A version of the following public comment was submitted to the Ohio Board of Pharmacy on January 28, 2026.
On behalf of Reason Foundation, we respectfully submit these comments opposing proposed rule OAC 4729-9-01.2 to classify mitragynine pseudoindoxyl—the primary alkaloid in kratom—as a Schedule I controlled substance. Reason Foundation is a 501(c)(3) nonprofit think tank dedicated to advocating for policy solutions that enhance public health, foster dynamic markets that offer economic opportunity, and ensure consumer access to safe, regulated products.
The rule and its supporting Business Impact Analysis (BIA) fail to satisfy the least-burdensome-regulation requirements of Ohio Senate Bill 2 of the 129th General Assembly (SB 2) and the Common Sense Initiative (CSI). While the board has identified legitimate public-health concerns related to certain high-potency kratom extracts, unsafe kratom manufacturing practices, and misleading advertising, a blanket Schedule I classification is a disproportionate response not supported by the requisite eight-factor analysis. Outlawing kratom-related products will do little to protect consumers from unsafe products, pushing some toward the illicit market where products are wholly unregulated. We advocate for Ohio to adopt a targeted regulatory framework that addresses the harms identified by the board while preserving adult access to kratom and capped amounts of 7-hydroxymitragynine (7-OH).
The eight-factor analysis does not support a “high potential for abuse” finding for Schedule I
In making a determination to add an unscheduled compound, the board is required to consider the following eight criteria: the actual or relative potential for abuse; the scientific evidence of the pharmacological effect of the substance; the state of current scientific knowledge regarding the substance; the history and current pattern of abuse; the scope, duration, and significance of abuse; the risk to the public health; the potential of the substance to produce psychic or physiological dependence liability; and whether the substance is an immediate precursor to a scheduled compound.
The BIA states that “based upon a review of the 8-factor analysis, the board determined mitragynine has a high potential for abuse” and therefore Schedule I placement is warranted under ORC 3719.44. This conclusion directly contradicts a 2018 peer-reviewed eight-factor analysis of kratom and mitragynine published in Psychopharmacology. That independent analysis, applying the same statutory criteria, concluded that kratom’s abuse potential is within the range of other unscheduled substances. It warned Schedule I placement would “seriously impede research” and could produce “serious unintended public health consequences.”
The board’s analysis neither cites this pivotal study nor explains why the board’s conclusion diverges so sharply. For the rule to be valid, the board must either provide a point-by-point rebuttal of the published eight-factor analysis or acknowledge that the statutory Schedule I standard is not met and pursue a regulated model.
The “precursor” argument for scheduling mitragynine is an overexpansion of policy
The board justifies scheduling mitragynine partly because it is metabolized into 7-hydroxymitragynine (7-OH), citing its higher potency. This “precursor” logic is flawed, and using precursor status alone to justify Schedule I is a radical policy overreach.
Banning a primary plant alkaloid because a more potent analogue exists would logically justify banning numerous other benign precursors, plant alkaloids, and semi-synthetic pathways now safely regulated via licensing and manufacturing controls. Ohio has already appropriately scheduled truly high-risk synthetics, like MGM-15, without criminalizing all upstream plant chemistry. In this case, the cited biosynthetic and pharmacokinetic data do not support equating typical mitragynine use with 7-OH abuse. While human studies indicate dose‑proportional 7‑OH formation and steady state after repeated dosing, they also show that at realistic oral doses, mitragynine was well-tolerated and did not produce significant classical opioid respiratory toxicity.
Most of the harms the board highlights (gas‑station shots, MGM‑15 tablets, heavy metals, salmonella) concern high‑potency extracts and full synthetics, not traditional or moderate‑dose mitragynine products. A rational response is targeted control of the high‑risk preparations, not a blanket ban on all products containing 7-hydroxymitragynine and mitragynine pseudoindoxyl, which will unintentionally criminalize many consumers. Targeted control may involve the state licensing, monitoring, or capping the content of any compounds of concern found in adult-use products.
