DEA MOVES TO TEMPORARILY MAKE 7-HYDROXYIMTRAGYNINE A SCHEDULE I SUBSTANCE

Since the rise of chemically altered products claiming to be kratom, lawmakers across the country have fallen into the trap of painting all forms of the plant with the same brush. A new decision by the federal government looks to clarify that debate. 

Following an announcement by the Food and Drug Administration (FDA) in July 2025, the Drug Enforcement Agency (DEA) recently announced a temporary order to schedule 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance under the Controlled Substances Act (CSA). The follow-through from the DEA comes nearly one year after the FDA originally targeted the trace alkaloid and looks to set the record straight on the science and policy surrounding natural leaf kratom vs. products that are masquerading as derivatives of Mitragyna speciosa. 

A document signed July 1 laid out the DEA’s case against 7-OH products and the legal pathway for the temporary scheduling. 

“Because the Administrator hereby finds that this temporary scheduling order is necessary to avoid an imminent hazard to public safety, it will take effect on the date the order is published in the Federal Register and remain in effect for two years, with a possible extension of an additional year, pending completion of the regular (permanent) scheduling process,” said the document. 

The document was published in the Federal Register on July 6. That extra year can be added to the order if federal regulators initiate the process of formally scheduling 7-OH. 

Under the temporary order, the specific threshold for what constitutes a 7-OH product applies to any “botanical material” that “contains more than 0.050 percent of 7-hydroxymitragynine on a dry weight basis.” In simple terms, leaf material must adhere to these standards to be considered legal, natural leaf kratom products. 

The guidelines also apply to any other product derived from Mitragyna speciosa that maintains that ratio of 0.05% in terms of weight/weight, weight/volume or volume/volume depending on what form the product is sold in. Products are also subject to this new rule if the quantity is “greater than 1.00 milligram of 7-hydroxymitragynine.” 

Per the terms of the CSA, the DEA notified the Department of Health and Human Services (HHS) of the temporary order in a letter dated Feb. 24, 2026. The threshold for 7-OH products was established in conjunction with HHS. The DEA’s notice also indicated that HHS had no objection and clarified that substances “meeting the statutory requirements for temporary scheduling may only be placed in Schedule I.” 

The debate over differences between natural leaf kratom and 7-OH products started in recent years when American producers began enhancing and synthesizing ‘new’ kratom products. Those producers claimed that 7-OH was natural and marketed the products as kratom, despite the scientific truth of the situation. 

In reality, 7-OH is an alkaloid of Mitragyna speciosa that occurs in trace amounts in dried kratom leaf and leaf powder. More specifically, it’s an oxidation byproduct that shows up in those forms during the drying process. The products marketed as derivatives of the plant are heavily synthesized and feature a drastically different chemical profile. Advocates for natural leaf kratom began sounding the alarm years ago and made the case against 7-OH during a congressional briefing in September of 2024. 

At that time, Dr. Christopher McCurdy, who is one of the leading kratom researchers in the United States, showed lab testing that emphasized the risk of 7-OH products, including several unknown substances that were found alongside the enhanced alkaloids. Research funded by the National Institute on Drug Abuse (NIDA) also showed that 7-OH has significant differences from mitragynine, which is the primary alkaloid of the kratom plant.  

The information presented by McCurdy and NIDA’s research was at the heart of the DEA’s decision to take action against 7-OH products. 

According to the notice issued by the DEA, “7-Hydroxymitragynine has opioidergic activity, sharing a similar pharmacological profile to schedule II opioids like morphine.  Preclinical data indicate that 7-hydroxymitragynine carries a high abuse potential with safety risks, including tolerance, dependence, and respiratory depression, which are comparable to those of classic opioid analgesics.” 

As more 7-OH products have made their way to customers in the United States, the DEA notes that “ambiguous dosages and misleading marketing” have created a “significant threat to public health”, especially when those products are labeled as natural derivatives of the kratom plant. The same products with elevated levels of 7-OH have also been found to contain “other opioid alkaloids” and create a situation where local lawmakers have been caught in a regulatory limbo.  

“These combinations, coupled with a lack of regulatory oversight, pose significant safety risk to unsuspecting consumers by exposing them to high doses of opioids,” said the DEA’s notice. “The absence of clinical evidence to support vendor health claims is deeply concerning.”

What is missing from the temporary order is any mention of, or restrictions on, the levels of mitragynine in natural leaf kratom products. When the FDA announced its intention to target 7-OH products last year, the agency specifically stated that it is not interested in targeting natural leaf kratom products. That decision was echoed in the DEA’s temporary order, which clearly distinguishes 7-OH from mitragynine. 

At the same time, the DEA does specifically reference the dangers posed by a lack of kratom regulations and highlights the 19 states that have passed versions of the Kratom Consumer Protection Act (KCPA). By operating in a legal gray area, the DEA said 7-OH products pose a significant risk to public health, which is why the agency acted to close the loophole that has allowed bad actors in the industry to take advantage of kratom consumers. 

The DEA concludes: “The abuse of 7-hydroxymitragynine in the United States is fueled by its pharmacological similarities to opioid analgesics, a lack of regulatory controls, and the relative ease of obtaining 7-hydroxymitragynine products via smoke shops and the Internet.”