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FDA Urges DEA to Classify Potent Kratom-Derived Opioid as Schedule I Drug

It triggers a DEA rule-making process for the concentrated kratom-derived compound.

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FDA Commissioner Marty Makary speaks alongside Health and Human Services Secretary Robert F. Kennedy, Jr., as they announce the sending of warning letters to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.
FILE - This Sept. 27, 2017 file photo shows kratom capsules in Albany, N.Y. (AP Photo/Mary Esch, File)
Food and Drug Administration (FDA) Commissioner Martin Makary speaks during a news conference at the USDA headquarters building in Washington, DC, on July 14, 2025. According to US media reports, ice cream makers in the US are planning to eliminate several artificial colors from their products by 2028. The announcement comes less than a week before National Ice Cream Day on July 20. (Photo by Brendan SMIALOWSKI / AFP) (Photo by BRENDAN SMIALOWSKI/AFP via Getty Images)

Overview

  • The FDA recommended scheduling 7-hydroxymitragynine — a concentrated synthetic byproduct of kratom — as Schedule I, the strictest category under federal law.
  • Agency officials warned that 7-OH binds to mu opioid receptors and exhibits potency exceeding morphine, raising concerns over its addictive potential.
  • Unapproved 7-OH formulations are sold nationwide as gummies, tablets and drink mixes at convenience stores, vape shops and online outlets without regulation.
  • Federal health agencies reported a surge in overdoses, poisonings and emergency room visits linked to concentrated 7-OH products.
  • The DEA will enter a rule-making phase with a public comment period before issuing a final scheduling decision.