Is Kratom Legal Federally?

Is kratom a controlled substance?

No. Neither the kratom plant nor its two main alkaloids appear in any schedule of the federal Controlled Substances Act.

Three laboratory-made compounds built from those alkaloids were scheduled in August 2026. None of them occurs naturally in the plant, and the 2026 section below covers that in the detail it needs.

The government came close to scheduling the plant twice. Once in 2016, when DEA announced it would place both main alkaloids in Schedule I and then reversed course six weeks later. Once in 2018, when the Department of Health and Human Services rescinded its own recommendation to schedule them. Both episodes are below.

Federal law is one layer. Ten states ban kratom on their own authority, and cities and counties in other states have rules of their own. Kratom law in every state covers that layer.

What did the federal government do before 2016?

The Food and Drug Administration moved first, and it moved on imports rather than on possession.

2012. FDA placed kratom on an import alert covering unapproved drugs.

February 28, 2014. FDA issued Import Alert 54-15, which lets border officials hold shipments of kratom and kratom-containing dietary ingredients without examining them first. It sets out FDA’s position that kratom is a new dietary ingredient under the food and drug law. The agency found no record of it being sold as one in this country before October 15, 1994. Import Alert 54-15 was in force at the last check above.

September 2014. U.S. Marshals, at FDA’s request, seized more than 25,000 pounds of raw kratom material from a facility in Van Nuys, California.

January 2016. Marshals seized nearly 90,000 bottles of a kratom drink held by a company in South Beloit, Illinois.

August 2016. Marshals seized more than 100 cases of kratom products in Grover Beach, California.

FDA keeps a running list of these seizures. None of them made kratom illegal to have. They were enforcement of food and drug law against companies, not drug scheduling.

What happened in 2016?

The closest the United States has come to banning kratom, and it lasted six weeks.

August 31, 2016. DEA published a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine in Schedule I. The citation is 81 FR 59929, docket DEA-442. The legal basis was 21 U.S.C. 811(h). That provision lets the government schedule a substance quickly on a finding of imminent hazard to public safety. A temporary order could have issued 30 days later.

October 13, 2016. DEA published a second notice that pulled the first one back. It gave two reasons. The volume of public comment it had received, and a scientific and medical evaluation it had asked FDA to prepare and had not yet been sent. The comments came from Members of Congress, advocacy groups and the public. The notice opened a new comment period, closing December 1, 2016.

One sentence in that second notice is the one worth reading. DEA wrote that the two alkaloids remain, as has been the case, noncontrolled substances under the Controlled Substances Act. That was true at the last check above.

What did FDA do after 2016?

It kept publishing, and the publishing got sharper.

October 17, 2017. The acting Assistant Secretary for Health at HHS wrote to DEA. The letter asked that both alkaloids go into Schedule I for good. The letter was not public at the time. We know what it said because the letter that later rescinded it quotes it.

November 14, 2017. FDA issued a public health advisory on kratom, citing 36 deaths associated with its use.

February 6, 2018. FDA published work by its own scientists, who had run the two alkaloids through a computer model. The agency raised the number of associated deaths to 44.

February to April 2018. FDA and the CDC looked into a salmonella outbreak across several states, traced to kratom products. On April 3, 2018 FDA ordered a mandatory recall against a Las Vegas company that would not recall on its own. It was the first mandatory food recall in the agency’s history, and it was a kratom product.

November 2018 and April 3, 2019. FDA released heavy metals testing on 30 kratom products and reported significant levels of lead and nickel.

Every one of these is a food safety or labeling action. None of them changed kratom’s status under the Controlled Substances Act.

Why did HHS reverse its own recommendation?

Because the Assistant Secretary for Health concluded the evidence behind it did not hold up.

August 16, 2018. Assistant Secretary for Health Brett P. Giroir wrote to the acting DEA administrator and rescinded the October 17, 2017 recommendation. HHS said the two alkaloids should not be controlled at that time, either temporarily or for good. Not until research could support it.

The letter was not announced. It surfaced in January 2021 through congressional oversight, and the members who obtained it confirmed it was genuine. Nothing has replaced it. There is no live federal recommendation to schedule the kratom leaf or mitragynine.

What has the federal record shown since?

Nine entries, in order, and they do not all run the same way.

April 12, 2019. CDC published an analysis of 27,338 overdose deaths. They were recorded across 27 states, between July 2016 and December 2017. Kratom showed up in the toxicology of 152 of them, or 0.56 percent. CDC noted that testing protocols were not written down and varied between states and within them.

May 2021. FDA announced another seizure, this one of adulterated products containing kratom.

