The Drug Enforcement Administration has formally sided in favor of its efforts to ban the two psychedelic substances that have been found by researchers to hold therapeutic potential. They recommend that these compounds be added as Schedule I in the Controlled Substances Act.
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.
Researchers and advocates including Panacea Plant Sciences, Students for Sensible Drug Policy and Students for Sensible Drug Policy have fought DEA in administrative hearings to make sure that psychedelics are still used for research.
The 118 page ruling by Soeffing stated that, “The record contains substantial proof regarding the eight criteria required to be taken into consideration pursuant to 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.
Further, I found that there was substantial evidence in the records regarding the three criteria required to be considered 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.
In the bulk of this recommendation, which is subject to approval by the DEA administrator prior to being codified, the DEA and the organizations that oppose the schedule action are outlined in the arguments they have made. The ruling might reignite the ongoing lawsuit that PPS filed against the DEA, which challenged the ALJ process in the rule-making drug schedule.
David Heldreth, CEO of PPS told MEDCAN24 that it was not surprising for a DEA worker to side with the DEA. We find the claimed impartiality of this judge highly suspect due to that. And we intend to appeal the ruling and continue the lawsuit against the DEA.
SSDP, along with other stakeholders, requested that the DEA hold a psychedelics public hearing to contest what it viewed as a dearth of scientific evidence in support of the proposed ban. Researchers point out that DOI & DOC are currently not scheduled substances but have played a key role in psychedelics studies that have shown promise in treating depression and anxiety, among other things.
Researchers also argued that DEA failed to demonstrate that either psychedelic compounds have a high potential for abuse. SSDP stated in its pre-hearing submission in July that there are no medically documented instances of DOI causing “distressing reactions or death”. Nor is it clear whether the drug poses a significant risk for dependence.
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.
DEA said that in 2023 it would try again to enact DOC and DOI prohibitions. It is still not clear from the notice that the proposal to schedule the substances has been made by the agency whether the compounds are directly linked with serious adverse events in health or have a significant abuse potential.
The report stated that there have not been any reports in the medical literature of DOI-related distressing or fatal reactions. The scientific literature does not report on the physiological dependency liability of DOI or DOC for animals and humans.
DEA stated that online reports indicated that these substances had hallucinogenic properties, which made it “reasonable” to believe that DOI or DOC could be a hazard for the user’s health and safety.
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 said, in a release issued on Monday, that it was “no accident” that World Psychedelics Day coincided exactly with the DEA ALJs’ new recommendations.
“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 was to keep this announcement under wraps because they knew that Americans and those who are concerned with public health were on our team.
Murti explained that DOI and DOC were crucial for understanding the serotonin system in the body. The DEA has pushed medical science to the dark ages by adding the drugs to Schedule I.
Alaina Jarster has a PhD. in pharmacology and toxicology. She is also co-chair of SSDP Science Policy Committee. The DEA Judge’s Decision was “disappointing, and it seems that the record, which is almost 120 pages long, reflects a reality very different from what I saw on the witness stand.”
She said that despite the fact the stipulations state “there is no documented DOI use, there are no deaths, overdoses, or diversions, it’s difficult to determine whether the anecdotal accounts which the DEA rely on actually contain DOI,” the Administrative Judge recommended scheduling DOI/DOC. As someone who is well versed in the pharmacodynamics, pharmacokinetics, and other psychedelics that DOI belongs to, I find it baffling that the government has targeted DOI/DOC.
The latest developments are a result of stalled proceedings in administrative hearings on the proposed rule that would move marijuana to Schedule III from Schedule I. John Mulrooney, a DEA ALJ who is not involved in the hearings at hand, oversees them.
In the face of the still-stalled rescheduling marijuana process, which is a legacy from the previous presidential administration, researchers at Congress have reiterated that legislators could implement the reform with “greater flexibility and speed” themselves if they chose, potentially avoiding legal challenges.
During the month of November, a Senate panel advanced Terrance Col’s nomination to the position of DEA administrator. The confirmation was made despite his refusal to commit to implementing a proposed marijuana rescheduling.
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 know more about where [agencies] Listen to experts, and understand the steps they’re taking.”
Cole said that he believes it is appropriate to create a working group to examine the disconnect between federal and state marijuana laws in order to stay “ahead of it”.
You can find the ALJ’s decision and recommendation regarding the psychedelics prohibition below.
‘Justice Is Still Being Denied’ To People With Past Marijuana Convictions As Legalization Spreads, Review By Advocacy Group Says
Students for Sensible Drug Policy.