Emerging Kratom Litigation: New Risks for Manufacturers, Retailers, and Online Platforms
Kratom, a botanical product increasingly popular for purported therapeutic benefits, is now at the epicenter of escalating litigation and regulatory scrutiny. The latest class-action suit, I.P. and J.M. v. Hundreds Premium LLC, filed on July 29, 2025, in the Southern District of California, epitomizes the rapidly evolving risk landscape. The lawsuit alleges deceptive marketing practices, claiming that Hundreds Premium misled consumers by promoting Exotic Blue Magic Kratom as a safe, natural supplement, without disclosing its opioid-like effects, significant addiction potential, and withdrawal risks.
This recent lawsuit underscores broader concerns already highlighted by multiple regulatory agencies, including the FDA, DEA, and CDC, and reinforces the emerging narrative: businesses involved in manufacturing, selling, or marketing kratom are increasingly vulnerable to serious legal repercussions.
Here’s what legal professionals need to know to strategically navigate this complex environment:
Three Essential Takeaways for Legal Professionals:
- Kratom litigation is intensifying, particularly around failure-to-warn and deceptive-marketing claims, threatening exposure across the supplement and wellness industries.
- Regulatory agencies (FDA, DEA) are signaling greater enforcement, possibly leading to kratom’s scheduling as a controlled substance, significantly escalating legal and commercial risks.
- Retailers and e-commerce platforms face heightened scrutiny and liability for inadequate disclosures about kratom’s addiction and health risks.
What is Kratom and Why It’s Under Fire?
Kratom comes from the Mitragyna speciosa tree in Southeast Asia. Local farmers and laborers have used it to boost energy and relieve pain for centuries. Traditional users would chew fresh leaves or make tea, taking moderate amounts when needed.
Modern Western usage looks completely different now. People use concentrated extracts, capsules, and stronger products that are nowhere near the strength of traditional preparations. These modern versions pack concentrated amounts of kratom's active compounds, which creates a very different risk profile than historical usage patterns.
The American kratom market has grown faster from a specialty botanical into a billion-dollar industry. In 2021, about 1.7 million Americans were taking kratom. They buy products marketed to improve wellness, energy, pain relief, and mood. The industry continues to thrive through smoke shops, convenience stores, and online retailers, even though the FDA hasn't approved kratom for medical use.
Kratom raises serious concerns because of its two main alkaloids: mitragynine and 7-hydroxymitragynine (7-OH). These compounds interact with the brain's opioid receptors just like morphine and heroin do. Research shows that 7-OH is substantially more potent than both mitragynine and morphine.
Scientists have found several concerning issues:
- 7-OH connects to mu-opioid receptors - the same way traditional opioids work to produce both benefits and harmful effects
- Users can develop dependency and experience withdrawal symptoms like opioid users
- Large doses might suppress breathing, which often leads to opioid overdose deaths
- 33% of users experience side effects.
Kratom's growing popularity has caught the attention of regulators, doctors, and legal experts. This increased scrutiny has led to the current wave of lawsuits.
Mapping the Emerging Risk Landscape
The litigation trajectory surrounding kratom, a botanical product containing opioid-like alkaloids such as mitragynine and 7-hydroxymitragynine, has sharply risen in recent years. Manufacturers and sellers previously marketed kratom as a safe, therapeutic alternative to prescription opioids. However, mounting scientific and regulatory evidence paints a starkly different picture:
Regulatory Catalysts: FDA, CDC, and DEA Actions
The FDA classifies kratom as an "unapproved dietary ingredient," explicitly banning it from dietary supplements due to health concerns, including addiction and overdose risks. In 2023, federal authorities notably seized kratom products worth over $3 million from an Oklahoma facility, further amplifying scrutiny.
The CDC’s analysis of overdose data revealed kratom involvement in 152 out of 27,338 overdose deaths from July 2016 to December 2017, with kratom identified as the sole substance in seven fatalities. Moreover, the DEA has labeled kratom as a "Drug and Chemical of Concern," placing it on par with regulated opioids regarding potential for abuse and addiction.
Latest Regulatory Update
On July 29, 2025, the U.S. Food and Drug Administration announced it will be taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA).
