FDA Proposes, Then Withdraws Study About Kratom and Psychedelics

In a surprising turn of events, the U.S. Food and Drug Administration (FDA) recently withdrew its notice of a proposed study on kratom and psychedelics.

On August 2, FDA published a notice in the Federal Register for a 60 day comment period for a proposed study on kratom and psychedelics. The study entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances" was, according to the FDA notice, "intended as a strategic response to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics". The FDA intended to conduct a survey of kratom and psychedelics consumers.

The American Kratom Association (AKA) criticized the study as poorly framed as to compare kratom, a federal legal substance, to psychedelics, which are classified as Schedule I.

In another notice, dated August 6 but released on August 12, the FDA published a statement withdrawing the notice. "FDA no longer intends to proceed with the proposed study as described because circumstances occurred necessitating changes to the scope of the study."

FDA went into no further detail as to why the intent to conduct the study was withdrawn.

The AKA supported the decision to discontinue the study, calling it an "embarrassing mistake".