A recent report from federal health regulators confirms what cannabis reform advocates have long said, that placing marijuana in the most restrictive tier under the federal Controlled Substances Act has hindered researchers' ability to study the drug's potential benefits and risks.
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The U.S. Department of Health and Human Services was required to issue its report on the health effects of marijuana and its compounds, as well as administrative obstacles to researching it, following the enactment of the Medical Marijuana and Cannabidiol Research Expansion Act, which President Joe Biden signed into law in Dec. 2022.
"Although research advances on the effects of cannabis have been made, regulatory barriers that emanate from the Schedule I control status of cannabis at the federal level can hinder progress," according to the report, which was transmitted to committees of jurisdiction in June and made public Friday.
Cannabis has been in Schedule I, the tier for drugs with no accepted medical use and a high likelihood of abuse, for more than five decades, requiring any researcher who wants to conduct studies on it to secure authorizations with a slew of federal regulatory agencies.
"Even experienced researchers have reported that requirements for obtaining a new Schedule I registration, adding new substances to an existing registration, and getting approval for research protocol changes are time-consuming," the report said. "Unlike for Schedule II through V substances, new and amended Schedule I applications go through additional and often duplicative reviews to those already conducted by" federal regulators.
The report observes that researchers are barred from legally obtaining or studying cannabis products sold in state-regulated cannabis markets, since these lack the requisite authorizations under federal law for manufacturing and handling Schedule I substances.
"As such, researchers must rely on study participants' self-reported use and/or photos of dispensary products, with testing and labeling requirements that are not consistent across jurisdictions," the report said. "Due to this variability — and because researchers cannot test these products — it is challenging to determine exactly what is in the products consumers are using and what characteristics of them are responsible for any reported therapeutic or adverse effects."
The report also encapsulates existing research into marijuana's effect on the body and brain, and includes a summary of adverse outcomes associated with its use, such as acute intoxication and impaired motor coordination and cognitive ability, and that long-term users are at increased risk for mental illness and substance use disorders.
"Analyses of comprehensive data from integrated healthcare systems in other countries demonstrate a connection between cannabis use and increased population-level rates of psychotic and other disorders," the report said.
The report also found that "cannabis products on the market today are vastly different that those of the past," with higher concentrations of delta-9 THC, the primary psychoactive compound in marijuana, and that cannabis can be manufactured and consumed via a wide array of wares, including vapes, edibles and tinctures.
The HHS found that adolescents and young people who use cannabis are more likely to develop mental health disorders and substance use disorders, though the more negative outcomes may be linked to consuming higher doses.
"Although causal relationships have not been established, it is possible that cannabis use may pose greater risks to the developing adolescent and young adult brain than to the fully-developed adult brain," the report said.
The report also notes that there are only four medications approved by the U.S. Food and Drug Administration, whose active ingredients are either plant-derived or synthetic cannabinoids, and that the 38 states that have legalized botanical cannabis for broad swath of medical uses did so outside the established drug-development process.
"U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses," the report said.
At the time of its passage, the MMCRE Act was championed by both proponents and opponents of legalization. The anti-legalization advocacy organization Smart Approaches to Marijuana, or SAM, publicly claimed credit for helping to draft the legislation and touted it as a sensible step toward improving cannabis research without changing marijuana's status as a federally controlled substance.
In a statement, SAM president and CEO Kevin Sabet said, "This report concludes what our organization, leading scientists, and medical professionals have been saying for years: today's marijuana is highly potent and highly dangerous across a variety of outcomes like psychosis, suicidality, and cognitive deficits."
Sabet continued, "Although FDA-approved marijuana-derived medications can be effective, more research is needed to uncover the drug's full effects. It's also unquestionably clear that the industry-driven narrative that raw marijuana products like joints and blunts are 'medicine' remains a falsity meant only to hook a new generation of users and fuel corporate profits."
The HHS recently recommended moving cannabis to Schedule III, finding that the drug has a "currently accepted medical use" in the U.S. owing in large part to data culled from state-regulated medical marijuana programs, and that marijuana's risk profile was lower than that of other Schedule I and II drugs. The U.S. Department of Justice concurred with the HHS' findings and issued a notice of proposed rulemaking to reschedule marijuana, which is currently pending.
"This report validates what we have known for years: reclassifying cannabis is paramount to effectively researching it," said Rep. Earl Blumenauer, D-Ore., a leading proponent of cannabis reform on Capitol Hill, who earlier this year pressed federal agencies to issue their findings as mandated by the MMCRE Act.
"I welcome these long overdue but anticipated findings as a signal that the federal government may soon be a constructive partner in the path forward," Blumenauer's statement continued. "The Biden-Harris Administration must now move quickly to complete the scheduling review and Congress redouble its efforts to allow for the research of dispensary grade cannabis. We are inching closer each day toward the inevitable legalization of cannabis."
--Editing by Emily Kokoll.
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