CHICAGO —(ENEWSPF)–January 7, 2016. United States Marshals, acting with investigators from the U.S. Food and Drug Administration, yesterday seized nearly 90,000 bottles of a beverage containing the herbal ingredient kratom.
The beverages were manufactured for and held by Dordoniz Natural Products LLC, of South Beloit, and marketed under the brand name RelaKzpro. The product is estimated to be worth more than $400,000.
The bottles were seized after the U.S. Attorney’s Office in Chicago filed a civil forfeiture complaint on behalf of the FDA. The complaint alleges that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The complaint, which was filed yesterday in U.S. District Court in Chicago, alleges that serious concerns exist about the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, vomiting, nervousness, weight loss and constipation, the complaint states. Kratom has been indicated to have both narcotic and stimulant-like effects. Withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and jerky limb movements, according to the complaint.
The complaint states that dietary supplements containing kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.
The seizure and complaint were announced by Zachary T. Fardon, United States Attorney for the Northern District of Illinois; and Melinda Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs. The government is represented by Assistant U.S. Attorney Donald Lorenzen.
The public is reminded that a complaint contains only allegations and is not evidence of liability. The government has the burden of proving a civil case by a preponderance of the evidence.
Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA by logging on to its website: www.fda.gov/medwatch/report.htm.