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Kratom is plant material from Mitragyna speciosa, a tree native to Southeast Asia. Its bioactive alkaloids include mitragynine and 7-hydroxymitragynine. FDA has not approved kratom or its known alkaloids as prescription or over-the-counter medicines and states that kratom is not lawfully marketed in the United States as a dietary supplement or conventional food ingredient.
read more about kratom ...Kratom alkaloids have activity at opioid receptors and can produce opioid-like effects. Reported effects vary with the preparation, amount, and other substances taken at the same time. Mitragynine is the predominant kratom alkaloid, while 7-hydroxymitragynine has stronger opioid-like activity.
People have reported using kratom for pain, mood symptoms, energy, or attempts to manage opioid withdrawal. These uses are not FDA-approved treatments. FDA warns against using kratom for medical treatment and states that no legally marketed prescription or over-the-counter kratom drug products exist in the United States.
There is no FDA-approved therapeutic dose or standardized U.S. treatment regimen for kratom. Products differ in plant material, extraction method, alkaloid concentration, and added ingredients, so amounts from one product cannot be assumed to apply to another.
FDA warns of serious adverse events including liver toxicity, seizures, and substance use disorder. Regular use can lead to tolerance, physical dependence, and withdrawal symptoms. Some products have also been contaminated with Salmonella or concerning levels of heavy metals. Deaths associated with kratom have been reported, usually with other substances also present.
No. FDA has not approved a prescription or over-the-counter drug containing kratom or its known alkaloids.
No. FDA states that kratom is not lawfully marketed as a dietary supplement.
No. There is no FDA-approved therapeutic dose or standardized U.S. regimen for kratom.
Yes. FDA has documented substance use disorder involving kratom, including tolerance, physical dependence, and withdrawal symptoms.
FDA and Kratom. U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/fda-and-kratom. Date Accessed October 8, 2026.
Kratom. Drug Enforcement Administration. https://www.dea.gov/factsheets/kratom. Date Accessed October 8, 2026.
Kratom. LiverTox. https://www.ncbi.nlm.nih.gov/books/NBK548231/. Date Accessed October 8, 2026.
Kratom. National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/health/kratom. Date Accessed October 8, 2026.
Kratom. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Kratom. Date Accessed October 8, 2026.