FDA Warns Consumers Not to Use OPMS Black Liquid Kratom
Important Notice to Consumers
Audience
Consumers who have recently purchased OPMS Black Liquid Kratom.
Product
OPMS Black Liquid Kratom sold online and in certain retail stores.
Purpose
The FDA is advising consumers not to consume OPMS Black Liquid Kratom, which is 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 related to this product. Other reported health effects include:
- Withdrawal symptoms
- Addiction
- Digestive issues
- Restless leg syndrome
- Skin problems
- Aggressive behavior
- Increased anxiety
- Lack of energy
- Inability to focus
The product label indicates the presence of kratom alkaloids: mitragynine and 7-hydroxymitragynine (7-OH mitragynine).
FDA’s Stance on Kratom Products
Products containing kratom have been marketed as foods, dietary supplements, or drugs with therapeutic claims. However, the FDA has not approved any prescription or over-the-counter drug products containing kratom or its compounds, mitragynine and 7-OH mitragynine.
The FDA has concluded that kratom is not lawfully marketed as a dietary supplement and cannot be added to conventional foods due to serious safety concerns. These concerns include risks of liver toxicity, seizures, and substance use disorder (SUD).
FDA Actions and Response
The FDA continues to evaluate adverse event reports for all kratom-containing products. This safety alert aims to warn consumers about the serious health effects associated with OPMS Black Liquid Kratom.
Recommendations for Consumers
Consumers should:
How to Report to the FDA
- Call an FDA Consumer Complaint Coordinator to speak directly about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form and mail it to the FDA.
For additional assistance, visit the FDA Consumer Complaint System.
Need Help Navigating These Updates?
Garg Law is here to assist you with understanding and complying with these FDA updates. Our expertise in FDA regulations ensures you stay compliant and informed.
Contact Us today for tailored legal advice and support.
Read the full FDA article here.