Regulating Kratom in Ohio and Beyond

Drug Enforcement and Policy Center | Data and Policy Analyses

In August 2025, Ohio Governor Mike DeWine called on the Ohio Board of Pharmacy (OBP) to designate all natural and synthetic kratom compounds as Schedule I drugs. This statement came just weeks after the U.S. Food and Drug Administration (FDA) announced their recommendation to place kratom compound 7-hydroxymitragynine (also referred to as 7-OH) products under Schedule I of the Controlled Substances Act (CSA). This page answers common questions about kratom and its compounds, details the regulatory efforts in Ohio and other states, and provides information on federal scheduling and public health information.

A bowl of powdered kratom beside capsules and kratom leaves on a wooden surface.

Actions by Ohio's Governor and the Ohio Board of Pharmacy

On December 11, 2025, Ohio Governor Mike DeWine updated his request to the Ohio Board of Pharmacy (OBP) to “immediately designate all synthetic kratom compounds and other dangerous compounds derived from the active ingredient in Kratom as illegal drugs through emergency rule.” The OBP responded the following day by issuing emergency rule, OAC 4729:9-1-01.1. The rule makes it illegal to sell, possess, or distribute any form of kratom-related products in the state of Ohio. A December 16, 2025 update clarified that the emergency rule "does not apply to isolated mitragynine, including products that are comprised of natural kratom in its vegetation form."

On January 6, 2026, the Ohio Board of Pharmacy (OBP) initiated rules to place both natural and synthetic kratom under Schedule I in Ohio. During the rulemaking process, rules must be reviewed by the Common Sense Initiative in the governor's office and the Ohio General Assembly's Joint Committee on Agency Rule Review (JCARR) and opportunities must be provided for the public to submit testimony. See Table 3 for more information on the scheduling process.

On April 13, 2026, the rule to place Mitragynine-Related Compounds (commonly referred to as synthetic kratom) under Schedule I advanced out of JCARR review. The rule went into effect mid-May and replaces the 180-day emergency rule. On June 22, 2026 JCARR called a meeting with OBP to discuss concerns about the synthetic kratom rule and its scope, and address questions regarding a guidance document published after the synthetic rule went into effect. A second rule that would schedule natural kratom is currently under the Common Sense Initiative and has not yet been forwarded to JCARR.

Read the Consumer and Retailer Notice

Actions by the Federal Government

On July 1, 2026, the Drug Enforcement Administration (DEA) published a Notice of Intent for a proposed rule that would temporary place 7-Hydroxymitragynine (7-OH), along with three related substances, on the list of controlled substances as a Schedule I drug. The proposed rule applies to kratom containing more than .05% of 7-OH on a dry weight basis. This also includes synthetic or processed kratom products (including extracts, concentrates, processed edibles, or pressed pills) containing more than .05% of 7-OH or more than 1 mg of 7-OH per product. Prior to the DEA notice, the Department of Health and Human Services confirmed that synthetic 7-OH and the other substances included have no accepted medical use and a high potential for abuse. The temporary scheduling order will be published in the Federal Register on or before August 5, 2026.

Read more about the proposed federal rule in the Federal Register

What is Kratom?

Mitragyna speciosa, or kratom, is a tropical tree native to Southeast Asia, where it has been used for centuries as a stimulant and for pain relief. About 60 years ago, soldiers returning from the Vietnam War and Southeast Asian immigrants brought the plant to the U.S. Kratom entered U.S. mainstream use approximately twenty years ago, with some attributing its rise to the proliferation of online marketplaces, and others tying it to the opioid epidemic. Currently, Ohioans can purchase kratom online as well as from local health and wellness businesses, gas stations, smoke shops, and even vending machines.

Alkaloids and their effects

Kratom plant consists of around 40 different alkaloids, with mitragynine and 7-hydroxymitragynine being the primary and most commonly studied alkaloids. These two compounds can produce various effects depending on the dosage, the age of the leaves when harvested, the method of production and consumption, and other individual factors. In smaller doses, users report experiencing stimulating effects similar to coffee, increased focus and stamina, and general energy and mood boosting qualities. In contrast, higher doses are reported to be used for relaxation, sleep, and pain relief.

