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HHS and FDA Move to Classify Potent Kratom Derivative as Schedule I

Regulators aim to curtail rising public health harms from potent synthetic kratom derivatives

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Overview

  • HHS and FDA have formally proposed placing 7-hydroxymitragynine (7-OH), a synthetic kratom byproduct, in Schedule I, triggering a DEA public comment and rule-making period.
  • FDA Commissioner Marty Makary described 7-OH as an opioid more potent than morphine with no accepted medical use.
  • Healthcare providers report increasing cases of kratom and 7-OH dependence marked by nausea, seizures and opioid-like withdrawal symptoms.
  • Advocacy groups and the American Kratom Association are urging third-party testing, standardized labeling and age limits for kratom products.
  • States including Alabama, Rhode Island and Wisconsin continue to tighten or enact bans as industry players like Botanic Tonics settle lawsuits over misleading marketing.