Cannabis use is on the rise and legal products are evolving by the day, but research efforts are struggling to keep pace due to regulatory hurdles, according to a new federal report.
The report from the Department of Health and Human Services, which was mandated by Congress, revealed a widening gap between cannabis consumption and scientific understanding, a gap often cited by legalization advocates as the reason medical cannabis should move down the rescheduling pole sooner rather than later.
“Cannabis sativa L. is a complex plant, and it is being manufactured and consumed in varying potencies and formulations for a wide range of medicinal and non-medicinal purposes,” the report says. “Although there is some credible evidence that cannabis has therapeutic potential for chronic pain, there is less support for its effectiveness in other conditions.”
‘Many uknowns’
About 22% of Americans aged 12 and older reported using cannabis in the past year, according to 2022 data cited in the report. Usage peaks among young adults, with 38.2% of those aged 18 to 25 reporting past-year use.
Product potency has also surged dramatically. The report noted that “the average Δ9-THC concentration in cannabis products seized by law enforcement increased 3.5-fold between 1995 (4 percent) and 2021 (15 percent),” while “the average concentration in dispensary products is around 20 percent.”
The report also noted that the Food and Drug Administration has approved limited cannabis-derived medications, including Epidiolex for certain seizure disorders and synthetic THC drugs for nausea and appetite stimulation in specific conditions.
However, researchers still face barriers studying cannabis products, particularly those sold in state-licensed dispensaries. The report explained that “researchers cannot legally obtain or analyze products sold through state marijuana dispensaries” as “the DEA must approve all sources of cannabis used in research, and no state-authorized dispensaries have been approved.”
Additionally, testing and labeling requirements vary from market to market, which makes it difficult to control tests. Plus, “researchers must rely on study participants’ self-reported use and/or photos of dispensary products.” That makes it challenging to evaluate what’s driving specific effects.
The report also outlined several potential risks associated with cannabis use.
“Although 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,” the report said.
Health care systems have been feeling some impact, too.
“Emergency department (ED) visits related to cannabis (both acute and chronic exposures) are on the rise,” the report said, attributing the trend to “various changes in the market” and expanding user populations.
The authors point out that recent legislation has been looking to expand research capabilities. The Medical Marijuana and Cannabidiol Research Expansion Act, signed into law in 2022, intended to “increase the number and variety of manufacturers authorized to provide cannabis for research and facilitate the process of obtaining a Schedule I registration to conduct cannabis research.”
The report concludes that “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.”
It recommends exploring partnerships to legally acquire dispensary products for research and even licensing existing dispensary suppliers as research-grade manufacturers.
Reactions
The report’s findings align with longstanding concerns from cannabis reform advocates about the impact of marijuana’s Schedule I status under the Controlled Substances Act. Rep. Earl Blumenauer said in a statement that the report “validates what we have known for years: reclassifying cannabis is paramount to effectively researching it.”
However, antilegalization groups, such as Smart Approaches to Marijuana (SAM), views the report as confirmation of their concerns.
SAM President and CEO Kevin Sabet told Law360, “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.”