On July 6, the United States Drug Enforcement Agency (DEA) published a notice in the Federal Register that it intends to place 7-hydroxymitragynine (7-OH) on Schedule I of the Controlled Substances Act. This is an emergency rule that would temporarily place covered 7-OH products in Schedule I for up to two years while the DEA considers permanent scheduling. The earliest a temporary Schedule I ban could take place would be August 5, 2026, after a comment period that will last through July 31.
The DEA states in the notice:
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine above a specified threshold, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 7-hydroxymitragynine above a specified threshold.
For a temporary scheduling action under 21 U.S.C. § 811(h), the DEA does not conduct the full eight-factor analysis used for permanent scheduling. Instead, the statute requires the DEA to consider only three of the eight factors from 21 U.S.C. § 811(c) when determining whether a substance poses an “imminent hazard to the public safety.”
The notice specifically discusses:
Factor 4. History and Current Pattern of Abuse. The DEA states that 7-OH products have rapidly emerged in the market and cites evidence that these products are being marketed and used for their psychoactive, opioid-like effects.
Factor 5. Scope, Duration, and Significance of Abuse. The DEA argues that the availability and use of 7-OH products have expanded quickly and that the products are now widely distributed across the United States. The agency points to increasing reports of misuse and concludes that the extent of abuse has become significant enough to warrant emergency action.
Factor 6. What, If Any, Risk There Is to Public Health. This is the primary focus of the notice. The DEA relies on reports of poison center calls, emergency department visits, overdoses, adverse events, dependence, and withdrawal, together with what they consider a sufficient amount of scientific evidence based on animal studies that 7-OH is a potent mu-opioid receptor agonist capable of producing opioid-like effects. Based on this information, the agency concludes that concentrated 7-OH products pose an imminent hazard to the public safety.
HHS Accepting Public Comments
The Department of Health and Human Services (HHS) is accepting public comments about this notice through July 31, 2026. HHS has issued specific guidelines on the opinions they are looking for:
1. Whether any additional data exist that further support this or an alternative threshold level, and specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety.
2. Whether data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent hazard to public safety.
Note that OASH is not soliciting comment on any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination for temporary scheduling. Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General.
Many of the comments published so far, however, have focused on 7-OH scheduling itself and the criminalization of 7-OH consumers and pain patients.
In a separate release, the DEA also announced a “Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I”. There are no public comments open for this proposed rule.
Reactions from Lobbyists
In support of the DEA, the American Kratom Association (AKA) said:
“Chemically manipulated 7-OH opioids are not kratom. They are dangerous products that exploited the reputation of natural
kratom leaf, misled consumers, and created a public health threat that responsible regulators can no longer ignore.”
The Global Kratom Coalition (GKC) also supports 7-OH criminalization, though it did not issue a formal news release about the recent DEA announcement. Recently on X, the GKC countered claims that mitragynine’s metabolism into 7-OH in the liver is similar to consuming 7-OH products. It argued, among other points, the “entourage effect,” arguing that kratom’s many alkaloids may modify or counter some opioid-like effects.
“This clear scientific boundary is exactly why the FDA, HHS, and AMA recommend making concentrated synthetic 7-OH products Schedule I, while finding a clear difference in the risk profiles for natural leaf kratom products.”
In a news release announcing a national advocate response call for July 7, the 7-HOPE Alliance said:
“We understand that this announcement is causing a lot of confusion, fear, and uncertainty throughout the consumer community…We understand how deeply personal this issue is for many people who rely on 7-OH every day. We know how frightening uncertainty can feel when access to something you depend on appears threatened.”
The New York Times characterized the 7-OH emergency scheduling as a “big win for makers of supplements containing the natural form of kratom, who had been losing market share to 7-OH rivals over the past few years.” NYT has also pointed to Secretary of Homeland Security Markwayne Mullin’s investment in Botanic Tonics as a reason that the Secretary urged the FDA change its language on kratom.
Arguments Against Psychoactive Substance Criminalization in General
Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), has argued that treating addiction primarily through the criminal justice system can worsen public health outcomes by increasing stigma and discouraging people from seeking care. Volkow has emphasized that substance use disorders are medical conditions involving changes in brain function, and she has advocated for approaches focused on prevention, treatment, and evidence-based interventions rather than punishment. She has warned that criminalization can push people away from healthcare systems and make it more difficult to address addiction as a public health issue.
Dr. Carl Hart, professor of neuroscience and psychology at Columbia University, has argued that criminalizing drug possession and use creates harms that often exceed the harms caused by the substances themselves. Hart has criticized policies that treat drug users as criminals, arguing that prohibition contributes to stigma, incarceration, and barriers to employment, housing, and healthcare. Based on his research into drug effects and human behavior, Hart has argued that many people who use drugs are capable of making rational decisions about their consumption and that public policy should focus on education, regulation, and reducing harmful consequences rather than criminal penalties.
Dr. Ethan Nadelmann, founder of the Drug Policy Alliance, has argued for decades that criminalization has failed as a drug-control strategy and has produced significant social harms. Nadelmann has pointed to mass incarceration, racial disparities in enforcement, and the growth of illicit markets as consequences of punitive drug policies. He has advocated for treating drug use as a public health issue through approaches such as harm reduction, regulated markets where appropriate, and expanded access to treatment rather than relying on criminal penalties to control behavior.