The Unregulated Rise of Kratom Drinks: Emerging Challenges and Policy Recommendations

The opioid epidemic left the US health system with devastating questions. How did a profit-driven pharmaceutical company fuel a crisis that claimed hundreds of thousands of lives? One answer lies in the unchecked influence of commercial interests on product marketing and regulation, a failure that enabled the rise of OxyContin and, more recently, Juul. Given the immense harm caused by these products, it is critical to monitor emerging industries whose products carry a risk of addiction for similar warning signs. We identify kratom drinks as one such product, arguing that lax regulation, aggressive marketing, and consumer confusion make them a looming public health threat.

Background

Kratom, scientifically known as Mitragyna speciosa, is a tropical tree native to Southeast Asia whose leaves have been traditionally consumed by chewing, smoking, or brewing as tea to treat common ailments.^1,2 Kratom contains at least 40 alkaloids, with mitragynine being the most common. Mitragynine exhibits pharmacologic actions across the serotonin and adrenergic receptors, and, to a lesser degree, opioid receptors. ³ A small percentage of mitragynine is metabolized in the body as 7-hydroxymitragynine, a much more potent opioid receptor stimulator. ³

During the past 20 years, kratom use has spread beyond Asia, particularly throughout North America and Europe. ⁴ The market now ranges from whole-leaf products to extracts such as 7-hydroxymitragynine and mitragynine pseudoindoxyl, which increase potency. At low doses, kratom has mild stimulant effects and improves alertness, energy, and sociability, while higher doses are taken for analgesia and relief of chronic pain.^5,6 Many people with opioid use disorder use kratom to manage withdrawal symptoms, and intermediate doses are valued for calming effects.^5,7 Relatively little is known about whether kratom use is associated with other substance use or how it interacts with other substances.

To estimate the current prevalence of kratom use in the United States, we examined weighted data from the National Survey on Drug Use and Health for 2021-2023. ⁸ In 2021, an estimated 1.62% (n = 4 401 485) of people aged ≥12 years in the United States had ever used kratom. This percentage increased by 10.5% in 2022 to 1.79% (n = 4 926 473) and increased again in 2023 to 1.84% (n = 5 069 109), suggesting a gradual uptick in kratom use and popularity. ⁸ Due to changes in survey collection and weighting, data from before 2021 are not comparable for trend analysis. Deaths reported to poison control centers and the State Unintentional Drug Overdose Reporting System show that 0.56% of people who unintentionally overdosed had kratom in their system and that polysubstance use plays a major role in deaths associated with kratom.^9-12

Despite this long history of medicinal use, kratom is not a dietary supplement that has been approved by the US Food and Drug Administration (FDA), and the rules and regulations defined in the Dietary Supplement Health and Education Act of 1994 ¹³ do not apply to kratom products. In 2017-2018, the FDA publicly expressed concerns about the addictive potential of kratom, and more recently, in July 2025, the FDA recommended a scheduling action for 7-hydroxymitragynine. ¹⁴ In addition to case reports, national surveillance from the National Poison Data System documents kratom exposures in the United States, supporting kratom’s risk as an emerging threat to public health. ¹⁵

In this commentary, we focus on kratom drinks that are sold as prepackaged beverages, typically in a shot or small volume size, and that are highly concentrated. Kratom drinks first began appearing in specialty shops in 2019, with Feel Free Wellness Tonic entering 7-Eleven stores by 2022. ¹⁶ This appearance marked a major shift in the kratom market: whereas earlier consumers actively sought kratom for specific effects, these drinks were now accessible to casual shoppers who may have no prior knowledge of the substance. Following their entry into 7-Eleven, kratom beverages quickly expanded into grocery stores, convenience stores, and gas stations. Like the opioid and electronic cigarette (e-cigarette) crises, concerns about harm from the rapid expansion of kratom beverages have been documented in the legal system.^17,18 For example, a recent lawsuit alleges that 7-Eleven engaged in unfair practices by selling kratom drinks without disclosing their harmful ingredients. ¹⁹

We focus on kratom drinks in this commentary because of their widespread availability. However, other concerning products are rapidly emerging, including 7-hydroxymitragynine formulations that appear to target children.^20,21 Tianeptine, another unregulated opioid-like product, may also be used as a substitute for kratom.^22,23 While whole-leaf kratom carries risks of tolerance, withdrawal, and addiction, these other opioid-like products elevate those risks considerably, ²⁴ and they warrant future study.

