Kratom is a botanical that in FDA’s opinion is a New Dietary Ingredient for which no safety studies have been submitted to the agency in the form of a NDI notification. In the past FDA officials have voiced grave concerns over the ingredient’s safety. On Feb. 28, the agency issued an import alert on the ingredient, stating, “Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.”
Kratom, known by a variety of names, is derived from the leaves of the Mitragyna speciosa tree, a member of the coffee family native to southeast Asia. The ingredient is said to have psychoactive properties that are not well characterized.
SNI National said it is voluntarily recalled its kratom-containing products including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 Pack, from distributors and retail locations. SNI National said it did not manufacture the products but did repackage, label and distribute them.