The American Kratom Association (AKA) is calling upon the Food and Drug Administration (FDA) Commissioner Robert Califf to “immediately” remove the FDA’s July 26 warning to consumers not to use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom “until the agency has independently verified the alleged claims regarding the death that they have not conclusively proven to be attributed to this product,” said Charles “Mac” Haddow, senior fellow on public policy for the American Kratom Association, Washington, D.C.
The FDA advised 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 said.
“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.” Haddow said.
Haddow said that the most recent FDA safety alert “vaguely” references a reported kratom death but provides no details or “credible” evidence that would link that death to the kratom product referenced by the FDA.
“The FDA safety alert claims that it is based upon an adverse event report relating to a ‘person who died after using OPMS Black Liquid Kratom,’ and stated that it was among many such reports,” Haddow said. “Yet, in a review of the current data available on the FDA Events Reporting System Dashboard those claims cannot be validated.”
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Products containing kratom have been marketed as foods, including dietary supplements, or drugs with claims of therapeutic benefits.
“Consumers may believe kratom products are safe because kratom is a plant material,” the agency said, but 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.
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