Once confined largely to traditional use in parts of Southeast Asia, kratom has moved into the mainstream of wellness and consumer markets in the United States, prompting new public health questions and a patchwork of policy responses. As sales increase and products diversify, regulators are focusing on how kratom and related substances fit within existing frameworks for food, supplements, and controlled substances.
Kratom products originate from the leaves of Mitragyna speciosa, a tree native to countries such as Thailand, Malaysia, and Indonesia, where people have long used the plant as fresh leaves or teas in sociocultural and work-related contexts. Research published in medical journals has documented traditional use to address fatigue and for self-management of opioid withdrawal symptoms, while also emphasizing that robust clinical trials are lacking to establish safety and efficacy for any therapeutic indication. In the United States, kratom products are typically sold as powders, capsules, extracts, gummies, and ready-to-drink beverages, and are promoted through a mix of online vendors, specialty shops, and convenience outlets.
The pharmacology of kratom centers on alkaloids, especially mitragynine and 7-hydroxymitragynine (7‑OH), which interact with opioid receptors and other targets in the body. Studies have shown that mitragynine is the most abundant alkaloid in the raw leaf, with 7‑OH naturally present only at trace levels, but with relatively high potency at mu-opioid receptors compared with mitragynine. As a result, the balance between these compounds, and the way they are processed or altered, plays a central role in how products are viewed by toxicologists and regulators.
In the U.S. marketplace, a notable development has been the emergence of concentrated or synthetic 7‑OH formulations that differ significantly from traditional whole-leaf material. Analyses of commercial products have identified items in which 7‑OH is the predominant alkaloid, often in nonswallowed forms such as shots, dissolvable strips, or chewables, a departure from typical dietary supplement use. Case reports, poison center surveillance, and state health advisories have linked higher-concentration 7‑OH exposure to outcomes such as rapid heart rate, increased blood pressure, and seizures, particularly when products are used in combination with other substances.
Federal agencies have responded by clarifying how kratom fits into existing statutory authorities and by focusing on concentrated derivatives. The U.S. Food and Drug Administration (FDA) states on its dedicated “FDA and Kratom” page that kratom is not lawfully marketed in the United States as a drug product, dietary supplement, or conventional food additive, and the agency has issued import alerts and warning letters to firms selling kratom-containing products with unapproved medical claims. In July 2025, FDA went a step further and publicly recommended that the Drug Enforcement Administration (DEA) classify 7‑OH under the Controlled Substances Act, citing a scientific review that described concentrated 7‑OH offerings as opioid-like products associated with significant safety concerns.
Even as federal scheduling of 7‑OH remains under consideration, use of kratom more broadly has grown. Data from the National Survey on Drug Use and Health (NSDUH), analyzed in a 2023 dataset released by the Substance Abuse and Mental Health Services Administration (SAMHSA), indicate that about 1.6 million people in the United States reported past-year kratom use, with prevalence estimates for adults hovering around 0.7 percent in combined 2021–2023 analyses. Peer-reviewed epidemiological work based on NSDUH has also found associations between past-year kratom use and markers of substance use disorders, while underscoring that most respondents who reported using kratom did not report severe adverse effects.
That growing footprint has intensified interest at the state level, where lawmakers and public health officials face decisions on how to classify kratom and 7‑OH, how to regulate manufacturing and retail sales, and what guardrails to put in place for labeling and age access. Before FDA’s 2025 scheduling recommendation, several states had already moved to treat kratom’s psychoactive components as controlled substances, effectively barring their sale. According to legislative analyses and state code compilations, jurisdictions including Alabama, Arkansas, Indiana, Louisiana, Vermont, Wisconsin, and the District of Columbia list mitragynine and 7‑OH in their controlled substances schedules.
Other states have opted for regulatory frameworks that allow kratom sales under defined conditions rather than prohibiting them outright. These laws often include minimum age requirements, restrictions on product forms or strengths, labeling rules, testing mandates, and registration or licensing for manufacturers and retailers, sometimes accompanied by excise or sales taxes. As of spring 2025, nearly half of U.S. states and the District of Columbia had enacted some form of statute or rule addressing kratom or its constituents, according to summaries compiled by health policy organizations and the Association of Food and Drug Officials’ kratom regulatory guidance.
The 2024 and 2025 legislative sessions highlighted how divided statehouses remain on the question of whether kratom should be restricted, regulated, or both. More than 30 states introduced bills dealing with the possession, distribution, sale, or manufacture of kratom products during that period. In at least seven states, lawmakers simultaneously considered measures that would schedule kratom alkaloids as controlled substances and competing proposals that would set up regulatory systems focused on consumer protection and age gating. This pattern of conflicting bills in the same jurisdiction illustrates the unresolved debates among policymakers, advocates, and public health practitioners on kratom’s risks, benefits, and appropriate role in harm reduction or pain management.
For states that have chosen a regulatory path, executive branch agencies have become key actors in defining practical rules governing the kratom marketplace. Utah was among the early movers, passing SB 58 in 2019 to establish basic standards for labeling kratom products and directing the state Department of Agriculture and Food to write rules on testing and registration. Utah’s administrative code now includes requirements for contaminant testing, disclosure of alkaloid content, and labeling that discourages use by minors, providing a template that other states have studied.
