This article originally appeared on the Bloomberg School of Public Health website.
A potent, opioid-like product called kratom is being sold at gas stations, convenience stores, and smoke shops across the U.S. The largely unregulated drug has surged in popularity in recent years and has been linked to several deaths, raising concerns about its safety and availability.
In 2025, 3,434 cases of kratom exposure were reported to poison centers nationwide—a 1,200% increase in exposures compared to 2015. Kratom products were found during investigations into the September deaths of two students in Mississippi, although authorities have not confirmed whether kratom contributed to either death. Earlier this year, health officials in Utah linked four deaths to potent kratom-derived compounds found in mislabeled products.
In this Q+A, adapted from the Oct. 19 episode of Public Health On Call, Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, explains what kratom is, what the risks are of using it, and where regulation of the drug stands at the federal and state levels.
What is kratom?
Kratom is the common name for the leaf of a Southeast Asian tree and for the products derived from it. The leaf contains dozens of psychoactive compounds, including mitragynine and 7-hydroxymitragynine (7-OH). Kratom has been used in Southeast Asia for centuries to treat pain and fatigue, and in some cases opioid dependence, because it binds to opioid receptors and can produce effects of pain relief, euphoria, reduced anxiety, and improved mood.
How do people in the U.S. access kratom?
Kratom is a largely unregulated drug that is sold over the counter. It first appeared in the early 2000s in gas stations, smoke and vape shops, and convenience stores. For the past 10–20 years, it's become increasingly available and can be purchased via mail.
It is estimated that 1%–6% of the U.S. population has used kratom at some point. People consume it by chewing the leaves, brewing them as tea, smoking them, or swallowing dried leaves. Some people may be using it without even knowing, as packaging often makes kratom products look like vitamin supplements or energy drinks. This is one of the reasons the estimates of how widely it's used may vary—there may be individuals who use it without knowing they're ingesting kratom.
What are the risks associated with using kratom?
Using these substances is risky. The risks vary depending on the user and the product, and not all kratom is the same. Some formulations are much more concentrated than others.
Because kratom acts on the same receptors as opioids, the harms look a lot like opioid-related harms, including addiction and dependence. Some people develop substance use disorders with kratom: They ingest more than they intend to, crave the product, develop tolerance, and keep using it despite its consequences. People can also experience kratom withdrawal, which is similar to opioid withdrawal, with symptoms including irritability, restlessness, gastrointestinal upset, and agitation. Babies exposed to kratom before birth can develop a syndrome that mimics neonatal abstinence syndrome.
Kratom can also cause other serious medical harm, including seizures and liver injury. There have been deaths associated with kratom, although other drugs are usually involved, making it difficult to isolate the role that kratom may have played.
Is kratom regulated at the federal level?
Kratom is not an FDA-approved drug. No kratom products have been subject to the regulatory scrutiny that comes with prescription drugs, dietary supplements, or food additives, which require demonstrated evidence or reasonable assurance of safety. There's been a lot of debate about how kratom should be regulated and the potential role of scheduling by the Drug Enforcement Administration.
In 1970, Congress passed the Controlled Substances Act, which sorts drugs into different levels of harm based on whether they have an accepted medical use, how likely they are to be used non-medically, and how much dependence they may cause. Schedule I products—LSD and heroin, for example—have a high potential for abuse and no accepted medical use as designated by the FDA and the Department of Health and Human Services. Schedule II products, like oxycodone or fentanyl, may have accepted medical uses but have high abuse potential, while products in Schedules III to V carry progressively less risk. When a drug is placed in Schedule I or Schedule II, it increases the criminal penalties for the unauthorized manufacturing of it or for the sale and possession of the drug. The DEA typically schedules products by asking the FDA to do a scientific and medical evaluation of the potential merits and harms of a product.
In 2016, the DEA announced it was going to designate mitragynine and 7-OH as Schedule I substances, and there was an enormous backlash. Users and advocates of the products argued that people were using kratom to get off of prescription opioids, fentanyl, and heroin, and that the DEA should not make it harder for people to access what they argued was a safer alternative.
The DEA ended up withdrawing its notice and asked the FDA for a formal evaluation. In 2017, the FDA produced an analysis that supported placing mitragynine and 7-OH in Schedule I. HHS initially recommended scheduling the compounds but withdrew its recommendation in 2018, citing gaps in the evidence and concern that scheduling kratom could push users toward illicit opioids.
In July 2025, the FDA recommended scheduling 7-OH while leaving whole-leaf kratom alone. Earlier this year, the DEA temporarily placed three compounds related to 7-OH on the Schedule I list. On Oct. 9, the Department of Justice announced updated plans to restrict concentrated 7-OH and related compounds. Whole-leaf kratom and mitragynine remain federally uncontrolled substances, and their availability varies from state to state.
How is kratom being regulated at the state level?
Some states have issued temporary statewide bans on all kratom products, while others have issued emergency bans on 7-OH products. Utah and West Virginia follow rigorous models that only allow sales through licensed retailers, and only for products that are included in a state registry. Utah also requires independent laboratory testing and restricts sales to pure-leaf products rather than concentrated extracts.
The result is a patchwork of policies: A product could be banned in one state or municipality, but may be legal five miles away, or available online.
What's your advice to anyone who may be considering using kratom?
If someone is inclined to chronically use kratom, I would recommend seeing a clinician. Clinicians are much better positioned to suggest treatments for depression, anxiety, and other psychiatric illnesses than someone at a gas station or a smoke or vape shop.
This interview has been edited for length and clarity by Ruth Watson, a resident physician in the combined Family and Preventive Medicine Residency at Medstar Franklin Square and Johns Hopkins. She is an MPH candidate at the Bloomberg School of Public Health currently rotating with Public Health On Call.
