Federal Register #HHS-OASH-2026-0232

Request for Public Input on Temporary Scheduling Threshold for 7-Hydroxymitragynine (7-OH)

This opportunity is a request for public input from the Health and Human Services Department, Office of the Assistant Secretary for Health (OASH), regarding the temporary scheduling of 7-hydroxymitragynine (7-OH) under the Controlled Substances Act. - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Assistant Secretary for Health (OASH) - Purpose: - Soliciting comments on the proposed threshold for scheduling 7-OH, a compound found in Mitragyna speciosa (kratom) and related products - Seeking input on what concentration or quantity of 7-OH should be considered an imminent hazard to public safety - Requesting scientific or technical data to support or challenge the proposed threshold - Scope: - Applies to kratom-derived, synthetic, and processed forms of 7-OH - Includes alternative measurement expressions for threshold determination - Excludes broader policy questions or permanent scheduling decisions - No OEMs or vendors are named, as this is a regulatory information request, not a procurement of goods or services - Unique Requirements: - Respondents must provide scientific or technical evidence related to 7-OH thresholds - Focus is strictly on the temporary scheduling threshold for 7-OH, not on other substances or permanent scheduling

Description

The Office of the Assistant Secretary for Health (OASH) is requesting public input on a proposed threshold for scheduling 7-hydroxymitragynine (7-OH) under the Controlled Substances Act. The notice seeks comments on the specified threshold level of 7-OH in products derived from Mitragyna speciosa (kratom) and alternative articles containing 7-OH. Public comments will be considered by the Secretary for Health and Human Services and the Attorney General. Comments are due by July 31, 2026.

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