U.S. marshals, at the FDA’s request, seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 1000 kilograms of bulk kratom. These dietary supplements are manufactured by Botanic Tonics LLC, located in Broken Arrow, Oklahoma. The dietary supplements (sold in liquid and capsule formulations) are marketed under the brands “Feel Free Plant Based Herbal Supplement.”
The seized products are worth approximately $3M. The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Oklahoma alleging, among other things, 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; therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.