More than 207,000 units of dietary supplements and bulk dietary ingredients containing kratom were seized by US Marshals at the request of the Food and Drug Administration (FDA).
Kratom, also known as Mitragyna speciosa, is a plant indigenous to Southeast Asia that has been shown to exert both narcotic and stimulant-like effects. The consumption of kratom can lead to serious medical outcomes including respiratory depression, tachycardia, and seizures. Withdrawal symptoms such as hostility, aggression, and muscle/bone pain have also been reported.
The seized dietary supplements are manufactured by Atofil, LLC, a subsidiary of Premier Manufacturing Products, and are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo.
According to the FDA, dietary supplements and bulk dietary ingredients containing kratom are considered adulterated under the Federal Food, Drug, and Cosmetic Act as there is inadequate information currently available to provide reasonable assurance that the herbal does not present a significant or unreasonable risk of illness or injury. The FDA is warning consumers not to use any products labeled as containing kratom.
“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” said Judy McMeekin, PharmD, the FDA’s Associate Commissioner for Regulatory Affairs. “The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”
Any adverse events related to kratom products should be reported to the FDA’s MedWatch program.
FDA announces seizure of adulterated dietary supplements containing kratom. [press release]. Silver Spring, MD: US Food and Drug Administration; May 21, 2021.