Boards of pharmacy, pharmacy associations, schools of pharmacy and individual pharmacists: The U.S. Department of Health and Human Services is accepting comments on the proposed federal scheduling threshold for 7-hydroxymitragynine (7-OH). Your clinical and medication-safety expertise should be in the administrative record.
DEA's scheduling notice admits no clinical trials have established a safe dose of concentrated 7-OH. A non-zero threshold therefore leaves regulators guessing how much opioid risk is acceptable.
This page is designed for pharmacy professionals and organizations whose work intersects with medication safety, opioid regulation, and public health. HHS will benefit from hearing directly from:
Your professional judgment on dose-response, safety margins, and evidence-based practice provides critical context that policymakers may not otherwise consider.
The U.S. Department of Health and Human Services (HHS) has opened a public comment period on the proposed federal scheduling threshold for 7-hydroxymitragynine (7-OH). The threshold selected will directly affect how these products are regulated, labeled, and made available to the public.
Pharmacists are the medication-safety experts. You understand that without a demonstrated safe dose, any non-zero threshold is pharmacologically arbitrary and clinically unsafe. No controlled clinical trial has established a safe dosage or standardized dosing regimen for 7-OH products. Approving any non-zero threshold absent evidence of safety undermines the foundational principles of medication safety.
DEA's notice states: "Controlled clinical trials have not established a safe dosage or standardized dosing regimen for 7-hydroxymitragynine products." — DEA, 91 Fed. Reg. 35647 (2026)
Without a demonstrated margin of safety, setting a numeric threshold is arbitrary. Pharmacists routinely apply the precautionary principle when evidence of safety is absent.
Percentage-based thresholds create clinical and regulatory problems that are often overlooked. Here are the key challenges pharmacy professionals face:
A percentage threshold does not control the actual dose a patient receives. At 0.050%, a 5-gram product contains 2.5 mg of 7-OH; a 20-gram bulk package could contain 10 mg. Without a per-unit-dose limit, a percentage threshold provides no meaningful patient protection.
Setting any non-zero threshold may be interpreted as HHS having determined that amount is safe. But DEA has explicitly stated that no clinical trials have established a safe dosage. This creates a dangerous regulatory implication: the threshold could be mistaken for a de facto safe dose.
Manufacturers may seek to formulate products to comply with any legal threshold, creating ongoing compliance and enforcement considerations. A percentage threshold encourages formulation to the limit rather than ensuring patient safety.
Unlike other scheduled substances, 7-OH has no FDA-approved medical use. There is no therapeutic benefit to justify any non-zero exposure. The precautionary principle demands zero tolerance where safety is unproven and benefit is absent.
Your organization's comment should address the clinical and regulatory realities. These are the questions HHS needs to consider, and your professional experience can help answer them.
DEA's notice explicitly states that no controlled clinical trials have established a safe dosage. Without dose-response data, a non-zero threshold lacks a scientific basis. HHS should be asked to identify the specific safety data that would justify any non-zero amount.
A 0.050% threshold in a 5-gram product allows 2.5 mg of 7-OH. In a 20-gram product, the same threshold allows 10 mg. Without a per-dose limit, a percentage threshold does not control total exposure. HHS should address whether the threshold is per package, per serving, or per unit.
Setting a non-zero threshold may be interpreted as a determination that amounts below that threshold are safe. Since no safe dose has been established, this implication is scientifically unsupported and clinically misleading.
Pharmacokinetic and pharmacodynamic data for 7-OH are limited. Chronic use, accumulation in tissues, and interactions with other drugs have not been studied. A threshold based on a single acute dose cannot address these risks.
Given the absence of safety data, the lack of therapeutic benefit, and the potent mu-opioid agonist activity, a zero threshold is the only standard consistent with the precautionary principle and professional standards of medication safety.
The impact of a percentage threshold extends beyond clinical pharmacology. Here is how each area is affected:
Federal agencies and professional observers have already raised concerns that directly support a zero-threshold approach.
Federal agencies take public comments seriously. Comments from professional organizations, especially pharmacy associations and boards, carry significant weight because they represent expert, clinical perspectives on implementation.
Your organization's comment can help shape a federal scheduling policy that is scientifically defensible and consistent with professional standards of medication safety.
All of the evidence on this site documents harms associated with whole-leaf kratom and mitragynine — not extracts, not 7-OH isolates. Click any card below.
Use the templates below to submit your comment. Customize the bracketed fields with your specific credentials and experience.
Before your organization or you individually submit a comment to the HHS docket, review this checklist to ensure your submission is as effective as possible.
HHS needs to hear from pharmacy professionals. Submit a comment explaining that no non-zero dose of 7-OH has been established as safe and that a percentage threshold is clinically indefensible.
Submit Your Comment Now