Is Kratom Safe? What the Agencies Say, Read by a Company That Sells It

Is kratom safe? None of the agencies quoted on this page says it is. The FDA warns consumers not to use kratom "because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD)." Several of the same agencies also describe the serious harms as rare, and say that most deaths linked to kratom involved other drugs as well. Both halves are true at once. A page that gives you only one of them is leaving out half the picture.

We sell kratom, which is a reason to read this carefully rather than a reason to skip it. Where nobody knows, the page says so.

Is kratom safe? Six sources, in their own words

The FDA's position is the strictest. The FDA's kratom page also says "There are no prescription or over-the-counter drug products containing kratom or its known alkaloids that are legally on the market in the U.S." That is a warning and a finding about lawful marketing, not a controlled-substance listing. The DEA's kratom fact sheet confirms that kratom is not a controlled substance, while noting that "there may be some state regulations or prohibitions against the possession and use of kratom" and that "DEA has listed kratom as a Drug and Chemical of Concern."

On deaths, the FDA is measured. In the rare deaths associated with kratom, it says, "kratom was usually used in combination with other drugs, and the contribution of kratom in the deaths is unclear." That is the thread through much of what follows: the deaths in the record cluster where kratom meets other drugs, though not only there.

Liver injury: rare, and rated a likely cause

NIH's LiverTox entry on kratom, last updated in April 2020, calls kratom liver injury rare and gives kratom a "Likelihood Score: B (likely cause of clinically apparent liver injury)." Keep both halves. The entry also says kratom "is often used with other agents, including drugs of abuse, and its causative relationship to liver injury in published cases is not always clear."

Onset is "usually within 1 to 8 weeks of starting regular use of kratom powder or tablets, with symptoms of fatigue, nausea, pruritus and dark urine followed by jaundice." It can be severe. LiverTox counts "At least two dozen cases" with jaundice in the medical literature and a similar number reported to the FDA, and says patients "usually recover once it is discontinued." NIDA says the serious liver cases it describes "appear to occur unpredictably in a small minority of people who use kratom." Unpredictably is the word to keep.

Seizures, heart and breathing

NIDA's kratom page describes case reports of "very rare but serious adverse effects associated with kratom exposure", including "mental and neurological symptoms (confusion, tremors and seizures), heart and lung problems (high blood pressure and slow breathing), gastrointestinal problems (nausea and vomiting) and liver problems." A case report describes individual patients. It shows what can happen, not how often.

The DEA lists "hepatotoxicity, seizure, and hallucinations" among the effects users have experienced. Poison Control says that "With higher doses and overdoses of kratom, more severe effects have been reported, including seizures, coma, high blood pressure, abnormal heartbeat, and liver problems." Some people report milder side effects; NIDA lists "nausea, constipation, dizziness and drowsiness."

Breathing is where the agencies are most careful. NIDA: "In general, neither kratom leaves nor mitragynine appear to lead to respiratory depression (trouble breathing) that is characteristic of a life-threatening opioid overdose. However, in laboratory models, 7-OH can cause respiratory depression that is reversed by naloxone." The FDA lists "respiratory depression that may lead to death" among the effects that mitragynine and a minor kratom alkaloid may produce. Neither agency says kratom cannot affect breathing.

Dependence, as each agency words it

The agencies choose different words here, and the differences are the point. The DEA: "Kratom consumption can lead to addiction." The FDA: "Cases of kratom-related SUD have also been observed", in people who met criteria such as using more or for longer than they intended, craving it, keeping going despite the consequences, needing more for the same effect, and having withdrawal symptoms when they stopped.

NIDA is the most careful: "Studies suggest people may experience mild to moderate withdrawal symptoms when they stop regular kratom use, but more research is needed to understand to what extent people develop substance use disorder symptoms related to kratom." It adds that "There are currently no approved medical therapies for these conditions", meaning none approved specifically for kratom withdrawal or kratom use disorder. Involve a clinician all the same. Nobody on this list says dependence is impossible, and how often it happens is still being measured. If stopping has become hard, our state-by-state list of help lines is a place to start.

Pregnancy and newborns

Neither agency that speaks to this says kratom is safe in pregnancy. The FDA "is also aware of cases involving neonatal abstinence syndrome, in which newborns experienced withdrawal signs such as jitteriness, irritability, and muscle stiffness following prolonged exposure to kratom prior to birth." NIDA: "Effects on pregnancy are not well understood."

NIDA cites a 2021 report that identified "at least five cases" of the syndrome in infants born to women who regularly used kratom but not opioids; the infants "all responded well to standard treatments". Five reported cases is a count, not a rate, and none of these agencies puts a figure on the risk. If you are pregnant or nursing, this is a conversation for your clinician.

Contamination: what has actually been found

Some of the documented harm had nothing to do with the plant's chemistry. The FDA says it "has warned the public when certain kratom products were contaminated with Salmonella and/or concerning levels of heavy metals."

Salmonella, 2018. In February 2018 the FDA relayed the CDC's early outbreak figures: 28 people infected in 20 states, 11 of them hospitalized. Those were not final totals. In April 2018 the FDA ordered a mandatory recall of one company's powdered kratom products after several were found to contain salmonella, although the strains in that company's products were not, at the time, linked to the outbreak.

Heavy metals, 2019. The FDA tested 30 kratom products and found "significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake," concluding that "the typical long-term kratom user could potentially develop heavy metal poisoning". That page is current as of April 2019, and the FDA does not describe the 30 as a random sample of the market.

A fair caveat from NIDA: "researchers and regulators have found similar instances of contamination in many other products marketed as herbal supplements." Contamination is not unique to kratom. It is, though, one of the few risks on this page that a buyer can partly check.

Concentrated and synthetic products are a separate question

Much of the federal action since 2025 has not been aimed at kratom leaf at all. In July 2025 the FDA announced warning letters to seven companies over "concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous." Two weeks later it recommended that the DEA schedule certain of those products, saying it "is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products." It warned that such products "are sometimes disguised or marketed as kratom."

Then came synthetic substances. A DEA temporary scheduling order published on 26 August 2026 placed mitragynine pseudoindoxyl, MGM-15 and MGM-16 in Schedule I until 26 August 2028. The order says these three "are produced through synthetic modifications", unlike the alkaloids that occur naturally in the plant, and cites at least 56 overdose cases in which mitragynine pseudoindoxyl was identified between February 2025 and May 2026, 48 of them fatal. A separate proposal covering the minor alkaloid itself, above a proposed threshold, was still pending on 6 October 2026, with no temporary order in the Federal Register. The practical point is simple: a leaf product and a concentrated alkaloid product are different things, and you should know which one you are holding.

What the 2026 CDC poison center report counts

The newest federal numbers on kratom exposures come from a CDC report published on 26 March 2026, built on the National Poison Data System, which collects data from 53 U.S. poison centers, and covering people aged 12 and older. Its headline: "During 2015-2025, U.S. poison centers documented 14,449 kratom exposures; the 3,434 exposures reported in 2025 represent an increase of approximately 1,200% compared with the 258 reported in 2015".

Know what that counts. An exposure report is a call about "actual or suspected contact with a substance that prompted a consultation with a poison center, regardless of toxicity or clinical manifestations." Reporting is voluntary and repeat callers are included. More reports means more calls. It is not a rate of use, or of harm, among people who use kratom.

Among the CDC's own stated limits is this one: the data "do not include information about whether the kratom use involved traditional leaf products or semisynthetic or concentrated formulations". The report says the 2025 increase "coincides with the emergence of high-potency, semisynthetic formulations". Coincides is the CDC's word. It did not say which products drove the rise, and neither should anyone quoting it.

Mixing kratom with alcohol and other drugs

The clearest pattern in the CDC data is mixing. The most common substances in multiple-substance reports were "ethanol, 22%; opioids, 16%; benzodiazepines, 15%; cannabis and cannabinoids, 12%; and stimulants, 11%", with antidepressants at 14%. Among the 184 deaths that involved more than one substance, opioids were reported in 62%, benzodiazepines and stimulants in 20% each, and ethanol in 19%.

The CDC's explanation: "Kratom use with alcohol, opioids, benzodiazepines, stimulants, and antidepressants might increase risk through additive pharmacodynamic effects on central nervous system pathways and through pharmacokinetic interactions that increase systemic exposure to substances used with kratom." Put plainly, the effects may add up, and kratom may raise how much of the other substance reaches your system. NIDA notes case reports in which polysubstance use involving kratom was tied to "severe adverse effects, such as death and liver problems."

So the most cautious reading of the evidence on mixing is also the simplest. Do not combine kratom with alcohol, opioids or benzodiazepines. If you take any prescription medicine, antidepressants included, tell the prescriber about kratom.

What is still unknown about kratom safety

A lot, and the agencies say so. The FDA "recognizes that there is much that is not known scientifically about kratom", noting "few published reports from well-designed scientific studies where kratom was administered to humans." As of that page, a well-designed human abuse potential study had not been conducted; the FDA awarded a grant for one in September 2024.

NIDA: "Long-term health and safety effects are not well understood." The impact of kratom impairment on driving or operating heavy machinery "has not been extensively studied," and "kratom products vary, so effects are difficult to predict." LiverTox says the mechanism behind the liver injuries is unknown. And, in NIDA's words, "Researchers have not proven kratom to be safe or effective for any medical purpose".

What the agencies tell you to do

No agency here publishes a way to use kratom safely; the FDA's advice is not to use it. What they publish are steps for when something goes wrong.

An emergency. If someone is unresponsive, not breathing normally or having a seizure, call 911. Poison Control: "If the person is not breathing, administer bystander naloxone." And "If the person has a seizure, you can place them in a safe position on their side until help arrives."

