compliance
DEA scheduling of kratom
What program administrators need to know about kratom's federal status, FDA import alerts, the state-level scheduling patchwork, and the implications for workplace and clinical drug-testing panels.
·12 min read
Quick answer
Kratom (Mitragyna speciosa) and its principal alkaloid mitragynine are not federally scheduled under the Controlled Substances Act. The DEA announced an intent to place kratom in Schedule I in 2016 and withdrew that notice after public comment. The FDA continues to maintain import alerts that allow detention of kratom shipments without physical examination, and a patchwork of state and municipal laws — including outright bans in a handful of states — governs where kratom can lawfully be sold or possessed. Most workplace drug-testing panels do not include mitragynine; programs that need kratom coverage must add a dedicated assay.
What kratom is and why scheduling matters
Kratom is a tropical evergreen tree native to Southeast Asia whose leaves contain dozens of alkaloids. The two pharmacologically dominant compounds — mitragynine and 7-hydroxymitragynine — bind at the mu-opioid receptor with a partial-agonist profile and also act on adrenergic and serotonergic targets. Federal agencies have repeatedly described kratom as having opioid-like and stimulant-like properties depending on dose and product, and the NIH National Institute on Drug Abuse (NIDA) maintains a DrugFacts page summarizing the literature.
For program buyers — HR leaders, medical review officers, clinical lab directors, sober-living operators, and rehab admissions teams — the scheduling status of a substance dictates three downstream questions. First, is it lawful for an employer to test for it and act on a positive result? Second, must the program treat positives differently from controlled-substance positives (for example, in how the medical review officer handles a donor explanation)? Third, what panel configuration is required to detect it, since most off-the-shelf drug-test devices target federally controlled substances rather than uncontrolled botanicals?
Kratom sits in an unusual middle position. It is not federally scheduled, it is widely sold in the United States as a dietary ingredient or botanical product, and yet it is the subject of FDA enforcement action, has been placed in Schedule I by several states, and is increasingly cited in clinical-toxicology and overdose-decedent literature. That combination — legal-but-flagged at the federal level, restricted in some states, and absent from standard panels — is exactly the situation that drives the questions program administrators receive most often.
The 2016 DEA notice of intent and withdrawal
In August 2016 the Drug Enforcement Administration published a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine into Schedule I of the Controlled Substances Act using emergency-scheduling authority. The agency cited an imminent hazard to public safety, pointed to a rising number of calls to U.S. poison-control centers, and noted decedent reports involving kratom alkaloids. Under Schedule I, the substances would have been treated as having no accepted medical use and a high potential for abuse, on par with heroin and LSD for federal enforcement purposes.
The notice triggered an unusually large public-comment response from consumers, advocacy groups including the American Kratom Association (AKA), researchers, and a bipartisan group of members of Congress who urged the DEA to allow a full public-comment period and an evaluation by the Department of Health and Human Services. In October 2016 the DEA withdrew the temporary-scheduling notice and reopened the matter for public comment. As of this writing, the DEA has not finalized a federal scheduling action for kratom, and the agency continues to list kratom on its Drug Fact Sheet pages as a drug of concern rather than a controlled substance.
The history matters operationally because programs occasionally still receive policy questions framed around the 2016 notice — for example, an applicant asking whether kratom "is now Schedule I." The accurate answer for federal purposes is no. The accurate caveat is that the FDA has continued enforcement activity, several states have scheduled it, and the federal posture has been described by agencies as actively under review.
FDA enforcement posture and import alerts
While the DEA has not scheduled kratom, the U.S. Food and Drug Administration has maintained a sustained enforcement posture. The FDA's kratom landing page summarizes the agency's safety concerns, references multiple consumer advisories regarding adulteration and contamination findings (including heavy metals and Salmonella in tested products), and reiterates the agency's position that kratom has not been approved as a drug, dietary supplement, or food additive for any indication.
Operationally, the most consequential FDA tool is the import alert. Import alerts allow FDA field staff to detain shipments of an identified product without physical examination — a category known as DWPE, or detention without physical examination. The FDA has long-standing import alerts covering kratom and kratom-containing dietary supplements, on the basis that the products are unapproved new dietary ingredients and adulterated under the Federal Food, Drug, and Cosmetic Act. The practical effect is that legitimate U.S. import is restricted, even as a substantial domestic retail market continues.
