Support for medical cannabis is overwhelming, with over 90% of Americans consistently expressing approval in national polls. This widespread support is reflected in the 48 states that have enacted medical cannabis laws, giving millions of patients access to cannabis products despite ongoing federal prohibition. These state initiatives were born out of necessity to meet the immediate needs of patients under a compassionate use framework. Over the past few decades, patient advocates have driven this progress by using state-level initiatives as “laboratories of democracy” to address barriers raised by the Department of Health and Human Services (HHS), Drug Enforcement Administration (DEA), and Department of Justice (DOJ), in repeated denials to rescheduling petitions for decades.

To that end, patient advocates have achieved significant milestones, including establishing product safety standards, collaborating on labeling requirements, and creating medical education and dosage guidelines. Their work even influenced international drug treaties to recognize the medical value of cannabis, paving the way for the United States to revisit cannabis scheduling. These efforts culminated in the recent recommendation from HHS to reschedule cannabis due to its “accepted medical use.” While this news was welcomed, it was hardly unexpected for those who have long fought for this recognition.

However, media coverage of rescheduling has largely ignored the patient perspective. Instead of exploring how rescheduling validates the therapeutic benefits of cannabis and the patients that need it, much of the media parroted cannabis business press releases, focusing on tax implications for companies or speculating about rescheduling as part of President Biden’s re-election strategy. Often uninvestigated and speculative, these narratives detracted from critical discussions about patient needs and much anticipated federal policy reform.

This focus had real consequences, casting doubt on HHS’s findings and the sincerity of the medical cannabis movement and redefined, albeit faded, partisan line around medical cannabis policy. So instead of a groundswell of support for patients or grand gestures to restore our federal rights and create avenues for nationwide access, the most visible impact of the news of HHS and DOJ findings about the medical benefits of cannabis was a (temporary) surge in stock prices for publicly traded cannabis companies and a rekindling of anti-cannabis sentiments with no exceptions made for patients. 

The resurgence of the anti-marijuana lobby in Washington, D.C. wasted no time, and by July 9, 2024, they were able to sway the House Appropriations Committee to pass a version of the Commerce, Justice, Science, and Related Agencies (CJS) appropriations bill that included language to block rescheduling efforts altogether and weaken the medical cannabis protections established in 2014. The next day, they flaunted their reemergence with a letter to Attorney General Merrick Garland condemning the rescheduling process signed by 25 Republican Senators and Representatives.

The positive impacts of medical cannabis on patients and the healthcare systems that serve them are well-documented. Medical cannabis has been shown to alleviate chronic pain, reduce anxiety and depression, and improve the quality of life for those with conditions like epilepsy and multiple sclerosis. It also has the potential to reduce reliance on opioids, offering a safer alternative for pain management. However, the state-by-state compassionate use model has significant limitations. It excludes patients in states unwilling to pass medical cannabis laws and leaves out federal employees, contractors, and veterans relying on VA healthcare. Marginalized, outside the broader healthcare system, medical cannabis patients now find themselves competing with recreational consumers for cannabis products and state protections. 

Patient advocates have never viewed rescheduling as a panacea, well aware that the benefits of cannabis medicines will remain inaccessible to many due to fragmented policies, inadequate research pathways, and a lack of comprehensive federal legislation. Validation was not the intended outcome patients are hoping to gain from rescheduling but view it as the wedge that will finally allow the national debate to move from 50 years of asking, “Does cannabis have medical value?” to “How can we ensure better access for patients?”

Unfortunately, the 118th Congress has largely sidestepped these issues, advancing legislation that prioritizes recreational and hemp markets over medical cannabis. Many of these proposals could harm patients by pushing cannabis regulation into the control of the FDA, where the only available framework for medicines is the drug approval process, which is ill-suited for complex botanicals like cannabis.

The challenges facing medical cannabis go beyond the remnants of prohibition—they reflect a deeper struggle over how the U.S. defines medicine. If cannabis policy remains focused on single-molecule pharmaceuticals rather than whole-plant medicine, rescheduling could become a symbolic gesture rather than a transformative moment.

Patient-centered advocacy efforts also face significant funding and resource challenges compared to well-funded recreational cannabis businesses and government agencies. This disparity limits the ability of advocacy organizations to shape public discourse and educate stakeholders on medical cannabis policy. Media coverage plays a crucial role in shaping public perception and informing policymakers, yet it often conflates medical cannabis with adult-use markets or overlooks patient stories entirely.

Patient experiences are central to understanding medical cannabis. Accurate reporting on medical cannabis and cannabis policy must include patient perspectives, which reveal both the resounding benefits patients derive and also the real-world challenges of accessing treatment, managing healthcare costs, and navigating inconsistent legal protections. Journalists must engage directly with patients to capture the true challenges, benefits, and gaps in current systems.

Patients report issues such as inconsistent product quality, lack of access to specific formulations, and prohibitive costs. Coverage should reflect patient voices and reveal how state programs and policies impact their health, well-being, and rights. Patients offer firsthand insights into the efficacy of cannabis treatments, the barriers they face, and the urgent need for federal reform.

Funding for Medical Cannabis Patient Advocacy Has Fallen Drastically, Not Patient Issues

Funding for medical cannabis advocacy has decreased by as much as 90% in recent years. This lack of resources affects the ability of these organizations to hire the communication staff needed to compete with better-resourced businesses and government agencies that do not provide the complete picture of the state of cannabis. It also means limited resources to advocate for comprehensive medical cannabis regulations, patient protections, and the development of standardized, evidence-based cannabis medicines.

The fact that patients’ voices are being overshadowed by the success narrative of the rise of cannabis businesses has led to the under-reporting of issues that still need to be addressed through advocacy and to the overshadowing of organizations that continue to do this work. This has left patient-centered efforts underfunded, undermining education, outreach, and policy reform initiatives, and is now creating a backlash in the form of reporting on the harms of cannabis that patients have been describing all along.

Medical cannabis is not just widely supported—it is urgently needed. For decades, patient advocates have shouldered the responsibility of demonstrating cannabis’ value as a medicine, tirelessly working to advance state and federal policy. Their efforts have delivered life-changing relief for millions of Americans in 38 states. As of election night 2024, voters in Nebraska are poised to make it the 39th state to adopt a medical cannabis program.

Despite the media’s focus on recreational cannabis markets, support for medical cannabis remains overwhelming. For more than a decade, national polls have consistently shown that over 90% of Americans support medical cannabis, with support exceeding 80% even twenty years ago. This enduring approval highlights the widespread recognition of cannabis as a medicine—not just a political talking point or a steppingstone for recreational markets.

Medical cannabis patients themselves created state-based distribution programs to provide relief in the face of federal inaction. These programs were designed as a form of triage, giving patients a way off the battlefield of the War on Drugs while advocates worked to remove federal barriers to a national medical cannabis program. These efforts culminated in 2023 when federal health agencies finally acknowledged what patients and advocates have long argued: cannabis has accepted medical use in the United States. This historic recognition came through the Department of Health and Human Services’ (HHS) recommendation to reschedule cannabis based on its therapeutic benefits.

Rescheduling: Closes a Chapter, Not the Book

With cannabis rescheduling now within reach, this milestone highlights the next critical phase: integrating cannabis into the U.S. healthcare system. While rescheduling is an important step, it alone will not secure the inclusion of cannabis medicines in modern healthcare. It demands a reexamination of how the U.S. defines and approaches medicine.

State medical cannabis programs have already proven cannabis’ immense value. These programs provide relief for patients with chronic pain, epilepsy, multiple sclerosis, and other debilitating conditions, reducing reliance on costly prescription drugs and hospitalizations. Patients report life-changing improvements, and the economic benefits are clear: these programs reduce healthcare costs and alleviate pressure on overburdened systems. Federal action is needed to ensure that these benefits are extended to all Americans. Patients continue to face significant barriers, including high costs, inconsistent access, and a lack of legal protections. Many healthcare providers remain hesitant to recommend cannabis due to stigma and legal uncertainties, leaving patients without the guidance they need.

