WASHINGTON, D.C. (WDNews) – The U.S. Food and Drug Administration (FDA) is recommending new federal controls on 7-hydroxymitragynine (7-OH), a concentrated byproduct of the kratom plant, citing its potential for abuse and danger to public health.
The move targets 7-OH products, not the natural kratom leaf, after a medical and scientific review found the substance binds to opioid receptors and can be more potent than morphine. The FDA says 7-OH is being sold in various forms, including gummies, drink mixes, and even ice cream cones, often in packaging attractive to children and teens.
“We’re taking action on 7-OH as a critical step in the fight against opioid addiction,”Health and Human Services Secretary Robert F. Kennedy, Jr.said. “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 warned that many vape shops, gas stations, and online sellers are marketing 7-OH products without clear labeling and sometimes misrepresenting them as kratom.
“After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” Makary said.
The FDA issued warning letters in June to seven companies illegally distributing 7-OH products and has now sent a letter to health care providers about the risks. The agency has also released public education materials to help consumers recognize and avoid dangerous 7-OH products.
The Drug Enforcement Administration will now review the FDA’s recommendation and decide whether to place 7-OH under the Controlled Substances Act. That process will include public comments before any final decision is made.
