FDA has notified its field personnel that it may detain certain products containing "kratom" without physical inspection because the agency has determined that the new dietary ingredient (NDI) poses such adverse health effects as aggression, hallucinations and vomiting.
The list of products subject to detention without physical inspection come from Canada, Indonesia and Malaysia.
Shipments of the ingredient are contained in capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves and bulk liquids that are made of leaf extracts.
Kratom is a new dietary ingredient that does not appear to have a history of safe use, the agency stated in a Feb. 28 import alert that the American Herbal Products Association (AHPA) shared with its members.
"In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems," FDA stated. "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 also is known as mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.
FDA said the import alert represents its guidance to its field personnel concerning the products at issue, and does not confer any rights or bind the agency or the public.