The 7-OH Ban: FDA Actions, State Laws, and Concentration Limits

The 7-OH ban is not a single law. Federal regulators treat concentrated 7-hydroxymitragynine products as illegal opioids that cannot lawfully be sold in any form, and a growing list of states have imposed their own bans, emergency scheduling orders, or concentration limits. The Drug Enforcement Administration has not yet placed 7-OH on the federal controlled-substances schedule, so the compound’s precise legal status still varies significantly by state.

Federal Status of 7-OH

The FDA’s position is that 7-OH cannot be lawfully sold to consumers at all. The agency says there are no approved 7-OH drugs, the compound is not a lawful dietary supplement ingredient, and it cannot legally be added to conventional foods.¹

The agency began acting on that position in June 2025, issuing warning letters dated June 25 to seven companies distributing concentrated 7-OH: Shaman Botanicals, My Smoke Wholesale, Relax Relief Rejuvenate Trading (doing business as RRR Trading or EDP Kratom), Thang Botanicals (doing business as 7OHMZ), Royal Diamond Imports (doing business as Roxytabs.com), Hydroxie, and 7Tabz Retail. Products labeled as foods or supplements were treated as adulterated because 7-OH is a “new dietary ingredient” without adequate safety data. Products carrying therapeutic claims were treated as unapproved new drugs.¹²

On July 29, 2025, the FDA formally recommended that the DEA place 7-OH products under the Controlled Substances Act, releasing a scientific report on the compound’s risks alongside letters to healthcare professionals and consumers.³ As of mid-2026, the DEA has not completed a scheduling action, which requires a formal rulemaking process with a public comment period. Representative Rob Bresnahan sent a letter to the DEA in March 2026 urging emergency scheduling of 7-OH as Schedule I, and a joint explanatory statement accompanying government-funding legislation expressed Congress’s “strong support” for swift DEA action.⁴ Separately, Representative Gus Bilirakis introduced H.R. 8000, the End Needless Distribution of 7-OH Act, on March 19, 2026. The bill would place synthetic 7-hydroxymitragynine on Schedule I. It has been referred to the House Energy and Commerce and Judiciary Committees, but no hearings have been held.⁵

While scheduling remains pending, the federal government has already moved from letters to physical seizures. After two of the companies that received warning letters continued distributing 7-OH, the Department of Justice filed a civil forfeiture complaint on November 21, 2025, in the U.S. District Court for the Western District of Missouri targeting products held by Shaman Botanicals and Relax Relief Rejuvenate Trading. FDA inspectors had already tagged and detained roughly 76,000 units at three Kansas City-area warehouses on November 12 and 13.⁶⁷⁸

State Bans and Restrictions

Because the federal scheduling process has not concluded, state law is where the sharpest 7-OH prohibitions currently sit. The rules fall into three groups.

States That Ban All Kratom Alkaloids

Alabama, Arkansas, Indiana, Louisiana, Vermont, and Wisconsin classify both mitragynine and 7-OH as Schedule I controlled substances, effectively banning all kratom products. The District of Columbia has done the same since 2016.⁹

States That Have Recently Banned or Scheduled 7-OH

Florida. On June 22, 2026, Attorney General James Uthmeier signed an emergency rule classifying 7-OH and six related compounds as Schedule I controlled substances, effective immediately. Selling or possessing products that exceed one milligram of these compounds per gram of solid or per milliliter of liquid is a felony. Any product containing 7-OH must also contain at least 100 times more regular mitragynine by mass, a threshold designed to exempt trace amounts in unmodified kratom leaf. Violations can carry penalties of up to 30 years in prison.¹⁰¹¹

Ohio. The Ohio Board of Pharmacy issued an emergency rule on December 12, 2025, making it illegal to sell, possess, or distribute concentrated 7-OH products. A clarification four days later specified that the ban does not cover natural kratom in vegetation form. A permanent version took effect on May 14, 2026, replacing a temporary executive order signed by Governor Mike DeWine.¹²¹³

