March 26, 2020
For the second time in four years, the US Drug Enforcement Administration is proposing regulatory changes to procedures governing the federally licensed manufacture of cannabis for clinical research purposes.
In a Notice of Proposed Rulemaking, published this week in the Federal Register, the agency acknowledges its longstanding failure to act upon the 35 bulk cultivation applications before it. The DEA now estimates that, under the new rules, it may approve between three and 15 total applicants. Almost all of the applicants have been awaiting a response for two or three years.
Commenting on the proposed regulatory changes, NORML’s Deputy Director Paul Armentano said: “These new rules are unduly onerous, expensive, and impractical. Even if they are ultimately implemented, it is unlikely that they would greatly facilitate clinical cannabis research in the United States.”
He added, “Further, the DEA has an incredibly poor track record in this arena – having for years now promised to expedite and streamline this process, but failing to deliver. As the saying goes, ‘Fool me once, shame on you; fool me twice, shame on me.’”
Under the proposed changes, the agency would purchase and warehouse all of the cannabis produced by federally licensed manufacturers. That is a change from the existing rules, which currently allow for only a single licensed manufacturer – the University of Mississippi – which maintains harvested cannabis on their premises.
The DEA states that, going forward, they will need to take possession of any marijuana grown by a federally licensed entity, including the University, in order to be compliant with the international Single Convention treaty.
The agency also estimates that it will require millions of dollars in additional funding in order to offset the financial costs involved in administering the updated procedures.
Investigators seeking to clinically study the therapeutic efficacy of cannabis have long complained that the existing regulations in place are unnecessarily burdensome and that the quality of cannabis cultivated by the University of Mississippi is of inferior quality. In 2016, the DEA publicly announced that it would, for the first time, begin accepting applications from private entities wishing to grow research-grade cannabis. However, since that time, neither the agency nor the Justice Department had taken any further action to move the application process forward. Last August, the agency announced that it would once again be reassessing and amending its policies.
The agency is accepting public comments on its proposed rule changes until May 22, 2020. Those entities who wish to either cultivate low-THC crops (those containing no more than 0.3 percent THC), or who wish to extract cannabinoids from plants that meet the federal definition of hemp, are not subject to the DEA’s licensing requirements.
The DEA’s proposed rules appear online here.
