What is it?
What kratom is
1Kratom is the leaf of Mitragyna speciosa, a Southeast Asian tree in the coffee family. Plain leaf powder, leaf-filled capsules, tea and concentrated extracts differ in alkaloid exposure. A capsule describes packaging, not whether its contents are leaf or extract.
What the newer leaf trial actually found
6A randomized placebo-controlled trial enrolled 116 healthy adults: 49 received leaf powder and 67 placebo. No serious adverse events or deaths occurred. Events increased with dose and included nausea, dizziness, headache and raised ALT liver enzymes; six participants withdrew early because of events suspected to be product-related. Meaningful withdrawal was not observed under these short study conditions. NP Pharma funded the study. It was a tolerability study, not proof of everyday cognitive benefit or long-term safety.
Names, aliases and forms
Mechanisms of action
Mitragynine, 7-OH and opioid receptors
2Mitragynine is a major kratom alkaloid. It and 7-hydroxymitragynine (7-OH) interact with opioid receptors, alongside other pharmacological actions. Natural leaf contains small amounts of 7-OH; intentionally enriched products are a different exposure. Receptor activity does not establish cognitive efficacy.
Potential effects and evidence map
Human studies describe leaf-product tolerability, alkaloid pharmacokinetics and drug interactions. They do not establish reliable focus, memory or productivity benefits. Self-reported alertness or relaxation is not equivalent to a controlled cognitive outcome.
Users report alertness and energy, but controlled evidence of better focus or productivity remains limited.
Relaxation and drowsiness are reported; these can reflect impairment rather than a useful cognitive effect.
Mood-related use is reported, without reliable evidence of benefit for healthy adults.
Typical dosages and timing
Healthy adults aged 18-55 received assigned doses of encapsulated MitraLeaf powder containing 6.65-53.2 mg mitragynine. A single-dose phase was followed by 15 once-daily doses. These are research exposures for one specified product, not a recommended routine or an equivalent amount of extract.
Timing & effect horizon
A small study of 2 g leaf tea found median plasma peaks around 1-2 hours for several related alkaloids and terminal half-lives around 24-45 hours. These are group-level pharmacokinetic findings, not a proven duration of focus, a redosing interval or a safe clearance time. Retail extracts cannot inherit this timing automatically.
The featured 15-day value describes consecutive daily exposure in the leaf-powder trial. It is not a suggested cycle or the time needed for cognitive benefits. Follow-up and a separate single-dose phase extended study participation beyond those 15 days.
Safety, side effects and risk profile
Frequent, sustained leaf use can lead to tolerance, withdrawal and difficulty cutting down.
Kratom can alter exposure to some medicines; combinations with sedatives or opioids add concern.
Increased blood pressure and other cardiovascular reactions have been reported.
Kratom-associated liver injury can be clinically important and occur within weeks, not only after years of heavy use.
Prenatal kratom exposure has been associated with withdrawal in newborns.
U.S. marketing rules and substance-control rules are different and change over time.
Interactions and cautions
In 12 healthy completers, a 2 g leaf tea increased exposure to midazolam by about 40% and its peak concentration by 50%, consistent with inhibition of intestinal CYP3A. Dextromethorphan exposure was unchanged. A pharmacist needs the exact medicines and product to assess compatibility; the study does not validate a stack or imply every drug is affected equally.
Legal and regulatory status
As of October 12, 2026, FDA states that kratom is not lawfully marketed in the United States as a drug, dietary supplement or food additive in conventional food, and no kratom drug is FDA-approved. This is a U.S. marketing position, not a statement that possession is banned worldwide. Local rules and product eligibility require separate checks.
In the United States, as checked October 12, 2026, DOJ reported on October 9 that DEA had not yet issued a temporary 7-OH scheduling order and was issuing a revised notice of intent. Related substances MGPI, MGM-15 and MGM-16 had been temporarily placed in Schedule I on August 26, 2026 and remained controlled. Proposed concentration and ratio thresholds are recommendations in this process, not a general authorization to sell kratom or 7-OH. The update distinguishes trace botanical levels from enhanced products.
Practical buying and quality notes
- Compare leaf powders by net leaf weight and leaf-filled capsules by total leaf grams, not capsule count alone. Compare extracts only when their alkaloid amounts are declared. A ratio such as 50x does not state the measured mitragynine or 7-OH per serving. Concentrated 7-OH products do not belong in a like-for-like leaf price ranking.5
- A lot-specific certificate of analysis (COA) should identify the tested batch and report mitragynine, 7-OH, heavy metals and microbial results. For label arithmetic, 1% mitragynine by weight equals 10 mg per gram; it does not mean the product is 1% 7-OH or establish a safe serving. Testing can identify quality problems but does not remove intrinsic drug effects.2
FAQ
Does the 7-OH scheduling news ban all kratom leaf?
10No blanket conclusion about leaf follows from a notice aimed at concentrated opioid products. The October 9, 2026 U.S. DOJ update described a new notice of intent for 7-OH, not a completed temporary scheduling order for it. FDA marketing restrictions remain separate; this page is not a state-by-state or international legality checker.
Are capsule count and leaf weight interchangeable?
4No. The capsule must disclose its fill and whether it contains leaf or extract. For a plain-leaf product, 100 capsules containing 500 mg each represent 50 g of leaf. This comparison arithmetic says nothing about alkaloid potency or whether that product is suitable to use.
How long does kratom last, and is a cycle established?
4There is no well-validated cognitive-effect duration or cycling schedule for retail kratom. Measured alkaloid kinetics and short trial windows answer different questions; neither defines when impairment ends or a safe time to take more.
What is a safe kratom dose?
6A universally safe kratom dose has not been established. The controlled leaf-powder study cannot cover every preparation, susceptible person or duration. Its research range should not be converted into a personal dose, redosing schedule or cycle.
References
- National Center for Complementary and Integrative Health. Kratom.
- U.S. Food and Drug Administration. FDA and Kratom.
- U.S. Drug Enforcement Administration. Kratom Drug Fact Sheet.
- Tanna RS, Nguyen JT, Hadi DL, et al. Clinical Pharmacokinetic Assessment of Kratom (Mitragyna speciosa), a Botanical Product with Opioid-like Effects, in Healthy Adult Participants. Pharmaceutics. 2022;14(3):620.
- U.S. Food and Drug Administration. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers.
- Huestis MA, et al. Safety and Tolerability of Single and Multiple Daily Oral Doses of Dried Kratom Leaf Powder in a Randomized Trial in Healthy Volunteers. Ther Drug Monit. 2026;48(5):665-675.
- Ahmad J, et al. Liver Injury Associated with Kratom, A Popular Opioid-Like Product: Experience from the U.S. Drug Induced Liver Injury Network. Drug Alcohol Depend. 2021;218:108426.
- Rogers JM, et al. Kratom addiction per DSM-5 SUD criteria, and kratom physical dependence: Insights from dosing amount versus frequency. Drug Alcohol Depend. 2024;260:111329.
- Tanna RS, et al. Clinical Assessment of the Drug Interaction Potential of the Psychotropic Natural Product Kratom. Clin Pharmacol Ther. 2023;113(6):1315-1325.
- U.S. Department of Justice. Department of Justice Announces Updates to Emergency Scheduling Actions for 7-OH and Related Opioid Substances. October 9, 2026.