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22h ago

FDA Seeks Schedule I Classification for Potent Kratom Byproduct 7-OH

Clinicians are being warned about unregulated vapes and gummies containing the compound during the DEA’s public review of its Schedule I recommendation.

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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 has formally recommended that the DEA classify 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance due to its high abuse potential.
  • Commissioner Martin Makary highlighted that 7-OH binds to mu-opioid receptors and can be up to 13 times more potent than morphine.
  • Seven companies received warning letters for illegally marketing products containing 7-OH under names like 7-OHMG without safety evaluation.
  • The compound has been detected in vapes, gummies and drinks at gas stations and smoke shops, often misbranded as kratom leaf products and lacking dosage controls.
  • The DEA has opened a public comment period on the scheduling proposal as federal officials mobilize new research and surveillance on 7-OH exposures.