Lawmakers from both sides of the aisle now recognize medical cannabis’ potential to alleviate suffering, reduce healthcare costs, and address unmet medical needs. However, achieving meaningful reform requires bold action from Congress. The future of cannabis policy will hinge on decisions made in the next session, including rescheduling, regulating hemp-derived cannabinoids, and integrating cannabis into federal healthcare frameworks.

The Medical Cannabis & Cannabinoid Act is the Solution for Patients

The proposed Medical Cannabis & Cannabinoid Act offers a comprehensive roadmap to address patient needs. Key provisions of the act include:

• Establishing a National Regulatory Framework: Create uniform standards for product safety, labeling, and quality.
• Facilitating Research: Remove barriers to clinical research, ensuring cannabis-based treatments are evidence-based and scientifically validated.
• Ensuring Patient Protections: Provide legal safeguards for patients, including protections for employment and housing.
• Addressing Affordability: Develop pathways for insurance coverage and reduce the financial burden on patients.

Such legislation is essential for cannabis medicines to evolve and integrate into modern healthcare systems. This process is far more complex than debating whether cannabis should be an intoxicant left to state regulation—it demands a commitment to innovation and a willingness to redefine medicine itself.

Media's Role in Progress

Despite overwhelming public support and the demonstrated benefits of medical cannabis, media coverage often marginalizes this critical issue, focusing disproportionately on recreational markets and business interests, perpetuating a distorted narrative that sidelines patients and their advocates. In fact, medical cannabis issues are now only polled with adult use questions, and medical cannabis is rarely a topic in coverage of related healthcare issues. This lack of patient-centered reporting on cannabis lets policymakers off the hook and has allowed them to deprioritize medical cannabis in favor of recreational markets or even allow language slide that would roll back patient protections.

The media has a vital role in correcting this imbalance. By elevating patient voices, exploring the healthcare implications of medical cannabis, and holding policymakers accountable, journalists can bring this underreported issue into the national spotlight. Accurate, balanced reporting can reshape public discourse and ensure medical cannabis is treated as the urgent healthcare issue it is—not just a footnote in debates about recreational cannabis.

Medical cannabis is more than a widely supported policy—it is a lifeline for millions of Americans. Advocates and patients have already done the heavy lifting, building the foundation for reform through state programs and decades of persistent advocacy. They have proven cannabis’ value in alleviating suffering and improving lives. Now, it is time for Congress and the media to reflect this reality.

Federal lawmakers must seize this moment to advance comprehensive legislation like the Medical Cannabis & Cannabinoid Act. This is not just about recognizing cannabis as medicine—it is about ensuring every patient has safe, affordable, and consistent access to it.

The media has an important role to play in bridging the gap between hype and reality. By focusing on the human stories behind medical cannabis and the systemic barriers patients face, journalists can amplify the urgency of this issue and help drive meaningful change. Americans want cannabis medicines. Congress must act decisively, but they will have to be held accountable in the press by ensuring that this issue receives the attention it deserves.

Chronic diseases such as diabetes, cardiovascular disease, obesity, and degenerative joint disease are among the most prevalent and costly health challenges in the United States. These conditions are often accompanied by chronic pain, depression, and opioid misuse, exacerbated by chronic stress. Similarly, rheumatic diseases—including rheumatoid arthritis (RA), Crohn’s disease, and lupus—affect millions of Americans and contribute to significant healthcare costs and diminished quality of life.

Current therapies for these conditions frequently fail to provide sufficient relief or pose risks of significant adverse effects, such as immune suppression, gastrointestinal issues, and cardiovascular problems. Moreover, the reliance on opioids for chronic pain management has fueled an epidemic of addiction and overdose deaths. The U.S. healthcare system spends approximately $35 billion annually on opioid misuse and related healthcare costs (Pew Charitable Trust, 2021). Furthermore, according to the National Organization on Rare Disorders (NORD), there are over 10,000 rare diseases that together affect more than 30 million Americans.

Research into the endocannabinoid system—a network of receptors involved in regulating inflammation, pain, and mood—suggests that medical cannabis can in many cases, provide a safer, cost-effective alternative or adjunct therapy for managing these conditions. Despite federal inaction, state medical cannabis programs have demonstrated tangible benefits for patients and the healthcare system, offering a glimpse of what a national program could achieve.

The Burden of Chronic Diseases & Rheumatic Conditions

Chronic and mental health conditions are responsible for 90% of the $4.1 trillion spent annually on U.S. healthcare (Centers for Disease Control and Prevention, 2023). Among these, rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis affect mobility, productivity, and quality of life, especially as their prevalence increases with an aging population.

Current treatment options are often insufficient, leaving patients reliant on costly biologics or high-risk medications. Furthermore, these conditions are frequently accompanied by chronic pain, which has driven patients toward opioids despite the risk of addiction and overdose. Medical cannabis offers a promising alternative for addressing these unmet needs, interacting directly with the endocannabinoid system to modulate inflammation, alleviate pain, and improve mood.

State Programs Demonstrate the Potential of Medical Cannabis

State medical cannabis programs have yielded impressive results, showcasing the potential for medical cannabis to reduce healthcare costs and improve quality of life:

• Lower Healthcare Costs
  A study published in Health Affairs in 2017 found that states with medical cannabis laws saw a reduction of $165.2 million annually in Medicare Part D prescription drug spending. If implemented nationally, these savings could approach $1 billion per year (Bradford & Bradford, 2017).
• Reduced Opioid Dependency
  States with medical cannabis laws experienced a 23% reduction in opioid overdose deaths, according to a 2021 study published in JAMA Network Open (Wilson et al., 2021). Patients using medical cannabis as part of their treatment report a significant decrease in opioid use, with some studies showing a 64% reduction in opioid consumption (Boehnke et al., 2016).
• Improved Patient Outcomes
  Patients participating in medical cannabis programs report better symptom management, fewer side effects, and improved mental health. For instance, rheumatic disease patients using medical cannabis report decreased pain, enhanced mobility, and improved sleep (Fitzcharles et al., 2021).
• Economic Benefits to the Workforce
  States with medical cannabis programs have seen a 13% decline in workers’ compensation claims, reflecting improved workforce participation and productivity (Seaman et al., 2016).

Implications for Federal Healthcare Systems

Expanding medical cannabis access through Medicare and the Veterans Health Administration (VHA) could replicate these state-level successes on a national scale, with profound implications:

• Substantial Cost Savings
  By substituting cannabis for costly prescription medications, Medicare could save billions annually. Similarly, the VHA could reduce expenditures on opioids and other high-cost therapies for pain management, offering veterans a safer alternative.
• Enhanced Care for Veterans
  Veterans often suffer from chronic pain, post-traumatic stress disorder (PTSD), and other conditions that could be effectively managed with medical cannabis. By integrating medical cannabis into the VHA, the federal government could improve health outcomes while reducing reliance on opioids.
• Long-Term Economic Benefits
  Beyond healthcare savings, improved productivity and reduced disability among Medicare and VHA beneficiaries would generate broader economic gains, benefiting taxpayers and the economy.

Why the Federal Government Must Act

The federal government has a unique opportunity to build on the successes of state programs by establishing a national medical cannabis framework. Such a program would:

• Ensure consistent safety and quality standards across all states, reducing patient exposure to contaminants and inaccurate labeling.
• Facilitate research into cannabis’ efficacy and safety, helping to integrate it into the healthcare system.
• Save taxpayers money by reducing dependence on expensive pharmaceuticals and addressing opioid misuse.

The compassionate use of medical cannabis offers an evidence-based solution to some of the most pressing challenges in healthcare today. Policymakers must seize this opportunity to reduce suffering, save money, and improve lives.

