The Drug Enforcement Administration (DEA) is again retreating on a proposed ban on psychedelic compounds that scientists say have research value.
In April, the agency published a notice of its intent to place the hallucinogens DOI and DOC in Schedule I of the Controlled Substances Act (CSA), which would strictly criminalize the compounds and create significant research barriers for investigators interested in studying their therapeutic potential.
But after the company Panacea Plant Sciences and researchers from Emory University challenged the scheduling action, DEA has now decided not to defend the planned prohibition. Instead, it announced on Friday that it is withdrawing the proposal altogether.
The notice, which is set to be formally published in the Federal Register on Monday, doesn’t give a specific reason for rescinding the ban of the two phenethylamine hallucinogens. But this marks another win for scientific community, coming just one month after DEA abandoned separate plans to place five tryptamine psychedelics in Schedule I.
“DEA is withdrawing the proposed rule, terminating all proceedings related thereto, and will be publishing a new proposed rule using an amended procedure,” the new notice on 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) says.
The agency’s justification for the original ban lacked evidence that directly connected DOI and DOC to serious adverse health events or demonstrated a high abuse potential, as Psychedelic Spotlight reported earlier this week.
“To date, there are no reports of distressing responses or death associated with DOI in medical literature,” the agency said in the initial proposal. “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.
Panacea Plant Sciences had scored a procedural victory after filing a motion challenging DEA’s proposal, with the agency being required to respond to the motion by August 29. There was a possibility that, as with the prior case involving five different psychedelics, it would have ultimately needed to hold an administrative hearing to defend its decision.
For the time being, at least, that’s no longer necessary, though DEA did signal that it is looking into potentially filing an amended administrative scheduling process for the two substances.
“This is a victory and I’m just incredibly happy because now it’s one less thing that we have to worry about going forward,” Panacea Plant Sciences CEO David Heldreth told Marijuana Moment in a phone interview on Friday. “DOI and DOC are incredible tools for research, as well as mental and physical health.”
Heldreth was also involved in the challenge to DEA’s proposed ban on five other psychedelics—4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT—that the agency ultimately withdrew last month.
DEA faced significant criticism over the proposal, receiving nearly 600 messages during a public comment period, with most opposing the rule change and requesting a hearing. The agency’s own administrative court subsequently agreed that there was a need to hold a hearing on the matter before the prohibition could be enacted—but DEA pulled the proposal instead.
Matt Zorn, an attorney with an extensive background litigating against DEA, told Marijuana Moment that the takeaway from both of these cases is that “public outrage is great, but you have to direct it in the right way, or you’re not going to get the results.”
“The public’s being listened to—but because it is putting pressure on the right levers of power in the right way,” he said.
Separately, DEA is being sued—again—over its refusal to allow a doctor to treat terminally ill patients with psilocybin therapy pursuant to federal and state “Right to Try” (RTT) laws, which are aimed at expanding access to Schedule I investigational drugs that aren’t currently approved for general use.
The agency is also facing increased political pressure from bipartisan lawmakers, who are taking an extra step to provide additional congressional clarification, filing companion bills in the House and Senate last month to reaffirm that the scope of Right to Try policy should include psychedelics.
The bill filing came about six months after bipartisan members of Congress sent a letter, led by Rep. Earl Blumenauer (D-OR), requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.
Meanwhile, in May, Sens. Cory Booker (D-NJ) and Brian Schatz (D-HI) separately pushed top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
Federal health officials recently recognized that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops.
Activists—including one of the plaintiffs in the RTT case, Erinn Baldeschwiler—staged a demonstration outside of DEA headquarters in Virginia in May, demanding that the agency allow terminally ill patients to access psilocybin therapy.
DEA is separately being sued over repeated delays in processing requests for public records related to psychedelics and marijuana.
The agency has separately increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.
Photo courtesy of Wikimedia.