How a Crisis Gets Built: The Kratom Statistics Don't Add Up
The statistics behind America's kratom bans don't hold up against the primary sources. A documented investigation into the deaths that aren't what they're called, the escalation that was measured into existence, and the patent trail behind the scheduling push.
TL;DR: What the Record Actually Shows
- No single-substance deaths: There is no confirmed case of a death caused by kratom or 7-OH alone anywhere in the federal record. Every fatal case involves other drugs, often fentanyl. Federal toxicologists say so themselves.
- The escalation was manufactured: The "dramatic rise" in kratom poison-center reports was measured across exactly the window when new tracking codes were implemented. That's a detection increase, not a harm increase.
- The key study doesn't apply: The abuse-potential case rests primarily on one rat study using intravenous injection at doses no oral user could reach. The same study found mitragynine, kratom's primary alkaloid, showed no abuse potential at any dose.
- The adverse-event count is inflated: The FDA's own table double-counts cases, producing a sum of 61 against a stated total of 53. The foundational document was misread by the agency citing it.
- A prior finding was never addressed: In 2018, HHS formally recommended against scheduling kratom and 7-OH, warning of "significant risk of immediate adverse public health consequences for potentially millions of users." The current notice reverses that finding without ever mentioning it.
- The patent trail is documented: Memorial Sloan Kettering and Columbia University hold patents on therapeutic uses of kratom-derived compounds. A company founded by one of those patent inventors is actively developing a kratom-derived drug for opioid withdrawal. The timing is damning.
The Deaths That Are Not What They Are Called
The statistic driving bans across the country is a death count. Here is what that count actually shows when you read the primary documents.
There is no confirmed case of a death caused by kratom or 7-hydroxymitragynine alone anywhere in the federal record. Not one. Despite years of widespread use across tens of thousands of retail locations, every fatal case in the documented record involves other substances. The federal toxicologists reviewing these cases say so themselves, in their own filings: they cannot determine how much, if anything, kratom contributed to the fatal outcome in the presence of the co-occurring drugs.
The CDC's own data on kratom-associated deaths shows that nearly 80 percent explicitly involve kratom combined with other substances, most often opioids, benzodiazepines, stimulants, or alcohol. The remaining cases do not establish single-substance causation either. They reflect the limits of toxicological attribution, not confirmed kratom-only deaths.
The DEA's Own Language on Co-Occurring Substances
The DEA's own notice of intent (FR Doc. 2026-13580) names the co-occurring substances found in fatal cases explicitly: opioids such as fentanyl, benzodiazepines such as bromazolam, and ketamine. The notice's own toxicologists state they cannot determine kratom's causal contribution in the presence of these substances.
Fentanyl is independently lethal at microgram doses. Benzodiazepine-opioid combinations are a well-documented cause of fatal respiratory depression. Presence in a toxicology screen is not causation.
The "Alone or in Combination" Problem
State death counts carry the same fundamental problem. North Dakota's own definition of a kratom-related death states that a medical examiner determined kratom's effects "contributed to, whether alone or in combination, the fatal toxicity." The state's own count does not distinguish which category applies. Neither do most other state counts.
The Tolerance-Drop Mechanism
Many co-occurrence of kratom and opioid deaths has a documented explanation that has nothing to do with kratom being dangerous on its own. When someone substitutes kratom or 7-OH for opioids over a sustained period, their opioid tolerance drops. This is the same well-documented mechanism that makes the period immediately following detox or incarceration so deadly: tolerance falls, someone returns to their previous opioid dose, and a dose that was once manageable is now lethal. Kratom appears on the toxicology report. It was not what killed them.
The Most Severe Case in the Record
The DEA's notice cites Broul et al., a case report involving self-amputation, as evidence of kratom's danger. The paper's own title names cannabis as a co-involved substance alongside kratom. Cannabis-induced psychosis is a recognized clinical entity with substantial peer-reviewed literature. The agency cited a paper that contradicts its own characterization. The contradiction is in the paper's title.
The Escalation That Was Measured Into Existence
The DEA's notice describes a dramatic escalation in kratom-related poison-center reports as evidence of a growing public health emergency. The escalation is real in the data. What the notice does not explain is how it was produced.
The National Poison Data System implemented dedicated tracking codes for kratom between February and May 2025. Before those codes existed, kratom exposures were coded into general categories that made systematic tracking difficult. After those codes were implemented, reported cases climbed sharply.