Synthetic 7-Hydroxymitragynine

7-hydroxymitragynine is a primary alkaloid in kratom that appears naturally in trace amounts, in levels ranging from .01% to 2%. Similar to the intoxicating hemp market, kratom producers have been able to synthesize 7-hydroxymitragynine and create concentrations of up to 98% of the total content, far surpassing natural levels. Heavily concentrated 7-hydroxymitragynine products have caused public health experts and concerned citizens to call for action against these synthetic products. Reports suggest that these products are creating effects similar to heroin and other opioids, while being unregulated and sold with minimal regulation. Symptoms from using these products include nausea and vomiting, agitation, confusion, high blood pressure, rapid heart rates, seizures, and respiratory depression.

Policy and Regulation

Ohio Regulatory Efforts

Governor DeWine’s recommendation to schedule kratom is not Ohio’s first attempt to regulate kratom. In 2018, OBP initiated a process to classify mitragynine and 7-hydroxymitragynine as schedule I substances. Although the board approved the rule change in fall 2018, the rule was never adopted. According to the Board, the rule was put on hold to allow the Ohio General Assembly (OGA) to review proposed legislation to regulate kratom introduced shortly after their proposed rule.

The OGA has also taken actions to adopt kratom regulations, although no bill has made it to the Governor’s desk. House Bill 318, introduced in summer 2019, and Senate Bill 103, introduced in spring 2023, were referred to the chambers’ committees on health but garnered no other legislative action. Both bills proposed kratom regulations, requiring registration of kratom products with the Director of Agriculture, addressed labeling requirements and set age limits for purchase of kratom products. They would have also restricted synthetic alkaloids and set limits for 7-hyroxymitragynine concentration per product.

HB 236, introduced in 2022, proposed similar regulations as previous legislations, but also created a processor license. The bill also prohibited OBP from adopting any rules that would place kratom or kratom products on Ohio’s list of controlled substances. HB 236 passed the House and was introduced in the Senate, but stalled in the Health Committee and was never reintroduced.

In mid-October of 2025, the Ohio Senate proposed SB 299, which was followed by the House companion bill, HB 587. These bills attempt to provide regulation for kratom products and businesses, while creating a limit for certain compounds found within the plant.

In May of 2026, the Ohio Board of Pharmacy enacted a rule placing mitragynine-related compounds (often referred to as synthetic kratom) under Schedule I. A rule to place natural kratom in its vegetative form under Schedule I is under review.

Table 1. Pending legislation in Ohio General Assembly addressing kratom

Statute CategorySenate Bill 299/House Bill 587
Definition

"Kratom" means the plant Mitragyna speciosa and any part of that plant.

"Kratom product" means a finished article containing either of the following:

  • Any part of a leaf of the plant Mitragyna speciosa in fresh, dehydrated, or dried form.
  • A kratom extract that is manufactured using United States food and drug administration approved food grade solvents.
Oversight and Authority

Rulemaking Authority:

  • Food Processing Establishments - Director of Agriculture
  • Retail Food Establishments - Director of Agriculture & Director of Health

Rules Required by Statute:

  • Application procedures and fees for product registration.
  • Civil penalties for:
    • Failing to register a product
    • Processing/packaging/manufacturing/holding/distributing an unregistered product
    • Selling an unregistered product
    • Failing to disclose factual basis on product label
  • Standard/procedures for appealing civil penalties
  • Procedures for seizing and destroying noncompliant products
  • Standards and procedures for product testing
  • Labeling standards
  • Any other necessary standards and procedures
Product Registration

Food Processing Establishments:

  • May not process, package, manufacture, hold, distribute, or sell kratom products unless registered with the Director of Agriculture.
  • Must apply for product registration as it is prescribed by the Director of Agriculture.

Retail Food Establishments:

  • May not store, process, prepare, manufacture, hold, or sell kratom products for retail unless registered with the Director of Agriculture.
  • Must apply for product registration as it is prescribed by the Director of Agriculture or Director of Health.
Product Restrictions

Food Processors cannot process, package, manufacture, hold or handle for distribution, distribute, or sell a kratom product if it meets any of the following:

  • Contains a controlled substance or residual solvent higher than is allowed in the United States Pharmacopeia General Chapter 467.
  • Contains 7-OH content exceeding the 2% alkaloid limit or 1mg per serving limit.
  • Contains a synthetic kratom-like compound or semi-synthetic alkaloid where mitragynine is not the majority of the alkaloid in the product.
  • Has a label that does not state the mitragynine or 7-OH content of the product.
  • Product must be registered with the Department of Agriculture Retail establishments cannot store, process, prepare, manufacture, hold or handle for retail sale, or a sell a product that meets any of the above criteria.
Protections for EstablishmentsProcessors and retailers are exempt from penalties if they prove, by a preponderance of evidence, good-faith reliance on another licensed or registered establishment’s compliance.
Labeling RequirementsProcessors and retailers cannot distribute and/or sell kratom products unless the label discloses the factual basis for representing the product as kratom. Product must also include label that displays the amount of mitragynine and 7-hydroxymitragynine contained in the product.
Age RequirementsProcessors and retailers shall not distribute and/or sell a kratom product to an individual who is under eighteen years of age.

 

Other States' Regulatory Efforts

Multiple states have already taken steps to regulate kratom in natural and synthetic forms, restricting kratom adulteration and contamination, as well as regulating the overall strength of the alkaloids within the product. According to a recent report from the Legislative Analysis and Public Policy Association, six states (Alabama, Arkansas, Indiana, Vermont, and Louisiana) have taken steps to effectively ban kratom by scheduling parts of the plant, specifically mitragynine or 7-hydroxymitragynine, to the state’s list of controlled substances.

While some states have undertaken efforts to ban kratom entirely, others have taken steps to regulate the product similar to alcohol and certain food products. Multiple states have set age limits for consumers purchasing kratom from a retailer, with some setting the age requirement at 21 and others at 18. Similar to states that have legalized marijuana, some states have adopted strict labeling requirements, restrictions on the makeup of a product, regulations on adulteration and contamination, marketing restrictions, and other rules restricting the plant within an overarching regulatory framework. Additionally, some states have adopted laws that require kratom retailers and processors to register with a state entity before they can sell or distribute kratom products.

Notably, the American Kratom Association (AKA) has been at the forefront of regulatory reform at the state and federal level. AKA has assisted federal and state lawmakers by creating model legislation for kratom regulation that has been commonly referred to as the Kratom Consumer Protection Act (KCPA). KCPAs regularly include definitions for kratom and its products, age restrictions, product and labeling requirements, requirements for processors and retailers, prohibitions against adulterated products, and other provisions establishing some form of regulatory framework that permits the plant. To date, seventeen states have adopted this type of legislation to regulate the plant according to the AKA.

Even as kratom’s sales continue to grow, most states have not taken advantage of the plant as a source of tax revenue. Mississippi is the only state that has taken steps to tax kratom products, requiring manufactures and wholesalers to pay an excise tax of 25% on kratom products. The tax is added to the selling price of the product and “recovered by the ultimate consumer or user.” For states seeking to regulate kratom, state governments could use Mississippi as a model and enact an excise tax similar to products like tobacco or marijuana.

If you'd like a copy of this data, email DEPC Research Associate Dexter Ridgway.

Federal Response

Following increased reporting of enforcement seizures and public health risks, in 2016 the U.S. Drug Enforcement Agency (DEA) announced its notice of intent to schedule the plant’s two main compounds (mitragynine and 7-hydroxymitragynine) as Schedule I substances. The announcement spurred opposition, with more than 140k people signing a petition on the White House website pleading for kratom to remain unscheduled. Shortly after, the DEA withdrew its notice of intent and solicited public comments on the matter while awaiting FDA's scientific and medical evaluation and scheduling recommendations.

In July 2025, the FDA announced their recommendation to the DEA to initiate scheduling action for certain 7-hydroxymitragynine products under the CSA. In the news release, the FDA indicated their recommendation is explicitly targeting 7-hydroxymitragynine products , rather than natural kratom leaf products. This recommendation follows an extensive medical and scientific analysis conducted by the FDA, in which they determined 7-hydroxymitragynine has a “significant potential for abuse” and that “prolonged use of 7-hydroxymitragynine would lead to tolerance, physical dependence, and potentially to opioid addiction.” The FDA’s recommendation is not final and the DEA is currently reviewing it before making any recommendations to classify 7-hydroxymitragynine under the CSA.

Scheduling Process

Before any drug can be scheduled under the Controlled Substance Act at the state or federal level, it must undergo a rigorous review and be subjected to an open comment period from the general public. Table 3 provides an overview of the scheduling process for the state of Ohio and the federal government.

