Navigating the Future of Medical Cannabis: Insights from Americans for Safe Access on the Cannabis Rescheduling Proposal
Focusing on the potential effects for medical cannabis patients, Americans for Safe Access held a high-level presentation and discussion on the rescheduling of cannabis.
Doctor writing on prescription blank and bottle with medical cannabis on table close up | Image Credit: © Africa Studio - stock.adobe.com
On May 17, 2024, Americans for Safe Access (ASA), held a briefing on the Department of Justice’s proposed rescheduling of cannabis, which was announced in a press release on May 16, 2024. Leading the discussion was Steph Sherer, founder and President of ASA, and contributing to the discussion was Pamela N. Epstein, Esq., LLM, Chief Legal and Regulatory Officer at Terpene Belt, Inc. and medical cannabis patient. Americans for Safe Access describes itself as “the largest national member-based organization of patients, medical professionals, scientists, and concerned citizens working to overcome political, social, and legal barriers to improve access to medical cannabis for patients and researchers.”
One of the unifying themes of this hour-long discussion was moving from the decades-old push to establish the medical value of cannabis to the new task of helping medical cannabis patients safely access their medicine. As Sherer stated, “We're all fighting for a day that you could actually just take your medicine without having to understand the nuances of every of every regulation.”
As Sherer commented, the proposal from the Department of Justice to move cannabis from Schedule 1 to Schedule 3 is not black and white; there are many complexities and variables. Sherer and Epstein covered many topics including details of the proposed amendments to the scheduling of cannabis, including how it applies to hemp and the definitions of “marijuana”; the many anticipated reactions from the Drug Enforcement Administration (DEA); the significance of cannabis rescheduling at the United Nations; the next steps in rescheduling and the organizations involved; the effect of an election year; the important role of Congress; ASA’s alternative proposed path of regulating cannabis; and how attendees can take action through ASA’s newly launched Compassionate Candidate Campaign to contact elected representatives as they address these issues.
Chart of the DEA's Proposed Scheduling Approach according to Americans for Safe Access | Image Credit: © Americans for Safe Access
In particular, Sherer and Epstein noted how certain cannabinoids will be classified. Epstein commented, “there's a lot that we don't know yet. So it's important to use this as a signpost of the direction of where we're going. In here we're really starting to see the DEA lean harder into what is tetrahydrocannabinol and separating it out from marijuana. When they take tetrahydrocannabinol and they remove the temporary ones and the fact that they added temporary ones is very telling that we're honoring the plant separate and apart from its lesser known and synthetic equivalents.”
Importantly, Sherer noted that, “there's actually nothing legally protecting the adult use market. There's nothing written from Congress. There's no direction from the Department of Justice. The lack of enforcement of Schedule 1 laws is really at the whim of POTUS, the President of the United States, at this point. This includes the manufacturing, distribution, dispensing, and possession. It would all remain applicable, the criminal provisions of the Controlled Substances Act (CSA). Any drugs containing a substance within the CSA would remain subject to the Food Drug and Cosmetic Act.”
Several slides in the presentation addressed how cannabis reclassified as a Schedule III drug concerns medical cannabis patients. This included potentially removing stigma and discrimination, which means patients could have more open conversations with their medical providers. However, several other aspects would still need to be addressed, such as the lack of Food and Drug Administration (FDA) approval of cannabis as a medicine.
Attendees had the opportunity to ask questions during the presentation. Topics included ASA’s recommended messaging for submitting public comments, the DEA’s five point standard for accepting that a drug has medical use, and the consideration of terpenes compared with cannabinoids in the rescheduling discussions.
The next steps in cannabis rescheduling, starting at Proposed Rule | Image Credit: © Americans for Safe Access
Cannabis, US Presidential Election 2024, and Beyond: A Roundtable Discussion, Part II
December 17th 2024With the recent 2024 presidential election behind us, the future of cannabis still has many unknowns moving forward and questions still to be discussed. In this roundtable discussion with four knowledgeable industry leaders, we explore the nuanced political landscape of cannabis legalization and rescheduling in the context of the election, including state and federal policies and possible paths forward for testing standardization. Join us in the second part of a compilation of responses from Kim Anzarut, CQA, CP-FS, CEO of Allay Consulting; Susan Audino, PhD, founder of S.A. Audino & Associates, LLC; Zacariah Hildenbrand, PhD, research Professor at the University of Texas at El Paso; and David Vaillencourt, CEO of The GMP Collective.
Cannabis, US Presidential Election 2024, and Beyond: A Roundtable Discussion, Part I
December 16th 2024With the recent 2024 presidential election behind us, the future of cannabis still has many unknowns moving forward and questions still to be discussed. In this roundtable discussion with four knowledgeable industry leaders, we explore the nuanced political landscape of cannabis legalization and rescheduling in the context of the election. We discuss what drives support or opposition from both sides of the aisle, the complexities of balancing state and federal priorities, and more. Join us in the first part of a compilation of responses from Kim Anzarut, CQA, CP-FS, CEO of Allay Consulting; Susan Audino, PhD, founder of S.A. Audino & Associates, LLC; Zacariah Hildenbrand, PhD, research Professor at the University of Texas at El Paso; and David Vaillencourt, CEO of The GMP Collective.
Work Smarter, Not Harder: How ASTM Standards for Cannabinoids Improve Your Operations
December 3rd 2024ASTM Standards D8557-24 and D8556-24, provide unified guidelines for GMP (Good Manufacturing Practices) and QMS (Quality Management Systems) in cannabis operations. These standards enhance compliance, product safety, and operational consistency across the industry for the benefit of operators, consumers, and other stakeholders in the industry.