Oregon followed with HB 4010 in 2022, assigning the Department of Revenue to oversee registration procedures for entities distributing or selling kratom products and requiring third-party testing before products go to market. Administrative rules finalized in 2023 detail the registration and testing process and outline penalties for selling unregistered or noncompliant products, positioning kratom regulations alongside the state’s broader efforts to supervise emerging cannabis and hemp-derived markets. These steps reflect a trend toward leveraging existing regulatory infrastructure for novel psychoactive substances that enter the consumer space through foods and supplements.
West Virginia used its 2023 SB 220 to direct the Commissioner of Agriculture to propose rules covering kratom manufacturing, distribution, and retail sales. The regulations that took effect in late 2025 address labeling, quality standards, and fee structures, creating a licensing scheme that gives the state more visibility into businesses operating in the kratom supply chain. Provisions in West Virginia’s framework echo elements seen in other consumer protection statutes, including requirements to withhold sales to individuals below a specified age and to prohibit adulteration with other active ingredients.
Several states have turned to explicit “Kratom Consumer Protection Acts” or similar legislation that combines product standards, age limits, and taxation. In Rhode Island, lawmakers approved HB 5565 and SB 792 in 2025, authorizing kratom sales to adults 21 and older while requiring products to be kept behind the sales counter. The statute assigns the Department of Health responsibility for licensing manufacturers, importers, distributors, and retailers, and imposes a 15 percent excise tax on kratom products. Such measures bring kratom closer to the regulatory treatment of other adult-use consumables, aligning oversight with the state’s public health and revenue priorities.
Florida’s Kratom Consumer Protection Act, CS/HB 179, also enacted in 2025, restricts sale and possession of kratom to individuals 21 and older and adds an 11 percent retail sales tax. Administration of the law falls to the Florida Department of Agriculture and Consumer Services, which is tasked with adopting rules and ensuring that products offered in the state comply with labeling and testing standards. Together, these acts in Rhode Island and Florida underscore a model in which states accept kratom as a consumer product under specified conditions while attempting to mitigate risks through age thresholds, oversight of supply chains, and financial disincentives.
Kratom is not the only substance prompting new questions for food and supplement regulation. Jurisdictions are also grappling with kava, hemp-derived cannabinoids, and psilocybin-containing products as they appear in beverages, edibles, and other consumables. The National Center for Complementary and Integrative Health notes on its kava information page that kava root has been used in traditional beverages for centuries in the South Pacific and is now widely promoted in the U.S. for anxiety and insomnia. At the same time, FDA has issued communications citing reports of liver toxicity and potential carcinogenic concerns, leading the agency to conclude that kava is not appropriate for use in conventional foods, even as it remains permitted as a dietary supplement when used in certain forms.
Hemp-derived cannabinoids, including various tetrahydrocannabinol (THC) isomers like delta‑8, delta‑9, and delta‑10 produced from hemp, have also proliferated in gummies, drinks, and snacks. The 2018 Farm Bill removed hemp from the federal controlled substances schedule but left significant room for interpretation about intoxicating derivatives, prompting a wave of state legislation and rulemaking. In a policy brief, the Council of State and Territorial Epidemiologists and other public health groups have described how differing definitions of “hemp” and “THC” in state law have produced divergent approaches to potency caps, packaging restrictions, and retail licensing for hemp-derived intoxicants.
Psilocybin, the psychoactive compound found in certain mushroom species, remains a Schedule I substance under federal law, meaning it is illegal to manufacture, possess, or distribute outside of approved research settings. However, some localities and states have moved toward decriminalization or tightly controlled therapeutic programs, creating ambiguity for related consumer products such as “mushroom edibles” that are not specifically addressed in the Federal Food, Drug, and Cosmetic Act. The U.S. Drug Enforcement Administration’s psilocybin fact sheet highlights its status as a substance without an accepted medical use at the federal level, even as clinical trials explore potential applications under controlled conditions.
For public health agencies, the convergence of kratom, kava, hemp-derived cannabinoids, and psilocybin-related products in food and supplement-like formats presents a common set of challenges. Regulators must determine whether products fall under dietary supplement provisions, should be treated as food additives requiring premarket approval, or belong in controlled substances schedules, often while working with limited or emerging data. Health departments also shoulder the responsibility of monitoring adverse event reports, engaging poison centers, and communicating with clinicians and consumers about known and potential risks without overstating or understating the current evidence base.
As policy debates continue, organizations such as the Association of State and Territorial Health Officials (ASTHO) and AFDO are tracking legislative trends, court decisions, and evolving scientific findings to assist states in developing coherent approaches. Their reports on kratom and other novel substances emphasize the importance of aligning laws with clear testing and labeling standards, transparent supply chains, and surveillance systems capable of detecting shifts in use patterns or health outcomes. The trajectory of kratom regulation over the next several years is likely to be shaped by this interplay between federal guidance, state experimentation, and ongoing research into how these products are used and how they affect public health.