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FDA Targets 7-OH Kratom With Warning Letters as DEA Moves to Schedule

Federal agencies are moving to restrict 7-hydroxymitragynine after TikTok videos highlighted underage demand

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Overview

  • The FDA has issued warning letters to at least seven companies marketing products containing the kratom-derived compound 7-hydroxymitragynine over safety concerns.
  • The DEA has launched a rule-making process to classify 7-hydroxymitragynine as a Schedule I controlled substance in response to its opioid-like effects.
  • Seven states, including Alabama, Arkansas and Wisconsin, have banned kratom after experts reported rising emergency visits tied to opioid-like effects.
  • Botanic Tonics maintains its 21-and-over sales policy and added warning labels to Feel Free tonics following an $8.75 million class-action settlement.
  • Pharmacists and addiction specialists caution that combining kava depressants with concentrated kratom extracts heightens the risk of severe dependency and withdrawal.