The DEA's own notice states both facts. It does not explain why an escalation measured from before dedicated codes existed to after they were implemented constitutes evidence of an actual increase in harm, rather than an increase in detection capacity. These are not the same thing.
What the Agency's Own Disclosure Shows
A rise measured from before dedicated codes existed to after they were implemented measures detection capacity, not incidence. The escalation described in the notice begins exactly when the agency started looking for these cases specifically. That is the definition of a surveillance artifact, not evidence of an accelerating hazard.
Source: DEA Federal Register Notice FR Doc. 2026-13580
The notice itself discloses that NPDS tracking codes for kratom and 7-OH were implemented in early 2025, and that the escalation in reported cases is measured across that same window. The disclosure is in the notice. The explanation of what it means is not.
The Study That Built the Abuse-Potential Case
A Schedule I finding requires a conclusion of high abuse potential. The DEA's abuse-potential case rests primarily on a single study. Here is what that study actually shows.
The study is Hemby SE et al. (2019), published in Addiction Biology. It used an intravenous self-administration paradigm in rats. Rats were given direct intravenous access to 7-hydroxymitragynine and trained to press a lever to administer it. The study found that the rats self-administered 7-OH.
Two things about this study do not appear in the DEA's characterization of it.
What the Same Study Found About Mitragynine
Finding 1: The same study tested mitragynine, the primary alkaloid comprising 60 to 70 percent of kratom's alkaloid content, using the same intravenous self-administration paradigm. Mitragynine was not self-administered at any dose tested. The substance that constitutes the overwhelming majority of kratom's active alkaloid profile showed no abuse potential in the same study the agency uses to establish that kratom-derived compounds have high abuse potential.
Finding 2: The intravenous route bypasses the oral nausea ceiling that governs real-world kratom use. Users who consume too much kratom orally experience nausea that functions as a biological dose limiter. Intravenous administration eliminates this ceiling entirely, producing a pharmacological environment that cannot occur through oral botanical consumption.
The DEA's notice acknowledges there are no controlled human clinical trials on 7-OH. The abuse-potential finding for Schedule I, the most restrictive classification in federal law, rests on one rat study with administration conditions that do not reflect human use.
"The intravenous route bypasses the oral nausea ceiling that limits real-world dosing, meaning the abuse potential the study demonstrates exists in a pharmacological context that cannot occur through oral kratom use."
Hemby SE, McIntosh S, Leon F, Cutler SJ, McCurdy CR. Addiction Biology. 2019;24(5):874-885.
The Adverse-Event Count Is Inflated
The FDA's foundational assessment of 7-OH contains a basic error in the document the agency is citing to support its scheduling recommendation.
The FDA's assessment of 7-OH, Document 34 of the public record under Docket HHS-OASH-2026-0232, includes a table summarizing adverse-event cases. Two categories in that table overlap, meaning some cases are counted in both columns, as if they were separate events, when they are actually the same cases counted twice. Add the columns together and you get 61. The actual deduplicated total is 53.
The agency appears to have read its own table as if the categories were distinct when they were not. The practical result: the adverse-event count being used to justify the scheduling action is inflated by 8 cases.
Why 8 Cases Matters in This Record
In a record where the total number of cases is already small enough that each one carries significant weight, 8 cases is not a rounding error. It is a meaningful share of the evidence base. And it is there because the foundational document was misread by the agency whose recommendation the entire federal action depends on.
The Prior Finding Nobody Mentioned
The current notice reaches an imminent-hazard conclusion. There were three prior expert findings that reached the opposite conclusion. The notice does not mention any of them.
2018: HHS Formal Recommendation Against Scheduling
The Department of Health and Human Services formally reviewed mitragynine and 7-hydroxymitragynine and issued a recommendation against scheduling either substance. The finding, authored by Assistant Secretary Brett Giroir, MD, stated that doing so would create "a significant risk of immediate adverse public health consequences for potentially millions of users." The letter specifically named intractable pain patients and warned that removing access would push people toward heroin and fentanyl. The letter named 7-hydroxymitragynine explicitly. The current notice reverses this finding without acknowledging it exists.
2018: Independent Eight-Factor Analysis
A peer-reviewed analysis applying the government's own eight-factor statutory framework for evaluating drugs reached the same conclusion: the evidence did not support scheduling, and banning kratom outright "risks creating public health problems that do not presently exist." The analysis was conducted by Henningfield et al. and applied the same legal criteria the current notice uses. The notice does not address it.
2021: World Health Organization Review
The WHO Expert Committee on Drug Dependence reviewed kratom and concluded the evidence did not warrant a formal critical review for international scheduling consideration. The current notice does not address this finding.