Dependence and withdrawal are insufficient bases for Schedule I classification
The BIA cites dependence and withdrawal symptoms drawn from case reports and Malaysian user surveys to support scheduling. Yet dependence liability is only one of the eight factors and is not, by itself, sufficient to establish a “high potential for abuse.” Moreover, such phenomena occur with many unscheduled and non-Schedule I substances, including caffeine, alcohol, many antidepressants, and benzodiazepine taper scenarios.
According to a World Health Organization (WHO) report, kratom withdrawal symptoms have been reported in humans; however, the report stated that “limited epidemiological evidence indicates that withdrawal is usually mild.” The WHO report recognizes some of the public health concerns, including liver toxicity cases after kratom intoxication, but found insufficient evidence to recommend critical reviews of kratom, mitragynine, and 7-hydroxymitragynine (7-OH), advising against scheduling.
Kratom-associated death data are misleading and do not justify prohibition
The BIA cites 202 Ohio deaths (2019-2024) where kratom was listed as a cause, citing “a growing number of deaths associated with kratom” as justification for scheduling. This claim is profoundly misleading. A recent public‑health review concluded that there are “several million” past‑year kratom consumers in the U.S., that serious adverse events are rare relative to this denominator, and that thoughtful regulation rather than prohibition is the most appropriate policy response. In reality, several factors make it difficult to conclusively attribute the cause of death to kratom in cases where it is present. These include:
- Polydrug Use: A review of 156 identified cases of deaths associated with kratom use found that one or more other drugs were present in 87% of cases with available toxicology data. Opioids were the most frequently encountered co-occurring drug. The BIA’s own data shows that 85% of kratom-positive deaths also involved one or more other substances. This is not sufficient evidence to suggest kratom as the sole or primary cause of death in the majority of cases.
- Small Proportional Impact: These 202 deaths represent approximately 0.8% of Ohio’s total overdose deaths for the period. Meanwhile, Ohio reported unintentional prescription and synthetic opioid deaths, and legally prescribed and illicit Schedule II–IV opioids remain involved in a far higher proportion of deaths (yet are regulated rather than outright banned). Unintentional prescription opioid overdoses caused 11,790 deaths in Ohio between 2010 and 2017, rising exponentially from 653 cases in 2010 to 3,674 cases in 2017. In fact, Ohio was also one of eight states where the opioid mortality rate doubled every three years from 1999 to 2016.
- Analytical Challenges: Identifying the two main active compounds, mitragynine and 7-OH, is challenging due to their instability at room or body temperature over time and the requirement for highly specific assays to differentiate them from their stereoisomers. Many cases also lack a comprehensive toxicological evaluation, meaning some novel psychoactive substances (NPS) may not be detected because accurate assays are not yet available.
“No accepted medical use” misinterprets Ohio law and ignores evidence
The board mentions that mitragynine has not been approved by the Food and Drug Administration (FDA) for medical use and has not undergone randomized, placebo‑controlled studies necessary to demonstrate efficacy for any medical condition. Considering this, the board concludes that kratom has “no accepted medical use.” However, Ohio law intentionally separates “accepted medical use” from FDA-approval status. Off-label prescribing and state medical marijuana programs demonstrate this distinction.
The board itself acknowledges that many users consume kratom to self-treat pain, fatigue, and even opioid withdrawal. However, because there is no FDA-approved medical use, the board classifies this self-treatment as abuse. Testimonials indicate some users see kratom as a way to reduce or end abuse of opioids. One of the direct consequences of a total ban, which makes even personal possession of such products illegal, would be the criminalization of many consumers attempting to treat pain without pharmaceutical opioids. Drug use is first and foremost a public health issue, and criminalization of individual possession and use is not an appropriate response.
In addition to self-reported benefits, emerging evidence supports the therapeutic potential of kratom, including Phase 1 clinical trials and extensive observational data, demonstrating plausible therapeutic value for pain, mood disorders, and opioid cessation and withdrawal symptoms with an acceptable safety profile at typical doses:
- Phase 1 Clinical Trial and Human Safety Data (2024). An exploratory study found that single oral mitragynine doses up to 40 mg in healthy adults were generally well tolerated, with only mild and transient adverse events, and measurable dose-related effects without clinically meaningful respiratory depression. Earlier pharmacokinetic studies likewise concluded that mitragynine’s linear kinetics and day‑long half‑life make it a plausible future pain‑management candidate.