The FDA has also issued warning letters to specific kratom marketers — for unapproved-drug claims, for opioid-withdrawal claims, and for adulteration findings — and has periodically issued public consumer advisories. None of those actions create a scheduling status, but they shape the regulatory backdrop a program administrator needs to be able to describe accurately when an applicant, an employee, or a patient asks why a product sold openly in a smoke shop is the subject of federal warnings.
The state and municipal scheduling patchwork
Because no federal scheduling action exists, state legislatures and a number of municipalities have set the most restrictive limits. A small number of states — including Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin — have placed kratom or its principal alkaloids in their state controlled-substances schedules, generally Schedule I, making possession or sale a criminal matter in those jurisdictions. Other states have moved in the opposite direction by enacting versions of the Kratom Consumer Protection Act, which leaves kratom legal but imposes labeling, age, and contaminant-testing requirements on vendors.
Several states have also legislated at the municipal level, and individual cities and counties — most commonly in Florida, California, and Colorado — have enacted local bans or age restrictions independent of state law. The result is a moving compliance map. Programs that operate across multiple states should not assume uniform status, and HR or clinical policy language that simply says "kratom is legal" or "kratom is illegal" will be wrong somewhere in a multi-state footprint.
For an employer, the state map informs three policy choices. Whether kratom should be named as a prohibited substance in the workplace policy, whether the program will test for it, and how to handle a positive result in a state where the substance is legal versus one where it is a scheduled controlled substance. Each of those choices belongs in the written policy rather than in unwritten supervisor discretion.
| Jurisdiction posture | Examples | Operational implication |
|---|---|---|
| State Schedule I (banned) | Alabama, Arkansas, Indiana, Rhode Island, Vermont, Wisconsin | Possession and sale criminalized; positives may be treated like other Schedule I positives in that state |
| Kratom Consumer Protection Act states | Several states have adopted KCPA-style frameworks | Legal but regulated — labeling, age, contaminant-testing requirements on vendors |
| No state-level scheduling, no KCPA | Many remaining states | Legal-but-unregulated; employer policy is the controlling document |
| Local bans or age restrictions | Selected counties and municipalities | Possession may be unlawful locally even where state allows sale |
AKA-FDA tension and the policy debate
The American Kratom Association, the leading consumer-advocacy organization for kratom, has publicly opposed federal scheduling, lobbied for state Consumer Protection Acts, and disputed the FDA's characterization of mitragynine's pharmacology and risk profile. The FDA has rejected those positions and has stated that available evidence does not support a safe use of kratom for any indication and that kratom-related adverse events — including reports of dependence, withdrawal, hepatotoxicity, and mortality involving kratom alkaloids alongside other substances — continue to accumulate.
Program administrators do not need to take a side in that debate, but they do need to understand it. An applicant or employee who is told that a positive will be treated as evidence of substance misuse may push back with AKA-aligned arguments that kratom is a lawful botanical and that any policy treating it as a drug of abuse is unjustified. A defensible workplace or clinical policy responds not by taking a clinical position but by anchoring the rule in the employer's safety-sensitive obligations, the variability of marketed product potency, and the documented overlap with opioid-receptor pharmacology that creates impairment and dependence risk relevant to fitness for duty.
For medication-assisted treatment (MAT) intake, the picture is different. NIDA, SAMHSA-aligned clinical guidance, and the published treatment literature describe kratom-use disorder as a clinical entity with opioid-like withdrawal features, and an intake screen that misses kratom can leave a clinician without an accurate picture of the patient's exposure history. Methadone, buprenorphine, and naltrexone programs increasingly view kratom screening as part of a comprehensive opioid-spectrum assessment rather than an optional add-on.
Implications for workplace and clinical testing programs
The single most important operational fact about kratom and drug testing is that mitragynine is not part of the SAMHSA Mandatory Guidelines panel and is not detected by standard opiate, oxycodone, methadone, or buprenorphine immunoassays. A program that wants kratom coverage must specifically add a mitragynine-targeted device or laboratory assay. Off-the-shelf 10-panel and 12-panel devices, even those marketed as broad-spectrum opioid screens, do not detect mitragynine unless the manufacturer states so explicitly.
