Florida has moved quickly to block the sale, possession, and distribution of concentrated forms of 7-hydroxymitragynine, or 7-OH. This potent opioid, derived from kratom, is now classified in the state’s strictest controlled substance category. The ban took effect immediately under an emergency rule signed by Attorney General James Uthmeier.
Emergency Rule and Immediate Ban
The rule makes it illegal to sell or distribute certain concentrated 7-OH products right away. Officials want to stop a dangerous opioid from spreading further, especially given how fast these products have appeared in stores. Concentrated 7-OH now falls under Schedule I, the category reserved for substances with no recognized medical use and high risk of abuse.
FDA Warnings for Young People
FDA Commissioner Marty Makary praised Florida’s action and explained why the federal agency is concerned. “Today I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an emergency rule to classify certain concentrated forms of 7-hydroxymitragynine, also known as 7-OH, as a Schedule I controlled substance in Florida,” he said.
Makary pointed out that some concentrated forms are marketed in ways that appeal to children and teens. “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,” he added.
Spread Across Communities
According to Makary, concentrated 7-OH products have reached communities across the U.S. “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,” he said.
He also urged other states to take immediate steps to protect young people. “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,” Makary said.
Link to Federal Action
Florida’s move is part of a broader federal effort. The FDA recently recommended controlling concentrated 7-OH products under the Controlled Substances Act. The Drug Enforcement Administration (DEA) is reviewing the recommendation and will make the final decision. Any scheduling action requires a public comment period before it becomes official.
What 7-OH Is and Why It’s Dangerous
7-hydroxymitragynine, or 7-OH, is a natural alkaloid found in kratom leaves (Mitragyna speciosa) and an active metabolite of mitragynine. Discovered in 1994, it forms in the liver through oxidation by the enzyme cytochrome P450 3A4.
It is the main driver of kratom’s pain-relieving effects, acting as a partial agonist at the μ-opioid receptor—the same receptor targeted by morphine and other opioids. In mice, 7-OH showed pain relief about five times stronger than orally taken mitragynine. Its effects can be blocked with naloxone.
The danger rises sharply with concentrated or synthetic products. Natural kratom contains only tiny amounts of 7-OH (less than 0.05–2%). Some commercial extracts, gummies, and shots contain up to 98%. At this strength, the effect on opioid receptors is 30–40 times higher than standard kratom, producing rapid and intense effects: strong pain relief, euphoria, slowed breathing, dependence, and withdrawal symptoms.
Some users report withdrawal symptoms almost identical to heroin. “The withdrawals from 7-OH are just about neck and neck with heroin withdrawals…,” an anonymous Reddit user wrote, describing insomnia, body aches, and severe anxiety.
For these reasons, the FDA warns against using products containing 7-OH. They are not approved for medical or food use and can be extremely dangerous, particularly for young people. U.S. authorities have started restricting access by placing 7-OH in Schedule I.
Alert Date: July 29, 2025
Even before the Florida ban, on July 29 the FDA issued a warning about 7-OH products. The agency flagged candies, gummies, ice pops, and flavored shots containing this kratom-derived opioid, often sold as natural supplements or remedies for pain and anxiety.
The main concern is transparency. Many labels do not clearly list 7-OH or misstate its concentration, misleading consumers about potency. The FDA sent warning letters to seven companies distributing these products illegally, demanding their removal from the market.
The agency also stressed the need to work with the DEA to list 7-OH as a Schedule I substance, which requires public consultation before final approval. Until then, the advice is simple: avoid 7-OH products. Source: Hiding in Plain Sight: 7-OH Products
Glossary
- 7-hydroxymitragynine (7-OH): an alkaloid from kratom, with strong opioid effects.
- Schedule I: U.S. classification for substances with no recognized medical use and high abuse potential. Schedule I substances cannot be legally produced, sold, or used for medical purposes in the U.S., except in authorized research. Examples include heroin, LSD, and concentrated opioids like 7-OH.
- Agonist: a chemical or drug that binds to a receptor and activates it, producing a biological effect. Opioids “turn on” μ-opioid receptors to relieve pain and cause euphoria.
- DEA (Drug Enforcement Administration): U.S. federal agency enforcing controlled substance laws.
- FDA (Food and Drug Administration): U.S. federal agency regulating drugs, food, and medical devices.
- Controlled Substances Act: U.S. law establishing controlled substance classifications.
- Emergency Rule: a measure taken to address immediate risks, effective immediately without the usual legislative process.
