A US drug policy group wants federal regulators to stop debating safe limits altogether and impose a full kratom opioid ban, arguing that no dose of the substance 7-hydroxymitragynine, known as 7-OH, qualifies as safe.

The Foundation for Drug Policy Solutions (FDPS) laid out its case in comments filed on 16 July on the federal plan to place 7-OH in Schedule I. Rather than argue over where regulators should draw a permitted limit, FDPS said they shouldn’t draw one at all. The group pointed to FDA warnings that manufacturers haven’t shown 7-OH products safe for any use.

Why FDPS says the numbers don’t add up

FDPS built its case for a kratom opioid ban on pharmacology it says leaves little room for debate. Laboratory assays put 7-OH at roughly thirteen times the potency of morphine. One forensic case recorded a death at a blood level of just 0.15 mg/L, and poison-centre data show serious outcomes in around a third of cases involving 7-OH alone. Any threshold regulators set, the group warned, simply becomes a target for manufacturers to test against, and pushing that number too high risks paying for it in opioid overdoses.

The group flagged the beverage aisle as the likeliest place a threshold would fail. Under the proposed 0.050% concentration limit, FDPS calculated that a two-ounce shot could still legally contain roughly 30 mg of 7-OH, and a twelve-ounce drink could carry about 177 mg. It’s the same dry-weight calculation, the group noted, that already produced a market of technically compliant but clearly intoxicating hemp-THC drinks.

Going after the source, not just the metabolite

FDPS then pushed its argument further than the federal proposal goes. It urged the Department of Health and Human Services to recommend controlling not just 7-OH but mitragynine, the kratom alkaloid the metabolite comes from. A threshold on 7-OH alone, the group argued, only solves half the problem, because mitragynine converts into 7-OH both inside the body and inside the product itself when exposed to light and heat. That means a drink testing “low” for 7-OH can still deliver a heavy opioid dose once consumed.

To back that up, FDPS cited CDC figures recording mitragynine in 5,208 overdose deaths between 2020 and 2024, alongside an estimated 1.6 million Americans who used kratom in 2023, almost none of them under a prescription.

The group also pre-empted an argument it expects the kratom industry to raise: that regulators already settled this question once and moved on. In 2016, the US Drug Enforcement Administration (DEA) moved to schedule mitragynine, then withdrew the proposal after an industry-organised campaign and a petition that gathered more than 100,000 signatures, the first time the agency had ever reversed a scheduling decision it had already announced. FDPS was careful to note that the DEA never withdrew because it found mitragynine safe.

In a companion filing the same day, FDPS backed a separate DEA proposal to schedule tianeptine, an opioid receptor agonist sold over the counter as a supplement, after some branded products turned up laced with synthetic cannabinoids and bulk tianeptine was found pressed into counterfeit hydrocodone and oxycodone pills.

FDPS summed up its position on 7-OH scheduling in a single line, arguing that “controlling mitragynine reaches the source,” while a threshold on 7-OH alone would only invite manufacturers to work around it.

Source: The Drug Report