The Administrative Law Problem
Under established administrative law, anchored in Motor Vehicle Mfrs. Ass'n v. State Farm (1983) and FCC v. Fox Television Stations (2009), an agency that reverses a prior factual finding must acknowledge the change and supply a more thorough reasoned explanation than a fresh decision would require. The current notice offers no explanation of what changed in the evidence between 2018 and 2026. It does not acknowledge the prior findings exist.
Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to judicial review. The process that would ordinarily catch this failure is unavailable in the very case that calls for it most clearly.
The Patent Trail
Natural 7-hydroxymitragynine is not patentable. A plant metabolite that has existed in nature for millennia cannot be owned. What can be owned is a modified analog, a proprietary manufacturing process, or a claimed therapeutic use. The record shows all three are already in place.
The Academic Institutions
Memorial Sloan Kettering Cancer Center
US Patent 11,046,692 B2 (granted 2021, filed 2016)
Title: "Mitragynine Analogs and Uses Thereof"
Inventors: Gavril Pasternak, Susruta Majumdar, Andras Varadi, Rashad Karimov
Coverage: Methods of using modified mitragynine compounds to treat pain and modulate opioid receptor activity
WO2016176657A1, the international PCT application that became the US grant above. Filed April 2016.
Pasternak spent his career at MSKCC and is one of the most cited opioid pharmacologists of the past half century, credited with foundational work on mu-opioid receptor subtypes. MSKCC is not a startup speculating on a market opportunity. It has held intellectual property claims on therapeutic uses of mitragynine analogs since 2016.
Columbia University (jointly with MSKCC)
WO2020160280A1 (filed 2020)
Title: "Deuterated Mitragynine Analogs as Safer Opioid Modulators"
Inventors: Kruegel, Sames, Javitch, Majumdar
Deuteration is a specific pharmaceutical strategy: replace certain hydrogen atoms in a compound with the heavier isotope deuterium, and the result behaves pharmacologically like the original while being sufficiently distinct to qualify as a new, patentable entity. This is a well-established industry technique for creating patentable versions of compounds that would otherwise remain unpatentable. The patent's own title states the goal: safer opioid modulators.
WO2017165738A1 (filed 2017)
Title: "Mitragynine Alkaloids as Opioid Receptor Modulators"
Inventors: Kruegel, Sames, Gassaway, Javitch
Manufacturing Process Patents (2025)
US Patent 12,466,830 and US Patent 12,492,201
Both cover a proprietary, controlled, reproducible method for converting mitragynine to pharmaceutical-grade 7-hydroxymitragynine at scale. Both issued November 2025, as the regulatory push against the natural product was already underway.
The Company Built to Commercialize This Research
The company is called Sparian Biosciences. It was co-founded by Gavril Pasternak and Jeff Reich, MD. Its pipeline is explicitly described on its own website as "derived from the Pasternak Lab at Memorial Sloan Kettering Cancer Center" and the Majumdar Lab. Pasternak passed away in 2019, but the company he co-founded continues operating with his patents and research as its foundation.
SBS-226: Sparian's Kratom-Based Drug Candidate
Sparian's lead kratom-derived compound is SBS-226. Their own pipeline page describes it as "a new chemical entity, based on Kratom, which was synthesized and developed in the Majumdar Lab." It is being developed for opioid use disorder and opioid withdrawal, in collaboration with the National Institute on Drug Abuse and Memorial Sloan Kettering Cancer Center.
Sparian's own description of SBS-226's properties: "can ameliorate opioid withdrawal but does not demonstrate abuse potential, respiratory depression, or physical dependence."
A pharmaceutical company is developing a kratom-derived compound, protected by patents held by Memorial Sloan Kettering and Columbia University, specifically to treat opioid withdrawal, at the same moment the natural plant millions of people currently use for the same purpose is being removed from the market.
Kures / KUR-101: A Second Company in the Same Pipeline
Kures is a separate pharmaceutical company developing KUR-101, described in SEC filings as "a deuterated version of mitragynine" specifically for the treatment of opioid use disorder. Kures is funded by ATAI Life Sciences, a publicly traded CNS-focused pharmaceutical company. A deuterated version of mitragynine is patentable in a way that natural mitragynine is not, for the same reason described above.
Two separate, funded pharmaceutical companies are actively developing kratom-alkaloid-based prescription drugs for opioid withdrawal treatment, both protected by patents held by major research institutions. Both are positioned to become commercially necessary if the natural plant is removed from the market.
