In the midst of the Trump administration, the U.S. Food and Drug Administration (FDA) embarked on the path of proposing federal restraints on kratom. Yet, a cohort of preeminent officials intervened, chastising the agency’s perceived “prejudice.” Swiftly and decisively, they halted the agency’s progression toward scheduling, as revealed by a former luminary in the realm of White House drug policy.
In a recent interview, Jim Carroll, who had helmed the Office of National Drug Control Policy during President Donald Trump’s tenure from 2018 to 2021, articulated, “The entire mosaic of facts eluded them—they were bereft of a comprehensive understanding. The mantle of science remained elusive to them. The FDA’s portrayal did not encompass the entirety. It is plausible that the full panorama eluded them, yet the collective comprehension was amply realized by others.”
Engaging in dialogue with Mac Haddow, a senior fellow at the American Kratom Association (AKA), during the National Conference of State Legislatures summit held earlier this month in Indianapolis, Carroll—currently an attorney and consultant in private practice—elucidated the circumstances. He unveiled that during the period when the Trump administration contemplated the potential scheduling of kratom under the aegis of the Controlled Substances Act, circa 2018, the FDA tendered a presentation to his office. This presentation, however, mischaracterized the drug’s hazard quotient and conceivable benefits.
The agency’s narrative implied that kratom was akin to an opioid, a categorization Carroll unequivocally contested. “The assertion rings erroneous—fundamentally erroneous,” Carroll posited. He continued, “The proclamation that it bears high addictive potential stands as a distortion. Disparate bodies, including Johns Hopkins and an array of independent medical researchers, have asseverated that its propensity for addiction does not eclipse that of a morning cup of coffee, a libation I indulged in before our present exchange.”
In the initial juncture, Carroll and his contemporaries inclined toward capitulating to the FDA’s reservoir of expertise. Reflecting upon that moment, he mused, “Sitting there, contemplation prevailed: this body is none other than the FDA, the venerable Food and Drug Administration. Their discourse carries the weight of expertise.” These words harken to his sentiments at that juncture.
Carroll conceded that his department held a measure of unfamiliarity with kratom. “This specimen of pharmacology had not yet been subjected to the strictures of scheduling; it stood as an entity being contemplated,” he expounded. “Thus, it lay beyond the realm of our office’s extensive preexisting engagement.”
During this epoch, the FDA readied itself to bestow an analogous briefing to the Drug Enforcement Administration (DEA), a body vested with the authority to affix its imprimatur upon the creation of novel controlled substances. Nonetheless, as the administrative machinery geared itself to ponder the scheduling of kratom, an interjection transpired. Brett Giroir, the erstwhile assistant secretary of health within the Department of Health and Human Services (HHS), became privy to the claims emanating from the FDA. Carroll recounted, “His injunction resounded, ‘Permit not this occurrence to transpire.'”
