I commented on HHS-OASH-2026-0232-0001, the Request for Information regarding the proposed 7-hydroxymitragynine (7-OH) scheduling threshold.

Comment Tracking Number: mry-8nrd-tg5g

I am submitting this comment in response to the Request for Information regarding the proposed 7-hydroxymitragynine (7-OH) scheduling threshold (Docket HHS-OASH-2026-0232).

First, on the imminent-hazard finding itself: temporary scheduling under 21 U.S.C. 811(h)(1) is meant to address genuinely urgent threats that cannot wait for ordinary scheduling procedure. I would ask OASH to specify the comparative risk data—overdose rate, dependence liability, and ER visits per capita of users—that establishes 7-OH at the proposed threshold as more hazardous than legal, widely available substances such as alcohol, which carries well-documented acute toxicity and tens of thousands of attributable deaths annually without triggering emergency scheduling. Absent that comparative showing, it is difficult to evaluate whether the proposed threshold reflects an evidentiary emergency finding or a policy preference.

Second, on the threshold and measurement question (Topic 2): the proposed threshold treats 7-OH concentration itself as the hazard, but concentration alone does not determine risk—labeling and dosing transparency do. High-proof alcohol is not restricted as a controlled substance because its strength is disclosed and dosing is within the user’s control; the same logic applies to 7-OH. A properly labeled product with clearly disclosed 7-OH content per serving allows a user to dose predictably regardless of concentration, while an unlabeled product at any concentration, including one below the proposed threshold, carries meaningful risk precisely because the user cannot know what they are consuming. I would urge OASH to consider a measurement and disclosure standard centered on accurate labeling and serving-size transparency, rather than a flat concentration cutoff that regulates potency without addressing the actual variable that drives harm.

Third, I would ask that the imminent-hazard analysis account for the public-safety costs of the scheduling action itself, not only the substance’s pharmacology. Placing a substance in Schedule I activates search, seizure, and arrest authority, and the resulting harms—including incarceration exposure prior to any conviction, loss of employment, and loss of housing—fall on individuals regardless of whether the underlying conduct caused any documented harm. A public-safety finding that weighs only the risks of the substance, without netting the risks introduced by enforcement, is measuring an incomplete ledger. I would ask OASH to consider and disclose this offsetting cost as part of its threshold recommendation.

I appreciate the opportunity to comment and urge OASH to ground its threshold recommendation in a complete accounting of both the substance’s documented risks and the risks introduced by the scheduling action itself.