The seizure, which was valued at roughly $1 million, focused on foods and dietary supplement products containing concentrated 7-OH as an added ingredient. Earlier this summer, the FDA recommended that 7-OH-containing products be scheduled under the Controlled Substances Act because the compound is increasingly recognized as having potential for abuse due to its ability to bind to opioid receptors.
FDA previously issued warning letters to companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots.
7-OH is present in naturally low amounts, often less than 0.05% of the leaves of the kratom plant, Mitragyna speciosa, which is native to Southeast Asia. As it is present in such low amounts, it is not economically feasible to extract 7-OH from the leaf. Instead, other alkaloids from kratom are isolated and then chemically synthesized into 7-OH, resulting in a man-made product that has significantly higher concentration than found in raw leaves. It is reported to be 13 times more potent than morphine. 7-OH products are sold as extracts, shots, powders or capsules in places like gas stations, convenience stores and smoke shops across the United States.
There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements, and 7-OH cannot be lawfully added to conventional foods.
“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, MD, MPH. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
Usage stats
According to market research by the Marwood Group, one million people now use 7-OH products each month. The same report states that 500 million doses of 7-OH have been sold in the U.S. Synthetic, concentrated 7-OH has only been on the market for two years. The report was commissioned by the Holistic Alternative Recovery Trust (HART), a 7-OH advocacy organization.
“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.”
The FDA worked with the Missouri Department of Health and Senior Services in this enforcement action.