Kratom drinks have expanded the market for kratom from a traditional remedy to a mass-marketed beverage, causing it to reach a broader, less-informed consumer base and raising urgent questions about product safety, transparency, and regulation. In the next section, we outline why the kratom drink industry represents a unique and concerning subset of the broader kratom market.

Why Kratom Drinks Are Different—and Dangerous

Kratom drinks are not simply a new form of delivery. They are a new industry, built on a model of fast access, minimal regulation, and misleading marketing. In this section, we outline reasons why these drinks deserve immediate regulatory attention, drawing parallels between the kratom drink industry and the opioid and e-cigarette industries.

Deceptive Marketing and Wellness Branding

Marketed as a “sober alternative,” kratom drinks exploit consumer desire for psychoactive effects without alcohol. ²⁵ Kratom drinks are also often branded as “all-natural” or “plant-based” herbal supplements, exploiting the health-halo effect, or the tendency to associate such labels with safety and wellness. This naturalistic fallacy obscures the fact that mitragynine, the active compound in kratom, engages opioid receptors and can lead to tolerance, withdrawal, and misuse. ²⁶

Like e-cigarette brands, kratom companies may increasingly rely on aggressive social media marketing to sell their products.^16,27 These platforms allow companies to target advertisements based on individual characteristics and search history, maximizing consumer engagement and revenue.

Kratom drinks often have advertised benefits such as increased relaxation, productivity, focus, and mood enhancement. While kratom does offer some of these effects, they differ substantially across individuals and products. Marketing materials often omit information about the potential adverse effects of kratom, including agitation, seizures, and central nervous system depression, as well as the risks of dependence and abuse.^28,29 This selective marketing may cause kratom drink users to hold inaccurate beliefs about kratom drinks and their risks.

Lack of Transparency and Informed Consent

Kratom drinks often have limited or confusing information about the quantity of kratom in their drinks, sometimes omitting that kratom is in their product at all. This gap in labeling transparency prevents consumers from being able to know the amount of kratom they have consumed and increases the risk of adverse reactions, including overconsumption and dependence. ³⁰ In the opioid crisis, incorrect labeling of OxyContin as a drug with low abuse potential helped contribute to the severity of the opioid epidemic and ultimately led to increased opioid-related deaths.^31,32 A lack of transparency in the e-cigarette industry, namely, through hidden flavor delivery technologies, targeted new users and consumers of e-cigarettes, which increased their use. ³³ We are uncertain about how many people actually understand and know what kratom is. Before the introduction of these beverages, kratom use typically involved intentional product selection and careful dosing, often accompanied by personal research about types, sources, and methods of use. ³⁴ In contrast, kratom drinks occupy a gray area: they are widely available and often consumed casually.

No Regulation and Easy Access and Consumption

Kratom is not regulated by the FDA or any other federal agency in the United States. As a result, dosages are not standardized, and consumers have no reliable way of knowing what they are getting. They may ingest higher-than-recommended doses or receive products with inconsistent quality or composition. Kratom drinks also contain a varying amount of kratom, limiting consumer ability to dose accurately. ³⁵ For example, mitragynine levels in 16 commercial kratom products ranged from 2.76 to 20.05 mg/g. ³⁶ When the number of servings per drink is advertised, there is a wide range of servings: from 1 serving in a single container to 15 servings in a single container, with the latter causing a higher risk of overdose. ³⁵ This wide range demonstrates the urgent need for labeling that discloses the exact amount of kratom in each product. In addition, semisynthetic mitragynine pseudoindoxyl product and semisynthetic 7-hydroxymitragynine products are often incorrectly labeled as kratom, or botanical mitragynine. ³⁷ Even though they are sold legally, no human safety data about their consumption are available, and they do not conform to supplement regulation standards. ³⁷ Users who consume kratom drinks cannot be sure that they are consuming actual mitragynine, which can result in dangerous or worse health outcomes.