A Solution That Saves Money & Improves Lives

Medical cannabis has already demonstrated its ability to reduce healthcare costs, improve patient outcomes, and provide relief for individuals with chronic and rheumatic conditions. Expanding access through a national medical cannabis program would amplify these benefits, creating a unified framework prioritizing patient safety, product quality, and affordability.

This is an opportunity to save billions of dollars annually while improving the lives of millions of Americans. Rather than dismissing this opportunity, Congress should embrace a solution that has already proven its value at the state level. Congress must embrace the evidence and act decisively to integrate medical cannabis into the U.S. healthcare system. By doing so, we can ensure a healthier, more compassionate future for patients and taxpayers alike.

Citations

Bradford, A. C., & Bradford, W. D. (2017). Medical marijuana laws reduce prescription medication use in Medicare Part D. Health Affairs, 36(5), 945-951.

Wilson, N., Kariisa, M., Seth, P., Smith, H. T., & Davis, N. L. (2021). Drug and opioid-involved overdose deaths — United States, 2017–2019. JAMA Network Open, 4(5), e2110264.

Boehnke, K. F., Litinas, E., & Clauw, D. J. (2016). Medical cannabis use is associated with decreased opiate medication use in a retrospective cross-sectional survey of patients with chronic pain. Journal of Pain, 17(6), 739-744.

Fitzcharles, M. A., Ste-Marie, P. A., Clauw, D. J., & Shir, Y. (2021). Rheumatologists’ attitudes and knowledge about cannabis use in patients with rheumatic diseases. The Journal of Rheumatology, 48(5), 745-751.

Centers for Disease Control and Prevention (CDC). (2023). Chronic diseases in America. Retrieved from https://www.cdc.gov/chronicdisease

The High Price of the Opioid Crisis, 2021 Increasing access to treatment can reduce cost Pew Charitable Trust https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2021/the-high-price-of-the-opioid-crisis-2021

National Institute on Drug Abuse (NIDA). (2021). Opioid overdose crisis. Retrieved from https://nida.nih.gov

Centers for Medicare & Medicaid Services https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet

Rescheduling cannabis has the potential to positively shift social attitudes, reduce stigma, and foster greater acceptance among medical professionals, employers, and policymakers. These changes could help normalize medical cannabis use and create a more supportive environment for patients. However, rescheduling alone will not address the systemic challenges faced by patients or businesses in current state medical cannabis programs.

State medical cannabis programs are protected from federal interference under the CJS amendment. Still, rescheduling cannabis to Schedule II, III, or even removing it from the Controlled Substances Act entirely, would shift regulatory authority over cannabis activities beyond personal use. Once rescheduled, these activities would fall under federal regulations and enforcement priorities, which are ultimately determined by presidential directives.

One of the few positive outcomes of rescheduling—especially to Schedule III—is its potential to advance cannabis research. Easing the costs and regulatory burdens associated with handling, storage, and security under Schedule I could make research more accessible, expanding scientific knowledge about cannabis’ effects, safety, and therapeutic applications.

STATUS QUO AFTER RESCHEDULING

Despite these benefits, rescheduling will not automatically integrate state medical cannabis programs into federally regulated frameworks. State program products would remain outside prescription-based protocols unless Congress provides clear guidance and establishes a formal registration process. Patients in state programs would not require prescriptions, and these products would remain ineligible for federally approved clinical trials focused on efficacy.

Furthermore, unregulated Schedule II or III substances would remain federally illegal. While simple possession charges are rarely enforced, activities such as cultivation, manufacturing, and distribution outside federal regulations would still be classified as trafficking, with severe penalties. For instance, trafficking Schedule III substances could result in penalties ranging from 10 years in prison and a $500,000 fine for individuals (first offense) to 20 years and a $1 million fine for subsequent offenses.

Rescheduling is also unlikely to alleviate tax burdens for cannabis businesses. While 280E explicitly applies to Schedule I and II substances, it is improbable that Schedule III cannabis products would qualify for business expense deductions, as federal law still considers manufacturing and distribution trafficking. Historically, the IRS has denied deductions for illegal business activities, including racketeering, sports betting, and other activities that violate federal or state law. Without changes to the tax code or federal legalization—both requiring Congressional action—cannabis businesses claiming deductions prematurely would likely face legal challenges.

IMPACT ON PATIENTS

Rescheduling is undeniably a victory for medical cannabis patients and advocates. By recognizing cannabis’ “currently accepted medical use in treatment in the United States,” the federal government has validated decades of patient-led advocacy and the role of state programs as “laboratories of democracy.” These programs, built with compassionate use in mind, were essential in overcoming barriers raised by HHS, DEA, and DOJ denials of rescheduling petitions over the past 50 years.

Patient advocates have worked tirelessly to establish product safety standards, collaborate with regulators on labeling requirements, and partner with medical professionals to create continuing education and dosage guidelines. Their efforts even contributed to international drug treaty reforms that acknowledged cannabis’ medical value. This advocacy paved the way for the recent HHS recommendation to reschedule cannabis, representing a significant milestone for patient rights.

However, while rescheduling marks progress, it is not the comprehensive solution patients need. Schedule III does not legalize medical cannabis, improve state medical cannabis programs, or restore federal rights for patients. Instead, it shifts the conversation from debating cannabis’ medical value to exploring how patients can safely access it. But, this shift does little to address the structural barriers limiting patient access today.

RESURGENCE OF OPPOSITION

Surprisingly, patient-centered perspectives were largely absent from media coverage of rescheduling. Instead, much of the media amplified cannabis business press releases, focusing on how rescheduling might impact taxes for businesses or tying the move to President Biden’s re-election campaign. These narratives, though unfounded, shaped debates on Capitol Hill and diverted attention from patient concerns.

Instead of galvanizing support for patients or creating avenues for nationwide access, the most visible impact of rescheduling thus far has been a temporary surge in cannabis company stock prices and a resurgence of the anti-marijuana lobby in Washington, D.C.

On July 9, the House Appropriations Committee passed a version of the Commerce, Justice, Science, and Related Agencies (CJS) appropriations bill that included language (Section 623) to block cannabis rescheduling efforts. Additionally, a proposed modification to the 2014 medical cannabis amendment (Section 531(b)) threatens to allow federal interference in state programs with harsher penalties. The very next day, 25 Republican Senators and Congressmen sent a letter to Attorney General Merrick Garland, condemning the rescheduling process as politically motivated and unsupported by science.

Unfortunately, the change in party leadership in the Senate means that many of the signatories of that letter will be in the very leadership positions that the President-elect would need to work with to move cannabis policy. Senate signatories include James Lankford, R-OK; Ted Budd, R-NC; Shelley Moore Capito, R-WV; John Cornyn, R-Texas; Bill Hagerty, R-TN.; Jerry Moran, R-KS.; Pete Ricketts, R-Neb.; Mitt Romney, R-Utah; and John Thune, R-S.Dakota.

119th Congress Senate Leadership John Thune (R-SD), Senate Leadership-Decides the agenda for the Senate, including what bills will have hearings and votes Shelley Moore Capito (R-WV)-GOP Policy Committee Chair James Lankford (R-OK)-GOP Policy Committee Vice-Chair Jerry Moran (R-KS)- Likely new chair for Approps. CJS Subcommittee Bill Hagerty (R-TN)- Likely new chair for Approps. AG subcommittee.

THE DOJ's PROPOSAL FOR SCHEDULING CANNABIS & CANNABINOIDS IS COMPLICATED

The proposed rule change is not black and white, and the upcoming road ahead to a final ruling promises twists and turns. While patients have not been the focus of much of the news coverage on the rescheduling process, they are at the center of the journey to this groundbreaking end to 50+ years of prohibition of cannabis.

THE PROPOSED RULE:

1. AMEND § 1308.11 SCHEDULE I.

(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers).

