SABER Welcomes DEA Action to Temporarily Schedule Concentrated and Synthetic 7-OH Products While Preserving Access to Natural Leaf Kratom 

The Scientific Association for Botanical Education and Research (SABER) welcomes the issuance of two Notices of Intent from the U.S. Drug Enforcement Administration (DEA) to begin the temporary scheduling of concentrated 7-hydroxymitragynine (7-OH) and three related synthetic derivatives, and commends the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) for the scientific and medical review that supported the action.

The action, announced July 1, 2026, consists of two Notices of Intent (NOIs) filed with the Federal Register. One NOI addresses the temporary placement of 7-OH above a specified threshold into Schedule I of the Controlled Substances Act (CSA). The second would place three derivatives that do not occur naturally in kratom (Mitragyna speciosa) into Schedule I:

• Mitragynine pseudoindoxyl (MP) 
• Dihydro-7-hydroxymitragynine (MGM-15) 
• The 9-fluoro derivative of 7-hydroxymitragynine (MGM-16) 

“This action reflects exactly the kind of science-based, targeted approach we have long advocated,” said Thomas Brendler, PhD, Chair of SABER’s Steering Committee. “Federal agencies reviewed the available evidence and drew a careful line between natural kratom and the concentrated and synthetic products that have raised serious public health concerns. Making that distinction is essential to protecting consumers without discarding a botanical with a long history of traditional use.”

Concurrent with the NOI addressing 7-OH, the HHS Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) seeking public comment on the proposed threshold level — specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety. After a 30-day comment period, OASH will forward the submitted comments to the Attorney General, who may then issue a temporary scheduling order placing 7-OH above the threshold in Schedule I for up to two years if such action is necessary to avoid an imminent hazard to public safety.

Federal agencies emphasized that the action is not intended to regulate natural kratom leaf that does not contain enhanced levels of 7-OH. Although 7-OH can occasionally be found in post-harvest kratom leaf in trace amounts as an oxidative degradation product of mitragynine, scheduling 7-OH above a defined threshold is not intended to capture leaf products. By contrast, MP, MGM-15, and MGM-16, which also do not occur naturally in the plant, are achieved only by chemical synthesis.

“As policymakers consider how to approach kratom and related products, it is important to recognize that not all products are the same,” said Paula Brown, PhD, a member of SABER’s Scientific Steering Committee. “Highly concentrated and synthetic 7-OH products marketed as kratom extracts are fundamentally different from the traditional botanical and treating them identically serves no one.”

Brown noted that the enforcement actions preceding the scheduling process — including FDA warning letters issued to companies marketing 7-OH products in 2025 and the subsequent seizure of unlawful 7-OH products — reflected mounting concern about concentrated and synthetic material entering the consumer market under the kratom label.

“Clear regulatory distinctions, grounded in science, allow legitimate research and responsible botanical products to move forward while removing the most dangerous material from the market,” she said. “That is a constructive outcome for consumers, clinicians, and public health.”

SABER views the temporary scheduling of concentrated and synthetic 7-OH derivatives as consistent with a broader movement toward evaluating botanical compounds through the same rigorous, evidence-based framework applied to other substances, and commends the DEA, HHS, and FDA for distinguishing these products from the natural botanical. SABER encourages continued investment in research to further clarify the safety profile of kratom and its constituent alkaloids and looks forward to informed public health decisions grounded in sound science.

About Scientific Association for Botanical Education and Research (SABER)

The Scientific Association for Botanical Education and Research (SABER) is a nonprofit organization dedicated to the evidence-based study, science-forward regulation, and safe access to botanical compounds. Led by a Scientific Steering Committee of medical professionals and researchers, SABER utilizes research partnerships, policy advocacy, and public education to ensure that natural products are studied responsibly and regulated appropriately. To learn more, visit www.saberscience.org.

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