There has been talk of “rescheduling” cannabis for years, a regulatory move that would significantly ease federal restrictions on the drug. Now, with a recent push from the White House to expedite the rescheduling process, we may see that change come to pass.
Moving cannabis to Schedule III — a less-restrictive classification for drugs — would represent a very important shift in how the federal government treats cannabis research, in that it would officially state that cannabis has medical use. This landmark decision would encourage some of the largest scientific investment in cannabis research to date and help build some of the strongest evidence of the value of cannabis-based therapies.
However, the move to Schedule III should be viewed as a transition rather than an endpoint.
How cannabis is regulated, today
Cannabis has existed in a complicated space in medicine, policy and public perception for decades.
More than 6 million Americans are registered to use cannabis through state medical programs. Clinicians participating in state medical cannabis programs generally “certify” and “recommend” specific cannabis products to certain patients, rather than write traditional prescriptions. Additionally, a handful of cannabis-derived and cannabinoid-based medications have received formal Food and Drug Administration (FDA) approval.
However, since the Controlled Substances Act was enacted in 1970, cannabis has been classified as a Schedule I substance. This category is associated with the highest level of restriction, including substances such as heroin, MDMA, and LSD.
Under federal law, Schedule I drugs are defined as having a high potential for abuse and no currently accepted medical use. Given some cannabis-derived drugs are FDA approved, it may seem contradictory that cannabis remains a Schedule I substance. The key is that federal drug scheduling, FDA drug approval and state cannabis laws are separate legal and regulatory systems.
Federal law classifies cannabis as a Schedule I drug. Separately, the FDA evaluates and approves individual cannabinoid medications for specific medical conditions. Independently, states can authorize cannabis for medical or adult use under their own laws, even though cannabis remains illegal under federal law.
This three-tiered regulatory landscape can be confusing for patients, clinicians and the general public alike.
Federal law currently classifies cannabis as a Schedule I drug.
(Image credit: Martin Deja via Getty Images)
Rescheduling would be a boon for research
For a few years, federal officials have recommended moving cannabis to Schedule III, which includes drugs with accepted medical uses that are subject to fewer federal restrictions. Ketamine and anabolic steroids, like testosterone, are examples. Compared with Schedule I substances, Schedule III drugs are considered to have a lower potential for abuse and can be prescribed for accepted medical uses under federal law.
Rescheduling cannabis would thus create a regulatory environment that’s more favorable to research, which could support the development of future FDA-approved cannabis-based medicines. Researchers are already exploring cannabinoids as potential treatments for conditions including chronic pain, post-traumatic stress disorder, inflammatory bowel disease and sleep disorders, but the available evidence remains limited for many uses.
Evidence is limited, in part, because for decades researchers studying cannabis have faced regulatory hurdles that extend beyond those encountered with many other controlled substances.
Studies using cannabis often require additional federal, institutional and local approvals, compared to research with less-restricted drugs. They have extra requirements around securely storing and handling cannabis. They require detailed record-keeping to document how research materials are received, stored and used, as well as Drug Enforcement Administration registration for the principal investigator conducting Schedule I research.
Additionally, federal restrictions have historically limited researchers’ access to cannabis products that reflect those people regularly use, such as commercially available flower, vape products and edible formulations.
This regulatory burden has historically discouraged some universities, healthcare systems and funding organizations from investing in cannabis research. These hurdles have made cannabis studies slower, more costly and smaller in scale than those conducted with more loosely controlled drugs.
Federal restrictions have historically limited researchers’ access to cannabis products that reflect those people regularly use, such as commercially available flower, vape products and edible formulations.
Shifting cannabis to Schedule III would help to reduce these barriers, opening opportunities for more universities and healthcare systems to conduct much-needed clinical studies for medical cannabis. It could help researchers conduct the larger, more rigorous clinical trials needed to determine which therapies are truly safe and effective — and which are not.
Such gold-standard studies would better evaluate cannabis’ potential benefits and risks, as well its effects in specific medical conditions and appropriate dosing for each. This evidence could, in turn, help reduce the stigma associated with cannabis use.
What rescheduling won’t accomplish
Rescheduling cannabis will not automatically make cannabis more accessible to patients or immediately establish where cannabis is beneficial, what doses are most appropriate or which patients are most likely to benefit.
It would not automatically convert existing state cannabis programs into the conventional prescription model used for most Schedule III drugs. And it would not immediately resolve the complexities surrounding state medical cannabis programs, which operate outside the traditional FDA-approved medication pathway.
Unlike most prescription drugs, medical cannabis is an umbrella term that includes hundreds of products that differ in cannabinoid content, formulation, dose and route of administration. Most of those products have not been approved by the FDA, so rescheduling would not automatically place them into the traditional prescription drug system or immediately resolve many of the financial and access barriers patients face when trying to use them.
Without robust follow-up research, rescheduling alone would do little to resolve the uncertainty surrounding many cannabis products.
In short, the greatest benefit of moving cannabis to Schedule III would not be the policy change itself; it would be the opportunity to build a stronger evidence base for cannabis science and medicine. Policymakers may open the door to Schedule III, but researchers, clinicians and regulatory agencies will determine whether this opportunity will actually lead to the appropriate and meaningful advances in cannabis science and medicine.
The value of rescheduling will be measured not by how quickly it changes patients’ access to cannabis, but by whether it helps create the scientific foundation needed to guide responsible medical use.
This article is for informational purposes only and is not meant to offer medical advice.
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