Kratom Regulation (FDA)
Current understanding
Kratom (Mitragyna speciosa) and its alkaloids sit at the intersection of FDA dietary-supplement/food regulation and DEA controlled-substance scheduling. Legislative activity has emerged to constrain how restrictively FDA may regulate kratom while DEA has moved to temporarily schedule certain kratom-derived alkaloids (e.g., 7-hydroxymitragynine and analogs) under the CSA.
Evidence log
- 2026-08-26 — Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I: cross-connection with drug-scheduling-controlled-substances: DEA Schedule I placement of kratom-derived 7-hydroxymitragynine analogs directly intersects with ongoing FDA/legislative debates over how kratom and its alkaloids should be regulated. (novelty: 3)
- 2023-10-04 — Federal Kratom Consumer Protection Act: cross-connection with fda-kratom-regulation: Both pages track federal kratom regulatory policy; the Federal Kratom Consumer Protection Act is the vehicle underlying both entries and they likely warrant consolidation. (novelty: 2)
- 2023-10-25 — Federal Kratom Consumer Protection Act: 2025 — Federal Kratom Consumer Protection Act (introduced) would require an FDA hearing and task force on kratom health and safety while prohibiting FDA from regulating kratom more restrictively than food or dietary supplements, effectively setting a statutory regulatory ceiling on FDA kratom oversight. (novelty: 2)
- 2026-03-19 — END 7-OH Act: cross-connection with drug-scheduling-controlled-substances: END 7-OH Act targets 7-hydroxymitragynine — a kratom alkaloid — linking CSA scheduling activity to the FDA kratom regulatory framework. (novelty: 2)
- 2022-12-20 — Federal Clarity for Kratom Consumers Act: cross-connection with drug-scheduling-controlled-substances: The Federal Clarity for Kratom Consumers Act would cap FDA’s regulatory posture on kratom at the food/supplement level even as DEA proceeds with temporary Schedule I placement of 7-hydroxymitragynine (above a threshold) and related alkaloids under the CSA. (novelty: 2)