Introduction
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). Despite an increase in regulatory efforts over the years, kratom and its compounds remain unregulated across many states and at the federal level.
NOTE: This page was published on October 27, 2025.
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.
Table 1. Pending legislation in Ohio General Assembly addressing kratom
| Statute Category | Senate 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:
|
| Oversight and Authority |
Rulemaking Authority:
|
| Product Registration |
Food Processing Establishments:
|
| 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:
|
| Protections for Establishments | Processors 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 Requirements | Processors 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 Requirements | Processors 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.
Table 2. Kratom regulations enacted by other states
| State | Type of Regulation | Age Requirement | Criminal Penalty for Possession | Product Requirements | 7-OH Limit | Labeling Requirements | Licensing | Taxation |
|---|---|---|---|---|---|---|---|---|
| Alabama | Prohibited - Schedule I – Mitragynine and Hydroxymitragynine | Not applicable | Class D Felony | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Arizona |
Regulated and Permitted Modeled after KCPA |
18 y/o | No |
No Adulterated or Contaminated Products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Labels must include alkaloid content |
2% |
|
None | None |
| Arkansas | Prohibited - Schedule I – Opium Derivatives (Mitragynine, 7-Hydroxymitragynine) | Not applicable |
<2g - Class D Felony 2-28G - Class C Felony 28-200g - Class B Felony |
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Colorado |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
Prohibits products adulterated with Fentanyl or any other Controlled Substances listed in § 18–18–201:207 Product label must include manufacturer and list of ingredients 7-hydroxymitragynine - up to 2% alkaloid content Prohibits products that are confection or mimic candy, and/or is appealing to children Prohibits combustible or vape products Prohibits synthetic or semi-synthetic alkaloid products |
2% |
Label must:
|
None | None |
| Connecticut | Pending Scheduling | Not applicable | No | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| D.C. | Scheduled | Not applicable | No | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Florida |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
Products must be packaged and labeled compliant with Chapter 500, F.S. Labels and advertisement must not make claims that it can diagnose, cure, mitigate, treat, or prevent disease Manufacturers of kratom products are subjected to requirements Chapter 500, F.S. and 21 C.F.R 111 Products marketed or labeled as dietary supplement are subject to requirements of Chapter 500, F.S. and 21 C.F.R 111 |
None |
Label must:
|
Entities distributing products must be registered as Food Establishments ($650 annual fee) | None |
| Georgia |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
Products must be derived from the natural kratom plant No kratom product sold or delivered in Georgia shall exceed 150mg mitragynine per serving, .5mg 7-hydroxymitragynine per gram, or 1 mg 7-hydroxymitragynine per serving Products are prohibited that are adulterated, that may include food substances considered unsafe in food products, or contain synthetically derived compounds of the kratom plant Products that deploy a heating element (vapes) are prohibited Products must be behind a counter in an area only accessible to store employees or in a secured display |
0.5 mg/g or 1 mg/serving |
Label must:
|
None | None |
| Illinois | Regulated and Permitted | 18 y/o | No | No | None | None | None | None |
| Indiana | Prohibited - Schedule I - Mitragynine and 7-hydroxymitragynine | No |
Class A Misdemeanor Level 6 felony if enhanced |
No | None | None | None | None |
| Kentucky |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
Prohibits adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic alkaloids derived from the kratom plant Residual solvents must meet limits established by United State Pharmacopeia Chapter 467 |
2% |
Label must:
|
None | None |
| Louisiana | Prohibited - Schedule I – Kratom (Mitragynine, 7-Hydroxymitragynine) | Not applicable |
<20g - Up to $100 fine >20g - First Conviction: up to $500 fine and/or up to 6 months in jail Repeat Convictions: up to $1,000 fine and/or up to 6 months in jail |
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Maryland |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Product must contain on packaging or label the amount of mitragynine and 7-hydroxymitragynine included Product must meet certain disclosure requirements Products that have not been recognized as a dietary ingredient or approved drug by the FDA are prohibited |
2% |
Label must:
