07.01.14
The United Natural Products Alliance (UNPA), Salt Lake City, UT, has aligned itself with FDA’s stance on the regulatory status and safety of kratom (Mitragyna speciosa). Recognizing the botanical’s potential for misuse or abuse, UNPA has initiated a new policy stating that as a condition of membership, no UNPA member may engage in the sale, distribution or marketing of any products that contain kratom for human usage or consumption. The policy was made effective May 1.
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 U.S. 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.”
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 U.S. 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.”