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  5. FDA Warns Consumers Not to Use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom
  1. Alerts, Advisories & Safety Information

FDA Warns Consumers Not to Use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom

July 26, 2024

Audience

  • Consumers who have recently purchased OPMS Black Liquid Kratom.

Product

  • OPMS Black Liquid Kratom sold online and in certain retail stores.
OPMS Black Liquid Kratom Extract

Purpose

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.

Summary of Problem and Scope

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).

FDA Actions/Response

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.

Recommendation for Consumers

Consumers should not consume OPMS Black Liquid Kratom. The FDA encourages anyone who suspects they have experienced an adverse medical event to report this to the FDA.

To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.

Additional Information

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