Many kratom drinks contain multiple plant extracts and substances. For example, many kratom drinks contain kava and kratom. One study analyzed the interaction of these substances, highlighting that taking these 2 products together during a single week is safe. ³⁸ It is important to note that this research was contracted by Botanic Tonics, the makers of Feel Free Classic Tonic. The long-term effects of the interaction from these 2 drugs has not been studied, meaning unintended and negative consequences may result from their interaction. Many users also buy kratom from smoke shops and liquor stores, increasing the likelihood of polysubstance use with kratom.

Kratom drink producers have made access to and consumption of kratom easy. Kratom drinks are often placed near checkout stands, which promotes brand recognition and impulse purchases, especially among uninformed consumers. ³⁹ Retailers may lack knowledge about kratom and cannot effectively inform consumers about its risks, leading to widespread misinformation and a general lack of consumer awareness. Traditional, or whole-leaf, kratom requires preparation and has a bitter taste, which may discourage impulsive use. It is composed almost entirely of fiber, which can lead to feelings of fullness and bloating. ⁴⁰ Kratom extracts and ready-to-drink beverages bypass this limitation, enabling people to consume far greater amounts than they otherwise could and making consumption easier and faster.

Rapid Expansion Is Outpacing Oversight

Kratom drinks have expanded the base of customers from people actively seeking kratom to anyone who frequents a gas station, convenience store, or grocery store. Young, health-conscious, or overworked professionals, people who might never otherwise consider consuming kratom, now have easy access to the drinks. The e-cigarette industry used a similar strategy, creating flavored products that appealed to young people and nonsmokers and downplaying their health risks. ⁴¹

The expansion of kratom to retail spaces has led to a rapid growth of the kratom drink market in the past 5 years. For example, Botanic Tonics announced in a 2024 press release that they had products in 30,000 stores in the United States, which more than doubled their previous store count. ⁴² One study conducted telephone calls of tobacco specialty stores and found that 72% of all stores sold kratom, and in 21 states, at least 90% of stores reported selling kratom. ⁴³

Taken together, these characteristics illustrate a concerning pattern. Kratom drinks have exploited regulatory gaps, consumer ignorance, and a health-halo effect to rapidly expand their market. Without meaningful oversight, they have the potential to contribute to the same types of misinformation and harm witnessed in the opioid and e-cigarette crises.

Implications for Public Health Practice and Policy

Public health officials have an opportunity to act before the damage is heightened. While policymakers can learn from the regulation of OxyContin and e-cigarettes, the regulatory pathways differ fundamentally. OxyContin advanced within an FDA-approved, US Drug Enforcement Administration Schedule II prescriber–mediated system; kratom beverages have no FDA-approved uses, have expanded in retail and online markets amid FDA consumer warnings, and (absent an accepted medical use) would default to Schedule I under the Controlled Substances Act. ⁴⁴ Although some states have passed consumer protection laws for kratom, they lag behind the beverage/extract marketplace. In the following section, we identify critical federal-level regulations to enhance the safety of kratom use.

Strengthen Federal Oversight and Regulation

Despite state and local legislation, rates of noncompliance with local ordinances banning kratom are high. ⁴³ High rates of noncompliance may stem from a lack of a preregistration process, whereby kratom drink producers would register their product specifications and manufacturing details with a local, state, or federal entity before the product is available for sale. This process would facilitate oversight for product approval and policy enforcement. Federal oversight, with the incorporation of a preregistration process, is needed to inform sellers, retailers, and consumers about kratom drink products. Continued FDA oversight of kratom, whether as a supplement or drug, alongside standardizing dosage and prohibiting semisynthetic analogs, is an important starting point for strengthening the safety of kratom products.

