Letter to the Editor: Centralized Federal Gatekeeping Isn’t the Only Way to Ensure Safety

Gottlieb argued that preserving Food and Drug Administration oversight of psychedelics and cannabis represented a “healthy balance.” But that framing assumes centralized federal gatekeeping is the only way to ensure safety. It isn’t — and it comes with real costs.

For patients with treatment-resistant depression or post-traumatic stress disorder, delays in access to promising psychedelic therapies represent lost time, prolonged suffering and, in some cases, lost lives. The question isn’t whether these treatments should be evaluated but whether a single agency should decide when competent adults may try them.

And cannabis should not be scheduled at all. We do not place alcohol — a substance with well-documented risks — on a federal schedule. Treating marijuana as something requiring special federal control is a policy choice, not a scientific necessity.

Also, Gottlieb claimed kratom is a gateway to opioid use, but the available data suggest that many people use kratom as an alternative to more dangerous opioids. Overdoses from kratom are uncommon; according to the Centers for Disease Control and Prevention, there were only 233 kratom-related deaths between 2015 and 2025, most involving multiple other substances.

FDA oversight may prevent some harms, but it also prevents access. A system that informs patients and physicians — rather than blocking their choices — would better balance safety with individual autonomy.