HHS Seeks Public Input on Threshold for Temporary Schedule I Placement of 7-Hydroxymitragynine

What this means for your practice

This HHS notice is critical for healthcare businesses, including telehealth providers, medspas, dental practices, and chiropractors, as it signals the potential federal classification of 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance above a specified threshold. If finalized, this action would severely restrict or prohibit the manufacturing, distribution, and dispensing of products containing 7-OH above the designated concentration. Practitioners must be aware that Schedule I substances are deemed to have a high potential for abuse and no currently accepted medical use in treatment in the United States. Even temporary scheduling impacts patient care discussions, potential liability, and the necessity for vigilance against illicit use or diversion. Any practice whose patients may be using products derived from Mitragyna speciosa (kratom) or synthetic alternatives containing 7-OH must monitor this development closely to ensure compliance with federal law and avoid potential legal ramifications for themselves and their patients.

Washington, D.C. — The Department of Health and Human Services (HHS), through its Office of the Assistant Secretary for Health (OASH), has issued a Notice and Request for Information (RFI) regarding the proposed threshold for 7-hydroxymitragynine (7-OH) under the Controlled Substances Act (CSA). This action comes as the Drug Enforcement Administration (DEA) has indicated its intent to temporarily place 7-OH, above a specified threshold, into Schedule I of the CSA.

Background on the Proposed Action

In a parallel action, the DEA has announced its intent to issue a temporary scheduling order to add 7-hydroxymitragynine, along with its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever their existence is possible, to Schedule I. This temporary placement is made under the authority granted to the Attorney General by 21 U.S.C. 811(h)(1), which allows for substances to be placed in Schedule I for two years if necessary to avoid an

Key Facts

| Detail | Value | |---|---| | Agency | Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS-OASH) | | Docket Number | HHS-OASH-2026-0232 | | Action | Notice; Request for Information; Establishment of a Public Docket | | Substance in Focus | 7-hydroxymitragynine (7-OH) | | Proposed Action | Temporary placement of 7-OH above a specified threshold in Schedule I of the Controlled Substances Act by DEA | | Comment Deadline | July 31, 2026 |

Frequently Asked Questions

What is HHS requesting information about?

HHS is requesting input and comments on a proposed threshold for 7-hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act (CSA), specifically seeking data on what concentration or quantity constitutes an 'imminent hazard to public safety'.

Why is 7-hydroxymitragynine being considered for Schedule I?

The Drug Enforcement Administration (DEA) noted its intent to issue a temporary scheduling order to add 7-hydroxymitragynine above a specified threshold to Schedule I under the CSA because it has found such action necessary to avoid an imminent hazard to public safety.

What is the proposed threshold for 7-hydroxymitragynine?

The DEA's specified threshold for 7-hydroxymitragynine is (A) any botanical material of the plant Mitragyna speciosa (kratom) containing more than 0.050% of 7-OH on a dry weight basis, or (B) any alternative article or material (synthetic or derived from Mitragyna speciosa and processed) with 7-OH present in amounts greater than 0.050% (weight/weight, weight/volume, or volume/volume) or greater than 1.00 milligram in the article.

What kind of data or comments is OASH looking for?

OASH is seeking input on whether additional data exist to support the proposed threshold or an alternative level, particularly concerning what concentration or quantity of 7-OH constitutes an imminent hazard to public safety. They are also interested in data supporting alternative measurement expressions for specifying the threshold level.

What is the deadline to submit comments?

Electronic or written comments, data, or information must be submitted by July 31, 2026.

Source: HHS — Notice: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information · 2026-07-06