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U.S. Regulators Move to Classify Potent Kratom Derivative as Schedule I Opioid

Health regulators propose Schedule I classification for kratom’s most potent derivative following a spike in severe dependence.

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Overview

  • On July 29, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary announced plans to begin DEA rulemaking to place 7-hydroxymitragynine, a concentrated kratom compound, under Schedule I.
  • 7-hydroxymitragynine binds to opioid receptors and is reported to be up to 13 times more potent than morphine, heightening risks of addiction and severe withdrawal.
  • Botanic Tonics and other producers have added 21-plus age checks and warning labels after an $8.75 million class-action settlement and multiple FDA warning letters.
  • Viral social media accounts describe users consuming as many as a dozen kratom-based tonics daily and enduring extreme physical and psychological withdrawal.
  • At least one kratom-related death from mitragynine and over 1,800 poison control calls since 2011 have intensified calls for mandatory testing, clear labeling and age restrictions.