BY REMOVING

paragraph(d)(23)-(23) Marihuana 7360

AND

paragraph (d)(58)- (58) Marihuana Extract 7350 Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, containing greater than 0.3% delta-9-tetrahydrocannabinol on a dry weight basis, other than the separated resin (whether crude or purified) obtained from the plant.

CHANGING:

(redesignating paragraphs (d)(24) through (d)(104) as (d)(23) through (d)(102), respectively)

2. AMEND § 1308.11 BY REVISING THE RENUMBERED PARAGRAPH (D)(30) TO READ AS FOLLOWS:

(31) (30) Tetrahydrocannabinols 7370

(i) Meaning tetrahydrocannabinols, except as in paragraph (d)(31)(30)(ii) and (iii) of this section, naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives extracts of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following: 1 cis or trans tetrahydrocannabinol, and their optical isomers 6 cis or trans tetrahydrocannabinol, and their optical isomers 3, 4 cis or trans tetrahydrocannabinol, and its optical isomers.

(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)

(ii) Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.

(iii) Tetrahydrocannabinols does not include any substance that falls within the definition of marijuana set forth in 21 U.S.C. 802(16).

3. AMEND § 1308.13 BY ADDING NEW PARAGRAPHS (H), (I), AND (J) TO READ AS FOLLOWS:

1308.13 Schedule III.

(h) Marihuana Marijuana, as defined in 21 U.S.C. 802(16).

(i) Marihuana Marijuana Extract, meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, containing greater than 0.3 percent delta-9- tetrahydrocannabinol on a dry weight basis, other than the separated resin (whether crude or purified) obtained from the plant.

(j) Naturally Derived Delta-9-Tetrahydrocannabinols.

Meaning those delta-9-tetrahydrocannabinols, except as in paragraphs (j)(ii) and (j)(iii) of this section, that are naturally contained in a plant of the genus Cannabis (cannabis plant).

Naturally derived delta-9-tetrahydrocannabinols do not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.

Naturally derived delta-9-tetrahydrocannabinols do not include any delta-9- tetrahydrocannabinols contained in substances excluded from the definition of marijuana as set forth in 21 U.S.C. 802(16)(B) (ii).

Referenced Citations:

7 U.S.C. §1639o. Definitions (1) Hemp- The term "hemp" means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

21 U.S.C. 802 (16)(A) Subject to subparagraph (B), the terms "marihuana" and "marijuana" mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

(B) The terms "marihuana" and "marijuana" do not include-

(i) hemp, as defined in section 1639o of title 7; or

(ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted there from), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

A CALL TO ACTION

Rescheduling cannabis is both a victory and a challenge. Without Congressional action, Schedule III could become another decades-long holding pattern. Congress now has an opportunity to enact policies that fully support patient health, but this requires decisive action.

Americans for Safe Access (ASA) has proposed the creation of a national medical cannabis program to address these challenges. This program would establish uniform regulations, restore federal rights for patients, ensure nationwide access for therapeutic use and research, and create a framework tailored specifically to cannabis therapeutics. ASA also advocates for a unique schedule designed to reflect cannabis’ distinct medical and therapeutic applications.

Comprehensive reform is needed to align medical cannabis policy with patient healthcare needs and the businesses that serve them; federal rescheduling alone is not enough to address these issues. Only Congress Can Fix This.

While Presidential candidates’ positions on cannabis may make for good headlines, the reality is that, aside from signing legislation and directing federal agencies, the office of the President of the United States (POTUS) does not have the power to fundamentally change cannabis laws. Even the rescheduling process currently in the hands of the DEA, resisting the move to Schedule III, will be out of reach of President Trump’s influence.

POTUS can’t:

• Change the CSA
• Reschedule, Deschedule, or Legalize Cannabis through Executive Order
• Change Tax Code (26 U.S.C. Internal Revenue Code 162 (c)(2) or 280E)

Despite speculation about his picks for crucial Executive Branch offices, like the Department of Health and Human Services (HHS) and the next Attorney General who will head the Department of Justice (DOJ), or his campaign promises, President-elect Trump's powers are limited regarding cannabis policy and even taxation. As defined in the United States Constitution, the President-elect must work with Congress to keep his promises. However, there are policy changes and Executive Orders he could issue to help patients immediately. For example:

POTUS can:

• Stop Evictions of Medical Cannabis Patients in Federal Housing
• Allow VA Doctors to Recommend Cannabis
• Stop Drug Testing Federal Employees & Contractors for Cannabis
• Reinstate the Cole Memo
• Ask Congress for Comprehensive Medical Cannabis Legislation

“...the Supreme Court has held that the President has the power to issue an executive order only if authorized by “an act of Congress or . . . the Constitution itself.” The CSA does not provide a direct role for the President in the classification of controlled substances, nor does Article II of the Constitution grant the President power in this area…Thus, it does not appear that the President could directly deschedule or reschedule marijuana by executive order."-CRS Report: Does the President Have the Power to Legalize Marijuana? Updated November 4, 2021

“The Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States; but all Duties, Imposts and Excises shall be uniform throughout the United States;...” -Article I, Section 8, Clause 1: United States Constitution.

POTUS & Cannabis Scheduling

The only way Trump can impact cannabis scheduling is to repeat the process Biden started. However, he cannot start a new process until the current one has run its course. Considering there is no statutory time requirement for the DEA to make its final ruling, lawsuits will likely follow. Several organizations are filing lawsuits now because they were not added to the witness list; the opportunity to start a new rescheduling process could be years in the future.

The most significant changes to medical cannabis policy have come from Congress, not the President. The Rohrabacher-Farr Amendment, later known as the CJS Amendment, was an action taken by Congress that prevented federal raids on cannabis providers and protected patients, even under the anti-cannabis administration of Jeff Sessions. The real power to end prohibition and create a lasting regulatory framework lies in Congress.

“Since 2012, 24 states (and Washington, D.C.) have legalized weed for personal use, meaning that 53% of Americans live in states with legal weed. Another 14 states have legalized medical marijuana, including Florida, North Dakota, where voters will decide whether to fully legalize weed at the ballot this year.”- Trump, Harris aren't as far apart as expected on reforming marijuana laws- APP Mike Davis 9/14/24.

The primary objective of the medical cannabis movement is to ensure safe and legal access for patients, not the broader legalization of adult-use cannabis. This frame is not only insulting but also extremely dangerous. Thirty-nine states have passed medical cannabis laws, and twenty-four have added adult-use legalization. Adult use is not and was never the end goal for medical cannabis.

This sentiment has crept into the minds of federal policymakers, even those who were once medical cannabis champions, and it threatens to jeopardize the evolution of policies for cannabis medicines. While adult-use legalization has spread rapidly in acceptance and availability, its commercialization often overshadows the needs of medical patients, who may require specific formulations, dosages, and consistent access. This focus on adult-use markets has led to the misconception that medical access is adequately addressed despite remaining unfinished at the federal level.

Medical cannabis programs were established as temporary measures to provide immediate relief to patients amidst the War on Drugs. After 25 years, these programs are at risk of collapse due to inadequate federal support and state regulatory frameworks that emphasize adult use. The conflation of medical and recreational cannabis poses risks to patient safety and the development of cannabis as a medicine.

The state-based compassionate use model for medical cannabis has gotten us this far, but it is far from perfect. It can still leave many patients vulnerable to the effects of prohibition. Medical cannabis patients can be evicted from federally funded housing, denied employment due to drug tests, and parents can face child custody challenges due to their patient status. Medical cannabis patients are excluded from protections under the Americans with Disabilities Act (ADA), further reinforcing inequality and rights afforded under the 2^nd Amendment. Veterans face additional barriers and stigma within the VA healthcare system due to their medical cannabis use.

The ongoing federal prohibition of cannabis leaves patients vulnerable to safety risks, inconsistent product quality, and exposure to harmful substances. Patients relying on state programs face a patchwork of regulations and often lack access to safe, consistent products. Federal prohibition stifles a unified regulatory framework, leading to insufficient consumer protections and labeling standards and a hodgepodge system that will eventually hinder interstate commerce. The lack of federal guidance also results in unreliable and inadequate knowledge about medical cannabis, among both the public and healthcare professionals.

