WASHINGTON, D.C.—Consumer-based, non-profit organization, American Kratom Association (AKA), has asked FDA Commissioner, Robert Califf, to remove its recent consumer warning statement for OPMS Black Liquid Kratom.
On July 26, FDA issued a safety alert in response to a death that has been associated with the use of a kratom product. The alert explained: "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."
FDA warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD).
Kratom Group Responds
"The FDA’s most recent mistaken and misguided safety alert, which warns consumers to not use OPMS Black Liquid Kratom, is clearly an unfortunate repeat of the exact mistakes that former HHS Assistant Secretary of Health, Dr. Brett Giroir, previously condemned when he correctly noted that the FDA has been relying upon ‘embarrassingly poor evidence and data’ on kratom," stated Mac Haddow, AKA Senior Fellow on Public Policy.
Kratom has a history of divisive opinions due to its opioid/stimulant-ike effects (read Kratom for Chronic Pain? for two viewpoints). Haddow contends that FDA is a mission to create false connections between kratom products and unrelated deaths. "The consistently unreliable and often false statements about kratom issued by the FDA over the past decade, which is a part of its relentless and misguided pursuit of banning kratom products that is not supported by reliable science, are wrong and Commissioner Califf should hold his agency fully accountable,” Haddow said in a press release. “The various autopsy reports that have claimed that kratom is the sole cause of deaths have been thoroughly refuted as incomplete, poorly documented, hastily concluded, or demonstrably incorrect.”
Haddow added: “The FDA staff is undermining Commissioner Califf’s own initiative to eliminate health misinformation, which the Commissioner himself said ‘poses the most serious threats to public health today.’ The FDA is not exempt from the solemn duty to accurately convey information only after it has been fully and credibly vetted and proven."
As WholeFoods Magazine has reported, AKA is working to enact proactive legislation to protect the rights of kratom consumers and ensure that consumers have access to safe products. Haddow has said: “The American Kratom Association recognizes that every effort should be made to keep kratom risks low, and protect consumers from adulterated and contaminated kratom products. With appropriate FDA consumer regulation, we can maximize the potential for kratom to be responsibly used for the improvement of health and well-being of individuals and public health in America.”