- Pharmacokinetic Data (2022). Studies confirm linear pharmacokinetics for mitragynine, as well as an elimination half-life that supports once- or twice-daily dosing and found no serious toxicity at studied dose ranges in healthy volunteers.
- Preclinical and Clinical Literature. Scientific literature documents analgesic, anti‑inflammatory, anxiolytic, and opioid‑withdrawal‑relief effects of mitragynine and related alkaloids, with fewer respiratory‑depression concerns than classical opioids. The board’s own eight‑factor analysis cites a 2024 review that expressly notes potential benefits of mitragynine, including antinociceptive, anti‑inflammatory, antidepressant, sedative, and anxiolytic effects, and management of opioid withdrawal; yet, the analysis emphasizes only the tolerance and withdrawal caveats and does not reflect these therapeutic findings in its “no accepted medical use” conclusion under ORC 3719.44.
Utah’s experience reflects weak regulation, not regulatory failure
The BIA cites Utah’s regulated kratom market and persistent “kratom-related” deaths as proof that regulation cannot adequately mitigate risks. This argument conflates correlation with causation and ignores Utah’s broader opioid crisis context.
Utah’s reported data show that most “kratom-related” deaths involve multiple substances, making it impossible to attribute causality to kratom alone. The BIA also fails to include a discussion of states that have successfully adopted a version of the Kratom Consumer Protection Act model, which imposes strict regulatory requirements rather than blanket bans. These frameworks include clearly defined and enforceable regulations that address many of the concerns mentioned by the board. Some examples of policies adopted under the KCPA model include:
- Age limits (18 or 21);
- Product standards and testing requirements;
- Labeling with alkaloid content;
- Alkaloid concentration limits for extracts;
- No prohibition of traditional or modest-potency leaves; and
- Civil penalties for non‑compliant products, while rejecting outright bans.
The Utah narrative does not establish that regulation is inherently ineffective but rather shows that a lax regulatory framework that does not control high‑potency extracts, fully synthetic analogs, or product quality will predictably leave regulatory gaps. Ohio can learn from those shortcomings by implementing a focused regulatory model for adult‑use kratom and tightly controlled, licensed 7‑OH products instead of defaulting to Schedule I or prohibition.
Contamination harms are a failure of regulation, not pharmacology
The BIA cites heavy metal contamination and a Salmonella outbreak as a reason for the prohibition. Yet these are classic symptoms of an unregulated market with unsafe manufacturing practices or sourcing, not inherent properties of mitragynine.
A comprehensive toxicology analysis concluded that nickel and lead contamination in kratom products stems from poorly regulated manufacturing practices and product testing. Similarly, past Salmonella outbreaks associated with kratom were traced to contamination.
The board ultimately conflates harms from contaminated, adulterated, or polydrug kratom use with harms from mitragynine itself. A blanket ban would not reduce these harms but instead eliminate safe, regulated products entirely while unregulated ones remain. We recommend an effective regulatory framework that includes guidelines for Good Manufacturing Practices, contaminant limits, proper testing for heavy metals and contamination, accurate labeling, and product-type differentiation to directly address these risks without the collateral damage of Schedule I criminalization.
The Business Impact Analysis fails SB 2 standards by rejecting alternatives
The BIA acknowledges the rule will result in the closure of kratom retailers and imposes criminal penalties under ORC 2925. However, the board failed to consider regulatory alternatives as required under Ohio statute.
In response to CSI Question 12 (“What alternative regulations did the agency consider?”), the board states: “No.” This admission is fatal to the rule’s compliance with SB 2. ORC 3719.44 authorizes, but does not require, Schedule I placement where criteria are met, but it also directs the board to consider a range of factors. The agency cannot satisfy SB 2’s “adverse impact” and CSI balancing requirements by simply stating that Schedule I is the chosen outcome and dismissing all intermediate options.
The CSI framework also directs agencies to eliminate excessive and duplicative rules and to balance the regulatory objectives that have an adverse impact on business with the costs of compliance by the regulated parties. Agencies are also told to “prioritize compliance over punishment.”
