Our comment on the proposed 7-OH threshold

The Social Pain Institute has filed a public comment in HHS-OASH-2026-0232, the docket on temporarily placing 7-hydroxymitragynine above a specified threshold in Schedule I. The comment and its technical appendix are below, together with the text we submitted alongside them.

Docket HHS-OASH-2026-0232Comment period closes September 10, 202617 pages, comment and appendix

Why we filed

SPI translates neuroscience concerning social pain and the endogenous opioid system into clinical research and policy. That is a narrow remit, and most scheduling dockets fall outside it. This one does not.

We are small, we are new, and we have no dose-response data of our own to add. What we can add is a reading of the record OASH already holds, so we screened it. We retrieved the posted comments from the regulations.gov API on August 19, 2026, while the docket was closed after its original July 31 deadline, and collapsed near-duplicate campaign submissions, leaving 19,344 distinct comments. The period has since reopened and runs to September 10, so the corpus is the original comment window as posted, and nothing filed since.

Pain is the most common reason in that record, and it is the reason a person can state plainly and be understood. 60.5% of comments mention pain in some form. Alongside it, 20.7% mention a psychiatric or neurodevelopmental term, and 5.6% raise one with no pain or physical condition anywhere in the comment. Those are floors rather than rates, and a comment record will understate them.

That population sits inside the exposure estimate FDA says it cannot supply, and it is the population our work is about. A record that does not describe it now will be considerably harder to describe afterward.

What we are and are not saying

We take no position on whether any scheduling action should occur. The comment addresses only the two questions OASH posed, and its argument is about measurement and attribution: what the record can support, what it cannot, and what it does not describe. The five points and the recommendations are in the submitted text below, and set out in full in the comment itself.

SPI has no financial interest in kratom or 7-OH products and receives no industry funding. The comment recommends no compound and takes no position on the relative merits of any μ-opioid agent. It does not claim that restriction has caused or will cause an increase in overdose deaths, because, as far as we’re aware, that data does not exist. Where we say the competing hazard is unmeasured, we mean unmeasured, not absent.

The population the record does not describe

At least two filers address what happens to people who lose access. Between them the record offers two routes: opioid use disorder treatment, and pain management. Both are gated on a diagnosis that a measurable part of this cohort does not have.

Someone using 7-OH for panic, for depression, or for the aftermath of trauma is not on that basis a person with opioid use disorder, and is not a person in pain management. Under the pathway the record describes, reaching any alternative would mean accepting a label whether or not it fits. Needing something that acts on the opioid system in order to function is not currently a legible reason to need it.

That is the part of this SPI expects to still be working on after the docket closes. Our long-term interest is the endogenous opioid system as a therapeutic target for social pain, chronic suicidality, and trauma-spectrum conditions. Whether 7-OH has any place in that is an empirical question, and one that this action makes harder to answer. We did not ask OASH to answer it. We asked that the action not foreclose it, and that the people in question be counted while they are still reachable.

Read the comment

The appendix begins after the comment and carries the method behind every figure reported, along with the filed passages the comment summarizes. The deduplication and screening code, the random seed, and the list of retained comment IDs are available on request.

The text we submitted with it