The psychedelics industry reached a historic turning point in late August 2025 when the U.S. Drug Enforcement Administration (DEA) announced it would forward a petition to reschedule psilocybin to the U.S. Department of Health and Human Services (HHS) for scientific review. For decades, psilocybin, the psychoactive compound in “magic mushrooms,” has been classified as a Schedule I substance, deemed to have “no accepted medical use” and a high potential for abuse. Now, for the first time, the DEA is officially engaging the scientific process that could shift psilocybin to Schedule II, opening pathways for research, medical use, and regulated therapeutic access.
Among the voices applauding this milestone is Psylutions, Colorado’s first licensed cultivator and manufacturer of regulated psilocybin mushrooms. Founded with a mission to combine scientific rigor, patient safety, and access to healing, Psylutions has positioned itself at the forefront of a movement where policy finally begins to align with science.
Why the DEA’s Action Matters
The DEA’s referral to HHS represents more than bureaucratic procedure; it is a signal that the era of blanket prohibition may be coming to an end. Should HHS recommend rescheduling, patients in palliative care and veterans who have PTSD could gain access under pathways like Right to Try. Clinical researchers would also face fewer barriers in studying the therapeutic potential of psilocybin.
“We commend the DEA’s decision to move the psilocybin rescheduling petition to HHS for scientific review. This crucial step reflects a long-overdue alignment between policy and science and brings healing one step closer to those who need it most,” said Rhonda DeSantis, founder of Psylutions.
This alignment is particularly meaningful in Colorado, where voters and lawmakers have already created a state-regulated framework for psychedelics. Licensed healing centers operate legally in the state yet struggle to navigate the ongoing tension between state-level legality and federal prohibition. Rescheduling would help bridge that gap, creating consistency for patients, clinicians, and providers.
Psylutions’ Role in Building Infrastructure for Access
Founded in Denver, Psylutions is the first company licensed by the state of Colorado to cultivate and manufacture psilocybin for regulated use. Its mission is summed up in three words: Precise. Verified. Effective.
The company has invested heavily in infrastructure to meet the highest standards of safety and reproducibility, including:
- Strain optimization to ensure consistent potency and predictable therapeutic outcomes.
- Lab-verified dosing, a critical step in moving psychedelics from folk medicine to evidence-based therapy.
- Triple HEPA filtration systems to mitigate contamination risks during cultivation.
By prioritizing scientific rigor, Psylutions has created products designed not only to meet regulatory standards but to earn the trust of clinicians, researchers, and patients. Today, Psylutions already partners with over half of the licensed healing centers operating in Colorado, supplying psilocybin for use in treatments for chronic pain, trauma, end-of-life care, and broader wellness applications.
“Once regulators reschedule psilocybin, patients with serious illnesses and veterans facing mental health challenges will have safe, legal access through Right to Try,” DeSantis said. “At Psylutions, we’re making sure that access comes through treatments that are effective, carefully tested, and responsibly produced.”
A Watershed Moment for Psychedelics
For Psylutions’ leadership, the DEA’s move is more than incremental progress—it is a signal of a fundamental shift.
“As agencies begin engaging with medical evidence over stigma, we are entering a watershed moment for psychedelics,” said Henry Baskerville, general counsel and partner at Psylutions. “I believe psychedelics hold even greater potential for significant medical applications than cannabis, but it is critical to approach this transition with the highest standards grounded in legal integrity and patient safety.”
Baskerville’s comments highlight the unique responsibility companies like Psylutions face as the psychedelic industry moves into mainstream medicine. Unlike cannabis, where commercialization often raced ahead of clinical validation, psilocybin enters the spotlight in an era where policymakers, clinicians, and the public are actively demanding evidence-based safety and efficacy.
The Broader Context
The timing of this milestone coincides with a broader wave of psychedelic reform:
- State-level legalization: Colorado and Oregon have established frameworks for legal psilocybin services, and other states are considering similar models.
- Federal research expansion: Universities and institutions across the U.S. are accelerating clinical trials on psilocybin for depression, PTSD, and addiction.
- Public opinion: Polling shows strong and growing support for regulated psychedelic access, particularly in the context of treatment-resistant conditions and end-of-life care.
Against this backdrop, the DEA’s move to reschedule psilocybin represents a crucial first step toward a national policy that aligns with both science and public sentiment.
What Comes Next
If psilocybin is rescheduled, the immediate impacts will include:
- Expanded research opportunities: Universities and biotech companies will face fewer hurdles in securing funding and conducting studies.
- Medical pathways for patients: Palliative care and veteran populations could access psilocybin under existing federal frameworks, such as Right to Try.
- Accelerated clinical adoption: Licensed clinicians and healing centers would benefit from streamlined compliance, paving the way for insurance coverage in the future.
Psylutions is already preparing to meet increased demand by expanding its strain library and partnerships with healing centers. "As access grows, safety, transparency, and successful patient outcomes will be paramount,” said Baskerville.
From Stigma to Science
Psilocybin’s journey from stigmatized Schedule I drug to a potential Schedule II medicine represents a profound cultural and scientific shift. While much work remains, including rescheduling, establishing a regulatory framework, and clinical adoption, the momentum is undeniable.
Companies like Psylutions demonstrate how strong partnerships, infrastructure and production standards can ensure that, as this transition unfolds, patients receive therapies that are precise, verified, and effective. As DeSantis put it, “This crucial step reflects a long-overdue alignment between policy and science and brings healing one step closer to those who need it most.”
