the sole purpose of supporting a predetermined conclusion.
Ultimately, however, the release of this memo is a good thing for several reasons. First, the government can no longer hide behind secret legal arguments to support further delay of applications for additional approved cultivators. As federal agencies create internal memos regarding cannabis policy in the future, they will do so with the understanding that the public is likely to see them. Second, the memo is effectively old news. The DEA has already released its interim rule to change those policies, and must turn to the pending applications in the near future. Hopefully the future will hold some good news for the applicants.
Disclaimer: This article has been prepared and published for informational and educational purposes only and is not offered or intended, nor should it be construed, to be legal advice.
 See 21 U.S.C. 822(a)(1).
 In re Scottsdale Research Inst., Case No. 19-1120 (D.C. Cir. 2019).
 See 21 U.S.C. § 823(i)(2).
 In re Scottsdale Research Inst., LLC, 2019 U.S. App. LEXIS 31233 D.C. Circuit Appeals Court (October 18, 2019)
 Scottsdale Research Institute LLC v. United States Drug Enforcement Administration, 2:20-cv-00605 (D. Ariz. March 25, 2020)
 See Single Convention art. 23.
 Licensing Marijuana Cultivation in Compliance with the Single Convention on Narcotic Drugs, Opinions of the Office of Legal Counsel in Volume 42, at 8.
 Id. at 15.
This article was shared with permission from the author. For more articles by Shuki Greer and Berger Greer LLP, visit their website here: