Kratom (Mitragyna speciosa) is a tropical tree native to Southeast Asia whose leaves are sold in the US online and in stores. People use it on their own for pain, anxiety, depression and opioid withdrawal, but FDA has not approved it for any medical use and warns consumers not to use it.
Also known as: Mitragyna speciosa, mitragynine, 7-hydroxymitragynine, 7-OH.
There is no FDA-approved kratom drug and no reference amount. FDA says kratom contains more than 50 alkaloids, mainly mitragynine; 7-hydroxymitragynine (7-OH) is less than 2% of the alkaloids in the natural leaf but is much stronger at the opioid receptor than mitragynine or morphine.
FDA's position: there are no prescription or over-the-counter drugs with kratom or its alkaloids legally on the US market. FDA has concluded that kratom is a new dietary ingredient without enough information to show it is reasonably safe, so supplements that contain it are adulterated, and that kratom is an unsafe food additive. In FDA's words, kratom is not lawfully marketed in the US as a drug, a dietary supplement or a food additive. The Drug Enforcement Administration lists it as a "drug of concern" but it is not a federally controlled substance (NCCIH); states may have their own rules.
FDA warnings: FDA warns consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder. Kratom's main alkaloids act on the same opioid receptors as drugs like codeine and may cause sedation, nausea, constipation, dependence and withdrawal, and slowed breathing that may lead to death. Deaths have been linked to kratom in rare cases, usually with other drugs. FDA has seen newborns with withdrawal after long exposure before birth, and kratom products contaminated with Salmonella or heavy metals. FDA has also acted against concentrated 7-OH products, including warning letters and seizures.
NCCIH adds that very little research in people has looked at kratom, that it has not been shown safe or effective for opioid withdrawal or any other use, and that regular users may have withdrawal when they stop.
There is no FDA label for kratom. FDA funded a single-dose study of kratom in people and says results will be published after peer review, so we do not list a half-life.
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