Table 3. Comparison of scheduling processes

StageFederal GovernmentOhio
1. Authority
  • Attorney General – authority is delegated to the Drug Enforcement Administration (DEA)
  • Federal – Ohio’s schedule automatically reflects federal updates
  • Ohio General Assembly (OGA) – legislation
  • Ohio Board of Pharmacy (OBP) – rulemaking and emergency rules
2. Initiation
  • Drug Enforcement Administration (DEA)
  • Department of Health and Human Services (HHS)
  • Interested Party (also covers legislation approved by Congress)
  • Federal Authority – automatic adoption
  • OGA – legislation
  • OBP – internal review/external request
3. Schedule I Criteria

Three criteria for Schedule I inclusion:

  • High potential for abuse: The substance has a significant likelihood of being misused for non-medical reasons, such as recreational use or for its euphoric or mood-altering effects.
  • No currently accepted medical use: The substance has not been approved for medical treatment in the United States, meaning it cannot be legally prescribed, dispensed, or administered for medical purposes.
  • Lack of accepted safety for use under medical supervision: The substance's potential risks and harmful effects are considered unacceptable even in a controlled medical setting

Following factors are considered by DEA/HHS when determining scheduling:

  • Potential for abuse
  • Pharmacological effects (scientific evidence)
  • Current scientific knowledge
  • History and current patterns of abuse
  • Scope, duration, and significance of abuse
  • Public health risks
  • Dependence liability (psychological or physiological)
  • Status as an immediate precursor
Same as federal criteria and consideration factors
4. Review and EvaluationPetition is submitted and DEA requests HHS (review is delegated to FDA) to complete a scientific and medical evaluation. Review considers factors mentioned above. Recommendation is submitted to the DEA and only considered binding if FDA (HHS) does not think the substance should be controlled. DEA has discretion to control substance.OBP conducts internal review and determines if substance meets required criteria to schedule. OBP may opt to propose new rule.
5. Rule Proposed

DEA is required to publish the Notice of Proposed Rulemaking in the Federal Register. Notice must include:

  • Statement of time, place, and nature of proceedings
  • Reference to legal authority for the rule
  • Text, substance, or description of proposed rules/issues
  • Plain-language summary (not more than 100 words) posted online

OBP publishes rule notice in the Register of Ohio. Rule is filed with:

  • Secretary of State (SoS)
  • Legislative Service Commission (LSC)
  • Joint Committee on Agency Rule Review (JCARR)

Notice will include:

  • Agency’s intent to adopt, amend, or rescind a rule
  • Synopsis of proposed change or subject matter
  • Statement of purpose or reason for the action
  • Hearing details (date, time, place, and must be 31-40 days after filing)
6. Public InputFormal comment period – 30-60 days generally, with up to 180+ days for complex rules. Agencies can extend or accept late comments.Public hearing is required. Affected parties/attorneys may testify, present evidence, or submit oral/written comments. OBP must consider all testimony/comments in their decision. OBP is also required to submit hearing report with JCARR.
7. Post-ReviewDEA must consider all comments before issuing the final rule. Final rule is published within the Federal Register. Rules must be published at least 30 days before its effective date with exceptions. Final rules must contain a concise general statement of their basis and purpose.JCARR will undergo their own review process and confirm, modify, or reject the proposed rule. Rule is then officially adopted and given date to become effective not less than 10 days after the rule has been adopted.

Public Health

Kratom has increasingly garnered concerns from public health experts due to the proliferation of highly concentrated 7-hydroxymitragynine synthetic products, the lack of regulations around these products and anecdotal evidence suggesting kratom’s role in accidental overdoses. Due to data limitations at the state and national level, it is difficult to determine how many accidental drug overdoses have involved or been attributed to kratom or its synthetic equivalents. According to the U.S. Center for Disease Control and Prevention’s (CDC) State Unintentional Drug Overdose Reporting System (SUDORS), from 2020 to 2023 kratom was detected on average in approximately 1,000 drug overdoses per year for the entire country. The number of overdose incidents involving kratom never exceeded 2% of all drug overdose per year. It is also unclear how many of these overdose incidents were a combination of other substances in addition to kratom. CDC data from the SUDORS dashboard during the months of July 2016 through December 2017, shows that .55% (152 out of 27,338) of overdose deaths tested positive for kratom; and only .03% of these incidents (7 out of 27,338) tested positive as kratom being the only substance involved. CDC also notes that it is possible that other substances in these cases were involved but at levels that were undetectable.

Besides overdoses, researchers studying mice have suggested that 7-OH can be formulated to levels producing effects ten times more potent than morphine. For policymakers and health experts, this is concerning because 7-hyroxymitragynine synthetic products have the capability of being used as a substitute for potent painkillers; potentially causing adverse health effects and problems with substance use and addiction. This is especially important due to kratom being commonly used as a way for opioid dependent users to reduce effects experienced during withdrawal. Users could be trying to eliminate their opioid reliance using an alternative approach but end up abusing an entirely new substance in the process.

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