July 23, 2021. FDA published a Federal Register notice asking for public comment. A World Health Organization committee was about to review kratom, and the United States needed a position. The docket is FDA-2021-N-0739. FDA reopened the comment period on August 16, and the docket drew 8,587 comments.

February 15, 2022. FDA published the recommendations that came out of that committee for international control. Three substances are named. Kratom is not one of them.

April 2023. FDA seized roughly $3 million of kratom products from an Oklahoma company. The agency updated its import alerts again in July 2023.

August 2024. FDA proposed a study of kratom purchase and use on August 2, then pulled the proposal ten days later, saying circumstances required changes to its scope.

September 2024. FDA awarded a grant for a human abuse potential study on kratom. That’s the larger trial, and FDA has not published its results.

January 22, 2025. DEA published a kratom drug fact sheet. It lists kratom under Drugs of Concern, a category the agency uses for substances it has not scheduled. The listing is older than the fact sheet. CDC referred to it in 2019, and the Congressional Research Service in 2023.

March 26, 2026. CDC published poison center figures in its Morbidity and Mortality Weekly Report. Poison centers logged 14,449 kratom exposure reports across the eleven years from 2015 through 2025. The 3,434 logged in 2025 were roughly twelve times the 258 logged in 2015. CDC counted 233 kratom-associated deaths in that period. Of those, 184 involved more than one substance, and opioids were reported in 62 percent. Read the report’s own limitation with it. The data does not record whether an exposure involved traditional leaf or a concentrated or semi-synthetic product. The authors say that leaves them unable to separate risks by product type. It’s a count of calls, not a rate per person or per package.

Has Congress ever passed a law about kratom?

No. Bills have been introduced. None has become law.

Members filed matching bills in the House and the Senate in October 2023, and similar ones in the Congress before that. The Congressional Research Service, which works for Congress, set out what they would do. They would neither ban kratom nor regulate it. They would direct the Secretary of Health and Human Services to hold a public hearing on kratom safety, to stand up a task force on federally funded kratom research, and to use formal rulemaking before issuing any kratom rule. They would also limit the Secretary, including a bar on enforcing an import alert against a product without evidence that the product itself is adulterated. Each bill left state law alone.

One more bill is worth reading because of how it’s drafted. H.R. 8000, introduced March 19, 2026, would add 7-hydroxymitragynine to Schedule I including its synthetic equivalents, but not including 7-hydroxymitragynine naturally contained in Mitragyna speciosa. Congress wrote the leaf out of the bill in the bill’s own text. It has not passed, and being introduced means only that it was filed.

There’s no federal statute written for kratom. What governs it is ordinary food, drug and controlled substances law.

Has the government run its own study on kratom?

Yes, one, and it’s published.

FDA sponsored a pilot trial of botanical kratom in people. It ran from August 16, 2023 to January 23, 2024 and is registered as NCT06072170. Forty recreational polydrug users took part, in five groups of eight, six on kratom and two on placebo in each group. The kratom used was a single-source encapsulated leaf powder with alkaloid levels representative of leaf products, and 7-hydroxymitragynine at trace levels.

The study stepped the amount up one group at a time. The first group took 1 gram. Later groups took 3, 8, 10 and 12 grams, each step cleared only after a safety review of the one before it. Everyone ate a high-fat meal first, and nobody went through more than one round. The 12 gram group swallowed 24 capsules inside five minutes.

Nothing serious happened at any level. Vomiting was the most common adverse event and rose at the 8, 10 and 12 gram steps, which the researchers linked to the sheer bulk of capsules going down at once. The other observed change was slight pupil dilation. The published paper reports no deaths and no serious adverse events across all forty participants, and its stated conclusion is that at the amounts tested, with the specific material sourced for the study, and under controlled clinical conditions, kratom was well tolerated.

The results appeared in the Journal of Clinical Psychopharmacology, volume 46, issue 4, pages 386 to 398, in the July and August 2026 issue. The lead author is an FDA pharmacologist. Among the co-authors is Christopher R. McCurdy of the University of Florida, whose research DEA cites in its own 2026 filings.

Who took part is worth knowing, because it shapes what the numbers mean. The study protocol required participants to be healthy and not dependent on anything, and to have used opioid drugs for non-medical reasons at least 10 times in their life and at least once in the 12 weeks before screening. They also had to have used at least two perception-altering or stimulant drugs on at least five occasions. This is the standard population for an abuse-potential study, because the question being asked is whether a substance produces the kind of experience someone would seek out again. It is not the same as testing the general public, and the paper calls itself a pilot built to shape the larger trial that followed.

