FDA

FDA moves to restrict potent kratom derivative amid rising public health concerns

July 31, 2025

FDA has formally recommended scheduling 7-hydroxymitragynine (7-OH)—a concentrated kratom derivative—as a controlled substance due to its opioid-like potency and rising misuse. Found in products like fruit-flavored gummies and wellness shots, 7-OH is widely available at gas stations, vape shops, and online, despite having no approved medical use and being illegal in dietary supplements.

Scientific analysis revealed 7-OH binds to mu-opioid receptors and may be up to 13 times more potent than morphine. The agency issued warning letters to seven companies for illegally marketing 7-OH products and launched public education efforts to highlight the risks, especially to youth. DEA is now reviewing FDA’s scheduling recommendation, which would make 7-OH subject to federal control.

Physicians should be aware of 7-OH’s presence in mislabeled consumer products and its potential for addiction, withdrawal, and overdose. FDA’s action underscores the need for vigilance and patient education as unregulated synthetic opioids continue to emerge.

Source:

(2025, July 29). FDA. FDA takes steps to restrict 7-OH opioid products threatening American consumers. [News release]. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers