On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance under the Controlled Substances Act (CSA). Historically, it appears the DEA has generally relied on a two-step process in scheduling a substance as Schedule I: first, the DEA issues a temporary scheduling order to address imminent threats, and then proceeds to permanent scheduling through rulemaking. Indeed, over the last 25 years, public records show the DEA has generally used temporary orders, except in limited circumstances, before finalizing Schedule I classification. However, the law does not require the DEA to use the emergency/temporary scheduling pathway. Rather, the DEA could pursue permanent scheduling directly using the full formal rulemaking process, but without a temporary/emergency order first. Given the language used during the July 29 joint HHS-FDA-DEA press conference, it appears that the DEA may pursue the emergency scheduling route as opposed to or in addition to the normal scheduling route. We believe this would be a departure from the traditional approach and could present legal and procedural challenges.
Emergency scheduling allows the DEA to schedule a substance as Schedule I without going through its full 8-factor analysis of whether scheduling is warranted. Emergency scheduling is temporary and remains valid for only two to three years. Importantly, emergency scheduling orders are not subject to judicial review, though such orders could perhaps be challenged in defending against a criminal prosecution. While public comment is not mandated for emergency scheduling, the DEA has, in past instances, provided opportunities for input before finalizing such orders.
Currently, the available evidence appears limited: there are no confirmed cases of fatalities from 7-hydroxymitragynine alone, only 53 reported poison control center calls nationwide over a three-month period, and a lack of seizure data, trafficking information, or signs of significant organized criminal activity. This evidence base distinguishes the current situation from previous emergency scheduling actions, where the DEA responded to patterns of multiple deaths, substantial law enforcement submissions, and notable increases in emergency department visits.
Relying primarily on preclinical animal research and laboratory receptor binding data marks a substantial shift from the established legal approach, which prioritizes real-world evidence of urgent public health risks. While laboratory findings show 7-OH’s high μ-opioid receptor activity, the potential pharmacological risk is not sufficient to establish an imminent hazard to public safety. For comparison, substances such as brorphine, fentanyl analogues, and isotonitazenes prompted action only after clear surges in deaths and enforcement activity—conditions not currently seen with 7-OH. In other words, the substances in question posed a clear and "imminent hazard" to public safety, indicating a rapidly escalating threat that is absent with 7-OH. Accordingly, current evidence may not meet the threshold typically used to justify emergency scheduling. Rather, if there is a concern, a more measured approach is required where the available scientific, medical, and public input is fully vetted before rendering a decision to schedule 7-OH permanently. Indeed, implementing emergency scheduling for 7-OH under these circumstances could set a precedent for applying emergency scheduling in cases where evidence is primarily preclinical, rather than supported by established patterns of harm, raising due process considerations and potentially departing from the statutory framework Congress designed. A more measured path through the ordinary scheduling process would fully utilize existing FDA and state tools while following standard CSA scheduling procedures, ensuring scientific rigor and meaningful public involvement—reserving emergency mechanisms for situations where a real and present public health crisis is clearly evident.
Given the information provided so far, it appears that the FDA, as in 2016, has potentially not provided the DEA with a sufficient basis to schedule 7-OH as Schedule 1, let alone through a temporary order. Indeed, many questions remain unanswered, so slowing down this march is necessary to ensure the right decision is made.
We are closely tracking ongoing developments from the FDA and DEA regarding 7-OH.
