A recent study published in the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) has shed critical light on the escalating public health concerns associated with the co-use of kava and kratom, two botanicals increasingly popular among young people as alternatives to alcohol. The report, co-authored by Christopher Holstege, MD, Professor of Emergency Medicine and Pediatrics at the University of Virginia School of Medicine, and his colleagues, details a significant surge in kava-related calls to U.S. poison control centers (PCCs), with a notable portion involving concurrent kratom exposure, leading to higher rates of serious clinical outcomes. This trend underscores a complex interplay of consumer choices, aggressive marketing, and a fragmented regulatory landscape that poses substantial challenges for public health authorities.
The Resurgence of Kava and the Rise of Kratom Co-Use
Kava, derived from the root of Piper methysticum, a plant in the pepper family, has a long history of traditional use in Pacific Island cultures, where it is consumed as a ceremonial and social drink. Known for its anxiolytic (anxiety-reducing), sedative, and mood-enhancing properties, kava’s primary active compounds are kavalactones. Its consumption in Western countries, however, saw a sharp decline after the U.S. Food and Drug Administration (FDA) issued a public warning in 2002, citing concerns about severe liver injury (hepatotoxicity) associated with its use. This warning, which prompted similar regulatory actions and bans in several European countries like Germany and Switzerland, significantly impacted the global kava market.
Despite the previous warnings, kava consumption began to rebound approximately a decade ago. This resurgence coincided with a growing interest in natural remedies and non-alcoholic social alternatives, particularly among younger demographics. During this period, a new trend emerged: the co-use of kava with kratom. Kratom, sourced from the leaves of Mitragyna speciosa, a tropical tree native to Southeast Asia, has been traditionally used for its stimulant, pain-relieving, and opioid-like effects, attributed primarily to its active alkaloids, mitragynine and 7-hydroxymitragynine (7-OH). At lower doses, kratom can act as a stimulant, while higher doses induce sedative and analgesic effects, akin to opioids. The combination of kava’s relaxing properties and kratom’s varied effects created a novel product category that rapidly gained traction.
Commercial products containing both kava and kratom are frequently marketed as "healthy alternatives to alcohol," often positioned near college campuses and in trendy health stores. Dr. Holstege expressed significant concern regarding this marketing strategy, stating, “These commercial products are commonly marketed as healthy alternatives to alcohol, sold near college campuses, and increasingly being combined with kratom, a psychoactive botanical with opioid-like effects, raising safety concerns.” The appeal of a "natural" option that offers relaxation or an energy boost without the perceived drawbacks of alcohol has resonated with a segment of the young adult population, often overlooking the potential health risks and the complex pharmacology of these botanicals.
Alarming Data from Poison Control Centers
The MMWR report highlights a stark increase in kava-related incidents reported to U.S. poison control centers. From 2011 to 2025, kava-related calls surged by an astounding 383%, climbing from 57 cases to 203. Even more concerning is the data for 2025, where approximately one-third of all kava-related calls also involved kratom, indicating a clear pattern of co-ingestion.
Dr. Holstege emphasized the gravity of these findings: “These data indicate a resurgence of overall kava exposure reports to poison centers, as well as an increase in kratom-related kava reports, which has coincided with higher rates of serious clinical outcomes. The findings in this report suggest the need for enhanced surveillance for, clinical awareness of, and public education regarding commercial products containing kava.”
The adverse effects reported varied, though nearly half (43%) of the kava-related calls involved other substances, including ethanol (alcohol) and benzodiazepines. While many reported symptoms were minor, such as nausea and dizziness, approximately one-third of cases led to hospitalizations or other serious clinical outcomes. Tragically, eight kava-related deaths were reported during the study period, underscoring the potential for severe, even fatal, consequences from these botanical combinations, especially when mixed with other central nervous system depressants.
This data builds upon previous warnings. Just a week prior to this kava-kratom report, the same research group issued another MMWR report detailing a 1,200% increase in kratom-related calls to U.S. poison control centers over the past decade. While this percentage increase appears dramatic, the researchers were careful to contextualize it, noting that these calls represent only a tiny fraction (0.28%) of the estimated 5 million kratom users. This distinction is crucial, as it highlights the difference between an increase in reported incidents and the overall prevalence of adverse events within the user population, though it still signals a significant rise in acute toxic exposures requiring medical attention.
A Tumultuous Regulatory History
The regulatory journey of both kava and kratom in the United States has been fraught with challenges and controversy, reflecting the difficulties authorities face in classifying and controlling botanicals that straddle the lines between traditional remedies, dietary supplements, and potentially harmful psychoactive substances.
Kava’s initial decline following the 2002 FDA warning illustrates the agency’s power to impact consumer behavior based on safety concerns. The liver injury reports, though debated in terms of specific mechanisms (e.g., whether they were due to specific kavalactones, inappropriate plant parts like stems and leaves being used instead of roots, or contaminants), led to a strong public health message that significantly reduced kava’s market presence for years. The current resurgence, coupled with the new PCC data, reopens old wounds and demands renewed scrutiny.
Kratom’s regulatory saga is even more contentious. In 2016, a previous MMWR report on kratom-related calls to poison control centers was cited by the U.S. Drug Enforcement Administration (DEA) to justify its efforts to classify the main kratom alkaloids, 7-hydroxymitragynine (7-OH) and mitragynine, as Schedule I controlled substances. Such a classification would have placed kratom in the same category as heroin and LSD, effectively banning its sale and possession nationwide. This proposal ignited a massive public outcry from kratom users, advocates, and some scientific researchers who argued for its potential benefits, particularly in managing chronic pain and opioid withdrawal symptoms. Faced with overwhelming public opposition and scientific challenges, the DEA ultimately withdrew its proposal.
