Businesses that sold a concentrated kratom byproduct known as 7-hydroxymitragynine, or 7-OH, and several users have filed a legal challenge to Florida’s emergency ban on the substance.

On Aug. 15, Attorney General James Uthmeier issued an emergency rule adding 7-OH to the state’s most dangerous drugs and prohibiting its manufacture and sale. The ban, effective immediately, targets the alkaloid found in products such as drinks, gummies and powders that had been sold in smoke shops across Florida. Doctors say 7-OH acts on the same brain receptors as opioids and can be equally addictive.

The administrative complaint filed Monday argues the emergency rule is invalid in part because Uthmeier’s office did not follow required rulemaking procedures and “was not adopted under a procedure which was fair under the circumstances.” Under Florida law, the attorney general may temporarily classify a “new substance” as a Schedule 1 drug through an emergency rule only to “avoid an imminent hazard to the public safety.” Schedule 1 drugs are defined as having a “high potential for abuse” and “no currently accepted medical use in treatment.”

The complaint, lodged at the state Division of Administrative Hearings, says there is “insufficient factual or scientific basis” to show the banned products are being used in a way that creates the level of public hazard required for emergency scheduling. It was filed on behalf of The Mystic Grove, LLC, which runs two Florida retail stores; Green Brothers Wholesale, Inc., a distributor of hemp, kratom and other smoke-shop products; and six individuals identified by initials — K.T., B.M., J.E., A.G., A.R. and M.D. They are represented by J. Stephen Menton of Rutledge Ecenia, P.A., and Paula Savchenko of PS Law Group.

The 44-page complaint says Uthmeier’s office “has provided no evidence of widespread or habitual misuse, no documentation of diversion from legal channels, and no indication that 7-OH poses a greater risk than comparable over-the-counter botanical or nutraceutical products.” It argues epidemiological data and real‑world usage patterns show the substance “has been widely used as a harm reduction tool” by people addicted to illicit opioids such as fentanyl or heroin, or to manage chronic pain. “The absence of overdose deaths attributable solely to 7-OH undermines any claim that the substance presents a substantial likelihood of harm under the statutory definition,” the lawyers wrote.

At an August news conference, Uthmeier said he planned to work with lawmakers during the 2026 legislative session to make the one-year emergency ban permanent. “It is a significant painkiller. It has been proven to be highly addictive and easily can be overdosed, so it’s very dangerous,” he said. “We are taking emergency action now because we see immediate danger.”

The complaint describes immediate business and personal impacts after the rule took effect. The Mystic Grove was left holding “significant inventory of 7-OH that, although legal to possess and sell the day before, was suddenly illegal,” and it estimates losses of several thousand dollars per month. Green Brothers reported sales falling roughly 60 percent after the ban, which the complaint says reflects an industry-wide decline.

The filing also includes individual stories. It says “M.D.” struggled for years with opioid addiction; kratom powder helped reduce his dependence, but he credits 7-OH tablets with allowing him to achieve lasting control over his addiction. The complaint warns that emergency scheduling “threatens to upend his progress and poses a direct risk of relapse.”

Uthmeier’s action followed federal steps by the Trump administration to add 7-OH to the national list of dangerous drugs as part of efforts to confront opioid addiction. The Florida challenge contends no new scientific evidence has emerged since the U.S. Food and Drug Administration abandoned a 2018 effort to ban 7-OH. “There is no compelling new scientific evidence that has suddenly become accepted in the scientific community to support a claim of an imminent health crisis sufficient to reverse the 2018 FDA determinations,” the complaint states.

Florida already restricted kratom sales to people 21 and older in 2023, but broader legislation to regulate or ban the plant has not passed. 7-OH is one of kratom’s most potent active alkaloids; it exists at low levels in whole kratom leaves, while isolated or concentrated forms are much stronger and are often marketed as natural or health supplements.

The dispute has split the kratom industry, pitting makers and users of concentrated 7-OH against advocates for powdered or leaf kratom. The rapid appearance of 7-OH products at gas stations, smoke shops and other retailers also took market share from powdered and leaf-based kratom, industry experts say.

Families of overdose victims have pressed for stricter controls. David Bregger, whose son died of an overdose in Colorado, blamed the death on a concentrated kratom product mixed with diphenhydramine and other over-the-counter sleep aids. Calling 7-OH “a horrible dangerous substance,” Bregger has urged tight regulation of the kratom market. “Pure leaf kratom is safe. It shouldn’t be banned,” he told The News Service of Florida in August. “You can’t overdose on it, really.”

Proponents of 7-OH counter that national opioid deaths have fallen since the concentrated product entered the market two years ago. The complaint concludes that “without clear evidence of a surge in hospitalizations, toxicological alerts, or overdose deaths, there is no basis to suddenly declare an imminent hazard to public health.”

This article was adapted from an original report published on wusf.org. All rights belong to the original publisher.