In the Absence of Regulation, Kratom Products Liability Lawsuits Arise

By Samantha Fow, Joshua Kappel, Barine Majewska

Sep 24, 2025

Key Takeaways

• This article explores the emergence of kratom as a novel ingredient in the wellness market and new legal risks facing companies in this sector.

• Beyond kratom's traditional uses, its rise in popularity as a recreational and alternative health product is giving rise to an evolving regulatory environment in the United States.

• There are growing risks and legal challenges facing kratom businesses, particularly with respect to product liability lawsuits.

• The article content explores best practices for reducing litigation exposure among operators in the kratom supply chain.

• Seek assistance from Vicente LLP's dedicated psychedelics practice if you operate a kratom business and are concerned about your exposure to legal risks.

What is Kratom, and Why is it Used?

Kratom is a tropical tree native to Southeast Asia, traditionally used in countries such as Thailand, Malaysia, and Myanmar for several hundred years. Indigenous communities in these areas would consume raw leaves orally by chewing or smoking them, but more frequently, the leaves are boiled in water to produce teas. In addition to these more traditional preparation methods, the leaves may be dried and processed into powders, capsules, and extracts. Historically, kratom has been used in folk remedies for treating a range of ailments, including as a means to address symptoms of opiate withdrawal, pain, fatigue, and to produce euphoria.

Kratom is often used as a recreational drug, particularly in the West. Kratom extracts contain multiple biologically active phytochemicals, which account for the substance's psychoactive properties. Its reputation as a recreational substance led to the proposed categorization of kratom as a Schedule I drug under the federal Controlled Substances Act (CSA) by the U.S. Drug Enforcement Administration (DEA) in 2016, but it was ultimately listed as a Drug and Chemical of Concern and left up to the federal Food and Drug Administration (FDA) to regulate as a food additive or dietary supplement.

How Safe is Kratom?

Kratom's potential for dependence and addiction has been documented extensively. It is banned for recreational use in Malaysia and Thailand, though the Thai National Assembly recently legalized kratom for medical purposes. Nevertheless, the illicit use of kratom remains common, and in Thailand, it is among the most commonly used illegal substances.

In the U.S., the more fundamental issue underlying the growing demand for kratom is the current opioid abuse epidemic. In recent years, commercial preparations of kratom have become increasingly available. In 2017, there were an estimated 3 million to 5 million kratom users in the United States. Between 2011 and 2017, over 1,800 total calls related to kratom ingestion were received by U.S. poison control centers, with nearly two-thirds of these occurring in the last 2 years of the period. This acceleration indicates an increasing use of the substance. This has coincided with trends observed during the U.S. opioid epidemic, as patients with opioid dependence often resort to kratom to cope with addiction and withdrawal. In fact, in some circumstances, it has been heralded as a legal, inexpensive alternative to more formal opioid replacement regimens. Kratom is also sought out by those who wish to self-medicate for health conditions such as chronic pain.

The efficacy of kratom for such purposes remains highly questionable. More research is needed to establish a conclusive answer on whether the potential benefits of kratom outweigh the likely dangers associated with its own addiction potential in the course of regular use.

Aside from its potential for abuse, kratom poses numerous other risks to patients. Without regulatory oversight, there is little to ensure the authenticity, purity, quality, potency, and safety of commercially available kratom preparations. Consequently, it isn't easy to know for certain what substances are actually present within a commercially available kratom preparation. Additionally, due to adulteration, the concentration of psychoactive compounds can vary considerably. For instance, it has been reported that kratom products may be altered by artificially increasing levels of 7-OH-mitragynine (7-OH) to enhance potency.

Multiple instances of deliberate adulteration of kratom have been documented, for example, by adding synthetic substances such as phenylethylamine (PEA) or O-desmethyltramadol, both of which have resulted in deaths. Laboratory and epidemiological evidence also identified kratom as the source of a multi-state Salmonella outbreak in 2018, and there have been many cases describing the sale of kratom products later found to contain harmful heavy metal contaminants.

How are Novel Ingredients Like Kratom Regulated?

