Regulatory Watch: FDA Kratom Study Published, Signaling Potential Policy Shift

The U.S. Food and Drug Administration (FDA) has published a long-awaited pilot clinical study on kratom in the Journal of Clinical Psychopharmacology. This preliminary investigation involved 40 healthy adult participants who consumed ascending doses of plain leaf kratom capsules over a five-minute period.

The study administered doses ranging from 1g to 12g, with safety reviews conducted after each dose. Assessments included adverse event monitoring, laboratory tests, vital signs, ECG, physical examinations, and suicidality assessments. Crucially, no serious adverse events were reported, although nausea was noted at the atypically higher doses of 8g, 10g, and 12g – amounts not typically consumed by regular users in such a short timeframe. The 12g dose also showed increases in 'drug liking' subjective measures.

This research, first announced by lead contributor FDA scientist Chad Reissig at the Third Scientific Kratom Symposium in 2024, paves the way for a broader Human Abuse Potential (HAP) study expected to begin in late 2024 with results anticipated in late 2026. HAP studies are critical for FDA drug scheduling determinations and New Drug Applications (NDAs).

This development is particularly significant given past criticisms of the FDA by organizations like the American Kratom Association (AKA) for maintaining outdated information on kratom dangers. The article highlights a notable policy shift: in 2025, the FDA recommended to the Drug Enforcement Administration (DEA) that only 7-hydroxymitragynine, and not plain leaf kratom, be placed on its Schedule I controlled substances list. This contrasts sharply with the FDA's 2016 recommendation to schedule all kratom, a decision the DEA initially pursued but reversed due to widespread grassroots opposition.

The 'So What?':

• The FDA's recent pilot study on kratom, reporting no serious adverse events, signals a potential shift in the agency's policy, moving from a 2016 recommendation to schedule all kratom to a 2025 recommendation to schedule only 7-hydroxymitragynine, not plain leaf kratom.
• While no immediate changes to payment processing stability are noted, this positive regulatory signal from the FDA could contribute to a more stable environment for financial services supporting the kratom industry in the long term.
• There are no immediate shipping or logistics warnings directly stemming from this study's publication.

Source: Kratom Science via Sentinel Newsroom