Point-of-care mitragynine dip-card and cassette devices are commercially available and are typically configured around a 300 ng/mL urine cutoff for screening. Laboratory confirmation by LC-MS/MS can quantify mitragynine and 7-hydroxymitragynine and provide forensically defensible results when a screening positive needs to be reported as a verified positive. Programs that add kratom should treat it the same way they treat any other added analyte — written policy, donor notification, defensible cutoff, MRO review, and confirmation testing.
For DOT-regulated employers, the rule is straightforward at the federal level: kratom is not on the Part 40 panel and cannot be substituted for required testing. A DOT employer that wants kratom coverage must do it under its company authority outside the federally mandated test, with separate chain-of-custody, separate cutoffs, and separate adverse-action procedures that do not commingle with the DOT test. For non-DOT employers, the decision is a policy judgment informed by the industry, the state map, and the safety profile of the work performed.
Athletes and the WADA framework
The World Anti-Doping Agency (WADA) Prohibited List, which governs Olympic-movement sport and is adopted by reference by USADA and other national anti-doping organizations, does not currently list mitragynine. Some professional and collegiate sports organizations operate under different lists that may include kratom under a catch-all category for opioid-like substances. Athletic compliance programs should consult their governing-body list specifically rather than assume the WADA framework controls.
Military and federal employment
Each branch of the U.S. military maintains its own published list of prohibited substances under regulations that go beyond the federal Controlled Substances Act and reach kratom, CBD products, and certain dietary-supplement ingredients. Active-duty service members are generally prohibited from using kratom regardless of state legality. Federal civilian employees are governed by SAMHSA testing rules, which do not include mitragynine — so federal civilian positives for kratom are unusual unless a program has specifically added the analyte.
Practical guidance for program buyers
If a buyer asks whether they should add kratom screening to their panel, the right answer depends on three factors. The first is the state and municipal map for every location the program operates in, including remote-work jurisdictions for distributed workforces. The second is the safety profile of the role — kratom\u2019s opioid-receptor activity is relevant to operating heavy equipment, driving, patient care, and other safety-sensitive functions in a way that may not be relevant to a fully sedentary role. The third is the clinical context — MAT intake, sober-living urinalysis, and rehab admissions screening are settings in which kratom is unambiguously part of the substance-of-abuse landscape and should be on the panel.
Programs that decide to add kratom should update the written policy first, train supervisors and HR to discuss the substance accurately (including the fact that it is lawful in most states), route any positives through the MRO with the same medication-explanation process applied to other findings, and document the business justification in the program file. Programs that decide not to add kratom should be ready to explain that decision in adverse-action proceedings if a kratom-related impairment incident later occurs.
The kratom market continues to evolve, the federal posture remains under review, and state-level activity is the most active front. Program administrators should plan to revisit kratom policy on the same cadence they revisit cannabis policy — annually at minimum — rather than treating it as a settled question.
Key takeaways
- ✓Kratom and its alkaloids mitragynine and 7-hydroxymitragynine are not federally scheduled; the DEA\u2019s 2016 notice of intent to Schedule I was withdrawn after public comment.
- ✓The FDA maintains kratom import alerts and warning-letter activity, treating marketed kratom products as unapproved new dietary ingredients.
- ✓A small number of states — including Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin — have placed kratom in state Schedule I; others have enacted Kratom Consumer Protection Acts.
- ✓Standard SAMHSA-5, 10-panel, and 12-panel devices do not detect mitragynine — kratom coverage requires a dedicated assay.
- ✓DOT-regulated programs cannot add kratom inside the federal Part 40 test; non-DOT programs may add it under company authority with separate documentation.
- ✓MAT, sober-living, and rehab-intake programs increasingly screen for kratom as part of a comprehensive opioid-spectrum assessment.
Sources
- DEA·Kratom Drug Fact Sheet
- FDA·FDA and Kratom
- FDA·Import Alerts (kratom dietary supplements and bulk dietary ingredients)
- NIDA·Kratom DrugFacts
Information in this article is provided for educational reference and is not medical, legal, or clinical advice. Consult qualified professionals for guidance specific to your program.