FDA Issues Warning Letters for Products Containing 7-Hydroxymitragynine
Thursday, July 24, 2025
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  • On July 15, 2025, FDA sent warning letters to seven different companies for the illegal marketing of products containing 7-Hydroxymitagynine (7-OH). 7-OH is a naturally occurring chemical component of Kratom, a tropical tree native to Southeast Asia.
  • 7-OH and Kratom are prohibited from being marketed in the U.S. as a drug product, dietary supplement, or food additive. FDA views 7-OH as a novel potent opioid that has “not been proven safe or effective for any use.”
  • The warning letters targeted a variety of products, including over-the-counter medications, dietary supplements, and drink mixes. Respectively, the warning letters pertained to using 7-OH in unapproved new drugs, in adulterated dietary supplements, and in adulterated human foods as an unsafe food additive.
  • Keller & Heckman will continue to monitor FDA warning letters related to food additives and dietary supplements.
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