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Kratom, kava, and CBD are different substances, not interchangeable wellness products—and available evidence does not establish that one is universally safer or more effective than the others. FDA warnings identify distinct concerns: kratom has been associated with serious adverse events and substance use disorder; kava has a history of reported liver injuries; and CBD can cause liver-enzyme elevations, interact with medicines, and cause sleepiness or gastrointestinal effects. Product contents and U.S. regulatory status also differ.
What are kratom, kava, and CBD?
The labels refer to different substances and product categories. Comparing them as if they were three versions of the same supplement can obscure the questions that matter: what a product contains, what effect is claimed, what harms have been reported, and whether the particular product has been evaluated or approved for its intended use.
Kratom
Kratom products are derived from the kratom plant. The FDA warns of serious adverse events associated with kratom, including liver toxicity, seizures, and substance use disorder (SUD). Its account of reported SUD cases describes tolerance, cravings, taking more or using for longer than intended, continuing despite harms, and withdrawal. These are dependence-related concerns, not simply a question of whether a product produces a desired short-term effect.
FDA has also reported cases of neonatal withdrawal following prolonged prenatal exposure, and contamination alerts involving Salmonella or heavy metals. Those reports make both the substance and the quality of a particular product relevant to risk.
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Kava
Kava is a separate plant-derived product category. The FDA’s August 11, 2020 scientific memorandum reviewed reported cases of liver injury associated with kava, including cases described as severe or fatal. The memorandum also discusses possible contributions from dose, prolonged use, and co-medication. The cases and causality assessments vary, so they are a safety signal—not a reliable estimate of how often harm occurs or proof that every kava preparation causes liver injury.
CBD
CBD, or cannabidiol, is a cannabis-derived compound used in a range of products. “CBD” on a label does not by itself establish a product’s actual contents, quality, or regulatory status. The FDA says it has approved one CBD product, the prescription medicine Epidiolex, for specified seizure disorders; that approval is not an approval of other CBD products or of CBD for other uses.
How do their effects and evidence differ?
A claim about an intended effect is not the same as evidence that a product reliably produces that effect or is appropriate for a particular person. The FDA warnings summarized here document particular safety concerns; they do not provide a clinical comparison of the three substances’ effectiveness.
| Product | What the FDA material establishes | What it does not establish |
|---|---|---|
| Kratom | FDA warns of serious adverse events, including liver toxicity, seizures, and SUD. | A comparative benefit estimate or a universal safe-use threshold. |
| Kava | FDA reviewed reported liver-injury cases, including severe or fatal cases, and discussed possible contributing factors. | A precise incidence rate or proof that all preparations carry an identical risk. |
| CBD | FDA identifies potential harms and notes that one prescription CBD medicine is approved for specified seizure disorders. | FDA evaluation of non-approved consumer CBD products for treatment effectiveness, dosage, interactions, or safety. |
The evidence described here does not support a head-to-head ranking. There is no shared risk scale in the cited FDA material that puts kratom, kava, and CBD on a single ladder from safest to most hazardous. Nor does the existence of an approved prescription medicine establish that other products with a related ingredient have the same evidence, formulation, or quality.
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What are the best-documented risks?
Kratom: serious adverse events and dependence-related concerns
FDA states: “FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD).” Its description of reported SUD cases includes features such as tolerance, cravings, withdrawal, and continued use despite harms. These reports do not provide a rate that can be applied to every user or product, but they are substantial reasons not to treat kratom as a routine, risk-free supplement.
Pregnancy is a distinct concern: FDA reports neonatal withdrawal cases after prolonged prenatal exposure. Its warnings also describe contamination incidents involving Salmonella or heavy metals, so a product’s source and contents cannot be assumed from the plant name on its packaging.
Kava: reported liver injury, with uncertainty about cause and frequency
The FDA memorandum dated August 11, 2020 treats kava-associated liver injury as a real concern while acknowledging uncertainty. It reviews case reports and differing causality assessments, and discusses dose, duration, and co-medication as possible factors. A severe case report matters for identifying a potential hazard; it does not, on its own, say how likely injury is for a given person, product, or pattern of use.
This distinction prevents two opposite errors: dismissing the reports because causality is not settled in every case, and claiming that every kava product inevitably causes liver damage. The available material supports caution, not either overstatement.
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CBD: liver effects, interactions, sleepiness, and gastrointestinal symptoms
The FDA identifies potential liver injury, interactions with medicines, sleepiness, and gastrointestinal effects as concerns with CBD products. The agency advises consumers to be aware of potential risks and to discuss CBD use with a health professional, particularly when medicines are involved. A product’s nonprescription availability does not rule out interactions or make its use appropriate for an individual health situation.