The Controlled Substances Act (CSA) creates the federal framework for regulating drugs and other substances deemed to pose a risk of abuse and dependence. The CSA divides controlled substances into five numbered lists, known as Schedules I-V, with Schedule I status imposing the most stringent restrictions and no currently accepted medical use. Congress may modify these schedules through legislation, or the DEA can initiate rulemaking to schedule, reschedule, or deschedule substances under the CSA. Except for kratom, which is discussed in greater detail below, the novel ingredients discussed in this article are not regulated as controlled substances under the CSA. Instead, they are regulated as dietary supplements or sometimes, not at all.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, the FDA may regulate drugs and dietary supplements sold in the United States. The FDA is the federal agency that oversees both supplements and medicines, but FDA regulations for nutritional supplements are different from those for prescription or over-the-counter medicines. Dietary supplements are products intended to supplement the diet; they are not medicines and are not intended to treat, prevent, or cure diseases.

FDA must approve medicines before they can be sold or marketed, but supplements do not require this approval. Instead, it is up to supplement companies to be responsible for evidence that their products are safe and that the label claims are truthful and not misleading. However, as long as the product does not contain a new dietary ingredient, the company does not have to provide this safety evidence to the FDA before the product is marketed.

Dietary supplement labels may include certain health-related claims, which can confuse some consumers who expect this information to be vetted by an agency charged with oversight. Manufacturers are permitted to say, for example, that a supplement promotes health or supports a body part or physical function. Still, any such claims must be followed by the words, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

FDA monitors the marketplace for potential illegal products that may be unsafe or make false or misleading claims. If the FDA finds a dietary supplement unsafe, it may remove the product from the marketplace or ask the manufacturer to recall it voluntarily. The Federal Trade Commission monitors product advertising and requires information about a supplement product to be truthful and not misleading. These agencies can take legal action against companies and websites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

How is Kratom Regulated, Specifically?

Currently, there are no legal drug products in the United States that contain kratom or its main chemical components. The FDA has not approved any prescription or over-the-counter medications with kratom, mitragynine, or 7-hydroxymitragynine (7-OH-mitragynine). Suppose someone submits a new drug application for kratom or one of its components to treat a specific medical condition. In that case, the FDA will review the scientific evidence to determine if it is safe and effective for that use. Until then, according to the FDA, kratom should not be used in dietary supplements.

The FDA position is that supplements containing kratom are considered unsafe and are not allowed to be sold legally, and adding kratom to regular food is also not allowed. Products with kratom as a food additive are considered unsafe. Because of these reasons, kratom can't be legally marketed as a dietary supplement or food in the U.S. under the federal view. While enforcement has not been substantial, this position has resulted in the FDA issuing alerts, authorizing seizures of imported kratom products, and those manufactured in the U.S.

The FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, substance use disorder (SUD) and in rare cases, death. Even so, until the agency can thoroughly assess the safety and effectiveness of kratom or its compounds, the FDA will continue to advise the public not to use kratom as a treatment for medical conditions. The FDA will also keep monitoring new data and trends to understand kratom and its effects better.

Unapproved drug products are some of the most challenging products the FDA regulates. This is due to the complex and fragmented supply chain of distributors, wholesalers, retailers, and individuals. Entities in these supply chains are not usually registered with the FDA, may operate out of residences, and distribute kratom through sales made on the internet, social media or smoke shops. As of early 2025, the FDA has taken the position that kratom is an unapproved new dietary ingredient and therefore may not be marketed in the United States as either a nutritional supplement or a food additive. The FDA has issued a series of import alerts authorizing FDA personnel to seize imported kratom products from specified firms. The FDA has also seized kratom products manufactured in the United States, including an April 2023 seizure of kratom products worth approximately $3 million from an Oklahoma company.

As a result of growing concerns over the safety and availability of kratom, on July 29, 2025, the FDA announced its intention to take action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act. This follows action taken by the DEA in 2016, when the agency published notice of its intent to place mitragynine and 7-hydroxymitragynine in Schedule I on an emergency basis. If passed, this would have criminalized possession of kratom and made distribution a felony. However, the DEA withdrew that notice and instead elected to list kratom as a Drug and Chemical of Concern, but to date has not exercised its authority to schedule kratom or its active compounds under the CSA. There is also an increasingly broad patchwork of state-level bans on the sale and use of kratom.

