Concurring with the significant concerns expressed by the Food and Drug Administration (FDA) about the regulatory status and safety of kratom (Mitragyna speciosa), along with the potential for misuse or abuse of this botanical, the United Natural Products Alliance (UNPA), an international alliance of forward-looking companies dedicated to providing consumers with natural health products of superior quality, benefit and reliability, is initiating a new policy that states that as a condition of membership, no UNPA member will engage in the sale, distribution or marketing of any products that contain kratom for human usage or consumption. The policy is effective as of May 1, 2014.
In late February, FDA issued an import alert on kratom, citing that there is no information demonstrating that the substance was marketed as a dietary ingredient in the United States prior to Oct. 15, 1994, therefore making it a new dietary ingredient under the Food, Drug and Cosmetic Act. The agency stated that consumption of kratom could lead to a number of health impacts, including respiratory depression, nervousness, agitation, sleeplessness, nausea, vomiting and severe withdrawal symptoms.
“This new policy goes to the heart of the mission of UNPA,” said President Loren Israelsen. “Our members’ customers have a right to expect products that adhere to the regulatory framework in place and that can be reasonably considered safe. Until there is a change in the regulatory status of kratom and scientific consensus regarding its safety, we believe a ‘no sales’ policy is the best course of action.”
UNPA’s “no sale” policy of kratom joins similar policies regarding the sale of products containing ephedra or ma huang (Ephedra sinica), initiated in May 2005, and 1,3-dimethylamylamine, methylhexanamine or geranium extract, commonly known as DMAA or any chemically related substance, initiated May 1, 2013.
Kratom, known by various names, including kakuam, mitragynine extract, Maeng da leaf and Nauclea speciosa, is derived from a species of tree indigenous to Southeast Asia. The substance has purportedly been used as a traditional medicine in its native region. Products containing kratom, which come in a variety of forms, including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves and bulk liquids, have been marketed for pain relief, relaxation, energy and as an treatment for addiction.