Rescheduling Cannabis: Are We Entering A New Era?

The rescheduling of cannabis has become a hotly debated issue at the intersection of science, medicine, and policy in the US. For decades, cannabis has been classified as a Schedule I drug under the Controlled Substances Act (CSA) of 1970. This categorization places it alongside substances such as heroin, indicating a high potential for abuse and no accepted medical use. As a result, cannabis research has been heavily restricted, and its medical applications have remained largely underexplored. However, mounting evidence of the plant’s therapeutic benefits, coupled with a shift in public opinion, has driven renewed discussions on reclassifying cannabis to a lower schedule. This article examines what rescheduling cannabis would involve, the implications for various sectors, and the potential roadblocks that could arise along the way.

What Does Rescheduling Cannabis Mean?

Rescheduling cannabis means changing its classification within the CSA, which organizes drugs into five schedules based on their medical value, abuse potential, and safety profile. Schedule I is the most restrictive, denoting substances with no accepted medical use and a high risk of abuse. Moving cannabis from Schedule I to Schedule II or III, for example, would reflect a recognition of its medical utility while still maintaining regulatory controls to prevent misuse.

In contrast to rescheduling, de-scheduling would involve removing cannabis from the CSA entirely, effectively treating it similarly to substances like alcohol or tobacco, which are regulated under different frameworks. While full de-scheduling has been advocated by some, rescheduling appears to be a more politically feasible approach, maintaining federal oversight while allowing for greater flexibility in research and medical application.

When Will Rescheduling Happen?

Several significant developments predicted that momentum was building toward rescheduling cannabis. In recent years, the Food and Drug Administration (FDA) has approved Epidiolex, a cannabis-derived drug used to treat certain forms of epilepsy, signaling a shift in how the federal government views cannabis-based therapies. In 2023, the US Department of Health and Human Services (HHS) recommended rescheduling cannabis to Schedule III, propelling the discussion forward. By May of 2024, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking in the Federal Register to initiate rulemaking for the rescheduling of cannabis. While there is no set timeline for rescheduling, experts predict that the shift could happen within the year, especially given the increasing pressure from states that have legalized cannabis for medical or recreational use. However, political factors, including opposition from some lawmakers and advocacy groups, could still delay the process.

Benefits of Rescheduling

Rescheduling cannabis could unlock numerous benefits for various stakeholders, particularly in the realms of medical research, healthcare, and public policy.

1. Expanded Medical Research

One of the most significant advantages of rescheduling cannabis is the potential for expanded scientific research. As a Schedule I drug, cannabis is subject to strict regulatory controls that have made it difficult for researchers to study its potential therapeutic effects. The current classification requires researchers to obtain special licenses, navigate bureaucratic red tape, and source cannabis from limited, government-approved suppliers, all of which have stifled progress.

Moving cannabis to a less restrictive schedule would lower some of these barriers, allowing scientists to explore its potential in treating a range of conditions, from chronic pain and anxiety to multiple sclerosis and cancer-related symptoms. Rescheduling would also facilitate clinical trials, providing a clearer understanding of cannabis's efficacy, dosage, and long-term effects.

2. Increased Patient Access

For patients, particularly those in states where medical cannabis is not yet legal, rescheduling could improve access to cannabis-based treatments. A reclassification to Schedule II or III would make cannabis eligible for prescription under federal law, allowing doctors to prescribe it in a controlled and regulated manner. This could benefit patients suffering from conditions for which conventional treatments have proven inadequate or have significant side effects.

Rescheduling could also pave the way for insurance coverage of cannabis-based medications, making these treatments more affordable for patients who currently rely on expensive out-of-pocket purchases through state-licensed dispensaries.

3. Standardized Regulation and Quality Control

Rescheduling cannabis would likely lead to greater standardization and quality control in the production and distribution of cannabis-based products. Currently, the patchwork of state regulations results in inconsistent product quality and safety standards, with some states imposing rigorous testing requirements and others lacking comprehensive oversight. A shift to a lower schedule would bring cannabis more in line with other pharmaceuticals, ensuring that products meet federal safety, potency, and labeling requirements.