State Laws Addressing Kratom

As Congress and the federal regulatory agencies consider action on kratom products, several states have already moved to ban or regulate kratom and its key alkaloids, mitragynine and 7-hydroxymitragynine. As of August 2025, 21 states and the District of Columbia regulate kratom in some way, and an additional eight states ban kratom. This has created a patchwork of restrictions, requirements, and outright bans that anyone active in the novel ingredients sector must know. Here are a few quick facts about state-level kratom laws:

• States That Ban Kratom: Eight states, as of August 2025 (Alabama, Arkansas, Connecticut [effective October 2025], Indiana, Louisiana, Rhode Island [although it has reversed its ban effective as of April 2026], Vermont, and Wisconsin), outright ban kratom and its active compounds. In these jurisdictions, kratom is a controlled substance, and its possession or sale is punishable by criminal penalty.

• States That Regulate Kratom: The possession, sale, manufacture, and distribution of kratom products is regulated, either through a Kratom Consumer Protection Act or otherwise, in 21 states and the District of Columbia. These states impose various requirements, including, without limitation: (a) age restrictions; (b) marketing limitations; (c) what qualifies as an adulterated and contaminated product; (d) strength limits; (e) labeling requirements; (f) testing and sampling requirements; (g) registration and permitting requirements; (h) whether natural and/or synthetics are permitted; (i) local authority to adopt stricter controls or ban kratom entirely; (j) whether citizens have a private right to sue if harmed by a violation of kratom laws; and (k) taxes.

• States With No Kratom Laws: Twenty-one states do not control or regulate kratom. Additionally, kratom is not regulated or controlled in any of the U.S. territories.

It is important to note that many states have specific prohibitions on 7-OH, including, without limitation. On the concentration of 7-OH in kratom products or banning the sale of kratom products containing synthetic or isolated forms of 7-OH.

A map showing the status of state-level kratom regulation is provided below:

In addition to these existing laws, several other state legislatures are considering action on kratom. Tennessee, for example, is considering either a ban or tightly controlled regulation of kratom in the next legislative session. The varying nature of the proposed state-level kratom legislation underscores the differing perspectives on the substance's use and safety that are likely to be resolved by eventual federal action.

Kratom Products Liability Lawsuits Are on the Rise

The kratom product liability landscape has shifted. For kratom manufacturers, retailers, and online platforms, the message is clear: legal risks are on the rise.

Kratom and Products Liability

Products liability refers to the legal responsibility vested in manufacturers, sellers, or distributors for harm caused by defective products. It applies to all parties in the supply chain.

To establish a claim, plaintiffs must show the defendant sold a defective product, was a commercial seller, the product was used in a reasonably foreseeable way, an injury occurred, and the defect caused that injury.

There are three main types of defects:

1. Design defects – inherent flaws in a product's design.

2. Manufacturing defects – flaws occurring during production.

3. Marketing defects – inadequate warnings or instructions.

In most states, product liability is typically a strict liability offense, meaning that a plaintiff can recover against a defendant company if the product is defective and causes the plaintiff harm when used reasonably foreseeable, without the plaintiff having to show that the defendant company was negligent. However, claims can also be based on negligence, strict liability, or breach of warranty, depending on state law. Each state has laws governing product liability lawsuits in its jurisdiction, and no federal product liability law exists.

Due to the potentially harmful nature of kratom's pharmacological effects, there is a surge of litigation targeting alleged defects in product design, manufacturing, and especially marketing of kratom and its derivatives, particularly wrongful death and injury claims. This litigation risk is intensified by the increasingly stringent state-level regulations promulgated without federal action.

Why Kratom Businesses Are Facing Increasing Litigation Risks

As kratom's popularity continues to grow across the U.S., so does the legal fallout. Attorneys and consumer advocates expect a significant uptick in kratom-related lawsuits in 2025, including wrongful death claims and class actions tied to addiction, health complications, and deceptive marketing.

Recent lawsuits are increasingly alleging that kratom products are deceptively marketed as safe and natural, despite mounting evidence that high-potency kratom extracts can lead to addiction, withdrawal, and even death. For example, in I.P. and J.M. v. Hundreds Premium LLC, filed recently in July 2025, plaintiffs claim the company marketed "Exotic Blue Magic Kratom" without disclosing its potential to cause opioid-like dependency. This case is part of a broader trend where product liability, deceptive marketing, and failure-to-warn claims are increasingly being brought against companies in the kratom supply chain. Other recent high-profile verdicts include a $2.5 million wrongful death judgment against Kratom Divine, an $11 million default judgment against Grow LLC ("The Kratom Distro"), and several other multi-million dollar judgments based on wrongful death.