Medical cannabis faces challenges beyond the ongoing war on drugs. Historically, botanical medicines have been undermined and systemically removed from U.S. medicine. The current systems for defining medicine have failed to integrate complex plant-based medicines. The FDA approval process was created to regulate single-drug, single-target pharmaceuticals, and cannabis does not fit into this framework. While rescheduling cannabis could be a step forward, it reveals another struggle that medical cannabis advocates have long anticipated—how botanical medicines are researched, approved, and covered by insurance.

Americans for Safe Access (ASA) has advocated for a patient-centric approach, emphasizing the creation of a pathway that would allow medical cannabis to achieve the status of an accepted medicine and remove criminal penalties. Reporting that infers that adult use is the goal of the medical cannabis movement, or that the fate of cannabis medicines is in the FDA drug approval process, not only undermines the work of advocates but also takes the focus off the opportunity for Congress to innovate in our healthcare system.

Congress must establish a national framework to ensure patient safety, product consistency, product quality, and reliable access.

As adult-use cannabis programs have emerged throughout the United States, many assumed these programs would improve access for medical cannabis patients. Unfortunately, these assumptions have proven false.

Data from the Americans for Safe Access (ASA) 2022 State of the States Report: An Analysis of Medical Cannabis Access in the United States, including patient surveys, confirm what patients have been reporting for years: states with adult-use laws are prioritizing recreational markets at the expense of patients and the development of medical cannabis programs.

The needs of recreational adult use and medical cannabis programs are fundamentally different. Beyond shared product safety requirements for the supply chain, these markets require distinct regulatory pathways to meet patient needs effectively. However, the trend in many states is to merge the two programs, neglect medical program improvements, or, worse, roll back patient protections.

While some states offer tax breaks to incentivize participation in medical programs, these savings are often negligible when compared to the high costs of doctor visits and program enrollment fees. Moreover, legislatures rarely provide incentives for businesses to maintain patient-focused products. The combination of federal prohibition and state-level market restrictions forces many medical cannabis businesses to shift to the larger, more lucrative adult-use market to stay afloat. However, this transition means that these businesses move their focus to the larger market (anyone 21 years or older), which affects not only the types of products they produce but also the funds spent on research and development.

ACCESS CHALLENGES

Adult-use programs are restricted to individuals 21 and older, leaving patients aged 18–21 and pediatric patients without access to life-saving treatments, such as those for seizure disorders when adult-use retail replaces medical cannabis dispensaries.

Municipal restrictions often block the development of recreational dispensaries, exacerbating access deserts that are already affecting patients.

Adult-use laws often fail to include employment or parental rights protections, forcing patients to choose between their job and the medicine they need.

Cost-saving measures, such as exemptions from sales or excise taxes, are frequently absent, increasing financial burdens on patients who already pay out of pocket for their medicine.

CIVIL PROTECTIONS

Medical cannabis is a treatment for medical conditions and should be treated as such under the law. Unlike recreational cannabis, medical use deserves the same civil protections afforded to prescription medications. Without these safeguards, patients using cannabis risk discrimination, eviction, and punishment when forced into adult-use programs.

PRODUCT AVAILABILITY & QUALITY

Due to limited market size and restrictions from lack of federal legislation, to be able to sustain their business, many medical cannabis providers have moved to prioritize recreational/adult consumers. This movement diverts products from medical cannabis programs and restricts access to cannabinoid-based medicine for patients.

Medical cannabis patients rely on condition-specific products they know already work for them and are safe for use with other medications they are on. These products may not be found in adult-use markets. These include alternate modes of administration such as suppositories, under-the-tongue sublinguals, and inhalers. Also lacking in adult-use markets are a variety of ratio products such as high-CBD/low THC, 50/50 CBD/THC, and other cannabinoid profiles that medical patients rely on. Patients deserve a safe and consistent supply of medication.

Patients need access to medical cannabis experts to help guide them toward the right chemovar (strain) and mode of administration, as well as to assist with dosing guidelines. Generally, adult-use markets do not require an expert, such as a pharmacist, on staff nor provide this type of employee training.

Patients frequently require larger quantities of cannabis than what is allowed under recreational possession limits.

Despite efforts by Americans for Safe Access to address these issues, progress has been slow. ASA’s Medical Cannabis Equity Checklist outlines essential provisions for ensuring patients remain a priority under dual cannabis programs. However, without broader adoption, these programs risk perpetuating inequities and limiting access to necessary care.

Ultimately, a federal program, including the establishment of a National Office of Medical Cannabis and Cannabinoid Control (OMC), is essential for the evolution of medical cannabis programs. Until then, state programs will continue to face challenges, leaving patients to struggle under imperfect systems.

The ongoing federal prohibition of cannabis has created a fragmented regulatory landscape, leaving patients and consumers vulnerable to inconsistent product quality, safety risks, and exposure to harmful substances. While cannabis is widely regarded as a safe medicine, this assumption largely applies to whole-plant products free from contaminants and adulterants. Unfortunately, cannabis products available across various U.S. markets—regulated, grey, or illicit—often lack comprehensive safety evaluations, clear labeling, or testing for contaminants such as heavy metals, pesticides, or residual solvents. Without a national framework to ensure safety and quality, patients are left navigating a patchwork of state regulations that fail to adequately protect their health and well-being.

The Illusion of Safety

The widespread availability of cannabis products in the U.S. gives consumers and patients a false sense of security. Many assume these products are subject to rigorous safety evaluations, yet in reality:

Contaminants and Adulterants: Cannabis is especially susceptible to contamination during cultivation, manufacturing, handling, and storage. Unscrupulous producers may use harmful pesticides, synthetic additives, or adulterants to enhance weight, fragrance, or potency. Contamination often goes undetected without laboratory testing, and symptoms of exposure may not appear for weeks, months, or even years.

Uneven Regulations: State regulations vary widely in terms of testing protocols, acceptable contaminant levels, and enforcement. For example, only a few states require homogeneity testing to ensure even distribution of cannabinoids in edible products, a crucial measure to prevent accidental intoxication.

Limited Testing: Not all cannabis products sold in regulated markets undergo comprehensive testing. Significant disparities exist between states regarding required tests, contaminant thresholds, and procedures for handling failed tests. Many states also lack robust recall programs, meaning patients may not be notified when contaminated products are discovered.

Labeling Inaccuracies: Inaccurate labels further complicate safety concerns, making it difficult for patients and consumers to know whether a product contains harmful substances, meets potency claims, or adheres to safety standards.

Public Misinformation & Mistrust

Decades of federal "reefer madness" propaganda have left Americans with unreliable sources of information about cannabis. This legacy of misinformation undermines efforts to educate the public on health risks, symptoms of contamination, and drug interactions. As a result, warnings about contaminants and guidance on safe cannabis use are often viewed with skepticism. Without federal oversight, there is no trusted authority to provide consistent, evidence-based information about cannabis safety, further exacerbating public confusion and risk.

Health Risks for Patients & Consumers

Cannabis, in its natural form, is safe for most patients. However, contamination, adulteration, and inconsistent dosing can pose significant health risks:

Accidental Intoxication: Edibles with uneven distribution of THC or delayed onset of effects can lead to unintentional overconsumption, resulting in prolonged and intense intoxication.

Adverse Health Impacts: Contaminants such as heavy metals, pesticides, and residual solvents can harm various body systems, increase cancer risk, and complicate underlying health conditions. These risks are heightened when contaminants interact with prescription medications, which may hinder the body’s ability to eliminate toxins.

Unknown Safety Profiles: Highly concentrated cannabinoids, synthesized compounds, and novel additives in some cannabis products have not been thoroughly evaluated for safety, particularly regarding long-term use.

