A kratom-derived opioid now sold in gas-station “shots” is so dangerous there is no safe amount of it — and the government should go further than it planned and ban the kratom alkaloid it’s made from, too.
That’s the case the Foundation for Drug Policy Solutions (FDPS) laid out in comments filed July 16 on the federal plan to place 7-hydroxymitragynine — “7-OH” — in Schedule I. Rather than debate where to set a permissible limit, FDPS argued there shouldn’t be one.
“There is no scientific basis for identifying a permitted quantity of this potent opioid above zero,” the group wrote, pointing to FDA warnings that 7-OH products haven’t been shown safe for any use.
The pharmacology, FDPS said, isn’t close. 7-OH runs about thirteen times the potency of morphine in laboratory assays; a forensic case reported a death at a blood level of 0.15 mg/L; and poison-center data show serious outcomes in roughly a third of single-substance exposures. Any threshold, the group warned, becomes a target — and “the cost of setting it too high is measured in opioid overdoses.”
FDPS flagged the beverage aisle as the likeliest loophole. The proposed 0.050% concentration limit, it calculated, would allow roughly 30 mg of 7-OH in a two-ounce shot and about 177 mg in a twelve-ounce drink — the same “dry weight” math, the group noted, that produced a market of intoxicating hemp-THC beverages that are nominally “compliant.”
Then the escalation. FDPS urged HHS to recommend controlling not just 7-OH but mitragynine, the main kratom alkaloid the metabolite comes from. “The threshold is a stopgap,” the comment reads. “The durable solution is to control the alkaloid from which 7-OH is made.”
Its argument: mitragynine converts to 7-OH both in the body and inside the product on exposure to light and heat, so a drink that tests “low” can still deliver a heavy opioid dose. The group cited CDC data recording mitragynine in 5,208 overdose deaths from 2020 through 2024, and roughly 1.6 million Americans using kratom in 2023 — essentially none by prescription.
FDPS also pre-empted the industry’s likely defense: that regulators already passed on kratom. In 2016, DEA moved to schedule the alkaloid, then withdrew — “the first time the agency had ever reversed a scheduling decision after announcing it” — after an industry-organized campaign and a petition topping 100,000 signatures. Critically, the group noted, DEA “did not withdraw because it found mitragynine safe or lacking in abuse potential.”
In a companion filing the same day, FDPS backed DEA’s separate proposal to put tianeptine — a mu-opioid sold over the counter as a supplement — in Schedule I, noting some “Neptune’s Fix” lots were found laced with synthetic cannabinoids and that bulk tianeptine has been pressed into counterfeit hydrocodone and oxycodone pills. “Schedule I,” it wrote, “is the placement the CSA requires.”
FDPS’s bottom line on kratom fit on a single line: “Controlling 7-OH while leaving its precursor lawful will invite evasion; controlling mitragynine reaches the source.”