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:
Image courtesy of Students for Sensible Drug Policy.
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