DEA Judge Sides With Agency On Proposal To Ban Two Psychedelics Despite Challenge From Scientific Researchers

A Drug Enforcement Administration judge has formally sided with the agency
in its attempt to ban two psychedelic compounds that researchers say hold
significant therapeutic potential, recommending that they be placed in
Schedule I of the Controlled Substances Act (CSA).

In a ruling on Friday, DEA Administrative Law Judge (ALJ) Paul Soeffing
said he advised the agency to move forward with its plan to place the
psychedelics—2,5-dimethoxy-4-iodoamphetamine (DOI) and
2,5-dimethoxy-4-chloroamphetamine (DOC)—in Schedule I.

This follows administrative hearings where researchers and advocates,
including Panacea Plant Sciences (PPS) and Students for Sensible Drug
Policy (SSDP), have fought against DEA to ensure that the psychedelics can
continue to be utilized in research.

But in the 118-page ruling, Soeffing ultimately said that “the record
contains substantial evidence regarding the eight factors required for
consideration under 21 U.S.C. § 811(c) to support recommending the
scheduling of DOI and DOC,” referring to an administrative standard for
determining the health risks and benefits of substances before when placing
them in the CSA.

“Furthermore, I find that the record contains substantial evidence
regarding the three factors required for consideration under 21 U.S.C. §
812(b)(1) to support recommending the placement of DOI and DOC in Schedule
I,” he said, adding that the fact that the United Nations put DOC
specifically on its own controlled substances list justifies its
prohibition.

The bulk of the recommendation, which must be approved by the DEA
administrator before potentially being codified, recounts the competing
arguments between DEA and organizations opposing the scheduling action. But
this ruling could reignite an ongoing legal challenge that PPS levied
against the agency, challenging the fundamental constitutionality of the
ALJ proceedings in drug scheduling rulemaking.

“It’s not a surprise that a DEA employee would side with the DEA,” PPS CEO
David Heldreth told Marijuana Moment on Friday. “We find that the supposed
impartiality of the judge is highly questionable due to that, and we plan
to appeal this ruling and continue our lawsuit against the DEA.”

SSDP was among stakeholders who requested the psychedelics hearing in the
first place, in hopes of challenging what they view as a lack of evidence
justifying DEA’s proposed ban. Researchers have pointed out that DOI and
DOC, as currently unscheduled substances, have been key components in
psychedelics research that show potential in the treatment of anxiety and
depression, for example.

Researchers have also argued that DEA has failed to meet the statutory
burden of demonstrating that either psychedelic compound has high abuse
potential. There are no documented cases in medical literature of
“distressing responses or death” related to human consumption of DOI, nor
has there been any established evidence of a high risk of dependence, SSDP
said in a pre-hearing filing in July.

The initial scheduling of the administrative hearing on DOI and DOC came
about two months after a federal court dismissed the case challenging the
constitutionality of DEA’s process for adjudicating scheduling actions as
the agency has pursued the ban the two psychedelic compounds.

DEA first attempted to ban DOI and DOC in 2022, only to withdraw the
proposal amid pushback from the scientific community. The agency separately withdrew
from a proposal to ban five different tryptamine psychedelics in 2022.

In 2023, DEA announced that it would be trying to enact the DOC and DOI ban
again. The agency’s notice about the scheduling proposal still lacks
evidence that directly connects the compounds to serious adverse health
events or demonstrated a high abuse potential.

“To date, there are no reports of distressing responses or death associated
with DOI in medical literature,” it said. “The physiological dependence
liability of DOI and DOC in animals and humans is not reported in
scientific and medical literature.”

DEA said that anecdotal reports posted by people online signaled that the
substances have hallucinogenic effects, making it “reasonable to assume
that DOI and DOC have substantial capability to be a hazard to the health
of the user and to the safety of the community.”

It did point to one report of a death of a person who had used DOC in
combination with two other unspecified drugs—as well as two reports of
hospitalizations that it said were attributable to the use of DOC with
other drugs—but scientists say that hardly constitutes reason enough to
place them in the most strictly controlled schedule.

Kat Murti, executive director of SSDP, said in a press release on Monday
that the timing of the DEA ALJ’s new recommendations, which coincided with
World Psychedelics Day, is “no coincidence.”

“The DEA has relied on similar shady tricks throughout this process—such as
announcing their intent to schedule these substances during the winter
holidays in 2023 after withdrawing their 2022 attempt, which SSDP also
opposed,” she said. “Their strategy throughout has been to try to sneak
this ruling by unnoticed because they know the American public and anyone
who cares about public health is on our side.”

“DOI and DOC are crucial tools for understanding how serotonin works in the
body,” Murti said. “By adding them to Schedule I, the DEA is forcing
medical science into the dark ages.”

Alaina Jaster, who has a PhD in pharmacology and Toxicology and serves as
co-chair of SSDP’s Science Policy Committee, said the DEA judge’s decision
is “disappointing and the almost 120-page record seems to reflect a very
different reality than the one I experienced on the stand” when testifying
in the case.

“Despite the stipulations of fact that themselves state there is no
documented use of DOI, no deaths or overdose, no diversion, and it’s
impossible to know whether anecdotal reports which the DEA rely upon
actually contain DOI, the administrative judge has recommended placing
DOI/DOC in schedule I,” she said. “As someone who has extensively studied
the pharmacodynamics and pharmacokinetics of DOI and related psychedelics,
it’s baffling to me that the government is going after DOI/DOC.”

In the background of this latest development, proceedings on a proposed
rule to move marijuana from Schedule I to Schedule III have stalled amid
challenges from witnesses in the administrative hearings. Those hearings
are being overseen by a different DEA ALJ, John Mulrooney.

Amid the stalled marijuana rescheduling process that’s carried over from
the last presidential administration, congressional researchers are
reiterating that lawmakers could enact the reform themselves with “greater
speed and flexibility” if they so choose, while potentially avoiding
judicial challenges.

Meanwhile, last month a Senate committee advanced the confirmation of
Terrance Cole to become the administrator of DEA amid the ongoing review of
a marijuana rescheduling proposal that he’s refused to commit to enacting.

Cole—who has previously voiced concerns about the dangers of marijuana and
linked its use to higher suicide risk among youth—said he would “give the
matter careful consideration after consulting with appropriate personnel
within the Drug Enforcement Administration, familiarizing myself with the
current status of the regulatory process, and reviewing all relevant
information.”

However, during an in-person hearing before the Judiciary Committee in
April, he said examining the rescheduling proposal will be “one of my first
priorities” if he was confirmed for the role, saying it’s “time to move
forward” on the stalled process—but again without clarifying what end
result he would like to see.

“I’m not familiar exactly where we are, but I know the process has been
delayed numerous times—and it’s time to move forward,” he said at the time.
“I need to understand more where [agencies] are and look at the science
behind it and listen to the experts and really understand where they are in
the process.”

Cole also said he feels it’s appropriate to form a “working group” to look
at the federal-state marijuana law disconnect in order to “stay ahead of
it.”

*Read the DEA ALJ’s ruling and recommendation on the psychedelics ban
below: *

‘Justice Is Still Being Denied’ To People With Past Marijuana Convictions
As Legalization Spreads, Review By Advocacy Group Says

*Image courtesy of Students for Sensible Drug Policy.*

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Despite Challenge From Scientific Researchers appeared first on Marijuana
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