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14h ago

FDA Urges DEA to Classify Potent Kratom Byproduct as Schedule I Drug

Officials argue its high opioid potency in unregulated products is driving a surge in overdose reports.

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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)
Jackpot Alkaloids, Mitragyna Speciosa Extract and Tropic Thunder Kratom Shot.

Overview

  • The FDA recommended that the DEA list 7-hydroxymitragynine, a synthetic byproduct of kratom, as a Schedule I controlled substance due to its abuse potential.
  • Agency data show 7-OH binds to mu-opioid receptors and can be up to 13 times more potent than morphine, risking respiratory depression, addiction and seizures.
  • The recommendation triggers a DEA review and public comment period before any final scheduling under federal drug law.
  • HHS Deputy Secretary Jim O’Neill reported a spike in overdoses and emergency visits linked to mislabeled vapes, gummies and drinks containing 7-OH.
  • Industry groups including Diversified Botanics and the American Kratom Association back targeting synthetic 7-OH while opposing broader restrictions on natural kratom leaf.