Marijuana Prohibition Hinders Ability To ‘Fully Understand’ Its Effects, Top Federal Health Agency Says In New Report

Federal laws prohibiting marijuana “hinder our ability to fully understand” the therapeutic potential of cannabis, the U.S. Department of Health and Human Services (HHS) says in a new report. Scientific researchers, for example, should be able to access and study marijuana from state-legal dispensaries but are not able to under current policies.

In a report submitted to Congress, as required under the Medical Marijuana and Cannabidiol Research Expansion Act that President Joe Biden signed in December 2022, HHS detailed barriers to cannabis research, the health benefits and risks of marijuana use and more.

The 15-page document, which was due this past December but only sent to lawmakers in June—six months past the deadline—also address the “confusion” that’s resulted from the federal legalization of hemp and its derivatives with “perceived loopholes” that have allowed intoxicating cannabinoids to proliferate in markets across the country.

“Beyond the nuances of the control status of various cannabis products, there are numerous barriers that can deter scientists from pursuing research with Schedule I drugs,” HHS said. “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.”

One key research barrier connected to the Schedule I status of cannabis under federal law is the fact that “researchers cannot legally obtain or analyze products sold through state marijuana dispensaries.”

The Drug Enforcement Administration (DEA) must approve all sources of cannabis for study purposes, and the agency has not given that approval to any state-licensed retailers.

“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 says. “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.”

While DEA has moved to approve additional federally authorized suppliers of research-grade marijuana, it’s unclear how many new growers are being utilized or if their products reflect what people are buying in state-legal shops, so going forward, “it will be important to ensure that research-grade products reflect those that consumers are using.”

Rep. Earl Blumenauer (D-OR), co-chair of the Congressional Cannabis Caucus and sponsor of the marijuana research bill that led to the new report, said the HHS analysis “validates what we have known for years: reclassifying cannabis is paramount to effectively researching it.”

“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,” he said. “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.”

The new document notes that it comes after a 252-page review it completed as part of the ongoing marijuana rescheduling review and as such “includes some data that post-date that HHS recommendation and addresses some substances that are not within the definition of marijuana under the CSA and thus contains information broader than the scope of the scheduling recommendation.”

The report also discusses “credible evidence” that marijuana could be used as an effective treatment option for chronic pain, while adding that there’s “less support for its effectiveness in other conditions.”

“It is also worth noting that the 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,” HHS said.

The agency additionally identified a number of concerns with cannabis use as it concerns driving ability, emergency room visits, substance misuse and brain development.

HHS also addressed the “confusion” resulting from a “loophole” in the 2018 Farm Bill that federally legalized hemp and opened up a largely unregulated market of consumable cannabinoid products. Lawmakers on the House side have moved to effectively ban most of those products under the latest iteration of the agricultural legislation, as well as a separate appropriations measure.

While hemp and its constituents are considered federally legal if they contain no more than 0.3 percent THC by dry weight, many synthetic cannabinoids derived from the crop are available in commercial markets around the country, despite the fact that DEA has determined that synthetically processed compounds do not meet the definition of hemp and are therefore Schedule I drugs.

“Thus, indistinguishable compounds may be controlled differently depending on whether they are non-synthetic hemp/CBD-derived or derived from other sources,” HHS said. “These inconsistencies remain a source of confusion for scientists and could have a chilling effect on research by deterring scientists from conducting research on these compounds.”

“Additional guidance from the DEA, including on how researchers can determine the source of cannabis materials (i.e., whether they are hemp-derived and thus non-controlled) would be useful,” it said.

With respect to marijuana research barriers, HHS included recommendations for Congress, including passing the Halt All Lethal Trafficking of Fentanyl (HALT) Act, which would streamline research into Schedule I drugs like marijuana and psychedelics. Advocates have also criticized the legislation, however, as it would ramp up federal criminalization of fentanyl analogues.

The agency also noted that the National Institute on Drug Abuse (NIDA) is providing funding to support researchers who can develop a medical marijuana registry to track everything from how patients are obtaining and consuming cannabis to their health outcomes.

“Still, none of the efforts described above address the critical need for researcher access to the full range of state-authorized dispensary products; thus, there remains a substantial gap in understanding the impact of cannabis products on health,” the report says. “Innovative solutions to bridge this gap are needed.”

“Licensing cannabis growers that are already providing products to state dispensaries as approved manufacturers of research-grade cannabis is one possible path through which researchers could access some of the same products sold in state-legal markets,” it said. “Exploring partnerships through which the federal government could legally acquire and make available to registered researchers cannabis products from state-authorized dispensaries could also bridge this gap.”

The report concludes by reiterating that while “there are medical benefits associated with the use of FDA-approved cannabinoid medications and there is credible scientific support suggesting that cannabis has additional therapeutic potential, there are also risks and many unknowns.”

“It is imperative that we learn as much as we can about the wide variety of available products and their constituents, including cannabinoids other than delta-9 THC and CBD,” it says.

“By expanding the number of cannabis manufacturers and enacting legislation to make it easier to conduct cannabis research, federal policymakers have taken important steps toward advancing this work. Nevertheless, continued regulatory hurdles, including lack of access to the products the public is using, hinder our ability to fully understand cannabis’ potential as a therapeutic agent and its risks when used for medicinal and nonmedicinal purposes, and must be addressed.”

The HHS report was belatedly submitted to congressional committees months after the agency proposed moving marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA) following a directive from Biden. The department determined that the reclassification is appropriate in light of evidence that cannabis possesses some medical value with a relatively lower abuse potential than would warrant a Schedule I designation.

The Justice Department has since formally proposed rescheduling, and a public comment period on the rule change closed last week, with more than 40,000 submissions weighing in on the modest reform.

Read the full HHS marijuana report below:

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Photo courtesy of Mike Latimer.