Official FDA adverse event data, import restrictions, warning letters, and enforcement documents. A decade of federal concern over kratom safety.
Source: FAERS line listing, mitragynine/kratom only. Spontaneous reporting system – signals of serious harm.
Dietary supplement‑associated reports. Undermines the "just a botanical" defense.
| Reaction | Count | % |
|---|---|---|
| Toxicity To Various Agents | 326 | 20.34% |
| Drug Dependence | 220 | 13.72% |
| Drug Abuse | 205 | 12.79% |
| Drug Interaction | 170 | 10.61% |
| Death | 145 | 9.05% |
| Withdrawal Syndrome | 143 | 8.92% |
| Serotonin Syndrome | 101 | 6.30% |
| Seizure | 92 | 5.74% |
| Vomiting | 90 | 5.61% |
| Overdose | 73 | 4.55% |
| Unresponsive To Stimuli | 56 | 3.49% |
| Cardiac Arrest | 55 | 3.43% |
| Completed Suicide | 57 | 3.56% |
| Electrocardiogram QT Prolonged | 45 | 2.81% |
Data represent combined mitragynine/kratom cases. Death outcome in 744 of 1,603 total cases (46%).
*Partial year. Sharp increase since 2017 reflects growing adverse event reporting and product proliferation.
FDA orders detention without physical examination of all dietary supplements containing kratom. Cites serious health risks: respiratory depression, seizures, liver injury. Effective since 2014, reaffirmed 2025.
View Alert →FDA rejected notification for dried kratom leaf powder as a dietary ingredient. Agency unable to establish identity or safety. Concluded that kratom is not eligible for lawful marketing as a supplement.
Read Denial →Rejection for Mitragyna speciosa leaf extract standardized to 75% mitragynine. Inadequate safety and identity evidence. Reinforces that kratom extracts cannot be legally sold as dietary supplements.
Read Denial →Unapproved new drugs, misbranding. Claims to treat opioid addiction, pain, diabetes, and more. FDA: "public health emergency – opioid crisis."
View Letter →Claims to ease opioid withdrawal, depression, lower blood pressure. Unapproved new drugs; FTC joint action. "Potentially significant threat to public health."
View Letter →Unapproved new drugs; 7‑OH added to food is unsafe food additive. FDA notes 7‑OH is more potent than mitragynine and linked to addiction, withdrawal, death.
View Letter →Nearly 90,000 bottles of kratom supplements (RelaKzpro) seized, worth >$400,000. FDA: kratom is a new dietary ingredient with inadequate safety information.
Read Release →FDA's first mandatory recall order after Salmonella contamination. Company refused voluntary recall. Demonstrates industry cannot self‑police.
View Recall →FDA warns consumers after death linked to product. Withdrawal, addiction, aggressive behavior reported. Contains 7‑OH. "Not lawfully marketed."
Read Alert →Kratom is not lawfully marketed as a dietary supplement or food additive; no FDA‑approved uses. Risks include liver toxicity, seizures, SUD, neonatal abstinence, and death.
Read Statement →30 products tested – significant lead and nickel exceeding safe daily oral intake. Long‑term users risk nervous system damage, kidney injury, cancer.
View Data →199 cases, 41 states, 54 hospitalizations. 55% of FDA‑tested samples positive for Salmonella. First mandatory recall order.
Read Report →"Kratom is not a safe, benign plant. Compounds are opioids with potential for addiction and abuse." – Commissioner Gottlieb.
Read Statement →Detention without physical examination for kratom products. Importers required to prove product safety – repeatedly failed.
Review Alert →US Marshals seized adulterated dietary supplements containing kratom at FDA's request. Continued federal enforcement burden.
Read Release →FDA warned company after finding Klebsiella pneumoniae, Enterobacter, E. coli. Company refused to recall. Illustrates complete lack of quality control.
View Warning →⸻ Regulatory Sequence
If the federal government has flagged these risks for over a decade, why is kratom still sold unchecked in gas stations and online?
