FDA Kratom Regulation & Consumer Protection
Current understanding
To be populated as evidence accumulates.
Evidence log
- 2026-10-14 — Schedules of Controlled Substances: Temporary Placement of 7- Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I: cross-connection with drug-scheduling-controlled-substances: DEA’s concentration-threshold scheduling of two kratom alkaloids operates alongside FDA’s consumer-protection framework for kratom, with the threshold defining the regulatory boundary between FDA-regulated kratom products and CSA-controlled substances. (novelty: 3)
- 2023-10-04 — Federal Kratom Consumer Protection Act: Federal Kratom Consumer Protection Act (S3039) introduced — would require an FDA hearing and interagency task force on kratom safety and bar FDA from regulating kratom more restrictively than food, dietary supplements, or dietary ingredients. (novelty: 2)