Consumer Alert: FDA warns not to use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom
Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia. Products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores. Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. An estimated 1.7 million Americans aged 12 and older used kratom in 2021
The FDA is advising consumers not to consume OPMS Black Liquid Kratom, which is sold online and in some retail stores. OPMS Black Liquid Kratom has been linked to serious adverse health effects, including death.
The FDA recently received an adverse event report of a person who died after using OPMS Black Liquid Kratom. This is one of many reports of serious adverse events individuals have reported experiencing after consuming OPMS Black Liquid Kratom. Other reported adverse health effects include withdrawal symptoms, addiction, digestive issues, restless leg syndrome, skin problems, aggressive behavior, increased anxiety, lack of energy, and inability to focus. The product label for OPMS Black Liquid Kratom indicates the presence of kratom alkaloids, mitragynine and 7-hydroxymitragynine (7-OH mitragynine).
Products containing kratom have been marketed as foods, including dietary supplements, or drugs with claims of therapeutic benefits. However, the FDA has not approved any prescription or over-the-counter drug products containing kratom or associated compounds, mitragynine and the more potent metabolite, 7-OH mitragynine. Furthermore, the FDA has serious safety concerns with the use of kratom in dietary supplements and conventional foods. Based on the available scientific data and information, the FDA has concluded that kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.
The FDA continues to warn consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD).
The FDA continually evaluates adverse event reports of all products containing kratom.
The FDA is issuing this safety alert to warn consumers about serious adverse health effects associated with OPMS Black Liquid Kratom. We note that consumers may believe kratom products are safe because kratom is a plant material and is available online and in some retail stores such as vape/smoke shops. The FDA is investigating these complaints.
For more information, please visit FDA and Kratom.
