FLORIDA ADDS 7-HYDROXYMITRAGYNINE TO SCHEDULE I UNDER EMERGENCY RULE LAW

For years, state-level actions against kratom followed the guidance of federal agencies that were skewing the science on kratom. 

Florida is looking to reverse that trend and is using the latest action from the Food and Drug Administration (FDA) to help protect kratom consumers from bad actors in the industry. 

The state of Florida recently announced an emergency action against 7-hydroxymitragynine (7-OH), which is an alkaloid found in trace amounts in natural kratom leaf. Following in the footsteps of the FDA’s announcement to seek scheduling of 7-OH, Florida Attorney General James Uthmeier announced the measure on Aug. 13 and is putting pressure on the state legislature to follow up with a formal change to state law to target the products that are masquerading as “enhanced kratom.” 

“We are taking emergency action now because we see immediate danger,” Uthmeier said. “It’s not something that happens often; it truly needs to be a public health emergency, and 7-OH presents that threat.” 

Uthmeier’s actions were made possible by legislation passed in Florida that allows for the emergency scheduling of substances if they meet specific criteria for placement. The new guidance calls for the scheduling of any product that is “concentrated at a level above four hundred parts per million on a dry-weight basis.” 

The emergency rule was announced during a press conference at Tampa General Hospital, featuring FDA Commissioner Marty Makary, who had recently held his own press event to announce the agency’s decision to target 7-OH products. Makary has a background as a medical doctor and said at the press conference that “very few doctors” have even heard of 7-OH, instead attributing these issues to all forms of kratom. 

Protecting Consumers from Misleading Products

Rather than making wide-ranging criticisms of the plant, Makary said it is past time for the FDA to address the reality of the kratom industry and listen to advocates who have been calling for more limitations on adulterated kratom products, especially those that are marketed toward younger consumers. 

“We have to be proximate to what’s happening on the ground,” said. “We cannot live in the ivory tower of the ruling class…We’ve got to be in the vape stores, we’ve got to understand what kids are taking and what they experience and what the medical effects are.” 

As was the case during the FDA’s announcement last month, Makary reiterated that this law was not targeting natural kratom leaves and the mitragynine that is found in those products.  

“Our focus is not on the kratom leaf… which has trace amounts of 7-OH,” Makary said. “We need to know what’s going on.” 

Instead, Makary said that what they’ve learned about 7-OH products is what makes this situation a public health emergency. Due to developments in the science comparing kratom’s active alkaloids, Makary made it clear that there is a distinct difference in the effect of natural kratom products as compared to products with enhanced levels of 7-OH. 

“This is not just like an opioid–it does not just have opioid binding properties, it is not just an agonist on the mu receptor. It is scientifically meeting the criteria of an opioid and yet you can go in a vape shop in America on almost any corner and buy it like a cup of coffee,” Makary said. “We got burned with fentanyl, we got burned with prescription drugs, we cannot get behind the 8-ball again.” 

Expanding the State’s KCPA

The next step in Florida will be codifying protections against 7-OH products through the state legislature. 

Currently, the only law on Florida’s books that addresses kratom is a law dubbed the Florida Kratom Consumer Protection Act (KCPA). Instead of offering a robust set of regulatory rules like other KCPAs, the current law simply sets an age requirement of 21 years old to buy kratom products in the state. 

An effort was made to expand on that law during the 2025 legislative session in Florida by revising the current KCPA to align it more closely with laws that have been passed in other states. That proposed law included a section that would limit the total alkaloid fraction of 7-OH to just 2 percent of the total alkaloid composition in any product that would be considered kratom. 

It would have also banned all synthesized and semi-synthesized kratom alkaloids–the same type of products that are being targeted by the FDA and Florida’s emergency rule. The proposed KCPA additions would have also created a concise list of “delivery forms” that includes dried leaf, kratom beverages, powders, pills, capsules and “gummy or food that are not attractive to children.” 

Instead, the law died in committee and left the market unregulated, leading to this action by the Uthmeier to protect public health. 

As part of the press conference in Florida, the state’s surgeon general touched on the need to find a common ground between supporting dietary supplements and making sure that consumers are not presented with products that go beyond the scope of what is offered by natural kratom. Dr. Joseph Ladapo said he supported the personal right of consumers to supplement their daily routines with natural products, but said the line needs to be drawn at substances like 7-OH, which carry the same scientific properties as classic opioids. 

“I’m very supportive of people seeking alternatives outside of traditional Western medicine for wellness,” Ladapo said. “Our problem here is not with kratom. The problem today is with this 7-OH–we don’t need any more substances that disconnect people with reality.”