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FDA recommends concentrated Kratom be scheduled as illicit substance

UNITED STATES, JUL 29 – FDA urges classifying synthetic 7-hydroxymitragynine as Schedule I to curb opioid-like abuse while maintaining legal access to natural kratom used by over 24 million Americans.

  • On July 29, 2025, U.S. health officials proposed adding 7-hydroxymitragynine , a compound found in kratom, to the list of Schedule I controlled substances.
  • This action responds to rising concerns about synthetic 7-OH products that mimic opioids and pose health risks, unlike largely unregulated natural kratom.
  • The FDA previously sent warning letters on July 15, 2025, to seven companies marketing concentrated 7-OH in tablets, gummies, and drinks, stating these products may be dangerous.
  • FDA Commissioner Marty Makary emphasized that the focus is on the synthetic opioid derivative 7-hydroxymitragynine because of its addictive qualities, rather than on the natural kratom leaf or its ground form.
  • The scheduling is intended to protect consumers from harmful synthetic products while preserving safe access to natural kratom used regularly by over 24 million Americans.
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KPNX broke the news in Phoenix, United States on Monday, July 28, 2025.
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