The Full Chain
The sequence is traceable and public. Pasternak Lab research at MSKCC generates kratom alkaloid analogs. MSKCC patents the therapeutic uses. Pasternak and colleagues co-found Sparian Biosciences to commercialize those patents. Sparian develops SBS-226, explicitly based on kratom, for opioid withdrawal. The Columbia labs file their own patents. ATAI-backed Kures develops a deuterated mitragynine analog for the same indication. The natural, unpatentable version of these compounds gets scheduled. The prescription versions, developed by companies that hold the patents, are positioned to treat the same condition.
As of March 2026, HHS confirmed to the DEA there were no approved drug applications or investigational new drug filings for these substances. No prescription version had yet entered formal clinical trials. What existed was the intellectual property, the research base, the manufacturing infrastructure, and the companies. The regulatory environment making a prescription version commercially necessary was being created simultaneously.
The pattern documented here does not require a conspiracy. It requires only that well-capitalized institutions recognized the commercial value of kratom-derived compounds, patented them, built companies to develop them, and waited for the regulatory environment to make that development commercially necessary. That environment is now being created. The facts are public record. The connections are documented.
The timing is damning.
The Legislative Wave and the Timeline
Nine states have banned kratom as of mid-2026. The same statistical record underlies each action. Here is how that record was built, and when.
Early 2025
The National Poison Data System implements dedicated tracking codes for kratom and 7-OH, enabling systematic case count reporting for the first time.
February to May 2025
The escalation in reported cases, measured across exactly this window, is generated. Case counts climb sharply after the codes exist to capture them.
July 29, 2025
FDA Commissioner Marty Makary announces at an HHS press conference that FDA is initiating action to recommend DEA scheduling of 7-OH. DEA signals it will act "expeditiously."
November 2025
US Patents 12,466,830 and 12,492,201, covering proprietary manufacturing processes for pharmaceutical-grade 7-hydroxymitragynine, are issued.
July 1, 2026
DEA files two Notices of Intent: one for 7-OH above a specified threshold, one for three synthetic 7-OH derivatives (mitragynine pseudoindoxyl, MGM-15, MGM-16). HHS opens a 30-day comment period. Comment period closes July 31.
Simultaneously
State-level bans and scheduling bills move through legislatures in multiple states, all drawing on the same statistical record the federal action is built on. Bills are active in Delaware, Illinois, Michigan, South Dakota, Tennessee, and others in the same 2025-26 legislative session.
None of this proves coordination. What it does establish is a sequence: new measurement infrastructure produces an apparent escalation; the apparent escalation is incorporated into a federal finding without disclosure of the measurement change; the federal finding arrives as state legislatures are simultaneously considering their own actions; the state actions cite the same statistical record.
Readers can assess what that sequence means.
What the Record Actually Supports
The evidence, read in full, supports a narrower and more specific conclusion than the one being drawn from it. It supports regulation, not prohibition.
There is a documented contamination problem. Products marketed as kratom or 7-OH have been found to contain tianeptine, a substance with severe opioid-like dependence properties that adverse-event databases do not track separately. FAERS and poison-center data cannot distinguish a case where 7-OH caused an adverse event from a case where a tianeptine-contaminated product caused it. An unknown share of the harms attributed to kratom may be harms caused by unregulated adulteration, not by kratom itself.
There is a product-category distinction that most current legislation ignores. Natural kratom leaf, with its full alkaloid profile, behaves differently than a concentrated, processed product with 7-OH comprising 90 percent or more of its alkaloid content. Banning one because of evidence generated by the other is not a proportionate or logically supported response.
The Framework That Already Works
The Kratom Consumer Protection Act, now adopted in more than a dozen states, requires mandatory third-party laboratory testing with adulterant screening, certificate of analysis requirements, standardized labeling, and adult-only retail restrictions. This framework addresses the documented harms directly, without eliminating access for the millions of adults who use tested, labeled products responsibly.
Rhode Island tried prohibition, lived with it, and became the first state in the country to reverse a kratom ban, moving to a KCPA-style regulated framework instead, effective April 2026. Prohibition isn't the untested option here. It is the one already tried and abandoned for something that actually works.
Schedule I Prohibition Does Not Address the Documented Harms
Schedule I prohibition does not reduce demand. It eliminates the regulated market, removes quality controls, and drives production to unregulated sources where the contamination problems the agency cites as justification become significantly worse. Banning the plant does not clean up the products that were causing harm. It removes the only products that were subject to any quality control at all.
