FDA Withdraws Plans on Kratom/Psychedelics Research

Federal Register notice: FDA is withdrawing an 8/2 notice that sought comments on a proposed information collection entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.” At the time, the agency said the collection was intended to support scientific research to address emerging data on kratom and psychedelics suggesting an increasing use of these substances in certain populations, and reports noting risk and safety concerns with their use. FDA said that understanding the social, behavioral, and environmental contexts and motivations for use was included in its need to protect the public’s health, through data-informed strategic initiatives. Now, in an 8/12 withdrawal notice, the agency says it no longer intends to proceed with the proposed study as described “because circumstances occurred necessitating changes to the scope of the study.”