Alert: FDA Pilot Study on Kratom Published, Paving Way for Key Scheduling Research

A long-awaited pilot clinical study on kratom, conducted by the U.S. Food and Drug Administration (FDA), has been published in the Journal of Clinical Psychopharmacology. This preliminary investigation involved healthy adult participants and aimed to test the feasibility and design of a larger, more comprehensive study. While no serious adverse events were reported, the study is a foundational step for a broader Human Abuse Potential (HAP) study, which the FDA uses to determine drug scheduling and New Drug Applications (NDAs).

This research signals a continued federal interest in kratom, but its immediate implications for merchants are minimal. Key takeaways for merchants include:

• No immediate changes to kratom's legal status; this is a preliminary research step that does not alter current regulations.
• No direct impact on payment processing or banking stability is indicated by this research.
• No new shipping or logistics warnings are associated with this study's publication.

The broader HAP study is expected to commence at the end of 2024, with results anticipated by the end of 2026. The FDA has previously shown a shift in policy, recommending only 7-hydroxymitragynine (not plain leaf kratom) for Schedule I classification in 2025, a departure from its 2016 stance on all kratom.

Source: Kratom Science via Sentinel Newsroom