Worrying, but not an emergency. Call the Poison Help Line, 1-800-222-1222, which Poison Control describes as "free, confidential, and available 24 hours a day". Have every product to hand, prescription, over the counter and herbal, so the poison center can check the interactions that are known.

Liver warning signs. If you notice "fatigue, nausea, pruritus and dark urine followed by jaundice", in LiverTox's words (itching, then yellow skin or eyes), stop using kratom and see a clinician.

Any clinician visit. Mention kratom, its form, and everything else you take. The FDA's request is narrower: in its 2018 salmonella update, it asked people diagnosed with salmonellosis to "tell your health care provider about all products you may be using, including products reported to contain kratom."

Afterwards. The FDA asks consumers to report adverse reactions to its MedWatch program or the Safety Reporting Portal. You can call 1-800-332-1088 to request a MedWatch reporting form.

What a buyer can check, and what it cannot tell you

None of these checks makes kratom safe. They narrow a few of the risks above, mainly contamination, mislabeling and underage sales, and a careful buyer should run them on any seller, including us.

Age rules. There is no single national age. Florida's kratom statute makes it unlawful to sell a kratom product "to a person who is under 21 years of age", a second-degree misdemeanor, and Colorado's 2025 kratom law (SB25-072) prohibits selling to anyone under 21. Other states differ; the FDA says state agencies "are the best resource concerning applicable state laws."

Certificates of analysis. A certificate is a lab's report on one sample, so read it line by line. Check that its lot number matches the lot on your package; that metals and microbial panels are there at all, since a report on alkaloids alone says nothing about the contaminants the FDA and NIDA warn about; and the result column, because a line that reads FAIL matters whatever the rest of the page says. One lot's certificate tells you nothing certain about the next.

The form of the product. If something sold as kratom is a tablet, gummy, shot or drink mix, find out first whether it is a concentrated alkaloid product.

Industry GMP programs. The American Kratom Association, a kratom industry and consumer advocacy group, runs a GMP Standards Program built on third-party inspection of facilities, documents and labels, with an independent audit every year. In AKA's own words it "represents facility and process certification versus product certification", and "AKA does not endorse the quality of the product". It checks how a company operates, not what is in a given bag. The vendor list is public, so check it yourself for any seller you are considering.

The part a seller would rather not write

A company that sells kratom has every reason to want the first line of this page to say yes. We are not going to write it, because no agency quoted here supports it, and a seller's word that kratom is safe is not a finding of anything. If a sales page tells you otherwise, ask which agency said so, then go and read the agency.

Questions people ask about kratom safety

Is kratom dangerous?

It can be. The FDA warns consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder. NIDA describes the serious effects as rare. In the CDC's poison center data, a higher share of reports that named other substances alongside kratom ended in hospital than of reports naming kratom alone.

Has anyone died from kratom alone?

Rarely, on the records available. NIDA cites a 2019 report of 11 deaths from 2011 to 2017 associated with kratom exposure, two of them with kratom alone. The CDC's 2026 report counted 233 kratom-associated deaths reported to poison centers from 2015 to 2025: 184 involved multiple substances and 49 named kratom as the only substance. Where several substances were reported, the CDC said it could not determine which was most related to the death. These are different datasets and should never be added together.

Is kratom FDA approved or legal?

Kratom is not FDA approved for any medical use, and the FDA says it is not lawfully marketed as a drug, a dietary supplement or a food additive. The DEA says kratom is not controlled under the Controlled Substances Act, though three synthetic substances derived from kratom alkaloids have been temporarily in Schedule I since 26 August 2026. States set their own rules, including prohibitions and age limits, so check yours.

Is kratom safe during pregnancy?

None of the agencies on this page says it is. The FDA is aware of cases of neonatal abstinence syndrome, in which newborns showed withdrawal signs after prolonged exposure to kratom before birth, and NIDA says effects on pregnancy are not well understood. If you are pregnant or nursing, talk to your clinician.

What should I do if someone has a bad reaction to kratom?

If they are unresponsive, not breathing normally or having a seizure, call 911. Poison Control advises giving bystander naloxone if the person is not breathing. For anything worrying but not life threatening, call the Poison Help Line at 1-800-222-1222, which is free, confidential and open 24 hours a day. Afterwards, report the reaction to the FDA's MedWatch program.

Documents change. If a line here no longer matches its source, tell us, and if the line is wrong, the page will be corrected, with a new review date.

Disclaimer: this page summarizes publicly available material as of 6 October 2026 and links to primary sources so you can check them. It is general information, not medical advice, and it is no substitute for a clinician. Poison center figures are reports of calls, not counts of people harmed. Statements about botanical products have not been evaluated by the Food and Drug Administration, and no product is intended to diagnose, treat, cure or prevent any disease.