OHIO AUTHORITIES BAN TARGET ‘ENHANCED’ KRATOM PRODUCTS WITH EMERGENCY RULE

Following months of consideration, authorities in Ohio have announced a multi-step plan to target kratom products.  

What started as the Ohio Board of Pharmacy (BOP) acting on guidance from the governor recently evolved into an attempt to formally schedule kratom as a controlled substance in the state. The BOP started the process by penning an emergency rule to temporarily schedule “mitragynine-related compounds” as Schedule I and specifically mentioned 7-hydroxymitragynine (7-OH). Natural kratom products were covered by an exception in the rule, but after comments from Gov. Mike DeWine, the BOP reversed course and took the next step to initiate the process of targeting all forms of the plant.  

“In reviewing this issue over the past few weeks, national experts, including the FDA, agree that synthetic kratom compounds should be scheduled as illegal,” DeWine said. “While there is a clear path to take action on synthetic kratom, I still have deep concerns about natural kratom, given the harms, including fatalities, attributed to it.”

DeWine’s statements came as part of a news release that accompanied the emergency rule and after the BOP cancelled a hearing in August that would have considered the governor’s request to schedule all kratom alkaloids as Schedule I. Instead, the BOP settled on targeting 7-OH with the rule, while temporarily omitting mitragynine (the primary alkaloid in natural kratom products) from the temporary regulation.

Although DeWine cited the Food and Drug Administration (FDA) as the reason behind his actions, his statements left the door open to target natural leaf kratom products in the future. In the same documents used by DeWine in his executive order, the FDA specifically labeled 7-OH as a public health concern and said the agency did not plan to take action against natural leaf kratom. 

That differentiation didn’t stop the BOP from proceeding with an attempt to schedule all forms of kratom in Ohio, or DeWine from supporting the efforts.

“Pursuing the regular rule process for a ban on natural kratom will allow for hearings, testimony, and a deliberative process,” DeWine said. 

Details of the Developments

The emergency rule is OAC 4729:9-1-01.1 from the BOP and was enacted with executive order 25-08D from DeWine’s desk. That executive order was signed on Dec. 12 of last year and established an emergency rule for 180 days or until the rule is adopted through the formal rulemaking procedure by the BOP. 

At first, the rule created an exception for products that contain “pure mitragynine” and further clarified that kratom products containing “trace amounts of 7-OH” were exempt. That exception lasted less than a month. 

On Jan. 7, the BOP put out Common Sense Initiatives announcing two separate actions proposed by the board. The first was a formal process to target the same “mitragynine-related compounds” that were included in the initial executive order and would formalize the emergency rule into a permanent regulation. 

Rather than leaving the exception in place, the second action was a proposal to make mitragynine a Schedule I substance under the same rule-making process. The BOP’s chief pharmacist tied the two different actions into the same conversation and ignored the FDA’s new stance of differentiating natural leaf kratom and 7-OH products.

The state agencies targeting kratom claim that Ohio’s approach to kratom “is in line with the FDA,” as each step of the process cited the FDA as a basis for its rulings. The only issue, however, is that the FDA makes a distinction between 7-OH and mitragynine, while the authorities in Ohio tried to incorrectly conflate the two. 

Targeting the True Concerns

That framing could be confusing to consumers, as mitragynine and 7-OH are uniquely different alkaloids found in the natural kratom plant. The issue, according to the FDA, comes from manufacturers that are artificially enhancing 7-OH products beyond the trace amounts that are found in natural kratom products. 

Among those documents directly cited in DeWine’s executive order is a letter from FDA Commissioner Dr. Marty Makary, who directly states that 7-OH products “are far more dangerous than traditional kratom leaf products.” DeWine also references a report and a consumer guide posted by the FDA, but on further inspection, both pieces of information clearly state that 7-OH products create a risk factor that is not found in products derived from natural kratom leaf. 

In the documentation associated with the attempt to schedule mitragynine, the BOP instead highlighted the risks associated with 7-OH. The reasoning even went so far as to cite Makary’s warning about that alkaloid, without revealing that the Commissioner specifically made an exception for natural leaf kratom in his letter and comments on the matter. 

By using other alkaloids and the prospect of natural kratom leaf being synthesized into 7-OH products, the BOP claimed that kratom met the ‘8-Factor Criteria’ to schedule mitragynine. That is similar to the “Eight Factor Test” that the Drug Enforcement Administration (DEA) used to propose a similar action nearly a decade ago. 

After introducing the attempt to schedule kratom in August of 2016, the agency withdrew that effort in October of that same year. Later, a former federal administrator said the case against kratom contained "disappointingly poor evidence and data.” The decision by the DEA to abandon its attempt against kratom was heavily influenced by public backlash.

Now, Ohio is attempting to make that same case. Supporters of kratom in the state will have a chance to submit feedback to the BOP as lawmakers consider the future of kratom regulation. Comments must be submitted by Jan. 28. 

DeWine indicated in his executive order that the process to formalize the rule would run through the Joint Committee on Agency Rule Review (JCARR), a legislative oversight body that works directly with agencies such as the BOP. The next scheduled meeting for JCARR is set for Jan. 20, 2026.