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FDA and HHS Call for Schedule I Ban on Potent Kratom Extract

A report recommends placing 7-hydroxymitragynine on the nation’s highest-risk drug schedule to curb overdose threats, excluding the plant’s natural leaf.

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 Dr. Marty Makary holds up an example of a 7-OH product as he speaks about the sending of warning letters to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH, as part of their actions combatting opioids, during a press conference at HHS Headquarters in Washington, DC, July 29, 2025. (Photo by SAUL LOEB / AFP) (Photo by SAUL LOEB/AFP via Getty Images)
Jackpot Alkaloids, Mitragyna Speciosa Extract and Tropic Thunder Kratom Shot.
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Overview

  • FDA and HHS released a joint risk report recommending that 7-hydroxymitragynine be classified as a Schedule I substance pending DEA review
  • The agencies emphasized that natural kratom leaf products are exempt from the proposed restrictions on synthetic 7-OH extracts
  • FDA Commissioner Marty Makary warned that 7-OH can exceed morphine in potency and present significant respiratory depression and dependence risks
  • In mid-July, the FDA issued warning letters to seven companies marketing energy drinks, gummies and supplements containing unapproved 7-OH
  • Supplement manufacturers hailed the data-driven action as consumer protection while the American Kratom Association continues lobbying against expanded oversight