Impact on Patient Trust & Policy

The lack of consistent safety standards erodes patient trust and increases the likelihood of policy blowback. A public health crisis—real or perceived—related to contaminated or mislabeled cannabis products could lead to restrictive regulations or reduced access for patients. To prevent this, medical cannabis advocates must educate stakeholders on the importance of transparent production practices, use the power of the dollar to reward good actors who seek out robust testing protocols, and demand improved regulations that prioritize patient safety.

To address these critical gaps, Congress must establish a national framework for cannabis safety and regulation. Key priorities include:

Uniform Testing Standards: Develop nationwide requirements for testing cannabis products, including homogeneity, potency, and contaminant levels. Ensure all products undergo laboratory evaluation before reaching consumers.

Comprehensive Labeling Requirements: Mandate accurate and detailed labels that provide cannabinoid content, terpene profiles, contaminant test results, and potential drug interactions.

Recall Programs: Create effective recall systems with track-and-trace capabilities to notify consumers of contaminated products and remove them from the market.

Centralized Education and Guidance: Establish a trusted federal source for evidence-based information about cannabis safety, efficacy, and risks. This should include guidance for healthcare providers on drug interactions and contraindications.

Support for Patient Advocacy: Empower patients with the tools and information they need to make informed decisions about cannabis use and advocate for improved safety regulations.

The current patchwork of state regulations is inadequate to ensure the safety and efficacy of cannabis products. Without federal oversight, patients remain at risk of exposure to harmful substances and misinformation. The Office of Medical Cannabis and Cannabinoid Control (OMC), if Americans for Safe Access model legislation is enacted by Congress, could act decisively to protect patients and create a safer cannabis future. By implementing a national framework for cannabis regulation, we can move beyond the illusion of safety and ensure that every patient has access to high-quality, contaminant-free products that support their health and well-being.

For the last 22 years, ASA has worked with stakeholders across the country to create programs that meet the immediate needs of patients while addressing barriers preventing cannabis from advancing as a recognized medicine in the United States. Many of ASA’s projects and programs were created to address the concerns the Drug Enforcement Administration (DEA) documented in their denials of past rescheduling petitions, including developing product safety protocols for cannabis for human consumption, expanding commercial and research testing capabilities, working with the World Health Organization (WHO) to recognize the therapeutic uses of cannabis, and rescheduling cannabis in international drug treaties.

Today, cannabis-based therapies are providing relief to millions of Americans, often serving as a crucial alternative when conventional treatments have failed or as a safer option compared to pharmaceuticals. So, it shouldn’t have been a surprise when the recent HHS rescheduling review found cannabis has “accepted medical use in the United States.”

However, media coverage speculation that President Biden had initiated the scheduling review as a strategic move for his re-election cast doubt on their findings. DEA questions to the Justice Department’s Office of Legal Counsel (OLC) and comments in the proposed rule for rescheduling showed their skepticism of HHS’ approach, referencing data in HHS’ 2015 “Basis for the Recommendation for Maintaining Marijuana in Schedule I of the Controlled Substances Act” and DEA’s 2016 "Denial of Petition to Initiate Proceedings to Reschedule Marijuana." On July 10th, a group of 25 GOP Senators and Congressmen expressed a similar sentiment in a letter they sent to Attorney General Garland condemning the rescheduling process.

While Schedule III may seem like a large deviation from the recommendations provided by HHS and DEA in 2016, outright dismissing the finding of HHS and DOJ, “currently accepted medical use” does not take into account the enormity of the scientific and medical discoveries that have happened in the time since they were issued as well as the vast societal call for an updated approach to cannabis policy. Here are some examples of changes that happened between the last rescheduling denial and the current rescheduling process:

In 2011, at the time of the filing of the last rescheduling petition, while sixteen states had passed medical cannabis laws, only thirteen of the programs were operating, and only five had operating distribution programs, accounting for 286,243[1] registered medical cannabis patients (excluding WA, CA, HI no data available and DC, DE, NJ not online yet) and estimated 600,000[2] non-registered patients. Today, there are over 6 million patients utilizing the state medical cannabis programs [3].

2015-2022 As HHS noted in their findings and highlighted by the OLC: “Several states have also established processes through which experts can recommend additions to, or removals from, the list of conditions that marijuana may be used to treat, see, e.g., Conn. Gen. Stat. § 21a-408l(a), (c)(1), (d); Or. Admin. Rule 333-008-0090(3)(e), (4)(a)—indeed, HHS has informed us that 17 jurisdictions have added conditions that may be treated with marijuana using such processes; see HHS Part 1 Analysis Memo at 4. In short, it is simply not the case that state practice concerning medical marijuana is completely divorced from scientific and medical assessment.”[4]

April 2016- The Federation of State Medical Boards (FSMB) adopted “Model Guidelines for the Recommendation of Marijuana in Patient Care”[5] and several state medical boards have issued guidelines for physicians to incorporate cannabis into their patients’ treatment regime for example: “Medical Board of California’s Guidelines for the Recommendation of Cannabis for Medical Purposes.”[6]

January 2017- The National Academies of Sciences, Engineering, and Medicine published The Health Effects of Cannabis and Cannabinoids [7], which concluded: " There is conclusive or substantial evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults, as anti-emetics in the treatment of chemotherapy-induced nausea and vomiting, and for improving patient-reported multiple sclerosis spasticity symptoms."

October 2017- The United States declares the opioid crisis a “public health emergency” after reaching an average of “91 deaths a day.”[8]

2017-2018- Connecticut, Washington DC, Florida, Illinois, New Jersey, and New York add pain as a qualifying condition to their medical cannabis program following ASA report, “Medical Cannabis as a Tool to Combat Pain and Opioid Crisis: A Blueprint for State Policy.”[9]

January 2019-The World Health Organization recommends that the United Nations Committee on Narcotic Drugs reschedule cannabis based on “a multi-year review process conducted by the Expert Committee on Drug Dependence (ECDD), an independent scientific advisory body to the WHO. Based on scientific assessment, potential health risk and therapeutic benefit.”[10]

December 2020- “the UN Commission on Narcotic Drugs (CND), the drug policy making body of the UN re-classified cannabis and cannabis resin under an international listing that recognizes its medical value. The CND voted on recommendations made by the WHO’s 41st Expert Committee on Drug Dependence (ECDD), which suggested that cannabis and cannabis resin should be reclassified from its current listing alongside heroin, fentanyl analogues and other opioids considered to be exceptionally harmful to public health.”[11]

January 2023- International Narcotics Control Board (INCB) Report of the International Narcotics Control Board for 2022: “In 2018, WHO carried out a critical review of cannabis and cannabis-related substances and came to the conclusion that these substances can have a therapeutic value. Following the recommendation of WHO, the Commission on Narcotic Drugs decided in December 2020 to remove cannabis and cannabis resin from Schedule IV of the 1961 Convention as amended but to keep it in Schedule I. The 1961 Convention (in its article 28) allows States parties to cultivate and use cannabis for medical purposes under certain conditions. The Convention requires that States license and control cannabis production for medical use, establish a national cannabis agency, provide estimates of the national requirements for cannabis for medical purposes, and ensure that medicinal cannabinoids are used in accordance with evidence on their safety and effectiveness and under medical supervision. As far as the specific control measures for cannabis are observed, these medical cannabis programmes are in compliance with the conventions. However, in some States “medical cannabis programmes” are operated without the necessary I. control required by the conventions or by the standards recommended by WHO in relation to good manufacturing and good prescribing guidelines.”[12]

May 2023- Minnesota Department of Health issues, “Dosing and Chemical Composition Report: A Review of Medical Cannabis Studies Relating to Chemical Compositions and Dosages for Qualifying Medical Conditions."[13]

The current rescheduling process could drag on for years. While POTUS can’t interrupt this process, Congress can utilize the data from HHS’s findings and the experiences of their constituents to pass legislation not only recognizing the medical benefits of cannabis but also facilitating safe access at any time. 

