After Americans consumed roughly 2 billion servings of 7-hydroxymitragynine (7-OH) since 2023, the FDA’s adverse event database logged about 100 reports. That works out to one event per 20 million servings, fewer than the agency receives about ordinary soap. Yet the FDA Commissioner Marty Makary now wants the DEA to list 7-OH alongside heroin and LSD as a Schedule I narcotic, the most restrictive tier of the Controlled Substances Act.
The case for prohibition rests on two slogans: “13 times more potent than morphine” and “gas station heroin.” Both have been repeated on Fox & Friends, in HHS press conferences and by Health Secretary Robert F. Kennedy Jr., who has warned of a coming wave of addiction modeled on Oxycontin. But both fall apart on inspection and evidence.
The Actual Science
Pharmacology is not press-release material. In 2021, the Journal of Pharmacology and Experimental Therapeutics published binding-activity curves showing 7-OH at the mu-opioid receptor looks almost identical to buprenorphine — the molecule physicians use to treat opioid addiction and reverse opioid poisoning.
Federally funded research at Memorial Sloan-Kettering, conducted under a Department of Defense grant for non-addicting analgesics, found 7-OH does not induce respiratory depression, the mechanism that actually kills opioid users. A 2025 paper in the European Journal of Drug Metabolism and Pharmacokinetics found that only 2.7 to 3% of an oral dose survives first-pass metabolism. Most of the rest is broken down in the bloodstream before it reaches the brain. This is a huge factor not found in the outrage headlines.
Then there are the deaths. Dr. Edward Boyer, a Harvard-trained medical toxicologist who reviewed nationwide poison-center data, put it bluntly: “A signal arising from overdose death from 7-hydroxymitragynine is absent.” Dr. Andrew Monte at the Rocky Mountain Poison and Drug Center reached the same conclusion. America’s Poison Centers has not reported a single overdose death from 7-OH. There are no confirmed fatalities from 7-OH consumed in isolation. There are, however, more than 700 reports in the FDA database tied to traditional kratom-leaf mitragynine, the product the agency is leaving alone.
The Headlines Are Wrong
The cases driving cable-news coverage do not survive scrutiny. Los Angeles County Medical Examiner reports never measured 7-OH concentration at autopsy, skipped internal examinations in one-third of decedents, ignored pre-existing medical history and have not been published in peer-reviewed literature.
One headline death was reclassified once a blood-alcohol level several times the legal limit turned up. Because of how the body metabolizes kratom, 7-OH appears in the system of every kratom user, alive or dead. That is a metabolic tautology, not a body count.
The Lobby War is Real
The hypocrisy is that much of the lobbying for a Schedule I listing comes from the legacy kratom industry itself, the same powder-and-capsule manufacturers who survived the DEA’s 2016 emergency scheduling attempt and now want the federal government to do to their competitors what was nearly done to them. I have called this the boomerang effect. Regulators are mistaking a market dispute for a public health crisis.
Schedule I is reserved for drugs with no accepted medical use. Johns Hopkins drug-treatment data show 7-OH ranks fourth among kratom-related products causing substance use disorder, below the very leaf the FDA wants to keep legal. Many of the more than 1 million Americans using 7-OH are managing chronic pain or anxiety, or staying off prescription opioids and street fentanyl. A blanket ban will not push them to safer choices. It will push them to the cartels, which is contrary to President Trump’s agenda.
Smart Regulation is the Answer
Smart regulation already has a template. States can set potency caps so concentrated extracts cannot be marketed to children, mandate child-resistant packaging, age verification and third-party lab testing, and require clear dosage labeling. Several have already done it. None of that requires a Schedule I designation that treats a low-respiratory-risk compound like heroin.
The “gas station heroin” line was always a slogan in search of a study. The actual studies say something different. Our regulators and administrators should heed these in the coming weeks and months as America looks to launch a new wave of Prohibition that has no justification in science or policy.
Yaël Ossowski is deputy director of the Consumer Choice Center.
References
• FDA, “FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers” (press release) — https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers
• FDA, “7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat” — https://www.fda.gov/files/drugs/published/7-hydroxymitragynin_7-oh_an_assessment_of_the_scientific_data_and_toxicological_concerns_around_an_emerging_opioid_threat.pdf
• Fox & Friends, “FDA moves to restrict dangerous kratom derivative” (Dr. Marc Siegel) — https://www.youtube.com/watch?v=dw4RBN3rSoU
• LiveNOW from FOX, “What is kratom 7-OH? Why RFK and health officials are cracking down” — https://www.livenowfox.com/news/kratom-7-ban-fda-rfk
• Obeng et al., “Pharmacological Comparison of Mitragynine and 7-Hydroxymitragynine,” Journal of Pharmacology and Experimental Therapeutics (2021) — https://pmc.ncbi.nlm.nih.gov/articles/PMC7923387/
• Chiang et al., “In Vitro and In Vivo Pharmacokinetic Characterization of 7-Hydroxymitragynine,” European Journal of Drug Metabolism and Pharmacokinetics (2025) — https://link.springer.com/article/10.1007/s13318-025-00939-2
• Dr. Edward Boyer, testimony to the Ohio House Agriculture Committee (March 2026) — https://search-prod.lis.state.oh.us/api/v2/general_assembly_136/committees/cmte_h_agriculture_1/meetings/cmte_h_agriculture_1_2026-03-18-1130_1175/testimony/15793/uploaded-doc/
• Medical Economics, “The federal government is targeting 7-OH without presenting the evidence” — https://www.medicaleconomics.com/view/the-federal-government-is-targeting-7-oh-without-presenting-the-evidence
• R Street Institute, “Lawmakers keep trying to ban 7-OH. What do we know about this novel substance?” — https://www.rstreet.org/commentary/lawmakers-keep-trying-to-ban-7-oh-what-do-we-know-about-this-novel-substance/
• HART, “7-HMG (7-OH) Overview” (Marwood Group market data) — https://hartsupporter.com/7-oh-overview/
• LA Care Health Plan, “Fatal Overdoses Associated with 7-Hydroxymitragynine (7-OH) in Los Angeles County” health alert — https://www.lacare.org/providers/news/health-advisories/fatal-overdoses-7-OH
• America’s Poison Centers — https://www.americaspoisoncenters.org/
• Ossowski, “The Short History of Kratom Policy in the United States,” Florida Politics (March 4, 2026) — https://floridapolitics.com/archives/783216-yael-ossowski-the-short-history-of-kratom-policy-in-the-united-states/
• Ossowski, “The Boomerang Effect from Legacy Kratom Manufacturers,” Florida Politics (March 5, 2026) — https://floridapolitics.com/archives/783221-yael-ossowski-the-boomerang-effect-from-legacy-kratom-manufacturers/
• Ossowski, “The Present Federal Threat of Kratom Panic Policy,” Florida Politics (March 6, 2026) — https://floridapolitics.com/archives/783227-yael-ossowski-the-present-federal-threat-of-kratom-panic-policy/