AHPA Legal Alert
Editor's Note: David Kroll, a prominent pharmacologist recently published a column in Forbes criticizing FDA's recent assessment of kratom. Among other shortcomings, Kroll noted that FDA failed to read 20 years of published scientific literature, didn't demonstrate any mastery of current research on the biochemical pharmacology of opioids, was overly reliant on unpublished data from a computational model and made safety conclusions based on confirmation bias and in the absence of considering the impact of a kratom ban on public health. 

Nine scientists from leading research institutions also criticized FDA's assessment of kratom. In a letter to the Trump Administration, they requested FDA to "protect the American public by appropriate regulation of kratom, as the FDA's Office of Dietary Supplements has been working toward." 

February 9, 2018

Along with Tuesday's FDA warning, the agency also released  a 164-page document with case details on 28 deaths where kratom was present, first referred to in the November 2017 advisory. This report joins another from December showing  details of eight other deaths. Nick Wing, a  Huffington Post senior reporter,   dissected these fatal adverse reaction reports and found that in many, kratom and its constituents were likely innocent bystanders. The agency even includes among kratom-associated deaths cases of fatalities by hanging, gunshot and others where kratom was adulterated with the active metabolite of a prescription opioid,  O-desmethyltramadol.

My take? If Dr. Gottlieb's statement were a pharmacology graduate student's written qualifying exam answer to a question seeking an objective assessment of kratom pharmacology and toxicology, I'd have no choice but to issue a failing grade.

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