On Aug. 13, Florida Attorney General James Uthmeier filed an emergency rule to classify isolated and/or concentrated 7-hydroxymitragynine (7-OH) products as a Schedule I controlled substance in Florida.
The rule takes effect immediately and makes it illegal to sell, possess or distribute any isolated form of 7-OH in the state. The announcement comes a few weeks after the U.S. Food and Drug Administration (FDA) announced it would be taking steps to restrict 7-OH products.
“Due to the danger posed to the public, Florida is taking 7-OH off the shelves immediately. This dangerous substance is being marketed to teens and young adults and has a high potential for abuse and death,” Uthmeier said.
“Synthetic opioids derived from kratom pose a serious threat to both public and mental health. They undermine the intentions of individuals who use kratom safely and the progress we’ve made as a state to reduce overdose deaths,” added Florida Surgeon General Joseph Ladapo, MD.
7-OH is a compound that is a natural byproduct of kratom. Although natural, levels are low in whole kratom leaves and isolated or concentrated forms of 7-OH are much more potent and are often marketed as “natural or wellness supplements.” However, 7-OH is not legal for use in dietary supplements, conventional foods or prescription drugs, according to FDA.
The Florida Department of Health and other local agencies reported an increase in emergency room visits and adverse health effects linked to 7-OH, particularly in individuals under the age of 25. The products are often sold in gas stations, vape shops and convenience stores, sometimes in packaging designed to appeal to teens and young adults, according to the Uthmeier.
“7-OH mitragynine is a dangerous substance not only because of its chemical makeup, high potency and risk of addiction, but also due to the marketing and accessibility of the product. We’ve seen an increase of exposure in Florida, and it is essential that we bring awareness to the grave consequences of this lethal drug,” said Dr. Cory Howard, a medical toxicologist and emergency medicine physician at Tampa General Hospital.
FDA Commissioner Marty Makary, MD, MPH applauded Uthmeier for his efforts to ban 7-OH.
“The proliferation of concentrated 7-OH products is a major concern for the FDA. I am particularly concerned with the growing availability of concentrated 7-OH products appealing to children and teenagers, such as fruit-flavored gummies, candies and ice cream cones,” Makary said. “These concentrated 7-OH products have snuck into every community in America, and I’m glad to see Florida’s local leaders fighting back and educating Floridian parents, law enforcement professionals, teachers and community leaders about this threat to public health. I encourage other states to act now and use common sense regulation to safeguard the well-being of our youth and Make America Healthy Again.”