Mandate Accurate Labeling and Warning Requirements

Currently, kratom drink producers have no requirements for including warning labels on their products. However, a substantial body of research highlights that warning labels help consumers make informed decisions about product consumption. ⁴⁵ An FDA-created warning label for e-cigarettes was more effective than those created by individual companies, and it reduced e-cigarette use by increasing risk perception. ⁴⁶ Opioid medications currently feature a boxed warning, the FDA’s most serious safety warning. OxyContin’s ability to sidestep the effect of this warning, by promoting the idea that addiction to its product was rare, led to increased use and a false sense of safety about consuming the product. ⁴⁵ This example highlights the importance of not only requiring warning labels but also ensuring that they accurately convey the product’s risks and potential for dependence and abuse.

Restrict Marketing and Point-of-Sale Practices

In addition to regulating the product itself, regulation of the label, presentation, and marketing of the product is also critical. One study showed that geographic areas with less regulation of the marketing of e-cigarettes had higher rates of e-cigarette use in the past 30 days. ⁴⁷ Marketing kratom drinks as “natural” or “wellness” products should be closely monitored and restricted, because such framing can create a health-halo effect that leads consumers to underestimate the risks associated with the product. Kratom drinks should not be placed near checkout counters, and regulators should ensure that companies are not targeting populations at a heightened risk of developing dependence, such as people recovering from substance use disorder or children.

Educate Retailers and Consumers

Retailer education is especially critical when consumers are unfamiliar with the product they are purchasing. If someone reaches the front of the store, sees a kratom drink, and asks the retailer what it is, the retailer’s response may determine whether they choose to buy it.

Educating retailers about the harms of, and laws regarding, cigarette sales to minors led to a sustained reduction in sales. ⁴⁸ In July 2012, the FDA approved the Risk Evaluation and Mitigation Strategy, a drug safety program that the FDA requires for some medications, to educate health care providers and patients about the risks of opioids. ⁴⁹ Following this intervention, both the rate and volume of opioid prescriptions declined. ⁴⁹

Consumer education about the product is also important. Social media messaging about the risks of e-cigarettes increased knowledge and shifted beliefs about those risks. ⁵⁰ Similarly, a study evaluating a mass-media intervention on opioid misuse found that people with campaign awareness had greater opioid-related knowledge compared with those with no awareness of the campaign. ⁵¹ A public health campaign promoting safe kratom use, alongside improved front-label transparency, can reduce misuse and support healthier consumption choices of kratom drinks.

Expand Research and Surveillance

As was the case during the opioid and e-cigarette crises, the research and medical communities have lagged behind in studying and treating kratom use. Social media data indicate that many users have turned to online forums to overcome kratom addiction and manage withdrawal symptoms. ³⁴ Yet almost no guidance exists for practitioners on how to address these conditions.

This gap partly stems from the limited research on kratom, which is a consequence of limited data. The National Survey on Drug Use and Health is the only publicly available national health survey that includes kratom-related questions, and it began doing so only in 2019. Much of the existing research relies on data from self-identified kratom users, which may exclude people who unknowingly consume kratom in beverages. The lack of product transparency further undermines data reliability. Moreover, most studies aggregate all kratom products, mixing traditional forms with ready-to-drink formulations, despite these formulations being more accessible than traditional forms to a broader population. Consequently, current research may understate both the prevalence of kratom use and the associated risks. More research, supported by publicly available data on kratom and kratom drinks, is essential for understanding the full scope of kratom use in the United States.

Conclusion

No single actor is solely to blame for our limited knowledge about kratom drinks; rather, the rapid expansion of the kratom beverage industry has outpaced regulators, researchers, and health professionals, leaving them without the tools or data needed to respond effectively. The story of kratom drinks is still being written. Whether it ends as failed oversight or a successful intervention depends on what we do next.