Hiding in Plain Sight: 7-OH Products
The time to act is now. We can and must prevent the next wave of the opioid crisis.
7/13/2026 Update on 7-OH and Synthetic Kratom-Related Compounds
On July 1, 2026, the Drug Enforcement Administration (DEA) announced the start of the temporary scheduling process under the Controlled Substances Act and through a Notice of Intent (NOI) for 7-hydroxymitragynine (7-OH) above a proposed specified threshold, as well as three synthetic 7-OH derivatives (Mitragynine pseudoindoxyl, MGM-15, and MGM-16) not naturally occurring in the kratom plant. The same day, in a separate Request for Information (RFI) notice, the U.S. Department of Health and Human Services (HHS) opened a 30-day public comment period on the proposed 7-OH threshold in DEA’s NOI to publish a temporary scheduling order. The RFI notice is seeking input on whether: 1) there is additional 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; and 2) data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety. The agencies stated that these actions are intended to target concentrated and synthetic 7-OH products and are not intended to apply to natural kratom leaf containing only naturally occurring trace levels of 7-OH.
Pursuant to the CSA, no sooner than 30 days following publication of the NOI, the Attorney General may issue a temporary scheduling order placing 7-OH above a certain threshold in Schedule I. The CSA provides the Attorney General with the authority to issue a temporary scheduling order for two years if such action is necessary to avoid an imminent hazard to public safety
Get Help and Report Adverse Events
Report an Adverse Event
If you have a bad reaction to a product containing 7-OH, let the FDA know.
You can report an adverse event by using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form sent to you in the mail, then complete and return to the address on the form or submit it by fax to 1-800-FDA-0178.
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