The U.S. Department of Health and Human Services and Department of Justice endorsed emergency Drug Enforcement Administration measures to classify potent synthetic kratom extracts, specifically 7-hydroxymitragynine (7-OH), as Schedule I controlled substances. The action follows intensive lobbying by natural kratom groups like the American Kratom Association to protect raw plant sales while banning high-potency synthetic competitors, as well as mounting public concern following the September 2026 deaths of two University of Mississippi students.
HHS proposed scheduling thresholds
- ▪HHS Assistant Secretary Brian Christine recommended classifying 7-hydroxymitragynine and mitragynine pseudoindoxyl as Schedule I if either compound exceeds 1 milligram per gram in solids or 1 milligram per milliliter in liquids.
- ▪The Department of Health and Human Services recommended Schedule I classification if 7-hydroxymitragynine or mitragynine pseudoindoxyl makes up more than 1 percent of a product's mitragynine content.
- ▪Health Secretary Robert F. Kennedy Jr. stated the recommended threshold targets concentrated synthetic extracts while avoiding sweeping natural botanical kratom into Schedule I.
Federal actions to schedule synthetic kratom
- ▪The U.S. Drug Enforcement Administration previously placed three less common synthetic kratom-related compounds, including mitragynine pseudoindoxyl and MGM-15, into Schedule I without a threshold caveat.
- ▪The U.S. Drug Enforcement Administration in July 2026 proposed temporarily designating 7-hydroxymitragynine (7-OH) above a certain potency threshold as a Schedule I controlled substance.
- ▪An extended public comment period for the Drug Enforcement Administration's proposed 7-hydroxymitragynine scheduling rule closed on September 10, 2026 with nearly 36,000 submissions.
- ▪The U.S. Department of Justice on October 9, 2026 issued an emergency order placing 7-hydroxymitragynine (7-OH) and related synthetic kratom compounds on the Schedule I list of controlled substances.
Synthetic kratom composition and potency
- ▪Natural kratom from Southeast Asian tree leaves contains trace amounts of 7-hydroxymitragynine, whereas synthetic products concentrate high amounts of the compound into potent pills, chewable tablets, and liquids.
- ▪The Drug Enforcement Administration warned in the Federal Register that synthetic kratom products often contain additional potent opioid alkaloids, such as mitragynine pseudoindoxyl, alongside 7-hydroxymitragynine.
Health risks and warnings
- ▪The Food and Drug Administration stated that 7-hydroxymitragynine has no safe or effective use and warned it could become an option for individuals with opioid addictions.
- ▪U.S. poison control centers recorded 165 inquiries regarding adverse exposure to 7-hydroxymitragynine between January 1, 2025 and July 31, 2026, with a majority requiring medical treatment.
Retail marketing of synthetic kratom
- ▪The Drug Enforcement Administration warned that synthetic 7-hydroxymitragynine products are often labeled as botanical extracts, which can mislead consumers regarding the drug's potency.
- ▪Synthetic 7-hydroxymitragynine products are sold in gas stations, convenience stores, and vape shops under commercial brand names including Kama, Happie Tabs, Fruity Perks, and Hydroxie.
Investigation into Mississippi student deaths
- ▪Two University of Mississippi students died on September 21, 2026, with packages of synthetic kratom products containing 7-hydroxymitragynine found at the scene.
- ▪Authorities have not confirmed that synthetic kratom or 7-hydroxymitragynine contributed to the deaths of the two University of Mississippi students.
Kratom industry lobbying and campaign spending
- ▪The American Kratom Association has spent over $1 million on federal lobbyists over the past decade, including $443,000 in 2026, to block blanket bans on kratom and target synthetic alternatives.
- ▪Botanic Tonics founder Jerry W. Ross donated $1.1 million to PACs affiliated with Health Secretary Robert F. Kennedy Jr. and $443,000 to the Republican National Committee to secure access with Vice President JD Vance.
- ▪Ross allies formed a group called Stop Gas Station Heroin and paid lobbying firm Checkmate Government Relations at least $750,000 to promote natural kratom as a safer option over synthetic alternatives.
American Kratom Association advocacy
- ▪American Kratom Association senior fellow Mac Haddow stated that lobbying expenditures aim to secure government access and ensure fair decision-making alongside competing synthetic kratom interests.
- ▪The American Kratom Association estimates that 24 million U.S. consumers use natural kratom products to boost energy, manage chronic pain, combat anxiety and depression, and address opioid addiction.
New York synthetic kratom legislation
- ▪New York State Assemblyman Phil Steck sponsored legislation passed in June 2026 to ban synthetic kratom statewide, while acknowledging industry lobbying influenced state leaders to avoid banning natural kratom products.
- ▪The New York state legislation passed in June 2026 to ban synthetic kratom statewide remains awaiting Governor Kathy Hochul's signature to become law.
State regulation and bans on kratom
- ▪Utah regulation requires kratom sales to occur only at licensed specialty tobacco stores selling registered and third-party laboratory tested products, funded through state product taxes.
- ▪Massachusetts issued a temporary statewide ban on all kratom products in late August 2026, while addiction clinicians expressed concern that blanket bans risk causing severe withdrawal in dependent users.
- ▪Around two dozen U.S. states have passed versions of the Kratom Consumer Protection Act establishing age limits and regulatory standards, though critics consider these state protections too weak.
Debatable claims
- ▪Distinguishing natural botanical kratom from synthetic 7-hydroxymitragynine extracts is public-health justified
- ▪Placing high-potency 7-hydroxymitragynine on Schedule I does more harm than good
- ▪State Kratom Consumer Protection Acts provide insufficient protection against dangerous kratom products
- ▪Schedule I designation for synthetic kratom extracts unacceptably hinders medical research into their risks and benefits
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