A 2025 FDA trial summary gives a useful example of why numbers need their study context. In a randomized, double-blinded, placebo-controlled 28-day study, healthy participants received oral CBD solution at 250–550 mg per day. Eight CBD recipients—5.6% of that study group—had ALT elevations above three times the upper limit of normal; no placebo recipients met that threshold. FDA says these enzyme elevations did not produce clinically significant changes in liver function in the trial and returned to normal within one to two weeks after participants stopped the solution.
That 5.6% is a result from a particular study, formulation, dose range, duration, and group of healthy participants. It is not an estimate of the risk at every consumer dose, for every CBD product, or for every person. It also should not be read as proof that an elevation of liver enzymes is harmless in other circumstances.
Why product contents and formulation matter
Broad product names do not guarantee consistent contents. The FDA has described contamination incidents involving kratom and has raised concerns about CBD products whose actual CBD levels did not match their claims, as well as possible contaminants such as pesticides, heavy metals, and THC. A label or retail listing is therefore not proof of identity, purity, dose accuracy, or safety.
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Formulation matters especially when interpreting claims about effects or risks. FDA’s CBD trial result concerns an oral CBD solution under specified study conditions; it cannot be transferred directly to every product sold as CBD. Likewise, evidence about reported kava injuries does not establish identical risk for every preparation, and the FDA distinguishes concentrated 7-hydroxymitragynine products from natural kratom leaf.
Concentrated 7-OH is not the same category as natural kratom leaf
In an announcement dated July 29, 2025, the FDA described 7-hydroxymitragynine (7-OH) products as concentrated byproducts and distinguished them from natural kratom leaf. The agency recommended a scheduling action for certain 7-OH products. That announcement said the Drug Enforcement Administration had final authority and was reviewing the recommendation through a rulemaking process. The recommendation itself should not be described as a completed scheduling action; the announcement establishes the status as stated on that date, not a later outcome.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What is the U.S. regulatory status?
Regulatory status depends on the substance and the product’s intended use. A product’s presence in a shop or online does not establish FDA approval, safety, or lawful marketing.
Kratom
The FDA says kratom is not lawfully marketed in the United States as a drug, dietary supplement, or conventional food additive. This statement concerns those marketing categories; it should not be broadened into a claim about every state or local rule, or about the legal status of possession in every jurisdiction.
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Kava
The FDA memorandum discussed here addresses reported liver injuries and possible contributing factors. It does not establish a comprehensive account of kava’s legal status across U.S. jurisdictions or product types. The safety discussion should not be mistaken for an approval or a legal classification.
CBD
The FDA says only one CBD product—the prescription medicine Epidiolex—is approved, for specified seizure disorders. It has not approved other CBD products. FDA also says that adding CBD to food or labeling it as a dietary supplement is illegal under federal law, and that CBD products remain subject to FDA-regulated product requirements. These statements do not mean that all products marketed as CBD have been evaluated or that retail availability amounts to FDA approval.
What can—and cannot—be concluded from the comparison?
The available FDA material supports comparing types of concern, but not choosing a universal winner. Kratom warnings include SUD and serious adverse events; kava has a history of reported liver injury with uncertainty about causation and frequency; CBD carries concerns that include liver effects, medicine interactions, sleepiness, gastrointestinal symptoms, and variable product quality. Different evidence and different harms cannot be reduced to a single ranking without comparable data.
- Do not infer safety from origin. A plant-derived or cannabis-derived label does not establish that a product is harmless.
- Do not infer effectiveness from a claim. FDA has not evaluated non-approved consumer CBD products for treatment effectiveness, dosage, interactions, or safety.
- Do not generalize one formulation’s result to all products. A trial of oral CBD solution and reports about particular kava or kratom products do not establish an identical risk for every formulation.
- Do not treat availability as approval. Retail sale does not demonstrate FDA evaluation, product quality, or lawful marketing.
These limits matter because an individual’s medicines, health circumstances, and the specific formulation can change the relevance of a general warning. The evidence summarized here does not establish a personalized choice, a universal safe dose, or a comparative safety ranking.
Practical questions to raise with a health professional
If you are considering CBD, FDA recommends discussing it with a health professional, particularly because of possible medicine interactions. The same cautious approach is appropriate when a product could affect health or be used alongside treatment: bring the exact product label and ingredient information, rather than relying only on a broad category name.
- What is the exact product and formulation, and does the label clearly identify its contents?
- Could it interact with any prescription or nonprescription medicines you take?
- Is the claimed use supported by evidence for this specific product, rather than by evidence about a different formulation or an approved medicine?
- What should you do if you notice a concerning effect, such as unusual sleepiness or a possible liver-related problem?
These are discussion prompts, not a dosing plan or a way to establish that any product is safe. The cited FDA material does not supply a universal dose for kratom, kava, or consumer CBD products.
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