WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has taken decisive action to protect public health by recommending that 7-hydroxymitragynine, also known as 7-OH, be classified as a controlled substance under the Controlled Substances Act.
The move targets a concentrated byproduct of the kratom plant that binds to opioid receptors and has shown a high potential for abuse. The FDA emphasized that the action is not aimed at natural kratom leaf products but rather at synthetic or concentrated 7-OH formulations that are increasingly found in products marketed toward consumers, often with little or no labeling.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
FDA Commissioner Dr. Marty Makary expressed concern over the availability of 7-OH in everyday retail environments.
“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH,” Makary said. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”
There are currently no FDA-approved uses for 7-OH. It is not permitted in dietary supplements or conventional food, yet the agency has seen a rise in products containing the substance being sold online, in gas stations and at vape shops, often in forms attractive to children and teens, such as gummies, drink mixes and even ice cream cones.
In June, the FDA issued warning letters to seven companies marketing illegal 7-OH products. On Tuesday, the agency also sent an alert to health care professionals and released new public education materials to raise awareness about the health risks associated with 7-OH.
The Drug Enforcement Administration (DEA) will review the FDA’s recommendation and determine whether to schedule 7-OH, a process that includes a period for public comment.