A Case Western Reserve University report documented over 130 kratom-carrying retailers in Cleveland alone and at least 12 kratom-specialty stores statewide. Though the BIA admits the rule will likely result in the closure of these stores, it identifies no less restrictive alternative as required by the CSI’s own guidance. The board explicitly considered no graduated regulatory options (licensing, product standards, age limits, or potency caps) even though such options exist and are in use in other states.
Proposed path forward: A regulatory framework for adult access and consumer safety
Rather than scheduling or prohibition, Reason Foundation recommends the Board follow SB 2 guidelines and explore less-burdensome approaches to create a legal and well-regulated adult-use market for kratom with tightly regulated 7-OH products. To better align with public‑health goals and SB 2, we respectfully urge CSI and the Board to reject proposed OAC 4729‑9‑01.2 and instead pursue legislation and rulemaking to establish:
- Adult‑Only Access: Prohibit sales of kratom and kratom‑derived products, including any containing mitragynine, 7‑OH, or other kratom analogs to minors, require ID verification at point of sale and for online purchases, and impose civil penalties for non‑compliance.
- Product‑Type Differentiation: Maintain a legal, regulated market for traditional and modest‑potency mitragynine products (leaf, teas, low‑ratio extracts) that are tested, labeled, and sold only to adults.
- Potency and Formulation Limits: Set maximum allowable per-serving dosage of mitragynine and 7-OH derivatives in kratom extract products, require clear labeling of alkaloid content, and establish evidence-based regulations for the sale of such products.
- Marketing and Consumer Information: Ban disease‑treatment claims and youth‑oriented branding; require standardized warnings regarding dependence, withdrawal, and polydrug risks.
- Quality, Testing, and Contamination Controls: Require all kratom and kratom‑derived products sold in Ohio to be manufactured under current good manufacturing practices (cGMP) and tested by accredited third‑party laboratories for heavy metals (including lead and nickel), microbial contamination, and active alkaloid content; Authorize the board to mandate recalls, issue public safety notices, and impose civil penalties or license actions for non‑compliant products and false testing claims.
- Labeling, Warnings, and Marketing Restrictions: Mandate clear, standardized warnings regarding dependence and withdrawal potential, polydrug use risks (especially with opioids, benzodiazepines, and alcohol), and contraindications for pregnancy; mandate disclosure that kratom is not FDA‑approved for any medical indication; prohibit unsubstantiated disease‑treatment claims unless supported by evidence and authorized under federal and state law; and restrict youth‑oriented marketing.
Conclusion
Schedule I classification of mitragynine and 7-OH is not supported by a complete eight-factor analysis, contradicts emerging evidence of therapeutic potential, and fails to comply with SB 2’s mandate to minimize regulatory burden. A prohibitory approach risks increasing opioid overdose mortality by eliminating a less risky alternative for thousands of Ohioans, some of whom may return to illicit market opioids if kratom is banned.
Ohio has a legitimate interest in protecting public health from contaminated products, high-potency products without proper dosing information, and deceptive marketing. However, this can be better achieved through a tightly regulated, adult-use framework that directly targets the board’s identified harms of contamination, high-potency synthetics, and youth access, without the collateral damage of criminalization.
A sufficiently regulated, adult-use framework for kratom and its analogs—with strict labeling requirements, defined and evidence-based limits on dosage per serving, transparency requirements, and quality standards—better aligns with SB 2’s demand for the least‑burdensome regulation, targets the sources of harm rather than low-risk use, and preserves adult access to safe and regulated kratom products.
This framework would directly address the harms the board has specifically identified, including kratom dependence, abuse liability, adverse effects from bad manufacturing practices, semi‑synthetic analogs, quality products, labeling and transparency requirements, and youth access, while preserving the ability of adults and clinicians to use regulated mitragynine and carefully controlled 7‑OH as potentially safer alternatives to traditional opioids. It would also ensure that Ohio does not inadvertently increase opioid‑overdose mortality by pushing current kratom consumers back to more dangerous substances, as multiple expert analyses warn could occur under a prohibition model.
For these reasons, we strongly recommend that the CSI Office reject the proposed OAC 4729‑9‑01.2 in its current form and direct the Board of Pharmacy to develop a comprehensive, adult‑use regulatory framework for kratom-related products like 7‑OH, not a Schedule I ban.