Newly released documents reveal that the Food and Drug Administration (FDA) has determined that cannabis has a legitimate medical use and should be reclassified from Schedule I to Schedule III controlled substance.
The FDA’s recommendation was included in a 252-page report sent to the Drug Enforcement Administration (DEA) in August 2023. The report, reported by Bloomberg News in late August and potentially leaked to the news agency, was obtained by Houston lawyer Matthew Zorn, who filed a lawsuit in September to pressure the FDA to make its recommendation public. Zorn stated that the FDA responded just days before the court-ordered deadline.
Zorn, representing no clients, insisted, „This document belongs in the public domain.“ He found it absurd that public policy was being debated on a document recommendation that no one had literally seen.
The Bloomberg report sparked a debate, but no advocate, lawyer, or news organization was able to obtain an unredacted version of the FDA’s recommendation. Now that the complete report has been published, the DEA may be under greater pressure to act, although there is no obligation to do so, and no set timetable for action. However, lawyers anticipate a rulemaking proposal to shift cannabis from Schedule I to Schedule III soon.
„I expect it to come pretty soon, and the reason I expect it is because the President has directed the agencies to do so expeditiously,“ said Shane Pennington, a lawyer at Porter Wright who worked with Zorn on cases challenging DEA’s scheduling process, but was not involved in this lawsuit.
In October 2022, President Joe Biden stated that he was directing the Department of Health and Human Services and the Attorney General to „expeditiously review how marijuana is regulated under federal law.“
Howard Sklamberg, a lawyer at Arnold & Porter in Washington, D.C., said that the Biden directive „certainly spurred the agencies to reconsider rescheduling cannabis,“ but that it was likely to happen regardless, given the wealth of supporting information available since the last DEA rejection in 2016.
Sklamberg told Medscape that he expected a proposed rulemaking to be issued soon, with final regulations due by mid-summer. „Agencies generally want to get their important rulemakings done before they get too much into the political season and the potential end of a presidency,“ said Sklamberg, a former FDA deputy commissioner.
Substantial Medical Benefits
The FDA stated in its report that cannabis poses minimal risk to public health and has a lower abuse potential than Schedule I or II drugs such as heroin or cocaine.
While evidence showed that some individuals consume cannabis „at levels that are sufficient to present a risk to their health and the safety of others,“ there is also evidence in the community that „the vast majority of individuals who use marijuana do so in a manner that does not lead to harmful effects for themselves or others,“ the FDA noted.
The agency stated that „the risks to public health presented by marijuana are low compared to other drugs (e.g., heroin, cocaine, benzodiazepines),“ based on an evaluation of various epidemiological databases [emergency department] visits, hospitalizations, unintentional exposures, and, most importantly, overdose deaths.
The FDA assessed the widely accepted medical use of cannabis in seven indications: anorexia, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting, pain, and post-traumatic stress disorder, finding the strongest evidence for anorexia-related conditions, nausea and vomiting, and pain.
Interestingly, the agency said it also considered alcohol as a comparative substance in its risk-benefit assessment, even though it is not a controlled substance, due to widespread availability and consumption, „which is also observed in the non-medical use of marijuana.“
Sklamberg found this intriguing, stating that the majority of adults have consumed cannabis or know someone who has, making it comparable to alcohol. And just like alcohol, „these adults have reached their own conclusions about what marijuana is and is not,“ he said. „Many Americans feel that the health risks of Schedule I are overstated,“ he added.
It is uncertain whether cannabis will be rescheduled; after the Bloomberg report in August, Republican members of Congress sent a letter to DEA Administrator Anne Milgram, expressing that the agency should not reschedule the drug.
„The recommendation to remove cannabis from the DEA’s Schedule I dangerous drug list is not based on scientific findings – it is based on a reckless pro-pot agenda,” said Oklahoma Senator James Lankford (R) in September.
The letter claimed that there is no recognized medical use of cannabis and that „known facts about marijuana have not changed since 2016.“
However, the FDA partially based its recommendations on reviewing data from over 30,000 healthcare providers and six million patients who have used medical marijuana as part of state programs, largely introduced since 2016. Congress has instructed the agency to evaluate more of this kind of real-world evidence in reviewing products, Sklamberg said.
He stated that the FDA report is being taken seriously: „It’s a thorough and impressive document.“
„It’s not a document that looks like it was put together just by politicians or policymakers,“ added Sklamberg.
Alicia Ault is a freelance journalist based in St. Petersburg, Florida, whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.