Kratom (Mitragyna speciosa)Banned Substance

• Start with what is not true: kratom is not banned nationwide under US federal law [4].
  
  Much secondary and vendor coverage says otherwise. The primary agency record says the opposite, and that gap is the whole story here [3][4]. ^[4]

• DEA published a notice of intent on August 31, 2016 to place mitragynine and 7-hydroxymitragynine into Schedule I, citing an imminent hazard to public safety [3].
  
  It withdrew that notice on October 13, 2016, after numerous public comments challenging the move [4].
  
  In the Federal Register's own words, both substances remain — as has been the case — noncontrolled substances under federal law [4]. ^[4]

• DEA lists kratom as a Drug of Concern instead [5].
  
  That is an informal designation. It carries no legal force of its own, unlike scheduling. ^[5]

• The real federal restriction is FDA's, and it is about lawful marketing rather than drug scheduling [1].
  
  FDA has determined kratom is a new dietary ingredient without adequate safety data, which makes any supplement containing it adulterated under the FD&C Act [1].
  
  It has separately determined kratom is an unsafe food additive in conventional food, and has approved no drug containing kratom or its two main compounds [1]. ^[1]

• FDA enforces that at the border. Import Alert 54-15 directs officials to detain, without physical examination, dietary supplements and bulk ingredients that are or contain kratom [2]. ^[2]

• State law is where actual bans live. As of a January 2026 legal-analysis survey, six states plus the District of Columbia schedule mitragynine and 7-hydroxymitragynine as controlled substances [15].
  
  Those six are Alabama, Arkansas, Indiana, Louisiana, Vermont and Wisconsin, where possession is illegal [15].
  
  Roughly 30 other states regulate kratom without banning it, often under Kratom Consumer Protection Act frameworks requiring age verification, lab testing and labelling [15]. ^[15]

• Federal attention has since narrowed to 7-hydroxymitragynine (7-OH) in concentrated or synthetic form [10].
  
  7-OH occurs only in trace amounts in the natural leaf, but is sold far more potent in gummies, shots and tablets [10].
  
  FDA formally recommended scheduling concentrated 7-OH on July 29, 2025, while stating the recommendation targets concentrated and synthetic 7-OH rather than natural leaf [10]. ^[10]

• On July 1, 2026, DEA published notices of intent to temporarily place 7-OH above a defined threshold into Schedule I, plus three synthetic 7-OH-derived compounds [9][11].
  
  Those three are mitragynine pseudoindoxyl, MGM-15 and MGM-16 [11].
  
  The plant-material threshold is 0.05% 7-OH, and DEA stated the action is not intended to capture natural, low-7-OH kratom leaf [9][11]. ^[9]

• FDA and DEA flag the same cluster: liver toxicity, seizures, substance use disorder with withdrawal on stopping, and — rarely — death [1].
  
  FDA notes those deaths are usually associated with kratom used alongside other drugs, which often leaves kratom's specific contribution unclear [1]. ^[1]

• The mechanism explains the shape of the risk. Mitragynine and 7-hydroxymitragynine bind mu-opioid receptors — the same target as codeine — plus serotonin, dopamine, norepinephrine and kappa-opioid systems [1].
  
  That matches the dose-dependent pattern users describe: mild stimulation low, sedation and opioid-like effects higher [1]. ^[1]

• DEA's 2016 scheduling review listed the abuse-related health risks it had on file [3].
  
  Hepatotoxicity, psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor concentration and hallucinations all appear there [3].
  
  So do agitation, irritability, nausea, drowsiness and hypertension [3]. ^[3]

• FDA's own adverse-event database gives the sharpest single-year picture. Its 2021 CFSAN analysis found 78 kratom-product reports, 96% of which noted at least one adverse event [8].
  
  The six most commonly reported effect types were death, dependence, convulsion, malaise, anxiety and withdrawal syndrome, spanning many organ systems [8].
  
  The top self-reported reasons for use were pain, anxiety, depression and opioid or heroin withdrawal [8]. ^[8]

• A 2026 CDC analysis of national poison-centre data found kratom exposure reports rising, alongside growth in high-potency products enriched with isolated 7-hydroxymitragynine [7].
  
  Multiple-substance kratom exposures carried higher rates of hospitalisation and severe outcomes than single-substance ones [7].
  
  Single-substance exposures still made up 62% of reports, so this is not purely a polydrug phenomenon [7]. ^[7]

• Government and academic sources disagree on how directly to attribute deaths, and the disagreement is worth seeing.
  
  DEA's 2016 release attributed 15 kratom-related deaths between 2014 and 2016 to kratom directly [3].
  
  The peer-reviewed forensic literature stresses that kratom-associated deaths almost always involve toxic concentrations of other co-ingested substances, which usually makes kratom's causal share impossible to isolate [24]. ^[24]

• One pharmacological caveat from the same review: mitragynine may produce weaker respiratory depression than morphine, possibly through weaker recruitment of the beta-arrestin signalling pathway [24].
  
  That is offered as a possible explanation for why kratom-only fatal overdoses look rarer than polydrug ones in case reports [24].
  
  The review is explicit that this does not clear kratom as a primary or contributing cause of death [24]. ^[24]

• Dependence is documented, not theoretical. FDA describes kratom-related substance use disorder including tolerance, cravings, continued use despite harm, and withdrawal on stopping [1].
  
  Withdrawal syndrome ranked among the six most-reported effect types in FDA's 2021 adverse-event review [8]. ^[1]

• Pregnancy carries a specific, documented harm. Published case reports describe newborns of kratom-using mothers developing neonatal abstinence syndrome — jitteriness, irritability, increased muscle tone, excessive crying and poor feeding [17][19].
  