The Record the Agency Built
The record, read in full against its own primary sources, does not establish what the scheduling action claims it does. There are no confirmed single-substance deaths. The escalation was measured into existence by new tracking infrastructure. The central abuse-potential study uses conditions that cannot apply to oral kratom use. The foundational document was misread, inflating the adverse-event count. Three prior expert findings that reached opposite conclusions are nowhere addressed in the current notice.
Behind the regulatory action, a decade of intellectual property accumulation at Memorial Sloan Kettering and Columbia University, now commercialized through Sparian Biosciences and funded through ATAI-backed Kures, has positioned prescription-grade versions of kratom's active compounds for a market that will only exist if the natural, unpatentable version is removed from it.
This is not a close call on the evidence. The record as assembled does not meet the imminent-hazard standard the statute requires. And the commercial infrastructure waiting on the other side of this regulatory action is public, documented, and traceable to named institutions, named researchers, and named companies.
A Note on Sources
Every factual claim in this investigation is drawn from primary sources: the DEA's own Federal Register notice (FR Doc. 2026-13580), FDA Document 34 of Docket HHS-OASH-2026-0232, Hemby et al. (2019) in Addiction Biology, the 2018 HHS letter to the DEA (authored by Assistant Secretary Brett Giroir), US patent records at USPTO and Google Patents, Sparian Biosciences' own website, and SEC filings referencing Kures/ATAI. No claim rests on secondary characterization alone. Readers are encouraged to consult the primary documents directly.
Continue the Investigation
The Patent Race
The complete patent timeline: MSKCC, Columbia, Sparian Biosciences, and Kures. Who holds the intellectual property on kratom's active compounds and what they're waiting for.
Does 7-OH Meet the Legal Standard?
A close reading of the DEA's record against the specific statutory test it must meet. Spoiler: it doesn't, on its own terms.
Manufacturing Evidence
How adverse events get misattributed, how polydrug deaths become single-substance deaths in the record, and how the evidentiary standard shifts depending on who's asking.
Primary Sources
Every claim in this investigation is verifiable. Check the primary documents yourself.
Federal Regulatory Documents
- DEA Notice of Intent, FR Doc. 2026-13580 (July 6, 2026), Federal Register Vol. 91, No. 127
- FDA Assessment, Document 34, Docket HHS-OASH-2026-0232 (regulations.gov)
- HHS Letter to DEA, Assistant Secretary Brett Giroir (2018), recommending against scheduling kratom and 7-OH
- HHS Letter to DEA, March 6, 2026, confirming no approved NDAs or INDs for these substances
- WHO Expert Committee on Drug Dependence, kratom review, 2021
Scientific Literature
- Hemby SE, McIntosh S, Leon F, Cutler SJ, McCurdy CR. "Abuse Liability and Therapeutic Potential of the Mitragyna speciosa (Kratom) Alkaloids Mitragynine and 7-Hydroxymitragynine." Addiction Biology. 2019;24(5):874-885.
- Henningfield JE et al. Eight-factor analysis of kratom scheduling under the Controlled Substances Act (2018)
- Broul P et al. "Cannabis and kratom-induced self-amputation of ears and penis", case report cited in FR Doc. 2026-13580
Patent Records (All Verifiable via USPTO / Google Patents)
- US Patent 11,046,692 B2, Memorial Sloan Kettering, Pasternak/Majumdar/Varadi/Karimov (granted 2021, filed 2016)
- WO2016176657A1, same filing, PCT international application
- WO2020160280A1, Columbia/MSKCC, "Deuterated Mitragynine Analogs as Safer Opioid Modulators" (2020)
- WO2017165738A1, Columbia University, "Mitragynine Alkaloids as Opioid Receptor Modulators" (2017)
- US Patent 12,466,830, method of converting mitragynine to 7-hydroxymitragynine (November 2025)
- US Patent 12,492,201, same manufacturing process, second patent (November 2025)
Corporate Sources
- Sparian Biosciences: sparianbiosciences.com (pipeline, team, and story pages)
- ATAI Life Sciences SEC Filing (Form DRS, FY2021), Kures / KUR-101 disclosed as portfolio company with deuterated mitragynine for OUD
- HHS Press Release, July 1, 2026, FDA/HHS commending DEA action and confirming no approved NDAs
The Record Is Public. Read It.
Every claim in this investigation links to a primary source. The DEA's own notice contains the admissions. The patent records are searchable. The companies are real. Check it yourself.