Industry Self-Regulation & Safe Access to Medicine: A Conversation with Joe Robinson of PsiloSafe
This past Wednesday at The District House, we welcomed Joe Robinson, Founder of PsiloSafe, for an in-depth interview with Hannah Jo. Together, they tackled one of the most urgent issues in the psychedelic movement today: how do we keep people safe in an unregulated, prohibition-era marketplace?
Joe, a 20-year healthcare veteran who once held executive positions at leading pharmaceutical companies, knows the stakes firsthand. After transitioning into earth-based medicines through his company CC Brands, he founded PsiloSafe to set standards where none yet exist.
In the U.S., psilocybin remains a Schedule I substance, and legal change is moving slowly. Meanwhile, public interest is accelerating. Consumers are purchasing mushroom products through “traditional” underground channels, where quality, safety, and transparency are inconsistent at best.
Joe emphasized that we don’t have time to wait for the powers that be to overhaul federal or state laws. The grey market is here now, and with it comes the responsibility to protect those who are seeking healing and transformation.
As Joe put it, “PsiloSafe is one way to create safety—by setting the standard for safety.”
PsiloSafe is an industry self-regulating organization (SRO) working to establish safety standards for psilocybin products. Their mission is simple but powerful:
Establishing safety standards for psilocybin products to mitigate risk.
Supporting responsible producers, brands, and consumers with self-regulation that promotes transparency and quality control.
Believing in the profound potential of Earth Based Medicine to heal and transform lives.
PsiloSafe operates by working with responsible partners and producers to build a framework that positions outcomes over profits, while offering a practical roadmap for regulators when the time comes.
Joe described two emerging treatment paths:
The medical model – rooted in clinical trials, FDA approvals, and insurance reimbursement. While promising for some, critics argue that psychedelics may never fully fit within the rigid structures of Western medicine.
The traditional access model – rooted in underground practice and community-based healing. This path currently offers broader access but carries greater risk in the absence of regulation.
PsiloSafe is working to bridge the gap by setting standards today, ensuring that consumers and producers alike can navigate this landscape more safely.
Psychedelics are in the spotlight as people search for natural alternatives to pharmaceuticals for mental wellness. Yet prohibition increases risks by funneling demand into unregulated channels. Mislabeling, research chemicals disguised as psilocybin, and inconsistent dosing all endanger consumers.
By implementing safety standards, PsiloSafe Verified creates trust and transparency—ensuring that individuals know what they’re buying, consuming, and integrating into their healing journey.
For producers, PsiloSafe Verified offers a way to stand apart from less scrupulous brands. By adhering to consistent testing, accurate labeling, and dependable dosing, verified producers build loyalty and credibility.
This commitment not only protects consumers but also positions producers as leaders in shaping the future framework for psychedelic regulation.
PsiloSafe is structured as a 509(a) nonprofit, dedicated to promoting safety in the absence of government oversight. Their work centers on:
Good manufacturing practices for psilocybin products
Consistent testing for purity and potency
Accurate labeling and dosing information
Risk mitigation practices for producers and consumers alike
At its heart, PsiloSafe advocates for the right of all humans to access plants and fungi—for healing, expanding consciousness, and living in harmony with nature.
The psychedelic movement is at a tipping point. Interest is surging, access is expanding through traditional channels, and risks are mounting. As Joe Robinson reminded us at The District House:
“The time for oversight is now, and we can do it ourselves.”
At District216, we’re grateful to be in community with thought leaders like Joe, who are setting the foundation for safe, responsible, and conscious access to earth-based medicine.
💜
