DEA to Temporarily Schedule 7-OH and Other Compounds Found in Kratom

On July 1, 2026, the US Drug Enforcement Administration announced that it had filed its intent to temporarily place 7-hydroxymitagynine (7-OH) and three related substances, namely Mitragynine pseudoindoxyl (MP), Dihydro-7-hydroxymitragynine (MGM-15), and the 9-fluoro derivative of 7-hydroxymitragynine (MGM-16) into Schedule I of the Controlled Substances Act (CSA). These chemical compounds are naturally present in the plant kratom in negligible amounts, but are often used in their synthetic forms at high doses in adulterated supplements and beverages. DEA submitted two notices of intent (NOI), one to temporarily place 7-OH above a specified threshold in Schedule 1, and the other to temporarily the other three substances in Schedule 1.

The threshold set in the notice of intent for 7-OH was 0.050 percentage of 7-hydroxymitragynine on a dry weight basis in botanical materials, or 0.050 percentage by weight/weight, weight/volume, or volume/volume or greater than 1.00 milligram of 7- hydroxymitragynine in articles resulting from synthetic methods and materials derived from kratom but further processed into extracts, concentrates, edibles, and pills.

“Today’s action targets highly concentrated, synthetic 7-OH products, which pose a growing threat to public safety and health. Temporarily scheduling these substances underscores the emphasis this Administration has put on the safety, health and well-being of the American people,” said DEA Administrator Terrance Cole in a statement.“This action gives law enforcement and public health partners the tools needed to address this emerging threat. We appreciate the FDA's scientific expertise and our continued partnership with HHS to address emerging threats, and we will continue to act aggressively when dangerous substances threaten Americans.”

In July of 2025, the US Food and Drug Administration (FDA) sent 7 warning letters to companies illegally marketing products containing 7-OH. It was considered significant that FDA was targeting specifically 7-OH rather than kratom more broadly, and the actions were supported by groups such as the American Kratom Association (AKA) who consider the synthetic ingredients dangerous, and reflecting negatively on kratom more broadly. In response to DEA’s action, AKA also expressed support because the agency confirmed that temporary scheduling does not apply to botanical kratom products that contain naturally occuring amounts of 7-OH.

“This DEA action should end the debate,” said Mac Haddow, Senior Fellow on Public Policy for AKA, in a press release. “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 Natural Products Association (NPA) also expressed support. “The science clearly establishes that 7-OH is found in trace amounts in the Mitragyna speciosa plant,” said Daniel Fabricant, PhD, president and CEO of NPA in a press release. “We remain consistent in our position that highly concentrated amounts of 7-OH are falsely marketed as kratom and have not demonstrated pre-market safety through FDA’s new dietary ingredient notification process.”

Concurrent with DEA’s notices of intent, the Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) on seeking public comment on the proposed 7-OH threshold level in the NOI. This is a 30-day public comment period. The request is limited to obtaining comments on the following:

• Whether there is additional scientific data to support the proposed or an alternative threshold level – specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety.
• Data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety.

“I commend the DEA for taking decisive action to address these addictive and harmful substances,” said HHS Secretary Robert F. Kennedy, Jr. in a statement. “7-OH, MP, MGM-15, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk. HHS reviewed the science and recommended this action. The Trump Administration will continue using every available authority to stop these deceptive products, hold bad actors accountable, and protect American families.”