Even beyond wrongful death cases, litigators are increasingly making and defending arguments linked to serious adverse effects caused by modern kratom formulations (which, for the most part, bear little resemblance to the leaf traditionally used in Southeast Asian communities). Attorneys are seeing a steady increase in kratom-related products liability cases. At the center of many of these claims is the assertion that kratom manufacturers and retailers have failed in their duty to ensure consumer safety, such as through:

• Failure to Warn: Many kratom lawsuits are grounded in the argument that companies failed to provide adequate warnings about addiction potential, respiratory depression, or withdrawal risks. These cases are particularly prominent in jurisdictions that expressly require kratom product labeling.

• Deceptive Marketing and Fraud by Omission: Plaintiffs are increasingly targeting language such as "natural," "safe," or "therapeutic" on kratom packaging and websites. These deceptive marketing cases typically allege that companies omitted material information about the product's pharmacological effects. Businesses operating in California, Oregon, New York, and other states with strong consumer protection laws face heightened exposure.

• Mislabeling and Unapproved Claims: Some companies attempt to avoid regulatory scrutiny by labeling kratom products "not for human consumption," despite actively marketing them for ingestion. Others make therapeutic claims (e.g., "supports opioid withdrawal" or "pain relief") without FDA approval. This approach potentially triggers both litigation and regulatory enforcement.

• Product Contamination: The sale of adulterated or contaminated kratom products—especially those containing heavy metals, fentanyl, or synthetic compounds—can lead to strict liability under state product safety laws. Several states, including Utah and Oregon, now require third-party lab testing and clear labeling of alkaloid content.

Mitigating Product Liability Risk for Kratom Businesses

Because of the relatively high litigation risk posed to kratom businesses, vendors in this space should aspire to go above and beyond basic compliance to ensure their business and consumers are adequately protected. Here are some tips on best practices to avoid potential legal risks to your kratom business:

1. Prioritize rigorous quality control and testing: Every batch of kratom products should be tested for contaminants such as heavy metals, pesticides, bacteria, and residual solvents. Vendors should only work with reputable third-party laboratories that provide verifiable Certificates of Analysis (COAs) and maintain detailed records of testing protocols and results.

2. Accurate and transparent labeling: Product labels should clearly list the strain, dosage, and full ingredient list, and include disclosures about potential side effects, medication interactions, and warnings for at-risk populations. Unsubstantiated therapeutic claims, such as "opioid alternative" or "pain cure," must be avoided at all costs.

3. Comprehensive consumer warnings: These should include clear guidance on proper use, addiction potential (particularly for enhanced or concentrated products), and cautions against combining kratom with alcohol, prescription drugs, or other supplements. Updating labels and prioritizing consumer education can reduce harm and demonstrate the vendor's commitment to safety.

4. Maintain thorough documentation: This includes batch testing results, ingredient sourcing records, marketing materials, labeling archives, and internal safety audits. Such records can ultimately prove crucial in defending against product liability claims.

5. Know applicable laws and monitor legal and regulatory changes: Kratom laws are rapidly evolving. Staying informed about legal developments, adjusting packaging and distribution practices as needed, and working with legal counsel to implement compliant policies are all essential steps.

Conclusion & Key Takeaways

Kratom businesses should build a proactive legal strategy rather than wait for litigation to strike. Collaborating with a law firm experienced in kratom-related product liability can help vendors audit their compliance systems, review marketing and labeling materials, create a proactive litigation response plan, and train internal teams on best practices to avoid future risk.

Vicente LLP brings deep expertise in emerging substances and regulatory compliance. Our dedicated psychedelics department offers tailored legal guidance to businesses involved in the kratom industry. Contact our legal team for a complimentary consultation if you could benefit from some advice on risk mitigation, labeling practices, and evolving state and federal regulations impacting kratom and related products. In the meantime, stay informed about how and why kratom and other novel ingredients are controlled under the law by returning to our blog for regular updates and insights.