Silver Spring, MD-—The U.S. Food and Drug Administration (FDA) announced in a press release on January 6, 2016 that U.S Marshals, at the agency’s request, seized approximately 90,000 bottles of dietary supplements labeled as containing kratom from Dordozin Natural Products LLC, South Beloit, IL. Marketed under the brand name RelaKzpro, the seizure is valued at greater than $400,000.
Kratom has been on FDA’s radar for some time now, having issued an import alert on the substance in April of 2014, which authorized U.S. officials to detain dietary supplements or bulk dietary ingredients that contain kratom. A botanical substance derived from Mitragyna speciosa which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea, kratom has been reported to negatively impact health.
According to FDA, these health impacts include respiratory depression, vomiting and nervousness. Kratom has also been said to have narcotic and stimulant-like effects with withdrawal symptoms that may include hostility, aggression, aching muscles and bones as well as jerky limb movements.
FDA initially detained RelaKzpro earlier this month, under the Federal Food, Drug and Cosmetic Act (FD&C), as amended by the Food Safety Modernization Act, giving the agency a maximum of 30 days to determine whether or not to take further action, namely seizure. On behalf of FDA, the U.S. Department of Justice filed a complaint to the District Court for the Northern District of Illinois, alleging that kratom is a new dietary ingredient with inadequate information assuring its safety, therefore making dietary supplements containing the ingredient adulterated under FD&C.
Published in WholeFoods Magazine, February 2016 (online 1/7/16)