California. California treats kratom and 7-OH products as illegal to manufacture or sell for human consumption under the Sherman Food, Drug, and Cosmetic Act. The Department of Public Health issued a statewide consumer warning in October 2025 and has since seized more than five million dollars’ worth of products. By March 2026, enforcement visits to more than 4,500 licensed businesses had resulted in removal of over 3,300 illicit products, with the state reporting 95 percent compliance.¹⁴ In May 2026, the state sued Ashlynn Marketing Group (doing business as Krave Kratom) for allegedly continuing to manufacture and distribute products despite an embargo, seeking civil penalties of up to $1,000 per day per violation.¹⁵

Virginia. Governor Abigail Spanberger signed House Bill 360 on May 26, 2026, banning the sale of products containing 7-OH. The law also requires kratom products to be kept behind store counters, sold only to customers 21 and older, and labeled with a warning that they may cause dependence and opioid-like withdrawal.¹⁶¹⁷

Kentucky. In November 2025, the Beshear administration announced it was finalizing regulations to classify isolated and concentrated forms of 7-OH as a Schedule I narcotic, placing the compound alongside heroin and fentanyl under Kentucky law.¹⁸

Colorado. Senate Bill 25-072, the Daniel Bregger Act, was signed by Governor Jared Polis on May 29, 2025. It bans the manufacture and distribution of synthetic and semi-synthetic kratom, limits the allowable concentration of 7-OH, prohibits the sale of kratom as candy or in forms appealing to children, and requires labeling with serving sizes and warnings.¹⁹

Connecticut. The state’s Legislative Regulation Review Committee unanimously approved regulations in February 2026 designating kratom and 7-OH as Schedule I controlled substances.²⁰

States With Concentration Limits

At least 14 states have laws that stop short of scheduling kratom alkaloids but prohibit synthetic 7-OH and cap the allowable concentration of the compound, often at no more than two percent of the alkaloid fraction. Arizona and Colorado are among the states using this approach.⁹

Missouri: Enforcement Without a Statutory Ban

Missouri still lacks a statutory prohibition on 7-OH, but state enforcement has effectively shut down major distributors. Attorney General Catherine Hanaway sued CBD American Shaman and affiliated entities in Jackson County Circuit Court in March 2026, alleging violations of the Missouri Merchandising Practices Act.²¹ On June 4, 2026, American Shaman agreed to suspend all in-state sales of kratom and 7-OH to Missouri consumers, in stores and online, and to abandon Missouri-targeted retail advertising. The settlement bars founder Vince Sanders from creating franchises to sell kratom under a different name or altering chemical compounds to circumvent the ban. If the company breaches the agreement and does not immediately remedy the violation, the Attorney General can invoke an agreed five-million-dollar penalty. The agreement is not an admission of liability.²²

Why Regulators Are Targeting 7-OH

7-hydroxymitragynine occurs naturally in kratom leaves at trace levels, typically well under one percent by weight.²³ The products drawing regulatory attention are different: they are semi-synthetically produced in laboratories by chemically modifying purified mitragynine to create highly concentrated tablets, gummies, drink shots, and liquid mixes.²⁴

These concentrated forms bind to the same mu-opioid receptors as morphine and heroin. Preclinical research has found 7-OH to be roughly 13 times more potent than morphine and more than three times as potent at producing respiratory depression, the mechanism behind most opioid overdose deaths.²⁵²⁶ Reported health effects include nausea, vomiting, confusion, seizures, respiratory depression, and loss of consciousness. The Los Angeles County Department of Public Health issued an alert in September 2025 identifying fatal overdoses linked to 7-OH in the county, noting that combinations with alcohol or other sedatives posed especially severe risks. Naloxone has been identified as effective against 7-OH toxicity, though repeated doses may be required.²⁷ The FDA’s adverse-event database documented 13 suspected 7-OH cases, including two deaths, and DEA toxicology data showed roughly a threefold increase in fatal cases involving kratom alkaloids between the 2019–2022 and 2023–2025 periods.

