While demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant.
On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing “it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States.” This announcement comes in the midst of a growing demand for marijuana for medical and scientific research. Several years ago, in an August 11, 2016, press release, DEA first announced its intention to “expand… the number of DEA-registered marijuana manufacturers” because “only one entity was authorized to produce marijuana to supply researchers in the United States: the University of Mississippi.” Since that announcement, 33 entities have applied to DEA for a marijuana manufacturer registration. However, the approval process was stalled during Attorney General Jeff Sessions’ term in office, and to date no new applications have been approved. Meanwhile, the number of entities registered by DEA to conduct research on marijuana, marijuana extracts or marijuana derivatives has jumped from 384 in January 2017 to 542 in January 2019. Thus, while demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant.
DEA’s press release touches on two key issues related to cannabis[1] research: (i) increasing the amount and variety of marijuana available for research by approving additional marijuana cultivation applications; and (ii) clarifying the legal status of hemp and hemp-derived CBD for purposes of continued cultivation and research.
First, the press release announced that DEA is providing notice of pending applications from entities that have applied for marijuana manufacturing registrations. The Notice of Application was issued on August 27, 2019, and identifies 33 entities that applied for registration between August 2016 and May 2019. In the press release, acting DEA Administrator Uttam Dhillon explained that DEA “believe[s] registering more growers will result in researchers having access to a wider variety [of marijuana] for study.” Attorney General William Barr said he was “pleased that DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research.” Both the press release and the notice provide that DEA intends to issue new regulations that govern the program for the cultivation of marijuana for scientific and medical research, stating, “The new rules will help ensure DEA can evaluate the applications under the applicable legal standard and conform the program to relevant laws.”
Importantly, the DEA intends to enact these new rules before it approves any of the pending applications. As the DEA has not set a date by which it intends to promulgate these rules, the realistic impact of its August 26, 2019, press release remains to be seen.
While the DEA slow-walks the approval process, the public demand for adult-use and medical marijuana has increased—and with it the need for further research. At present, more than 30 states permit the use of medical marijuana to treat illnesses such as Alzheimer’s, Crohn’s disease and epilepsy. However, the list of qualifying conditions is developed largely based on anecdotal evidence from patients regarding areas such as pain or inflammation relief and appetite stimulation, rather than clinical studies on safety and efficacy that the U.S. Food and Drug Administration requires before it approves new medications. Expanded medical research could lead to the identification of additional health conditions that can be effectively treated with marijuana. Similarly, more than 10 states have legalized adult-use marijuana, with a number of other states considering similar measures this year. Yet there is relatively limited information on public-safety issues such as the length of time it takes for THC to dissipate in a person’s system. Research in this area could result in the development of more effective tools to evaluate marijuana intoxication, comparable to the roadside breathalyzers police officers use to measure blood-alcohol levels.
Second, the press release stressed that hemp is federally lawful in the wake of the Agriculture Improvement Act of 2018 (2018 Farm Bill). “[H]emp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.” The notice, too, referenced the legality of hemp: “this notice informs applicants that they may withdraw their applications if they no longer need to obtain a registration because of the recent amendments made by the Agriculture Improvement Act of 2018 to the definition of marihuana to no longer include ‘hemp’ as defined by law.” The assurance to businesses in the hemp-derived CBD industry that they can proceed with product research is significant because hemp-derived CBD products, including topicals, tinctures and vaporizers, have increased in popularity each year. While there have been many examples in the marketplace of entities making improper health-related claims regarding hemp-derived CBD, the ability to research these products without the need for a DEA registration will allow for more effective studies into their safety and efficacy.
Duane Morris will continue to monitor DEA’s marijuana cultivation registration program, and will provide updates after the DEA publishes its proposed rules for public comment.
For Further Information
If you have any questions about this Alert, please contact Frederick R. Ball, Seth A. Goldberg, Carolyn A. Alenci, Joseph J. Pangaro, any of the attorneys in our Cannabis Industry Group or the attorney in the firm with whom you are regularly in contact.
Notes
[1] “Cannabis” refers broadly to the plant Cannabis sativa L. “Marijuana” is the strain of cannabis that contains more than 0.3 percent tetrahydrocannabinol (THC) and is a Schedule 1 drug under the federal Controlled Substances Act (CSA), while “hemp” is the strain of cannabis that contains 0.3 percent or less THC and has been removed from the CSA.
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