Charles Feldmann, Esq.
After much speculation in the midst of historic momentum to legalize marijuana,
Drug Enforcement Agency (DEA) Acting Administrator Chuck Rosenberg recently
replied to petitions to remove marijuana from its Schedule I status. On
August 11, 2016, Rosenberg announced via correspondence to petitioners
that – at least for now – marijuana will remain classified
as a Schedule I substance under the federal Controlled Substances Act
(CSA). However, the correspondence also publically ushered in a new era
of a research-oriented approach, and painted the DEA as working with the
NIDA, FDA, and HHS to support and promote legitimate research of marijuana
and its constituent parts.
First, Rosenberg explained how the DEA’s legal obligations under
the CSA are based on the FDA’s drug approval process, and how the
various federal agencies work together to form scientifically based decisions.
The DEA is legally bound to follow the decisions made by these agencies
regarding the scheduling of a substance under the CSA. Rosenberg states
the conclusions are based on “a full review of the relevant scientific
and medical literature regarding marijuana.” Rosenberg noted that
the criteria for each Schedule is set by statute.
Acknowledging that marijuana “is less dangerous than some substances
in other schedules,” Rosenberg emphasized that the scheduling hierarchy
shouldn’t be thought of in terms of “relative danger.”
Instead, the Schedule upon which a substance is placed is based on specific
statutory criteria. Rosenberg stated, “[a] substance is placed in
Schedule I if it has no current medical use in treatment in the United
States …” and is not supported by safe use under medical
supervision. Despite recent discoveries about the sometimes miraculous
properties of marijuana, these discoveries are currently considered anecdotal,
because they are not supported by hard science, nor administered by Medical
Doctors. Rosenberg appeared to indicate through this announcement that
scientific research will now be broadened and encouraged to legitimize
the clinical benefits found from the marijuana plant.
Rosenberg touted a number of ways the DEA and NIDA have made efforts to
foster marijuana research at the federal level:
- Citing a doubling of the number of research registrations since 2014, Rosenberg
declared the DEA would propose rules to be published in the Federal Register
to approve additional marijuana growers to increase the supply for research.
Currently, only the University of Mississippi is permitted to grow marijuana
for research. Rosenberg indicated both private growers and research institutions
- Rosenberg also noted that no application from a researcher to study lawfully
produced marijuana has been denied, if the HHS deemed the study to be
- As further example of the DEA’s softening to research, Rosenberg
referenced its December 2015 decision to waive certain regulatory requirements
for cannabidiol (CBD) clinical-trials on human subjects, and noted that
no request for a waiver under this program has been denied.
- Finally, the DEA announced that it is creating an online application process
to expedite research registration, and is developing guidance materials
to assist researchers in the online application process.
Rosenberg concluded, “[i]f the scientific understanding about marijuana
changes – and it could change – then the decision could change.
But we will remain tethered to science, as we must, and as the statute
demands.” Rosenberg also promised the DEA “will continue to
seek ways to make the process for those researchers more effective.”
All things considered, the decision appears to be a net positive, setting
the stage to develop the research which will eventually support lifting
the federal ban on marijuana.