Top Takeaways:

• The FDA has formally requested the DEA to schedule 7-hydroxymitragynine (7-OH), a kratom-derived compound, as a Schedule I controlled substance.
• The compound is widely available in vape shops, convenience stores, and products like drinks and children’s gummies, raising alarm among health officials.
• FDA Commissioner Dr. Marty Makary emphasized its high potential for abuse due to its opioid-like properties and announced a national education and warning campaign targeting physicians and the public.

The U.S. Food and Drug Administration is urging the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH), a potent compound found in the kratom plant, as a Schedule I controlled substance, citing its opioid-like effects and rising availability in consumer products.

At a Tuesday news conference, FDA Commissioner Dr. Marty Makary warned that the synthetic compound — present in vape liquids, beverages, and even children’s gummies — poses serious public health risks. “It is sold in vape stores, smoke shops, convenience stores, and gas stations that are popping up all over the United States,” Makary said. “Yet it has no legitimate use and binds to the same receptors as opioids.”

According to the FDA, 7-OH is the most potent active metabolite of mitragynine, the primary alkaloid in kratom. While kratom itself remains legal under federal law, 7-OH is synthetically isolated or enhanced in many commercial products, amplifying its euphoric and sedative effects.

“Many Americans are unaware they’re ingesting an addictive opioid when they consume these products,” Makary added. “It’s not regulated, it’s not labeled properly, and it’s being marketed as something natural or benign.”

The agency’s scheduling recommendation to the DEA includes a proposed concentration threshold, above which the substance would be considered illegal under Schedule I — the same classification used for heroin and LSD. The FDA is also releasing a scientific analysis of the compound’s risks and mailing letters to every licensed physician in the country to raise awareness.

Dr. Janet Woodcock, a senior advisor at the FDA, noted that the compound’s abuse potential is “comparable to traditional opioids,” but it remains virtually unregulated at the federal level. “What we’re seeing is a loophole in how kratom derivatives are being marketed and sold,” she said.

The move marks the most aggressive federal action yet against kratom-derived substances. The FDA has previously issued warnings about kratom’s safety and has seized shipments containing kratom-based products mislabeled as dietary supplements.

The scheduling process now moves to the DEA, which will open a public comment period before issuing a final ruling. While some kratom advocates argue the plant has therapeutic potential, the FDA maintains that no approved medical uses exist for either kratom or its alkaloids.

“We’re going to continue to try to educate the public,” Makary said. “This is not a safe substance, and we cannot wait for another crisis to unfold before we act.”

The FDA did not indicate whether broader action against mitragynine or whole-plant kratom is under consideration.