One thing to know if you go looking. FDA’s own kratom page has not caught up. As of the version carrying a December 2, 2025 date, it says the manuscript has been submitted and that results will be released once a journal accepts it.

What has the National Institute on Drug Abuse done?

It has funded the university research, and in 2026 it opened the way to a clinical trial of one of kratom’s alkaloids as a drug candidate.

NIDA is the arm of the National Institutes of Health that funds drug research. It has backed kratom work at the University of Florida College of Pharmacy since 2018, under grants including UG3DA048353 and R01DA047855, covering the plant’s chemistry and the pharmacology of its alkaloids. Those grants are searchable by number in the NIH RePORTER database.

June 1, 2026. NIH announced that its investigational new drug application for mitragynine had taken effect with FDA. That clears the way for an NIH-led phase 1 clinical trial to evaluate mitragynine as a drug candidate in opioid use disorder. NIH and University of Florida researchers developed the purified mitragynine formulation used in it, and did the preclinical work behind the application. NIDA director Nora Volkow, M.D., was quoted in the announcement calling the application a major step toward expanding options.

Read that one carefully, because it’s easy to misread in both directions.

An investigational new drug application taking effect is permission to run a trial. It is not an approval, not a finding of safety, and not a finding that anything works. A phase 1 trial tests safety and tolerability in a small number of people, and it is the first of several stages.

The trial also does not study kratom. It studies a purified, single-alkaloid formulation made under pharmaceutical conditions. That’s a different thing from leaf sold in a bag, and the government drew that line itself.

What is the federal government doing about kratom in 2026?

Kratom is unscheduled, and the scheduling work moving through the government is aimed at something else. The agencies have said so in their own words, on the record, more than once.

On July 1, 2026 DEA filed two notices of intent, both published July 6. One, docket DEA-1644, covered three synthetic derivatives of a kratom alkaloid. FDA describes those three, mitragynine pseudoindoxyl, MGM-15 and MGM-16, as not naturally occurring in the kratom plant. They became a temporary Schedule I order on August 26, 2026. We do not sell them and never have.

The other, docket DEA-1570, is the one that touches the plant. Here is what the government said about it the day it was filed.

DEA’s own announcement: “This temporary scheduling action does not apply to botanical kratom products that contain naturally occurring 7-OH below the specified threshold. Instead, it targets synthesized products and those containing elevated concentrations of 7-OH.”

DEA Administrator Terrance Cole, quoted in that same July 1 announcement: “Today’s action targets highly concentrated, synthetic 7-OH products, which pose a growing threat to public safety and health.”

HHS Secretary Robert F. Kennedy, Jr.: “7-OH, MP, MGM-15, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk.”

That language did not start in 2026. FDA announced the underlying recommendation on July 29, 2025 at a press conference with Secretary Kennedy, Deputy Secretary Jim O’Neill and Commissioner Marty Makary. The agency’s release that day states that FDA “is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products.”

DEA’s announcement also describes the plant on its own terms. It calls Mitragyna speciosa a tropical evergreen tree indigenous to Southeast Asia, commonly used in religious or communal ceremonies, and says that in its botanical form 7-hydroxymitragynine is found in trace amounts.

Two facts from the notice itself, because a press release is not a law.

Mitragynine is not in it. The alkaloid the leaf holds most of is not part of the proposed action and would remain uncontrolled.

The action is written as a threshold rather than as a plant. It reaches material holding more than 0.050 percent 7-hydroxymitragynine by dry weight. It also reaches material made in a lab, or processed into an extract, a concentrate, an edible or a pressed pill, above that level or above 1.00 milligram in the article. No state has written a kratom law that way. A state ban asks what a product is. A threshold asks how much of one alkaloid is in it, which is a laboratory question rather than a label question.

Docket DEA-1570 had not issued as of the date at the top of this page. The Office of the Assistant Secretary for Health at HHS took public comment on the proposed threshold and extended that window to September 10, 2026. Until an order publishes in the Federal Register, nothing in that docket has legal force.

What does federal law let you do with kratom?

Have it, carry it, and ship it across state lines, so far as federal law is concerned.

What federal law does not do is approve it or set a standard for it. FDA’s published position is that kratom is not lawfully marketed in the United States as a drug, as a dietary ingredient, or as an additive in conventional food. No approved drug product contains kratom or its alkaloids. No federal rule says how a kratom product is tested, what has to appear on the label, or what is allowed in the package.

That gap is the reason states write their own rules and the reason they do not match. It’s also the reason a Kratom Consumer Protection Act exists as a model law at all.

Federal legality is not a safety finding. It means Congress and DEA have not scheduled the plant. Everything else about a bag of kratom is a question about the company that sold it to you.