  One documented US case required oral morphine [19]. FDA states it is aware of NAS cases tied to prolonged prenatal kratom exposure [1].
  
  NIH's LactMed advises nursing mothers to avoid kratom, since the effects of infant exposure to its CNS-active alkaloids through breast milk are unknown [18]. ^[17]

• 2012 — FDA issues its first import alert on kratom [2].
  
  It has been reissued and updated repeatedly since, including a 2021 republication as Import Alert 54-15, expanding the list of detained companies [2]. ^[2]

• February 2014 to July 2016 — by DEA's account, US law enforcement encountered over 55,000 kilograms of kratom material at ports of entry [3].
  
  Another 57,000-plus kilograms awaited an FDA admissibility decision. DEA estimated the combined total at over 12 million doses [3]. ^[3]

• April 2014 onward — states begin acting on their own timelines, ahead of any federal move [15].
  
  Wisconsin banned kratom in April 2014, Arkansas in November 2015 and Alabama in May 2016, with Indiana, Louisiana and Vermont following [15][16]. ^[15]

• August 31, 2016 — DEA publishes its notice of intent to temporarily schedule mitragynine and 7-hydroxymitragynine as an imminent hazard to public safety [3].
  
  October 13, 2016 — DEA withdraws it, opting to solicit further public comment and wait for FDA's formal scientific and medical scheduling recommendation [4]. ^[4]

• November 2017 — FDA issues a public health advisory about kratom's opioid-like risks [1]. ^[1]

• 2018 — FDA orders a mandatory recall tied to a multi-state kratom Salmonella outbreak [23].
  
  Warning letters over false or misleading medical claims and mislabelled imports continue through this period [23]. ^[23]

• 2019 — CDC publishes SUDORS overdose data covering July 2016 to December 2017 across 27 states [6].
  
  Of 27,338 overdose decedents, 152 (0.56%) tested kratom-positive on postmortem toxicology [6].
  
  A medical examiner or coroner determined kratom to be a cause of death in 91 of those 152 cases [6]. ^[6]

• July 2025 — FDA issues warning letters to seven firms marketing 7-OH products [10].
  
  July 29, 2025 — FDA formally recommends DEA schedule concentrated 7-OH, explicitly distinguishing it from natural kratom leaf [10]. ^[10]

• December 2025 — FDA, DOJ and US Marshals seize roughly $1 million of unlawful 7-OH products from three Missouri firms [9]. ^[9]

• April 1, 2026 — Rhode Island's 2017 kratom ban is repealed, moving a previously banned kratom product back to regulated-legal status [16].
  
  A Pew Stateline report describes it as the first US state ever to make that move [16]. ^[16]

• July 1, 2026 — DEA publishes two Federal Register notices of intent [9].
  
  They would temporarily schedule 7-OH above a defined potency threshold, plus three synthetic 7-OH-derived compounds, into Schedule I [9][11]. ^[9]

No confirmed lethal or toxic dose threshold for kratom has been established in humans [24].

A 2024 peer-reviewed toxicology review notes that oral lethality has been hard to reproduce even in controlled animal studies [24]. Polysubstance use and inconsistent postmortem testing make a human dose-response threshold hard to pin down.

The most concrete number in the literature is a blood concentration, not an ingested amount. A review of 6,860 blood-mitragynine-positive forensic cases at NMS Labs found concentrations above 1,000 ng/mL associated with elevated overdose risk [24].

That marker is not a bright line either. One published fatality reported blood mitragynine of 0.60 mg/L — 600 ng/mL, below the marker — in a death certified as possible kratom toxicity [25].

Therapeutic levels of OTC cold medication and benzodiazepines were present in that case too, which is how confounded these individual cases usually are [25].

Unquantified case reports are more common than dose-measured ones. A poison-control summary describes a 17-year-old with nausea, vomiting, abdominal pain and dizziness within an hour of taking two tablespoons of kratom powder, resolving after about six hours of supportive ED care [13].

A separate emergency-medicine report describes an adult who became hypoxic, cyanotic and unresponsive after an unquantified large amount bought at a gas station, requiring naloxone [12].

Products are not standardised and potency varies considerably between brands. An amount someone tolerated before is not a reliable predictor of safety with a different batch or product [24].

Some consumer and treatment-industry sources publish specific gram thresholds. None could be traced to a primary or peer-reviewed source, so they are excluded here rather than repeated [24]. ^[24]

Poison-control guidance regards any significant or unintentional kratom exposure as a call-now situation — especially in children, or an adult ingestion at a high or unclear amount [13].

In the US that is Poison Control at 1-800-222-1222, or 911 for severe symptoms [13]. Kratom's opioid-receptor activity has produced naloxone-responsive respiratory depression and hypoxia in published case reports [12].

One finding is clinically important and still under-recognised: rebound hypoxia 12–24 hours after a kratom overdose appears to have resolved, including after naloxone reversal [12].

Guidance from the Florida Poison Control Center, relayed in a case report, is therefore a full 24-hour observation window rather than discharge once initial symptoms clear [12].

If a patient leaves before that window against medical advice, the case-report authors recommend sending them home with naloxone and explicit instructions for delayed symptoms [12].

Recognition is the other problem. No standard urine or serum test reliably detects kratom in routine ED screening, so an exposure is easily missed unless self-reported or specifically tested for [12].

Because kratom toxicity typically responds to naloxone the way a classical opioid overdose does, that response can reinforce the wrong attribution [12].

General prevention guidance is the ordinary supplement-safety kind: store medicines and supplements up and out of children's reach, and speak to a doctor or pharmacist before starting anything new [13].

Where kratom use or exposure is a possibility in the household, poison-control guidance adds keeping naloxone accessible and knowing how to give it [13]. ^[12]