- A group of plaintiffs has filed a lawsuit against the state of Florida following the state’s ban on 7-hydroxymitragynine (7-OH). In July 2025, the state issued an emergency rule, which took immediate effect, classifying isolated and/or concentrated 7-OH from kratom as a Schedule I controlled substance in Florida. The rule made it illegal to sell, possess, or distribute any isolated or concentrated form of 7-OH in Florida.
- The complaint argues that “the emergency order was issued without public notice or hearings” and that the state’s actions were “unlawful, unnecessary and carried out without due process.” According to the complaint, 7-OH presents no public safety threat and has been legally sold in Florida for years under the Kratom Consumer Protection Act. Further, the rule was issued without due process and is arbitrary and inconsistent because it bans 7-OH but allows the mitragynine alkaloid, which the human body naturally converts into 7-OH. Finally, the ban has harmed consumers and small businesses.
- FDA has requested that the Drug Enforcement Administration issue a federal scheduling action to control 7-OH products nationwide under the Controlled Substances Act. Further, in July 2025, FDA sent several Warning Letters for illegally marketing products containing 7-OH, which FDA views as a novel potent opioid that has “not been proven safe or effective for any use,” as we previously blogged. FDA Commissioner Marty Makary has said that 7-OH products are “dangerous opioids” found in every community in America.
- Keller and Heckman will continue to monitor activity related to the sale of 7-OH and kratom products.
