The FDA's Groundbreaking Recommendation for Cannabis
In a significant development, the U.S. Food and Drug Administration (FDA) has taken a historic step by supporting the reclassification of cannabis as a Schedule III substance. This move, documented in a comprehensive 252-page report, could revolutionize the medical cannabis landscape, equating it with regulated substances like hormone replacement therapy or ketamine.
Understanding the Reclassification Proposal
The FDA's recommendation to the U.S. Drug Enforcement Administration (DEA) suggests shifting cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). This reclassification is based on an Eight Factor Analysis, which concludes that cannabis "has a currently accepted medical use in treatment in the United States" and is not an immediate precursor of another controlled substance.
The analysis considers various aspects, including the potential for abuse, pharmacological effects, scientific knowledge, history and pattern of abuse, public health risks, and dependence liability. The FDA's documents highlight that 43 U.S. jurisdictions currently authorize the medical use of cannabis, acknowledging its medical value.
Impact of Schedule III Classification
Reclassifying cannabis as a Schedule III substance, defined as having a "moderate to low potential for physical and psychological dependence," would bring significant changes. It would place cannabis in the same category as Tylenol 3, ketamine, anabolic steroids, and testosterone, all of which require prescriptions and are heavily regulated. This change would also mean that Internal Revenue Code 280E (IRC 280E) would no longer apply to cannabis businesses, allowing for tax deductions and other financial benefits.
However, it's important to note that this reclassification would not automatically legalize state-level cannabis programs. It would, instead, create a more conducive environment for research and development in the field.
Reactions from the Cannabis Industry
The National Cannabis Roundtable (NCR) and other industry players have welcomed this development. Saphira Galoob, Executive Director of the NCR, emphasized the positive impact on tax burdens and operational reinvestment for cannabis companies, especially small and minority operators.
Industry leaders like Wurk CEO Deborah Saneman and Socrates Rosenfeld, co-founder and CEO of Jane Technologies, have also expressed their support. They acknowledge the progress towards dismantling cannabis prohibition and recognize the medicinal and societal benefits of the plant.
Brady Cobb, a lobbyist and CEO of Sunburn Cannabis, shared a personal perspective, citing the report as a vindication and a significant step forward in cannabis reform.
The Path to Reclassification
The push for reclassification gained momentum following President Biden's directive on October 6, 2022, urging federal agencies to consider reclassifying cannabis. This directive led to various organizations and businesses providing feedback on the FDA's proposal.
The initiative was partly driven by attorney Matthew C. Zorn's efforts, who used a Freedom of Information Act (FOIA) request to obtain the rescheduling memo. This move follows a pattern of legal actions aimed at facilitating medical cannabis research and challenging the federal government's stance on cannabis.
On August 29, 2023, the U.S. Department of Health and Human Services (HHS) recommended to the DEA the reclassification of cannabis from Schedule I to Schedule III, marking a pivotal moment in the journey towards cannabis reclassification.
Opening Doors to Cannabis Research
The reclassification to Schedule III would significantly impact cannabis research, enabling more comprehensive and diverse studies. This change is eagerly anticipated by the industry, as it would provide new opportunities for scientific exploration and innovation in the field.
The industry is now closely watching the DEA's response to the recommendations from the HHS and FDA, as this decision could reshape the future of cannabis in the United States.