HHS urges DEA to schedule 7‑hydroxymitragynine, releases report and guidance

Deputy Secretary Jim O'Neil of the U.S. Department of Health and Human Services announced Thursday that HHS is initiating a process to recommend that the Drug Enforcement Administration schedule 7‑hydroxymitragynine (7‑OH) as a controlled substance when present above a concentration threshold.

The recommendation, O'Neil said at a Washington news conference, follows a rise in overdoses and emergency visits linked to products marketed as kratom extracts but containing concentrated, synthetic 7‑OH. "This is a recipe for public health disaster," O'Neil said, adding that many products are sold with "no quality control, no dosage control, and no warnings." He said HHS will distinguish trace amounts that naturally occur in the kratom leaf from concentrated synthetic forms in its scheduling recommendation.

The nut of the action is that HHS asked the DEA to begin the federal scheduling process and released an FDA report intended to inform clinicians, parents and the public. "We are initiating action to recommend scheduling of 7‑OH as a controlled substance by the DEA," said Dr. Marty McCary, identified at the event as Commissioner of Food and Drugs. McCary said the compound "binds to the mu receptor, which means scientifically, by definition, it is an opioid," and cited a paper in the Journal of Medicinal Chemistry that, he said, found 7‑OH to be many times more potent than morphine. He said the FDA's immediate focus is on the concentrated synthetic byproduct, not the kratom leaf itself.

Tom Provosnick, assistant administrator who leads the Diversion Control Program at the Drug Enforcement Administration, said the DEA had received HHS's formal recommendation and would "review it expeditiously, thoroughly, and in accordance with the law." He reiterated that DEA scheduling follows the Controlled Substances Act and that the rulemaking process will include a public comment period.

Patient testimony and congressional remarks accompanied the agency announcements. Melody Wolf of Kalamazoo, Michigan, who described herself as a 20‑year chronic pain patient, said powdered kratom had improved her quality of life but that concentrated 7‑OH products are dangerous and "need to be off of the shelves." U.S. Senator Markwayne Mullin of Oklahoma praised the department's action and described what he called industry tactics that market addictive products in bright, candy‑like packaging and place them near schools and military bases.

HHS and FDA described several immediate steps: release of an FDA report on 7‑OH with plain‑language and technical sections; a "dear doctor" letter to clinicians nationwide warning them about the compound; and letters sent to distributors and retailers flagging safety concerns and urging removal or other steps. Agency officials said they have notified distributors and received some positive responses but emphasized that final removal from retail shelves would depend on distributors' decisions and the DEA's scheduling rulemaking.

Agency officials also acknowledged data gaps. McCary and HHS officials said many clinicians do not recognize 7‑OH and that toxicology testing and overdose statistics are currently limited; NIH has been asked to expand research. When asked whether HHS considered kratom safe, officials said their current action focuses on synthetic concentrated 7‑OH and that the recommendation will draw a distinction between trace natural amounts in the leaf and concentrated synthetic material.

The DEA will now begin its administrative scheduling review under the Controlled Substances Act, including the agencies' eight‑factor analysis of abuse potential, medical use and public health risk. Provosnick said the DEA does not "play politics with science" and that the public will have an opportunity to comment before any final scheduling determination is made.

For now, the HHS recommendation is a formal referral to the DEA rather than a binding legal change. Agency officials urged clinicians, school boards and parents to discuss the risk and said distributors should heed the safety letters while the rulemaking proceeds.

—Reporting from the U.S. Department of Health and Human Services press conference. The DEA will accept public comment during its rulemaking process before issuing any final scheduling decision.