1. Bowles, Daniel W. (2012). "Persons Registered for Medical Marijuana in the United States." Journal of Palliative Medicine, Volume 15, No. 1.
2. Americans for Safe Access (2013, June 13). "What's the Cost."
3. Page 24, Basis for the Recommendation to Reschedule Marijuana into Schedule III of the Controlled Substances Act.
4. Page 20, OLC memo: Questions Related to the Potential Rescheduling of Marijuana
5. Federation of State Medical Boards. "Model Guidelines for the Recommendation of Marijuana in Patient Care."
6. Medical Board of California. "Guidelines for the Recommendation of Cannabis for Medical Purposes."
7. National Academies of Sciences, Engineering, and Medicine (2017). The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research.
8. S. Government Accountability Office (2018). "Opioid Crisis: Status of Public Health Emergency Authorities."
9. Americans for Safe Access (2017). "Medical Cannabis as a Tool to Combat Pain and Opioid Crisis: A Blueprint for State Policy."
10. World Health Organization. "Extract from the Report of the 41st ECDD: Cannabis and Cannabis-Related Substances."
11. World Health Organization (2020, December 4). "UN Commission on Narcotic Drugs Reclassifies Cannabis to Recognize Its Therapeutic Uses."
12. International Narcotics Control Board (2022). Report of the International Narcotics Control Board for 2022, Chapter I.
13. Minnesota Department of Health (2023). "Dosing and Chemical Composition Report: A Review of Medical Cannabis Studies Relating to Chemical Compositions and Dosages for Qualifying Medical Conditions."

SHEDDING THE PROHIBITION MINDSET: A NEW FRAMEWORK FOR MEDICINE & PUBLIC HEALTH

The September 2024 National Academies' report "Cannabis Policy Impacts Public Health and Health Equity," sparked cannabis-focused public health discussions in the media, and that dialogue was further elevated by the popular New York Times' October 4, 2024 article, "As America’s Marijuana Use Grows, So Do the Harms." While the piece offered some valuable information for consumers, it portrayed cannabis primarily as a harmful substance without providing a deeper investigation into the source of the reported complaints and did little to evaluate how we could approach cannabis public health differently.  Similarly, the recent "Changes in Self-Reported Cannabis Use in the United States from 1979 to 2022," published in Addiction, inspired the Washington Post’s October 16, 2024 editorial by Dr. Leana S. Wen, "Marijuana Use is Rising. The Government Needs to Correct its Mistake," which reinforced a similarly narrow drug-abuse perspective, overshadowing critical insights into the complexity of cannabis use.

Due to a near complete lack of federal oversight and data collection, it is unclear if the negative experiences Americans are having with “cannabis products” are from cannabis, hemp, or synthetic products, or contaminants such as heavy metals, pesticides, and residual solvents often found in unregulated or poorly regulated cannabis/hemp products. Thanks to decades of the federal government’s “reefer-madness” propaganda and prohibition, Americans still do not have a source they can trust when it comes to information about cannabis.  This means efforts to spread health warnings, educate on contaminants and cannabis harms, and even guidance on drug interactions are viewed by the public with immense skepticism.

Addressing the Use v Abuse Paradox

Under prohibition, all data collected on cannabis consumers by the National Institute for Drug Abuse (NIDA), the Drug Enforcement Administration (DEA), the International Narcotics Control Bureau (INCB), and the United Nations Committee on Narcotic Drugs (UNCND) was categorized as “abuse.”  Any “use” of illicit substances is viewed as abuse under a prohibition model, think cocaine, methamphetamines, etc. Through NIDA, the United States has funded billions of dollars to prove the harms of cannabis while underfunding studies that explore its therapeutic utility. So, it should be no surprise that data from this vantage point (i.e., looking at cannabis harms) dominates the number of research findings in comparison to those exploring its benefits. This can also be seen in how these agencies are responding to the increase of individuals “using” cannabis.

The framing of “Cannabis Use Surpassing Alcohol Use” in the US is deceptive and only serves the same stakeholders of prohibition, treatment centers, researchers exploring the harms of cannabis, and raising stock prices for businesses selling cannabis.  Why is this the only comparative data set where we compare a non-medical substance like alcohol to a medical one like cannabis? Their use cases are not the same; it is a clear apples-to-oranges comparison. 

We know from empirical data that healthcare costs are going down in states with medical cannabis laws, especially as it relates to other prescription drug use; we know that millions of Americans suffer from conditions that are not treated by options available in our current healthcare system.  

Many Americans turn to cannabis for conditions that traditional healthcare options cannot address. A study in ACR Open Rheumatology, "Substituting Medical Cannabis for Medications Among Patients with Rheumatic Conditions in the United States and Canada*," found that 62.5% of participants substituted medical cannabis for medications, with 54.7% replacing NSAIDs, 48.6% opioids, 29.6% sleep aids, and 25.2% muscle relaxants. Following substitution, most reported a reduction or cessation in their use of these medications.

*Boehnke, K.F., Scott, J.R., Martel, M.O., Smith, T., Bergmans, R.S., Kruger, D.J., Williams, D.A. and Fitzcharles, M.-A. (2024), Substituting Medical Cannabis for Medications Among Patients with Rheumatic Conditions in the United States and Canada. ACR Open Rheumatology. https://doi.org/10.1002/acr2.11717

Rethinking “Cannabis Use Disorder”

The rush to classify daily cannabis use as “Cannabis Use Disorder” and promote abstinence-only treatments overlooks the possibility of self-medication as a motivation. The idea that regular use, tolerance, and dependence would be enough to characterize something as abuse ignores the pharmacology of countless medications that create the same circumstance and do not have their own “use disorder.” There is a need for education and investment in research to provide better guidance rather than blanket assumptions and broad strokes about cannabis use.

If the U.S. had heeded the research recommendations of the National Academies' 2017 report, medical and public health professionals would have more tools at their disposal to discern the real harms from the benefits of cannabis and better educate and inform the public.  Today, there is a real risk of the outsized federal research funds that have previously been allocated to proving harm under prohibition moving directly into efforts to prove harm under the public health context. This sort of hyperfocus on harm is a risk to advancing cannabis-based medicines, leaving initiatives like the Medical Marijuana & Cannabidiol Research Expansion Act of 2022 without funding. While both areas deserve funding, and no substance is without its risks and harms, an understanding of the benefits of cannabis is likely to yield a better understanding of why people use cannabis and the best approach to address risks.

As for a better understanding of the harms of synthetic cannabinoids and those being manufactured (i.e., synthesized, not extracted) from hemp, the companies selling these products are responsible for proving they are safe rather than the US taxpayers doing that work for them. If only there was a federal agency responsible for consumer protection for novel drugs, hmm?

The status quo cannot stand. It is clear, that there is a need for regulations in and around cannabis that are not being served by the existing regulatory framework.  To address this voice, ASA has proposed creating an Office of Medical Cannabis and Cannabinoid Control (OMC) within the Department of Health and Human Services (HHS) to regulate cannabis as a medicine. This approach includes the creation of a new “Schedule VI” specifically for cannabis, which would remove all criminal penalties (i.e., decriminalization), establish safety protocols (i.e., standards), and promote a national medical cannabis program (i.e., equitable access).

The proposed national program draws on the success and lessons of state-based models, incorporating input from patients, regulators, researchers, healthcare professionals, and international programs. The goal is to provide a regulatory framework that ensures quality, access, and integration with broader healthcare systems.

The OMC will serve as a Central Research Authority:

By directing research through a centralized body focused explicitly on studying cannabis-based medicine, the U.S. can move beyond outdated and fragmented efforts, create a clearer picture of cannabis’ medical potential, enhance patient care through evidence-based treatments, and set a better framework to evaluate and address any harms associated with cannabis use.

