The U.S. government has released hundreds of pages of documents related to its ongoing review of marijuana’s status under federal law, officially confirming for the first time that health officials have recommended the Drug Enforcement Administration (DEA) place cannabis in Schedule III of the Controlled Substances Act (CSA).
The 252 pages of documents from the Department of Health and Human Services (HHS) explain that cannabis “has a currently accepted medical use in treatment in the United States” and has a “potential for abuse less than the drugs or other substances in Schedules I and II.”
Federal health officials said their review found that more than 30,000 healthcare professionals “across 43 U.S. jurisdictions are authorized to recommend the medical use of marijuana for more than six million registered patients for at least 15 medical conditions.”
“There exists widespread, current experience with medical use of the substance by [health care practitioners] operating in accordance with implemented jurisdiction-authorized programs, where medical use is recognized by entities that regulate the practice of medicine,” HHS said.
Attorney Matt Zorn, to whom the documents were released, sued the government following a Freedom of Information Act (FOIA) request to obtain the rescheduling memo.
Confirming the Schedule III recommendation, Zorn published the documents—including a letter to DEA Administrator Anne Milgram in which the Office of the Assistant Secretary for Health writes that “marijuana meets the findings for control in Schedule III”—through his On Drugs blog on Friday.
Much of the documents discuss the government’s eight-factor analysis for scheduling drugs, emphasizing the importance of marijuana’s abuse potential compared to other drugs, whether it has a currently accepted medical use (CAMU) and its relative safety and risk of physical dependence.
Regarding accepted medical use, the review looked both at current acceptance and whether available scientific literature supports those uses. On the first point, HHS acknowledged that most U.S. states have legalized marijuana for medical use, noting that some medical cannabis programs “have been in place for several years, and include features that actively monitor medical use and product quality characteristics of marijuana dispensed.”
Regarding efficacy, the memo says the “review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source.”
“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” it says.
Specifically, the agency found, “most authors concluded there is some benefit with marijuana in the treatment of pain conditions, generally ranging from low to moderate effect based on low to moderate quality of evidence.”
The review conducted by the Food and Drug Administration (FDA), however, “did not find support for marijuana providing benefit” for epilepsy or anxiety. And the memo says the agency found that the risk of adverse events associated with treating PTSD with marijuana “may be more substantial than any limited benefit in observational studies.”
“Overall, there is a lack of quality clinical data to support the use of marijuana for PTSD,” the agency said.
The review also found “some evidence of benefit in Crohn’s disease when treated with marijuana,” though positive effects appeared “mostly limited to subjective symptoms and not disease activity.”
“On balance,” the agency continued, “the available data indicate that there is some credible scientific support to substantiate the use of marijuana in the treatment of: pain; anorexia related to certain medical conditions; and nausea and vomiting (e.g. chemotherapy-induced), with varying degrees of support and consistency of findings.”
“Taken together, the data support that a substantial number of [health care practitioners] have gained clinical experience with at least one specific medical use of marijuana under state-authorized programs.”
Despite being less of an endorsement of marijuana’s medical benefits than some advocates might have hoped for, federal health officials said in the recommendation that “none of the evidence from the systematic reviews included in our…analysis identified any safety concerns that would preclude the use of marijuana in the indications for which there exists some credible scientific support for its therapeutic benefit.”
In terms of relative safety compared to other substances, the federal health review concluded that “the risks to the public health posed by marijuana are low compared to other drugs of abuse (e.g., heroin, cocaine, benzodiazepines), based on an evaluation of various epidemiological databases for [emergency department] visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths.”
“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” it said.
The National Institute on Drug Abuse (NIDA) is on board with the agency’s analysis, the documents say.
In comments about the newly released information, Rep. Earl Blumenauer (D-OR), founder of the Congressional Cannabis Caucus, said the news continues the progress made toward ending prohibition.
“Even though this has long been anticipated, it is still a very welcome development,” the congressman said. “It is another step toward the inevitable legalization of cannabis and ending this sad chapter of the failed war on drugs.”
The documents’ release represents a measure of public transparency so far not seen in the government’s rescheduling review. Prior to Friday, all that had been made public were a highly redacted version of the memo released to Zorn last month and a single page of the recommendation revealed in October, also heavily redacted.
News first broke of the health agency’s rescheduling advice in August. While it was widely believed HHS had recommended a Schedule III classification—alongside substances like ketamine and Tylenol with codeine—the documents released to Zorn on Friday are the first to formally confirm that detail.
If DEA ultimately accepts the HHS recommendation to move marijuana to Schedule III, that would not broadly legalize it under federal law. However, it would have a meaningful impact in other ways, for example by removing widely criticized research barriers and allowing state-licensed cannabis businesses to take federal tax deductions they’re currently barred from under an Internal Revenue Service (IRS) code known as 280E.
However, the final rescheduling decision ultimately rests with DEA, as the agency reminded Congress in a letter earlier this month.
“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 said. “DEA is now conducting its review.”
The agency’s statement came in response to an earlier letter from 31 bipartisan lawmakers, led by Rep. Earl Blumenauer (D-OR), that implored DEA to consider the “merits” of legalization as it carried out its review. That initial letter also criticized the limitations of simply placing cannabis in Schedule III, as opposed to fully removing the plant from CSA control.
The timing of any rescheduling announcement remains unclear and has become the subject of much speculation among cannabis advocates and observers. The Congressional Research Service (CRS), for its part, said in September that it was “likely” DEA would follow the HHS recommendation, at least based on past precedent.
Late last year, the governors of six U.S. states—Colorado, Illinois, New York, New Jersey, Maryland and Louisiana—sent a letter to President Joe Biden (D) urging the administration to reschedule marijuana by the end of this year.
“Rescheduling cannabis aligns with a safe, regulated product that Americans can trust,” says the governors’ letter, which points to a poll that found 88 percent of Americans support legalization for medical or recreational use. “As governors, we might disagree about whether recreational cannabis legalization or even cannabis use is a net positive, but we agree that the cannabis industry is here to stay, the states have created strong regulations, and supporting the state-regulated marketplace is essential for the safety of the American people.”
One of the first state officials to react to the HHS rescheduling recommendation, Colorado Gov. Jared Polis (D) also told Biden in an earlier letter in September that while he expects DEA will “expeditiously” complete its review and move marijuana to Schedule III, the policy change must be coupled with further administrative and congressional action to promote health, safety and economic growth.
Meanwhile, six former DEA heads and five former White House drug czars have sent a letter to the attorney general and current DEA administrator voicing opposition to the top federal health agency’s recommendation to reschedule marijuana. They also made a questionable claim about the relationship between drug schedules and criminal penalties in a way that could exaggerate the potential impact of the incremental reform.
Signatories include DEA and Office of National Drug Control Policy heads under multiple administrations led by presidents of both major parties.
On Friday, however, the attorneys general in a dozen states took the opposite approach, telling DEA to move forward with rescheduling as a “public safety imperative.”
While some in the cannabis space believe a Schedule III classification would be a boon to state-legal marijuana markets, others have warned that the reform could actually put broader state-level legalization at risk.
Read the full HHS marijuana documents below:
Photo courtesy of Mike Latimer.