The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.
“This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
The FDA worked closely with the Missouri Department of Health and Senior Services in this enforcement action, which builds on the FDA’s comprehensive efforts to protect Americans from dangerous, illegal opioid substances. In July of this year, the FDA recommended the scheduling of certain 7-OH products under the Controlled Substances Act and issued warning letters to companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. FDA also notified health care professionals and informed consumers of the risks associated with concentrated 7-OH products.
“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,” said FDA Deputy Commissioner for Human Foods, Kyle Diamantas, J.D. “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.”
These recent operations demonstrate coordinated federal enforcement efforts against concentrated 7-OH products. The FDA reminds all manufacturers and distributors that they must ensure their products comply with all applicable federal requirements.
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