Concentrated 7-OH vs. Traditional Kratom Leaf

Most of the current bans distinguish concentrated or synthetic 7-OH from natural kratom leaf. Ohio’s rule expressly excludes kratom in vegetation form.¹³ Florida’s rule uses a mitragynine-to-7-OH ratio designed to spare unmodified leaf.¹⁰ Colorado limits allowable 7-OH concentration rather than banning kratom outright.¹⁹

That distinction reflects a split within the kratom industry. The American Kratom Association characterizes concentrated 7-OH as “synthetic” or “chemically manipulated” and calls it “a massive fraud on consumers,” while promoting state-level Kratom Consumer Protection Acts that ban synthetic derivatives but preserve access to the natural leaf.²⁸ The Global Kratom Coalition draws the same line, framing concentrated 7-OH products as part of a “fourth wave” of the opioid epidemic through its “Stop Gas Station Heroin” campaign. On the other side, the Holistic Alternative Recovery Trust, representing some 7-OH manufacturers, argues that its products are no more dangerous than natural leaf and that the leaf-kratom industry is trying to eliminate market competition.²⁹ States that ban all kratom alkaloids, listed above, do not recognize this distinction and prohibit both.

What’s Still Pending

The single most consequential unresolved question is whether the DEA will place 7-OH on the federal controlled-substances schedule. Until it does, the compound’s legal status will continue to depend on the state, ranging from felony prosecution in Florida to concentration-limit regulation in states like Arizona and Colorado to no statutory prohibition at all in Missouri, where enforcement is proceeding through consumer-protection settlements rather than criminal law.³⁰ H.R. 8000 remains in committee with no hearings scheduled.⁵ Anyone buying, selling, or possessing a 7-OH product should check the current law of the state they are in, because the rules have changed several times in the past year and are likely to keep changing.

1
U.S. Food and Drug Administration. FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
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U.S. Food and Drug Administration. Warning Letter to Thang Botanicals Inc.
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U.S. Food and Drug Administration. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
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U.S. House of Representatives. Bresnahan Urges DEA to Take Emergency Action on 7-OH
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GovTrack. H.R. 8000: END 7-OH Act
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Missouri Independent. Feds Seize Thousands of 7-OH Products From Kansas City Warehouses
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U.S. Food and Drug Administration. FDA Seizes 7-OH Opioids to Protect American Consumers
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U.S. Department of Justice. Justice Department Seizes Unlawful 7-OH Products From Three Warehouses
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Legislative Analysis and Public Policy Association. Kratom Summary of State Laws
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Florida Office of the Attorney General. Attorney General Signs Emergency Rule Scheduling 7-OH
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News4Jax. Florida AG Signs Emergency Rule to Curb Concentrated 7-OH Products
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Ohio State News. Permanent Ban on Synthetic Kratom Sales in Ohio to Go Into Effect in May
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Ohio Board of Pharmacy. Consumer and Retailer Notice on Kratom in Ohio
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Office of the Governor of California. Governor Newsom Announces 95% Compliance With Prohibition of Illegal Kratom Products
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California Statewide Law Enforcement Association. CDPH Files Legal Action Against Kratom Manufacturer
16
Virginia Mercury. Kratom Product Sales to Be Regulated in Virginia
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WTVR. Virginia Kratom Restrictions
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Kentucky Lantern. State Health Cabinet to Ban Sale and Possession of Dangerous Kratom Derivative
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Denver Post. Polis Signs Kratom Regulations Law
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Connecticut Department of Consumer Protection. Department of Consumer Protection Applauds Passage of Controlled Substance Drug Schedule Updates
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Missouri Attorney General. Attorney General Hanaway Files Suit Against American Shaman
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Missouri Attorney General. American Shaman Agrees to Suspend Sales of Kratom and 7-OH in Missouri
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National Center for Biotechnology Information. 7-Hydroxymitragynine Pharmacology Study
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University of Colorado Anschutz Medical Campus. What Is 7-OH and Why Is It Being Targeted in Kratom Products
25
Texas Department of State Health Services. Serious Illnesses Associated With 7-OH Use
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U.S. Food and Drug Administration. 7-Hydroxymitragynine Scientific Assessment
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L.A. Care Health Plan. Fatal Overdoses Linked to 7-OH
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American Kratom Association. FDA Crackdown on Dangerous Chemically Manipulated 7-OH Products
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Politico. Kratom Wars Come to K Street
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KSHB. Missouri AG: American Shaman to Suspend Sales of Kratom, 7-OH in Missouri