The federal Drug Enforcement Administration (DEA) recently accepted a two-part drug analysis process from the nation’s health authority that the agency previously rejected — which created a major hurdle for rescheduling. Now it appears that a path has been cleared for marijuana to be rescheduled.
Last week, the DEA published a notice that it was placing two synthetic benzimidazole-opioid substances—N-pyrrolidino metonitazene and N-pyrrolidino protonitazene—in Schedule I under the Controlled Substances Act. The notice included a footnote that stated the agency was making the decision after accepting a Department of Health and Human Services (HHS) recommendation that was made based on a new two-factor analysis.
“On April 11, 2024, the Department of Justice’s Office of Legal Counsel (OLC) issued an opinion, which, among other things, concluded that HHS’s two-part test would be sufficient to establish that a drug has a currently accepted medical use,” said the DEA in a footnote in the notice.
Although it seems unrelated, this notice may be a turning point in the long wait for the DEA to reschedule marijuana. That’s because the agency has previously said the two-factor analysis was insufficient for determining how cannabis should be scheduled and the notice could be a hint that the DEA is no longer attempting to halt progress.
For years, the Biden administration has been struggling to reschedule marijuana. In October 2022, the president instructed the HHS secretary and the attorney general to begin reviewing the process of rescheduling weed under the Controlled Substances Act.
Currently, the drug is classified under Schedule I, grouping it with drugs such as LSD and heroin. In September 2023, the HHS released its official scheduling recommendation to the DEA, saying cannabis should be moved to Schedule III. Drugs in this classification are recognized as having some health uses and may be utilized in medicines.
Since the recommendation was made, the DEA has been taking its time with its own review of the HHS data. In May, the agency published its proposed rescheduling rules in the Federal Register. Following a period of public comment that elicited more than 43,000 opinions from voters and stakeholders, the Department of Justice (DOJ) has been tasked with combing through the submissions before a final rulemaking happens.
The DEA was reportedly boxed out of the rescheduling discussion by the DOJ. Attorney General Merrick Garland, the head of the DOJ, purportedly went around the DEA and signed the rulemaking proposal himself — a job that usually would have gone to DEA chief Anne Milgram.
The DEA reportedly only found out after the decision had already been made.
“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” wrote Garland in the proposal.
The DEA has repeatedly asserted its authority as the final say-so in scheduling decisions. In a December 2023 letter to Rep. Earl Blumenauer (D-OR), the DEA made sure its authority was clear:
“DEA has the final authority to schedule, reschedule or deschedule a drug under the Controlled Substances Act after considering the relevant statutory and regulatory criteria and HHS’s scientific and medical evaluation,” the letter reads.
The DEA’s biggest criticism of the HHS recommendation was that it chose to forego the usual five-factor test used to determine if a drug has medical use. The five factors of that test are: adequate safety studies, the drug’s chemistry is known and reproducible, there are adequate and controlled studies, the drug is accepted by qualified experts and there is widely available scientific evidence of the drug’s therapeutic qualities.
But the HHS instead used a novel two-factor test that looked at whether doctors and health care professionals are recommending cannabis to patients in the real world and whether there is credible scientific evidence supporting at least one therapeutic effect of the drug.
In March, HHS Secretary Xavier Beccera was asked why the agency employed the new two-factor test instead of the traditional five-factor analysis during a Senate Judiciary Committee hearing. Beccera said the two-factor test was an “updated” version of the analysis rather than a new one. He said the update was made in light of new research into cannabis’ health benefits.
Now that the DEA has accepted the two-factor analysis as legitimate in the case of the two synthetic opioids that were recently scheduled, the agency’s criticism of the test appears to have been discarded.
The DEA’s hearing on the proposed rule for rescheduling is set for December. While the agency has tacitly accepted the HHS’s recommendation, it will still have the final say on the matter. As long as there are no new hurdles introduced (and as long as the results of the presidential election in November have no effect on the rulemaking process), it appears likely that marijuana will be rescheduled in the near future.