Overview

• On July 29, FDA Commissioner Marty Makary formally asked the DEA to list the concentrated kratom compound 7-hydroxymitragynine as a Schedule I drug.
• An FDA report highlights that 7-OH’s opioid-like activity can exceed morphine potency and has coincided with a rise in emergency visits, poisonings and overdose reports.
• Regulators emphasized the action targets synthetic 7-OH products—found in energy drinks, gummies and powders at gas stations and vape shops—while leaving traditional kratom leaf unregulated.
• HHS announced new education campaigns and “dear doctor” advisories for medical professionals to raise awareness of the compound’s risks pending DEA’s scheduling decision.
• The American Kratom Association and kratom supplement companies welcomed the recommendation but called for third-party testing, clear labeling and adult-only sales rather than a blanket ban.