Safety advisory · FDA Alerts & Advisories

OPMS Black Liquid Kratom: FDA Safety Advisory (Sep 12, 2024)

Agency action: Sep 12, 2024Record ID: fda_alerts_&-01c8c77aebd2b570
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What happened

Original notice title

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

From the archived source record

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. 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 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. FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Published FDA communication
Source checked
Jul 16, 2026
Record revision
1f5a76e5f09b

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom; 7-hydroxymitragynine (7-OH mitragynine)
Company
Not specified
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.