The DEA has been swiping left on cannabis for years
But they may soon be ready to set up a date
Regulatory agencies in the United States have, for decades, resisted multiple calls for rescheduling cannabis-based medicine out of Schedule I, citing lack of clinical evidence on its safety and efficacy. Similarly, in Kentucky, certain legislators opposed approving a medical cannabis program was driven by the “we need more research” argument. In the current federal classification, it is virtually impossible to do gold-standard human clinical trials on cannabis.
The DEA is treating cannabis like it’s on a dating app. Read the profile? No. Open a conversation to see if it’s a compatible match? Nope. That’s like saying about a Tinder match, “I can’t go out with that guy because I don’t already know him.”
Only a handful of institutions stateside have the licensing to purchase and conduct research with cannabis. And even then, the red tape is onerous. Outside the US, many well-designed trials have been published. However, to meet the criteria for reclassifying cannabis, US agencies say they need more. If cannabis were reclassified to Schedule III, randomized controlled clinical trials could be performed, potentially reducing some of the barriers to research while maintaining necessary guardrails.
One confounder in cannabis research is the consistency of the substance being studied. Differences in genetic strain and growth environment can inherently alter the cannabinoid and terpene content. To study cannabis as a potential medicine, we need access to consistent, standardized material. We have precedent for this with another plant – tobacco. Researchers at the National Institute of Health developed a standardized cigarette for use in clinical trials. To truly glean applicable results, and to compare results among many studies, investigators must first have a consistent cannabis substrate. Standardization can only be accomplished if the current federal prohibitions are eased.
Another stumbling block for many people opposed to reclassifying cannabis is its potential for dependence. Certainly, cannabis use disorder (CUD) exists, but it is important to keep the risk in perspective. A 2023 cross-sectional study published in JAMA reported that among adults who used cannabis in a state where ‘recreational’ sales had been legalized, the prevalence of moderate to severe CUD was 6.5%.1 Compare that to a JAMA report in 2019 that found nicotine dependence prevalence among adult tobacco users was 56%.2 The prevalence of alcohol use disorder in the US is 10.2%, according to the most recent National Survey on Drug use and Health.3
To be sure, as frequency of use and THC concentration increases so too does the risk of developing cannabis use disorder. But, two of the top three most addictive legal and freely available substances humans consume – alcohol and nicotine – have far higher prevalence of dependence than cannabis, and collectively cause hundreds of thousands of deaths each year. The FDA has already approved a number of cannabis-derived or cannabis-analogue medications for the US market, thereby acknowledging the legitimate clinical utility of cannabis. Yet, regulatory wonks clutch their pearls at the thought of patients having safe access to medical plant-derived cannabis.
This year, the DEA announced it will hold hearings to, yet again, consider moving cannabis out of Schedule I. This is, not surprisingly, an arduous administrative process that will likely take months, if not years to finalize. First, a proposal must be reviewed by the White House Office of Management and Budget (OMB). Once OMB approves, the proposal is opened for public comment. Once feedback is collected the proposal will likely through a number of edits. After that, the proposal will need to be scrutinized per the requirements of the Congressional Review Act. While this process is progressing, the FDA will have its own policy reviews and updates to consider. Schedule III medications can only be dispensed by prescription, so the FDA will then need to consider what the broad term “cannabis” means and what will require FDA approval going forward.
Even if reclassification is begun by the DEA, cannabis will still run afoul with the 24 states that have legalized recreational sales. The current state- and municipality-level regulations differ from federal law and from each other, creating a confusing landscape on par with a psilocybin hallucination.
If cannabis is reclassified into Schedule III, the barriers to research would be much, much lower. In this, an election year, there is little Congressional attention on the cannabis contingent. Sharply divided legislatures hardly can keep the government running, much less pass meaningful, thoughtful healthcare policy. Even if voters swipe left on their representatives that do not support cannabis reform, setting up a date with C-III cannabis will be more difficult than finding true love on Tinder.
Lapham GT, Matson TE, Bobb JF. Prevalence of cannabis use disorder and reasons for use among adults in a US state where recreational cannabis use is legal. JAMA Netw Open. 2023;6(8):e2328934. doi:10.1001/jamanetworkopen.2023.28934.
Han, B, Einstein EB, Compton WM. Patterns and characteristics of nicotine dependence among adults with cigarette use in the US 2006-2019. JAMA Netw Open. 2023;6(6):e2319602. doi:10.1001/jamanetworkopen.2023.19602.
National Institutes on Health. Alcohol use disorder in the United States: age groups and demographic characteristics. https://www.niaaa.nih.gov/. Accessed 15 Sep 2024.