In December 2025, the U.S Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at about $1 million—from three firms in Missouri.
The seizure focused on foods and dietary supplements products—including liquid shots and tablets—that contain 7-OH as an ingredient. Concentrated 7-OH has been increasingly recognized as having a potential for abuse because of its “ability to bind to opioid receptors.”
According to FDA, 7-OH cannot legally be added to dietary supplements or conventional foods and these products are considered adulterated because 7-OH “does not meet applicable safety standards.” FDA has also not approved 7-OH for medical use.
FDA worked closely with the Missouri Department of Health and Senior Services with the enforcement action to protect Americans from “dangerous, illegal opioid substances.”
On July 15, 2025, FDA issued warning letters to companies for illegally marketing products containing 7-OH. On July 29, 2025, FDA recommended a scheduling action to control 7-OH products under the Controlled Substances Act.
“This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids. We must be proactive and vigilant to address emerging threats to our communities and our kids,” said FDA Commissioner Marty Makary, MD, MPH.
“The rise in the use of concentrated 7-OH as an illegal ingredient in foods and dietary supplements is of particular concern for the FDA,” added FDA Deputy Commissioner for Human Foods Kyle Diamantas, JD. “Actions like those announced today put a marker down that our agency will not tolerate the use of this dangerous ingredient in foods and dietary supplements, especially in products that are accessible to our nation’s youth.”
For more information, visit www.fda.gov.