The controversy was further amplified when a top federal health official in the first Trump administration later admitted that the DEA’s scheduling request was based on "embarrassingly poor evidence & data" from the FDA. This official acknowledged that banning kratom could result in "substantial risk to public health," suggesting that denying access to kratom might push users towards more dangerous substances or illicit markets. This admission underscored the need for more robust scientific inquiry and a nuanced approach to regulating complex botanicals.
More recently, the FDA has revived efforts to list only the potent alkaloid 7-OH as a controlled substance, distinguishing it from natural leaf kratom. This targeted approach aims to address concerns about highly concentrated or synthetic forms of 7-OH, which may pose greater risks than traditional kratom leaf, without outright banning the entire plant. As of the current reporting, the DEA has yet to act on this specific request, leaving the regulatory status of kratom in a state of continued uncertainty.
The "Feel Free" Controversy: A Case Study
The commercial product "Feel Free Classic," manufactured by Oklahoma-based Botanic Gardens (now Botanic Tonics), stands as a prominent example of the issues surrounding kava and kratom co-use. This tonic, containing both kava and natural leaf kratom, quickly became controversial. Media reports widely claimed the drink was addictive, possessed "opioid-like effects," and was "hooking young people," fueling public anxiety and regulatory scrutiny.
The company faced a class-action lawsuit alleging misleading advertisements that promoted Feel Free as a healthy alternative to alcohol. The lawsuit contended that the company failed to adequately disclose the product’s addictive potential and its psychoactive properties. Botanic Gardens ultimately settled the case for $8.75 million, agreeing to implement stronger safety warnings on Feel Free bottles and to limit sales to individuals 21 and older, acknowledging the need for greater consumer protection and responsible marketing.
In a significant regulatory action, the FDA seized nearly 250,000 bottles of Feel Free in 2023, alleging that the drink was an adulterated substance with inadequate safety information. The FDA’s move signaled a strong stance against products it deemed unsafe and improperly labeled. However, over a year later, the FDA quietly dropped the case, a decision that surprised many and raised questions about the agency’s long-term strategy for regulating these botanicals. The dismissal could be interpreted in various ways: perhaps the FDA lacked sufficient evidence to prove adulteration, or it reflected an evolving understanding within the agency regarding the regulation of natural kratom leaf products, potentially favoring a more nuanced approach than outright seizure.
Adding another layer to the narrative, a small, short-term clinical study funded by Botanic Gardens concluded that Feel Free was "generally safe, with only mild to moderate AEs (adverse events) reported, which were all transient in nature." While such industry-funded studies often face scrutiny regarding potential bias, they contribute to the scientific discourse and highlight the complexities of assessing botanical safety, especially for products with a range of active compounds and potential interactions.
Broader Impact and Implications
The rising co-use of kava and kratom, as documented by the CDC MMWR report, carries significant implications for public health, regulatory policy, and consumer awareness.
Public Safety: The primary concern remains consumer safety. The lack of standardized dosages, quality control, and comprehensive labeling for many botanical products, especially when sold as dietary supplements, leaves consumers vulnerable. The synergistic effects of combining kava and kratom, particularly with other central nervous system depressants like alcohol or benzodiazepines, can lead to unpredictable and potentially dangerous outcomes, as evidenced by the hospitalizations and deaths reported. The "natural" label can often mislead consumers into believing a product is inherently safe, overlooking its pharmacological potency.
Regulatory Dilemma: The ongoing debate surrounding kava and kratom highlights a fundamental challenge in regulatory science. How should agencies like the FDA and DEA categorize and regulate botanicals that have traditional uses, perceived benefits by some users, yet also possess psychoactive properties and documented risks? The current regulatory framework, which often forces substances into rigid categories (food, supplement, drug, controlled substance), struggles to adequately address the nuances of botanicals. A more adaptive and science-driven approach may be necessary, focusing on product safety, purity, accurate labeling, and age restrictions rather than outright bans that could drive markets underground. The FDA’s recent action to drop the Feel Free case could signal a shift towards greater emphasis on scientific evidence and perhaps a recognition of the legal complexities involved in regulating natural botanicals versus synthetic compounds.
Consumer Education and Clinical Awareness: The critical need for enhanced public education cannot be overstated. Consumers, especially young adults, need accurate, unbiased information about the potential risks and interactions of kava and kratom, particularly when co-used or combined with other substances. Educational campaigns should clearly articulate the lack of rigorous safety testing for many commercial botanical products and caution against the misleading claims of "healthy alternatives." Simultaneously, healthcare providers require better clinical awareness and training to identify and manage exposures to kava, kratom, and their combinations. Improved surveillance systems are essential to track adverse events more comprehensively and inform public health interventions.
Future Research: The ongoing controversy and rising incidence of adverse events underscore the urgent need for more independent, robust scientific research into the pharmacology, toxicology, and long-term effects of kava and kratom, both individually and in combination. Studies are needed to establish safe dosages, identify vulnerable populations, and elucidate potential drug-drug interactions. Such research is vital for informing sound regulatory policies and ensuring public safety in an evolving market of botanical products.
The latest MMWR report serves as a critical warning. While the allure of natural remedies and alternatives to conventional substances is understandable, the data unequivocally demonstrates that the co-use of kava and kratom is not without significant risks. Addressing this growing public health concern will require a concerted effort from regulators, public health officials, the medical community, and the industry itself to ensure that consumer safety remains paramount.