A compound called 7-hydroxymitragynine, also known as 7-OH, found in some kratom products, is now a Schedule 1 controlled substance in Florida.
Florida Attorney General James Uthemeir issued an emergency rule Wednesday that places 7-OH on a list of drugs, substances, or chemicals that are considered to have no accepted medical use but a high potential for abuse. Schedule 1 substances cannot be legally obtained with a prescription or readily dispensed for clinical use in the United States.
Food and Drug Commissioner Dr. Marty Makary joined a press conference along with Florida Agriculture Commissioner Wilton Simpson, Surgeon General Joseph Ladapo, Dean of the University of South Florida Morsani College of Medicine Dean Dr. Charles Lockwood, and USF Health emergency department physician Cory Howard.
“So it is a significant pain killer. It has been proven to be highly addictive and easily can be overdosed, so its very dangerous,” Uthmeier said.
Simpson said his agency, which exercises regulatory oversight of kratom sales, would begin enforcement efforts Thursday and that retailers needed to remove the products from their shelves.
Florida legislators already have made it illegal to sell kratom to customers under the age of 21. Nevertheless, Uthmeier said it’s being marketed and targeted to “kids.”
Meanwhile, the FDA’s Makary lauded the AG for taking quick action following the U.S. Food and Drug Administration’s decision last month to send warning letters to seven companies for allegedly illegally marketing products containing 7-OH.
Although 7-OH occurs naturally in trace amounts in kratom, the FDA’s letters focus on concentrated products such as tablets, gummies, drink mixes, and shots that may be dangerous.
USF’s Howard said he has seen four patients over the last two weeks, some in the emergency room, who took 7-OH.
“I’m seeing this firsthand pop up,” Howard said.
“Most consumers don’t even realize the danger of the product, right? They can easily access it on store shelves, gas stations, right? I’ve seen this pop up in tablets, gummies, you know, candy lookalikes, drink mixes, teas, shots, wellness supplements. I personally have seen this show up a the gym, at my local gym, being passed around as a wellness supplement or to get over arthritis or, you know, kind of help that fatigue after a strong workout.”
Not universally supportedThe rule isn’t supported by everyone, though.
South Florida attorney Paula Chavenko noted that the Holistic Alternative Recovery Trust (HART), formed in 2023, has been working with researchers, regulators, and public health stakeholders to investigate the safety profile and efficacy of 7-OH, including through evaluation of how it is used across different consumer populations, potential adverse health effects, additional toxicological and safety data, and abuse potential studies.
“Studies from HART have observed a notable 30% reduction in opioid overdoses, suggesting a possible role for conservative, controlled use of the plant in supporting recovery,” Chavenko said.
“We stand for a regulatory framework that safeguards public health, encourages responsible usage, and supports scientific inquiry — all without resorting to scheduling that could hamper both medical advancement and individual liberty,” she continued.
The substance, she said, “should remain accessible when manufactured, sold transparently and safely, but not banned in a way that harms research, takes away the ability for the American people to have access to this botanical alternative, and creates counterproductive outcomes,” she said.
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