A new year encourages hope and reflection, both of which are useful in evaluating existing cannabis policies at the federal level and what may be expected in the coming months.
Significantly, while the industry suffered a loss in the unsuccessful efforts to include the Secure and Fair Enforcement (SAFE) Banking Act in the National Defense Authorization Act, Congress did pass the first standalone piece of cannabis reform legislation, the Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454), which President Biden signed into law on Dec. 2, 2022.
However, the legislation has met with mixed reviews among industry professionals, and whether it ultimately benefits medical cannabis research endeavors or serves as an impediment to them remains to be seen.
How Will H.R. 8454 Change Cannabis Research?
The bipartisan Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454) eases federal restrictions on scientific research by streamlining the application process for approval of cannabis-related studies and simplifies requests for large quantities of cannabis for such studies.
Currently, the United States Drug Enforcement Administration (DEA) reviews and licenses marijuana cultivators and grants Schedule I licenses to scientists seeking to study cannabis in clinical environments.
The act changes this process by mandating that the United States Attorney General solicit cannabis cultivation applications for research or potential drug development purposes, and imposes a 60-day deadline for approval of research applications.
Theoretically, these changes will eliminate the DEA’s current lag times for approval of research protocols advanced by scientists working with cannabis, which have been known to drag on for years.
Additionally, the act encourages the Food and Drug Administration to support cannabis-derived medications and requires federal agencies to provide a report concerning the “potential therapeutic effects of cannabidiol or marijuana on serious medical conditions.”
The act also directs the Department of Health and Human Services to work with the National Institutes of Health to analyze the therapeutic effects of cannabis for epilepsy and other conditions.
Further, it will study how cannabis affects adolescent brain development, how it may impact the ability to operate motor vehicles, and determine how to overcome barriers that currently exist which inhibit cannabis research.
Who Grows the Research Crops?
One notable barrier to scientific research concerning the therapeutic benefits of cannabis that has existed for many years arises from current restrictions on the set of federally licensed cannabis cultivators.
At present, this pool is limited to the University of Mississippi, which was granted a federal cannabis cultivation license in 1968.
Unfortunately, the university has historically produced low-quality cannabis for research purposes, and the product’s inferiority arguably has caused significant distortion in the results yielded from research projects utilizing such cannabis.
While the DEA expressed its intention to expand the pool of growers beyond the University of Mississippi in 2016, expansion progress has moved at a glacial pace.
Five years passed before the DEA announced in May 2021 that it had approved several third-party cultivation applicants to grow cannabis for use in federally approved clinical trials. To date, no notable advances have been reported in that regard.
Cannabis Science Relies on Quality Samples
It is undisputed that the quality of cannabis available for scientific research is of paramount importance.
The language that would allow researchers to conduct studies on cannabis currently sold in state-legal markets, thereby aligning the quality of cannabis utilized in human clinical trials with the cannabis currently consumed by patients and adult consumers in state-legal markets, was removed before the act’s passage by the Senate.
Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws, criticized this omission, opining that “[w]hile the Expansion Act is a step in the right direction, the limited variety of cannabis cultivars accessible to federally licensed researchers does not represent the type or quality of cannabis products currently available in legal, statewide markets … The fact that nearly one-half of U.S. adults have legal access to these multitudes of cannabis products, but our nation’s top scientists do not, is the height of absurdity and highlights the need for continued legislative action if we want to more easily study the state-legal products that millions of Americans are actually using.”
A Counterproductive Nightmare?
Armentano’s astute observation highlights the disconnect that exists between current federal cannabis policies and the cannabis policies adopted by states with medical and adult use legal markets.
Oregon Democratic Representative Earl Blumenauer, co-sponsor of the legislation in the House with Maryland Republican Representative Andy Harris, commented in a statement that “[a]s we have seen in state after state, the public is tired of waiting for the federal government to catch up. More than 155 million Americans — nearly half of our nation’s population — now reside in states where adult use of cannabis is legal.”
Indeed, Blumenauer, founder and co-chair of the Congressional Cannabis Caucus, has worked on cannabis reform for decades.
He further observed in his statement addressing the act’s passage, “finally the dam is starting to break. The passage of my Medical Marijuana and Cannabidiol Research Expansion Act in the House and Senate represents a[n] historic breakthrough in addressing the federal government’s failed and misguided prohibition of cannabis.”
Nonetheless, the legislation is not without its critics, and perhaps for good reasons. Vicente Sederberg attorney Shane Pennington has dubbed it “a counterproductive nightmare,” observing that the Act imposes DEA registration requirements concerning CBD, whereas current law does not require any special DEA registration for CBD research.
In an article titled Turning Water Into Weed And Other Absurdities, Pennington concludes that “[b]y imposing registration requirements on these otherwise-non-controlled substances, this bill dramatically increases barriers to cannabis research.” (Emphasis original).
Shifting Cannabis Policy
Pennington observes that, via the attorney general, the DEA will have “unbridled authority to avoid licensing any marijuana manufacturers at all simply by refusing to place a notice in the federal register seeking more applications.” Currently, the Drug Enforcement Administration does not have such power over any application.
Pennington also points out that the legislation provides the DEA with the ability to avoid deadline triggers simply by refusing to accept an application as “complete,” in contrast to current DEA regulations under which the electronic filing system deems all applications received to be automatically complete or sends an error message advising of missing information necessary for resubmission.
Private research concerning the therapeutic benefits of cannabis is coming into its own. Recently, the Wana Brands Foundation, led by founder and chief executive officer Nancy Whiteman, awarded a $3 million grant to Johns Hopkins University to help further medical cannabis research.
It will be interesting to follow the quality of cannabis available and actually utilized for such research, in light of the Medical Marijuana and Cannabidiol Research Expansion Act.
One can only hope that Congress will continue on a trajectory that promotes and encourages significant shifts in federal cannabis policies in this new year. Only time will tell.
This article first appeared in Volume 4 Issue 4 of Cannabis & Tech Today. Read the full issue here.
