Understanding the 7-OH Threshold Proposal

The U.S. Department of Health and Human Services (HHS) is currently seeking public comments concerning the proposed threshold for 7-hydroxymitragynine (7-OH). This threshold is a significant decision that impacts the kratom community and should be addressed based on scientific evidence rather than sentiments.

Key Deadline and Docket Information

Public comments must be submitted by July 31, 2026. The HHS is operating under the docket ID HHS-OASH-2026-0232, where all relevant documentation and guidelines for submissions will be available.

Why Your Submission Matters

Evidence-based comments are invaluable for shaping policy decisions. They provide a basis for understanding the implications of threshold levels on public health and safety. Strong comments should include validated laboratory data, toxicology reports, and evidence for different threshold levels.

How to Submit Your Comments

Here’s a step-by-step guide to submitting your evidence effectively:

1. Locate the Docket:

Visit the official Regulations.gov website and search for HHS-OASH-2026-0232 to find the official docket.

2. Draft Your Submission:

Focus your submission on scientific evidence regarding the threshold for 7-OH, citing relevant studies and data that can back your claims.

3. Remove Personal Information:

Ensure privacy by removing unnecessary personal details that do not pertain to your comments.

4. Attach Supporting Sources:

Include references to studies, reports, and laboratory data to strengthen your arguments.

5. Submit and Save Confirmation:

Once submitted through the portal, ensure to save your confirmation for future reference.

Types of Evidence to Consider

Valid evidence can include:

• Concentration distributions of 7-OH
• Toxicology reports from independent laboratories
• Data on measurement uncertainty
• Manufacturing data that supports alternative measurement expressions
• Historical data demonstrating different threshold necessities

Focus on strong, evidence-based comments as they are more likely to be considered than weak or repetitive submissions which do not address specific questions posed in the docket.