HHS moves to schedule 7-hydroxymitragynine (7-OH) despite no confirmed deaths linked to the compound
Critics say the decision ignores scientific data and could harm consumers relying on safe, tested alternatives
Advocates warn the move benefits big kratom trade groups at the expense of public health and transparency
A coalition of plant-based medicine advocates is pushing back after the U.S. Department of Health and Human Services (HHS) announced plans to schedule 7-hydroxymitragynine (7-OH), a compound derived from kratom. The move, which could eventually lead to a Schedule I classification, has drawn fierce criticism for what advocates describe as a data-free, politically motivated decision.
The Holistic Alternative Recovery Trust (HART), a nonprofit that promotes access to regulated plant-based therapies, issued a sharp rebuke shortly after the announcement. Jeff Smith, HART’s National Policy Director, questioned the rationale and transparency of the federal move.
“No evidence was presented at today’s press conference. Not a single study. Not one data point specific to 7-OH,” said Smith. “If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented. It was not.”
Regulatory focus called misplaced
Advocates argue that the decision to target 7-OH, a metabolite of mitragynine (the primary compound in kratom), is misguided, especially given that HHS simultaneously clarified that natural kratom leaf products are not the focus of the action.
Data from the FDA’s own adverse event reporting system shows:
Zero confirmed deaths linked to 7-OH alone
Only three serious adverse events, two of which predated the current market’s tested and labeled 7-OH products
Conversely, 201 deaths have been linked to unregulated kratom leaf products, with 48 serious adverse events reported in Q1 2025 alone
“Why target 7-OH instead of kratom leaf, which has a far worse safety profile?” asked Smith. “This action defies logic unless other interests are driving policy.”
Lower toxicity, dependence risk, advocates say
HART points to preclinical research suggesting that 7-OH is less toxic than mitragynine, does not cause respiratory depression at therapeutic doses, and has a lower dependence potential than opioids.
While the FDA has framed its effort as a response to rising concerns about addiction, HART and other experts argue that responsible, tested, and regulated use of 7-OH offers a viable harm-reduction tool — one that could help reduce reliance on more dangerous opioids.
In a pointed statement, HART accused large kratom industry groups of scapegoating 7-OH to protect their market share, including funding staged protests and promoting consumer testimony based on hearsay rather than personal experience.
“The FDA needs to hear from researchers, toxicologists, and addiction science experts — and from the American people,” said Smith. “Cutting off access helps no one, but it will hurt many.”
What's next?
If 7-OH is placed under Schedule I of the Controlled Substances Act, it would be deemed to have no accepted medical use, high abuse potential, and no safety margin, effectively banning its sale and use. HART and other advocacy groups are calling on consumers and scientists to submit public comments, contact their lawmakers, and demand a science-based regulatory approach.
For background on kratom and the FDA's recent crackdown, see ConsumerAffairs’ coverage: FDA Plans Action Against Kratom, a Potent Opioid Alternative