FDA’s Proposed IND Study For ‘Abuse Potential’ Could Close US Kratom Supplement Market

RFP states FDA "previously warned consumers about the use of Kratom (Mitragyna speciosa)” and although botanical’s “use is prevalent, to date, clinical evaluations of abuse potential have not been performed.”

The US Food and Drug Administration has asked for proposals to conduct an investigational new drug trial for kratom “to help characterize its abuse potential” after previously recommending scheduling ingredients from the botanical as controlled substances.

The agency’s request for proposals states the FDA “has previously warned consumers about the use of Kratom (Mitragyna speciosa),...