In a historic move, the Drug Enforcement Agency (DEA) has initiated the process to classify marijuana as Schedule III. (For those of you who don’t know, marijuana is any part of the cannabis plant that has THC content greater than 0.3%). After a recommendation by the Department of Health and Human Services (HHS), this move acknowledges that cannabis has medicinal value.
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Consequently, universities and other research institutions will have better access to the plant. US Tax Code 280E, disallowing deductions for normal business expenses, will be repealed. However, Cannabis will remain a controlled substance. The Food and Drug Administration (FDA) has not established the safety and efficacy of the plant, and despite a high rate of acceptance by States and territories, it’s likely that the federal government will create speed bumps and hurdles along the way.
The good news is that we’ve come a long way…
In 1937, the US Congress prohibited cannabis by the Marihuana Tax Act (MTA). The MTA, combined with Reefer Madness, essentially forced the use of cannabis underground. Thirty years later, psychologist Timothy Leary fought back. After being arrested for transporting cannabis across the border, Dr. Leary challenged the MTA and won.
The Supreme Court deemed the MTA unconstitutional in Leary vs the United States. Although Congress repealed the MTA, it quickly enacted the Controlled Substances Act (CSA), another prohibitive Cannabis law. Cannabis was to remain classified for fifty-four more years as a Schedule 1 drug.
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In October 2022, President Joe Biden called for a scientific and medical evaluation of cannabis by the HHS. Currently, 88 percent of American adults agree that cannabis should be permitted for medical use. Thirty-eight states, the District of Columbia, and four federal territories have legalized the use of medical marijuana. Biden also gave cannabis users a symbolic nod of approval by pardoning the Americans who were federally convicted of simple cannabis possession.
On August 29, 2023, HHS recommended to the DEA that marijuana be moved to Schedule III. The compelling reasons were that more than 30 thousand healthcare practitioners across 43 jurisdictions recommend Cannabis to more than six million registered patients for at least 15 medical conditions. On May 16, 2024, the DEA initiated the process for rescheduling, a historic move that acknowledges cannabis as medicine.
The bad news is that the feds will drag their feet…
Ask physician and scientist Dr. Sue Sisley. She tried performing a clinical trial on whole-plant cannabis under Schedule I and ran into delays. After ten years of bureaucracy, she was given moldy cannabis with stems, sticks, and leaves.
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In their rescheduling proposal, the Department of Justice (DOJ) notes that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” Sounds to me like they are predicting doom even before the studies have started. Although Schedule III is less restrictive than Schedule I, it continues to limit access to community-sourced cannabis.
Will scientists run into the same bureaucratic resistance under Schedule III? The DEA or its legal agent must have physical possession and ownership of Schedule III cultivated cannabis and assume control of distribution within four months of harvest. There are currently seven DEA-approved bulk cannabis suppliers in the United States. On the other hand, products sourced from state-authorized adult-use and medical-use programs are subject to a patchwork of inconsistent standards and safety requirements. FDA clarified that the analysis and conclusions on the available data are not meant to imply that cannabis safety and effectiveness have been established. In other words, we have a long way to go.
Do we really need federal approval?
After hundreds of botanical drug applications, only two have been approved by the FDA. As Schedule III, cannabis would remain subject to provisions of the Food and Drug Cosmetic Act (FDCA). For example, a drug containing cannabis would need FDA approval to be lawfully introduced into interstate commerce. I’m proposing that the best route to federal approval is to create a distinct regulatory pathway for cannabis, thereby bypassing FDA standards not suited for plant-based medicine.
Forty-five US states, territories, and sovereign nations have already established cannabis regulatory agencies, and the industry is unlikely to reverse paths. Cannabis is already subject to state laws that have allowed a multibillion-dollar industry to develop. The DOJ acknowledges that this change may have large impacts related to federal taxes, research, and development investment, among other things. However, the manufacture, distribution, dispensing, and possession of cannabis will also remain subject to applicable criminal prohibitions under the CSA. The DOJ also realizes that rescheduling may have unique economic impacts and is seeking comments prior to rescheduling.
As a physician involved in cannabis research, I don’t have a Schedule I license, and I’m happy to no longer need one. Where I practice, most people access cannabis from a neighbor or grow their own. California also has state-approved dispensaries for anyone over 21 years old. My patients will very likely reject the idea of federally approved cannabis. Why would they trust a restrictive process that has historically produced questionable quality?
I study real-world cannabis produced and used in the community. Despite almost a century of prohibitive laws and top-down suppression, cannabis remains a viable grass-roots commodity valuable for health, well-being, and industry. That will never change.
*This op-ed was submitted by a guest contributor. The author is solely responsible for its content.