Potential Drawbacks of Rescheduling

While the rescheduling of cannabis offers many potential benefits, it is not without challenges. Some concerns include regulatory complexities, commercialization risks, and public health implications.

1. Regulatory Hurdles

Rescheduling cannabis would introduce new regulatory challenges, particularly in aligning federal and state laws. While federal rescheduling could make cannabis available for medical purposes nationwide, it may conflict with existing state-level recreational cannabis laws. States that have fully legalized cannabis could face challenges in reconciling their regulatory frameworks with new federal controls. Additionally, federal agencies like the FDA would need to establish guidelines for the approval, marketing, and distribution of cannabis-based drugs, which could be a lengthy and contentious process.

2. Risks of Commercialization

Rescheduling could open the door to increased commercialization of cannabis, raising concerns about corporate control, product pricing, and the potential for profit-driven motives to overshadow public health interests. Large pharmaceutical companies may dominate the market, potentially squeezing out smaller businesses and local growers. Additionally, there is concern that aggressive marketing tactics could lead to an increase in recreational use, especially among vulnerable populations, despite tighter controls under rescheduling.

3. Public Health Concerns

Some public health experts warn that rescheduling cannabis could lead to unintended consequences, such as increased use among adolescents and the general population. While a lower schedule would allow for more research on the therapeutic benefits of cannabis, it could also result in the perception that cannabis is safer than it truly is, especially for recreational use. As with alcohol and tobacco, there is a risk that rescheduling could normalize cannabis consumption, potentially leading to increased dependency and misuse.

Can Rescheduling Be Blocked?

Despite the growing support for rescheduling, there remain political and legal hurdles that could block or delay the process. Some members of Congress, law enforcement agencies, and anti-drug advocacy groups oppose any move to reclassify cannabis, arguing that it could lead to increased substance abuse and complicate efforts to regulate other illicit drugs. Additionally, some industries, such as pharmaceuticals and alcohol, may resist cannabis rescheduling due to concerns about competition.

Legal challenges could also emerge, particularly in relation to state-federal conflicts. States with strict cannabis laws or outright prohibitions may seek to challenge federal rescheduling, further complicating the landscape. Moreover, public opinion remains divided, with some segments of the population still associating cannabis with criminal activity and moral decay.

Next Steps

The DEA accepted public comment and requests for hearing participation until September 30, 2024. The hearing is set for December 2, 2024. After the completion of the hearing and public comment period, the DEA will assess all of the information that has been gathered and finalize a ruling. The final rule will be submitted in a report to Congress. Congress will then have 60 days to review the rule. This could advance or delay the rule depending on Congress.

Conclusion

The rescheduling of cannabis marks a turning point in the way society, science, and the law approach this complex substance. While the shift is likely to unlock vast opportunities for medical research and patient care, it also comes with its own set of challenges. As the federal government inches closer to reclassification, stakeholders in healthcare, law, and public policy will need to navigate the benefits and risks of a new era in cannabis regulation. Whether rescheduling happens smoothly or is met with opposition, it will undoubtedly reshape the landscape of cannabis research and its role in modern medicine. A full review of the background, current state, and updates on cannabis rescheduling can be found in the Federal Register (1).

Reference

1. Schedules of Controlled Substances: Rescheduling of Marijuana https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana (accessed Sep 6, 2024).

About the Columnist

Lo Friesen is the founder, CEO, and Chief Extractor of Heylo. With a background in chemistry and clinical research, Lo was inspired to explore cannabis as a medicine and to enter the emerging industry. She joined Eden Labs, a leading CO₂ extraction equipment manufacturer to support and expand a Research and Development department. There she managed the development of their latest and greatest CO₂ extraction system. In 2017, after working with Eden Labs and another cannabis processor, Lo launched Heylo with a mission to help people get more out of life with cannabis.

How to Cite this Article

Friesen, L., Rescheduling Cannabis: Are We Entering A New Era?, Cannabis Science and Technology, 2024, 7(5), 10-13.