• Standardized Research Protocols: Develop consistent methodologies, terminology, and data collection guidelines to enhance research quality and comparability across studies and institutions.
• Integrated Research Agenda: Coordinate efforts across federal agencies, aligning with national health priorities and directing resources toward critical research questions, such as cannabis’ effects on vulnerable populations (e.g., children, elderly, and pregnant women).
• Research-Grade Cannabis Standards: Establish guidelines for standardized cannabis products, ensuring reliable, high-quality materials for clinical studies.
• Public Health Surveillance: Include cannabis-related questions in national health surveys to track usage patterns, health outcomes, and potential risks.
• Focus on Safety and Efficacy: Prioritize studies on the safety, quality, and medical potential of cannabis, enabling a comprehensive understanding of its therapeutic applications.

Why Schedule VI?

• Correcting Misclassification: Cannabis was placed in Schedule I for political reasons in 1970. Schedule VI would reflect cannabis therapeutic benefits and abuse profile, allowing for tailored regulations but removing it from DEA jurisdiction.
• Recognition of Botanical Medicine: Cannabis, with its complex blend of active compounds, requires unique regulations that do not fit the traditional pharmaceutical framework established by the FDA.
• Support for Patient Needs: Schedule VI would ensure regulations that address the distinct needs of patients using cannabis as medicine and protect patients’ medical rights in restrictive states.

The Medical Cannabis and Cannabinoid Act (MCCA) is a groundbreaking proposal developed by Americans for Safe Access with input from patient organizations, regulators, researchers, and medical professionals. Its enactment will bridge the gap between research, the experience of patients, product development, and medical professional education to better serve patient populations and will unify medical cannabis and cannabinoid policies. MCCA will centralize medical oversight, providing the necessary framework to support the evolving landscape of medical cannabis while ensuring that all Americans have access to the therapeutic benefits of cannabis with high safety standards.

While not widely debated in Washington, among cannabis businesses and activists, there is a strong push to fully deschedule the cannabis plant, removing it from the Controlled Substances Act altogether. Not only is this unlikely, but this “deschedule or bust” approach to cannabis policy not only prevents seeking more viable solutions with the same desired impact but is also often based on a misunderstanding of what descheduling actually does, and lacks consideration of the real-life implications.

Descheduling does not mean an unregulated free market: The laissez-faire relationship both Hemp and Cannabis have at the federal level is not going to last, and if we do not create an oversight body to treat cannabis differently than prescription drugs, tobacco, or alcohol, then all cannabis plant stakeholders will lose. The financial pressures on those driving the cannabis and hemp markets have replaced long-term vision with inaccurate soundbites to generate headlines for the next quarter.

Descheduling does not mean decriminalization: The Controlled Substances Act (CSA) is only one section of criminal law statutes. If cannabis is regulated under the FDA like tobacco, it would be descheduled. However, any possession, cultivation, manufacturing, or distribution outside of the narrow allowance of the FDA would be subject to criminal penalties. Case in point, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act’s legislative intent is, “To decriminalize and deschedule cannabis, to provide for reinvestment in certain persons adversely impacted by the War on Drugs, to provide for expungement of certain cannabis offenses.” creates a new set of criminal penalties “SEC. 5942. Criminal penalties. (a) Fraudulent Offenses —Whoever, with intent to defraud the United States— (1-5) shall, for each such offense, be fined not more than $10,000, or imprisoned not more than 5 years, or both.”

The Need for Codification: In reality, simply descheduling cannabis does little to protect patients or their rights. Imagine cannabis is federally descheduled, yet you live in a restrictive state like North Carolina. The initial impression may be, “this is legal,” but legality would ultimately depend on state law, as federal descheduling provides no direct protections. Even if cannabis is descheduled, North Carolina, for example, would still not recognize it as medicine. As a medical cannabis patient traveling from a neighboring state, you could still be criminalized for possessing your medicine. Without Schedule VI status (or another form of medical codification), nothing would prevent states like North Carolina from treating patients as criminals. Descheduling removes cannabis from the CSA and leaves regulation to the states, a unique and inconsistent approach for a medicinal product.

However, a Schedule VI classification could help resolve these issues by formally codifying cannabis as medicine and extending protections for patients under the Americans with Disabilities Act. This approach would prioritize patient rights alongside business interests, creating a framework that balances commercialization with the essential protections that patients deserve.

The Cannabinoid Safety & Regulation Act (CSRA), a recent legislative proposal to regulate hemp products, creates a dangerous path for cannabinoid regulations. Like legislative proposals for adult cannabis use, the bill proposes creating a center for cannabinoid products in the FDA, using language similar to the 2009 Tobacco Control Act, which made the Center for Tobacco Products and gave the FDA regulatory authority over tobacco. 

While the legalization of recreational cannabis (i.e., marijuana) and descheduling bills like the Cannabis Administration and Opportunity Act (COA) and the Marijuana Opportunity Reinvestment and Expungement (MORE) Act are still likely years away, Congress is feeling the immediate pressure to regulate hemp products after the 2018 Farm Bill legalized a market without fully defining hemp products. But handing off cannabis to the FDA, which has already admitted they don’t have the bandwidth or the model to properly regulate CBD, could prove to be a disastrous decision for the businesses as well as patients.

Putting cannabis and cannabinoids under the FDA would reinforce roadblocks to cannabis’ future as a recognized medicine. While regulations for cannabis and hemp are paramount, misguided policies could place cannabis under unattainable FDA pharmaceutical regulations, putting patients back where they started 25 years ago, creating new barriers to access, and potentially a new illicit market.

We need only look at nicotine regulation for a cautionary example: since the FDA assumed control in 2009, smoking rates have declined, but vaping rates have soared unchecked. The FDA restricted flavored nicotine products and mandated registration for e-cigarette products, pledging not to approve flavored options that might appeal to youth. Yet despite these efforts, more flavored e-cigarette products than ever flood smoke shops, often bypassing legal channels and operating in an even less regulated space. If the FDA gains similar control over cannabis, expecting a different outcome would be unrealistic—especially in light of the complex history of cannabis prohibition.

These complex layers are crucial to understand and to press elected officials about policies that redefine medicine in the United States that would allow cannabis to be treated as a medicine and not pushed down the same bumpy path as nicotine products or stuck in an unrealistic pathway for medicine.

The Food and Drug Administration (FDA) is, at its core, a consumer protection agency. It was created to monitor labels for food and drugs for accuracy and to ensure they are free from adulterants. For medicines, the power of monitoring labels evolved into evaluating health claims that led to the pathway for FDA drug approval. “FDA Approved” has become synonymous with “medicine” in US healthcare systems.

The current FDA drug approval process is based on the single path transduction model (“single-target/single-drug”), which has successfully delivered many valuable one-size-fits-all treatments to the public. In other words, the model is based on isolating a single compound (often from a plant) and standardizing it for prescription use. This method has been applied to “cannabinoids” found in the cannabis plant by isolating and even synthesizing single compounds; the result has been widely reported as subpar to the natural product, which is reflected in patient uptake of these medications compared to botanical cannabis.

The FDA currently lacks a clear pathway for approving and regulating botanical medicines like cannabis. It is disingenuous for the FDA to point to the “Botanical Drug Development Guidance for Industry”  as a solution for cannabis medicines when, in the same document, they admit its limitation for “multi-target/multi-component” to achieve drug approval: “The Agency recognizes that demonstrating each botanical raw material’s contribution to safety and efficacy in a product with multiple botanical raw materials may not always be feasible.” This is also why, in the twenty years since the FDA released this guidance document, only three extractions have achieved drug approval, and all three are categorized as single-compound therapeutics.

Medical cannabis requires a unique oversight structure that considers its botanical nature, varied formulations, and individualized usage. Creating an Office of Medical Cannabis and Cannabinoid Control (OMC) within HHS, separate from the FDA regulations and DEA oversight, would allow for a regulatory body dedicated to developing safety standards, research priorities, and patient access programs tailored to medical cannabis.