By: IPP Bureau
Last updated : August 03, 2025 2:05 pm
7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors
The U.S. Food and Drug Administration (FDA) today recommended scheduling certain 7-hydroxymitragynine (7-OH) products under the Controlled Substances Act (CSA) to protect Americans from dangerous, illegal opioids.
7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors. The FDA clarified that this action does not apply to natural kratom leaf products. A new FDA report highlights health concerns linked to 7-OH and distinguishes it from kratom leaves.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS Secretary Robert F. Kennedy, Jr.
This recommendation follows a thorough FDA medical and scientific review. Currently, there are no FDA-approved 7-OH drugs. It is not lawful in dietary supplements or in food.
“7-OH is an opioid that can be more potent than morphine,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We need regulation and education to prevent another opioid wave.”
The FDA is concerned that 7-OH products, often sold in gas stations, vape shops, and online, are sometimes marketed to children in forms like gummies and ice cream cones. These may be mislabeled or disguised as kratom.
In June, the FDA sent warning letters to seven companies selling illegal 7-OH products, including gummies, tablets, and shots. It also issued a new letter to health care professionals and a consumer warning.