Described by the Food and Drug Administration (FDA) as “another wave of the opioid epidemic,” a rapidly expanding surge of wrongful death and product liability lawsuits is targeting manufacturers, distributors, and retailers of kratom products across the United States. These actions, filed in jurisdictions spanning from Washington State to New York, assert claims including strict liability, negligence, failure to warn, breach of warranty, fraud, and wrongful death. Plaintiffs’ firms have secured significant verdicts, including a $2.5 million jury award in Washington (see Coyne v. Chin 2 Corp.) and an $11 million default judgment in Florida (see Filippelli v. Grow, LLC et al.), signaling that courts are willing to impose substantial liability on industry participants.1 This Legal Update summarizes the key complaints and regulatory developments that manufacturers and distributors should monitor.
What is Kratom?
Kratom and 7-hydroxymitragynine (7-OH), a concentrated kratom byproduct, are plant-based, psychoactive substances. While traditionally used as a stimulant at low doses and a sedative at high doses, kratom has gained popularity in the United States as an unregulated herbal supplement. Kratom products are commonly used as a natural alternative to prescription painkillers to manage chronic pain and to treat conditions related to anxiety and depression, opioid use disorder, and opioid withdrawal.
Although some users find kratom products helpful, both the FDA and the Mayo Clinic have warned against its use. Among other things, kratom can be addictive and lead to substance use disorder (SUD) with individuals using kratom for longer than intended, using more kratom than intended, having cravings for kratom, continuing to use kratom despite adverse consequences, building tolerances to kratom, and experiencing withdrawal symptoms when kratom use was stopped. Kratom has also been linked to side effects such as liver toxicity, seizures, and—in rare cases—death. There is also evidence that certain kratom products were contaminated with Salmonella and/or concerning levels of heavy metals.
Manufacturers, retailers, and distributors of kratom and 7-OH products face material risk from both private plaintiff litigation and FDA enforcement. Private plaintiffs are pursuing wrongful-death, product-liability, failure-to-warn, consumer-protection, and related claims against actors throughout the supply chain, exposing manufacturers, retailers, and distributors to significant defense costs, expert-heavy causation disputes, punitive-damages demands, reputational harm, and potentially substantial verdicts or judgments. At the same time, the FDA’s position that kratom is not lawfully marketed as a drug, dietary supplement, or food additive, together with warning letters and scheduling recommendations for certain 7-OH products, can threaten product lines, importation, distribution channels, and retail sales.
Current State of Litigation
The complaints filed to date—spanning jurisdictions including Washington, Georgia, Florida, New York, Pennsylvania, Texas, California, Ohio, Colorado, Connecticut, and New Mexico—assert a recurring constellation of legal theories. Strict products liability is the most prevalent claim, asserted under three theories: manufacturing defect, design defect, and failure to warn. The complaints also assert negligence, alleging breaches of duty in the design, manufacture, testing, marketing, labeling, and sale of kratom, as well as wrongful death on behalf of decedents’ estates. Breach of implied warranty of merchantability and breach of express warranty appear in most filings, with plaintiffs alleging defendants represented kratom as safe, natural, lab-tested, and non-addictive when it was not. Some actions additionally plead survival claims seeking recovery for pre-death pain and suffering.
Beyond the common-law claims, many lawsuits add violations of federal and state laws. Some allege negligence per se, arguing that companies violated the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act (DSHEA) by failing to notify the FDA before selling a “new dietary ingredient” and by misbranding their products. Others bring consumer protection claims and class actions challenging allegedly deceptive marketing. Claims for fraud and misrepresentation are also common.
Finally, several complaints push beyond traditional product liability theories. In Devera v. Advanced Nutrition (Wyoming), LLC et al., the plaintiff alleges a broad conspiracy among manufacturers, distributors, and the American Kratom Association to illegally import, adulterate, and sell kratom while using opaque corporate structures to evade liability, and asserts alter ego and veil-piercing theories to reach individual defendants.2
Punitive damages are sought in nearly every case, with plaintiffs alleging willful, wanton, and reckless conduct demonstrating conscious indifference to consumer safety. This litigation wave continues to accelerate, with new wrongful death and product liability actions filed throughout 2025 and into 2026, as well as a fraud class action in the Northern District of California and state enforcement actions in Texas targeting retailers selling kratom products with illegal synthetic alkaloids.
Regulatory and Press Context
The litigation wave is unfolding against a backdrop of intensifying regulatory pressure. The FDA has consistently maintained that kratom is not lawful for sale as a dietary supplement and cannot be added to conventional foods, deeming it “adulterated” under the Federal Food, Drug, and Cosmetic Act. In February 2018, the FDA publicly stated that “kratom affects the same opioid brain receptors” and called on sellers to cease distribution immediately. The FDA has rejected all six New Drug Applications submitted for kratom.
On July 29, 2025, the FDA took its strongest action yet, recommending 7-OH, a concentrated kratom byproduct up to 30 times more potent than morphine, be scheduled under the Controlled Substances Act. The FDA issued warning letters to seven companies illegally distributing 7-OH products and expressed particular concern about products appealing to youth, such as fruit-flavored gummies. The DEA has categorized kratom as a “Drug and Chemical of Concern” and maintains that it has “no legitimate medical use in the United States.”
At the state level, the regulatory landscape is shifting rapidly. On May 4, 2026, a Utah federal court denied a preliminary injunction challenging Utah’s newly enacted Kratom Regulation Act, which bans the sale of kratom products mixed with non-kratom substances. The court rejected federal preemption arguments, holding that nothing in federal law requires any particular kratom product to be sold and that states retain the police power to ban such products.
What This Means for Manufacturers, Distributors, and Retailers
The kratom litigation landscape presents significant challenges for similarly situated manufacturers, distributors, and retailers. Plaintiffs’ theories rest heavily on failure-to-warn claims, areas where manufacturers, distributors, and retailers with robust compliance programs may be able to distinguish themselves from the more egregious actors featured in these complaints. Many of the cases to date have targeted companies that allegedly did not provide warnings, actively marketed kratom as a “safe” opioid alternative, used opaque corporate structures to evade accountability, or sold products that were illegally imported and adulterated.
Plaintiffs will argue that, in any event, the FDA’s persistent position and Utah’s legislative action demonstrate that nothing can be done to cure the inherently unsafe nature of the product. Manufacturers, distributors, and retailers should immediately evaluate their product labeling, marketing claims, corporate structures, and import documentation, and should retain experienced regulatory and litigation counsel to assess and mitigate exposure before plaintiffs’ firms come calling.
Footnotes
1. 28 Wash. App. 2d 1004 (2023); WL 11799560 (S.D. Fla. May 12, 2023).
2. Compl., No. 23-A-4832 (Ga. State Ct. Cobb Cnty. Oct. 24, 2023).
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