Companies that sell a kratom byproduct called 7-hydroxymitragynine (7-OH) and several users are suing to block Florida’s emergency rule that bans its manufacture and sale.

On Aug. 15, Attorney General James Uthmeier issued an emergency rule adding the alkaloid 7-OH to the state’s Schedule 1 list of the most dangerous drugs, immediately prohibiting its sale. The concentrated kratom byproduct — sold in drinks, gummies and powders at smoke shops around Florida — has surged in popularity in recent years. Doctors say 7-OH acts on the same brain receptors as opioids and is similarly addictive.

The challenge, filed Monday, argues the ban is invalid because Uthmeier’s office did not follow proper rulemaking procedures and “was not adopted under a procedure which was fair under the circumstances.” Florida law permits the attorney general to adopt emergency rules temporarily classifying a “new substance” as Schedule 1 when needed “to avoid an imminent hazard to the public safety.” Under state law, Schedule 1 drugs have a “high potential for abuse” and “no currently accepted medical use in treatment.”

The 44-page administrative complaint, filed at the Division of Administrative Hearings, says there is “an insufficient factual or scientific basis” to show the banned products are being used in a way that creates the substantial likelihood of harm required for an emergency designation.

Plaintiffs include 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 7-OH users identified only 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 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 use show 7-OH has often been used as a harm-reduction tool by people addicted to fentanyl, heroin or coping with chronic pain. The filing adds that the absence of overdose deaths attributable solely to 7-OH undermines any claim of an imminent public-health hazard.

Uthmeier has said the emergency ban, effective for one year, will be followed by efforts to make it permanent during the 2026 legislative session, which begins in January. “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 at an August news conference. “We are taking emergency action now because we see immediate danger.”

The complaint describes economic fallout from the sudden ban. The Mystic Grove says it was left with “significant inventory of 7-OH that, although legal to possess and sell the day before, was suddenly illegal,” costing the company several thousand dollars a month. Green Brothers reports business down about 60% since the rule took effect, which the complaint says reflects an industry-wide contraction.

The filing includes personal stories, saying one plaintiff, “M.D.,” struggled for years with opioid addiction. He initially reduced opiate use with kratom powder and later credited 7-OH tablets with helping him achieve lasting control over his addiction. The emergency scheduling, the complaint says, “threatens to upend his progress and poses a direct risk of relapse.”

The timing follows weeks after President Donald Trump’s administration took initial steps to add 7-OH to the federal list of dangerous drugs as part of efforts to address opioid addiction. The complaint notes that no new science has emerged since the FDA dropped a 2018 effort to ban 7-OH, arguing there is no “compelling new scientific evidence” to justify declaring an imminent health crisis now.

Florida already restricted kratom — the plant mitragyna speciosa — in 2023 by prohibiting its sale to people under 21, but broader legislation to regulate or ban kratom has not passed.

What is 7-OH?

7-hydroxymitragynine is one of kratom’s most potent natural alkaloids. It occurs at low levels in whole kratom leaves, but isolated or concentrated forms are far stronger and are often marketed as supplements. The rise of concentrated 7-OH products at gas stations, smoke shops and other retailers has undercut sales of powdered and leaf-based kratom, industry observers say.

The push to ban 7-OH has split the kratom community. Some consumers and manufacturers defend powdered leaf products while criticizing concentrated alkaloids, and advocates for stricter oversight point to safety concerns. David Bregger, whose son died of an overdose in Colorado, blames a concentrated kratom product mixed with diphenhydramine and other over-the-counter sleep aids and called 7-OH “a horrible dangerous substance” while supporting strict regulation. “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.”

Plaintiffs counter that national opioid deaths have declined since 7-OH entered the market two years ago and say there is no clear evidence of a surge in hospitalizations, toxicology alerts or overdose deaths to justify an emergency public-health declaration.

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