|
None | None |
| Minnesota | Permitted | 18 y/o | No | No | No | None | None | None |
| Mississippi |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
7-hydroxymitragynine - up to 1% alkaloid content and not exceeding .5mg per container of the product Prohibits products containing any controlled substances with exceptions
|
1% |
Label must:
|
None | None |
| Nebraska |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Prohibits combustible products, products intended for vaporization, or that are injectable Products must be registered with the state |
2% |
Label must:
|
Processors must maintain a valid FDA food facility registration for manufacturing, packaging, or labeling sites. | None |
| Nevada |
Regulated and Permitted Modeled after KCPA |
18 y/o | No | Prohibits adulterated products | No |
Label must:
|
None | None |
| Oklahoma |
Regulated and Permitted Modeled after KCPA |
18 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 1% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Prohibits products containing any controlled substances with exceptions Residual solvents must meet FDA Q3C limits Certain products must include a calibrated measuring device |
1% |
Label must:
|
None | None |
| Oregon |
Regulated and Permitted Modeled after KCPA |
21 y/o | No | No | No | None |
Processors must register with Department of Revenue ($460 annual fee) Registration requires third-party testing certification |
None |
| Rhode Island | Pending Regulation | No | No | No | No | None | None | None |
| South Carolina |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
Prohibits adulterated or contaminated products Prohibits fully synthetic alkaloid compound derived from the kratom plant Residual solvents must meet limits established by United State Pharmacopeia Chapter 467 Products must meet label requirements established pursuant to Section 44-53-2030 Products must be kept in an area inaccessible to individuals under 21 years old |
No |
Label must:
|
None | None |
| South Dakota |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products |
2% |
Label must:
|
None | None |
| Tennessee | Regulated and Permitted | 21 y/o | No | Prohibits products that are not in natural form | No |
Label must:
|
None | None |
| Texas |
Regulated and Permitted Modeled after KCPA |
18 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Prohibits products containing controlled substances listed under the Texas Controlled Substances Act |
2% |
Label must:
|
None | None |
| Utah |
Regulated and Permitted Modeled after KCPA |
18 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Prohibits synthetic mitragynine and 7-hydroxymitragynine products Label must include alkaloid content of mitragynine and 7-hydroxymitragynine in product Products must be registered with the state |
2% |
Label must:
|
Processors must register as food establishments under §4-5-301 Processors must pay fee associated with being a food establishment |
None |
| Vermont | Regulated Drug Rule - Mitragynine and 7-hydroxymitragynine | No |
<10 doses - Up to 1 year in prison and/or up to a $2,000 fine ≥10 - Up to 5 years and/or up to a $25,000 fine ≥100 - Up to 10 years and/or up to a $100,000 fine ≥1,000 - Up to 15 years and/or up to a $500,000 fine |
No | No | None | None | None |
| Virginia |
Regulated and Permitted Modeled after KCPA |
21 y/o | No | No | No |
Label must:
|
None | None |
| West Virginia |
Regulated and Permitted Modeled after KCPA |
21 y/o | No |
No adulterated or contaminated products 7-hydroxymitragynine - up to 2% alkaloid content Products must be registered with the state |
No |
Label must:
|
Manufacturers, processors, distributors, and retailers must obtain a state permit ($1,500 application fee and $300 annual renewal) These entities and other businesses outside of the state doing business in West Virginia must obtain a West Virginia business registration certificate |
Imposes a 11% privilege tax on retailers selling kratom products Funds from tax are distributed as follows:
|
| Wisconsin | Prohibited - Schedule I - Mitragynine and 7-hydroxymitragynine | Not applicable |
First Offense - Up to 1 year in prison and/or up to a $5,000 fine Second and Subsequent Offense - Class I Felony |
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
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
| Stage | Federal Government | Ohio |
|---|---|---|
|
1. Authority |
|
|
| 2. Initiation |
|
|
| 3. Schedule I Criteria |
Three criteria for Schedule I inclusion:
Following factors are considered by DEA/HHS when determining scheduling:
|
Same as federal criteria and consideration factors |
| 4. Review and Evaluation | Petition 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:
|
OBP publishes rule notice in the Register of Ohio. Rule is filed with:
Notice will include:
|
| 6. Public Input | Formal 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-Review | DEA 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.