Legal Milestones: Jury Verdicts and Class Actions
Recent verdicts have dramatically increased litigation pressure:
- Kratom Divine faced a $2.5 million wrongful-death verdict, significantly impacting industry perceptions.
- Grow LLC (The Kratom Distro) received an $11 million default judgment in a wrongful-death case, emphasizing the substantial liabilities tied to inadequate warnings.
Beyond wrongful-death claims, class actions alleging consumer deception and breach of warranty, like the recent case against Hundreds Premium LLC, expand the potential plaintiff pool, thus escalating exposure dramatically.
Geographic Impact: State Bans and Localized Restrictions
Six states (Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin) have banned kratom. San Diego and other municipalities have also instituted localized prohibitions. Such bans underscore regulatory momentum and encourage additional litigation nationwide.
Core Legal Theories: Strategies and Counterstrategies
Plaintiffs primarily advance claims under state consumer protection statutes, including:
- California’s Unfair Competition Law (UCL) (Cal. Bus. & Prof. Code § 17200 et seq.)
- California’s False Advertising Law (FAL) (Cal. Bus. & Prof. Code § 17500 et seq.)
- California’s Consumers Legal Remedies Act (CLRA) (Cal. Civ. Code § 1750 et seq.)
- Oregon’s Unlawful Trade Practices Act (UTPA) (Or. Rev. Stat. § 646.605 et seq.)
- New York General Business Law § 349 (Deceptive Acts and Practices)
- New York General Business Law § 350 (False Advertising)
Fraud by Omission vs. Truth-in-Labeling Defenses
Plaintiffs argue companies deliberately concealed kratom’s addictive nature. Defendants typically counter that their marketing complies with federal labeling requirements or that kratom's risks remain scientifically disputed.
Failure to Warn: Product Liability and Defenses
Plaintiffs argue that sellers failed to adequately warn consumers about addiction and overdose risks. Defense strategies often hinge on federal preemption arguments, suggesting compliance with ambiguous federal labeling standards should negate liability.
Unjust Enrichment and Warranty Claims
Recent suits include unjust enrichment and breach-of-warranty claims, asserting companies knowingly profited from misleading kratom marketing. Defendants may respond by emphasizing consumer responsibility and existing general disclaimers.
Challenged Practices That Drive Litigation
Analysis of current litigation patterns and regulatory oversight indicates several industry practices that may precipitate future legal actions:
1. Misleading "Natural" or "Safe" Marketing
The characterization of kratom products as benign herbal supplements without sufficient disclosure of their pharmacological properties, specifically the presence of alkaloids (mitragynine, 7-hydroxymitragynine) that demonstrate opioid-receptor activity comparable to traditional opioids.
2. Absence of Addiction and Health-Risk Warnings
The omission of comprehensive warnings regarding potential addiction, withdrawal symptoms, overdose risks, proper dosing guidelines, and known physiological effects.
3. Illegal & Adulterated Product Sales
Distribution of kratom products containing contaminants such as heavy metals or undisclosed additives in violation of established product safety regulations and standards.
4. Unapproved Therapeutic Claims
Marketing communications suggesting medical or therapeutic benefits including pain management, anxiety reduction, depression treatment, or opioid withdrawal assistance without requisite FDA approval.
5. "Not for Human Consumption" Labels
The practice of intentionally mislabeling kratom products as non-consumable items such as incense or botanical specimens to circumvent regulatory requirements applicable to consumable products.
6. Targeting Vulnerable Consumer Groups
Marketing strategies directed toward potentially vulnerable populations, including individuals with substance dependence, chronic pain conditions, or mental health concerns, without adequate risk disclosures.
7. Enhanced or Concentrated Kratom Products
The manufacture and distribution of high-potency kratom extracts or isolated alkaloid products without corresponding disclosure of increased potency levels and associated risks, including enhanced addiction potential and more severe withdrawal manifestations.
Looking Ahead: Potential Regulatory and Litigation Outcomes
Legal professionals must remain vigilant as litigation and regulation around kratom evolve. Important questions remain open:
- More Class Actions, Mass Torts, & Copycat Lawsuits: Will the filing of class actions and mass torts nationwide continue to spread?
- DEA Scheduling: How would formal DEA scheduling of kratom as a controlled substance transform the legal landscape, potentially triggering widespread product bans?
- MDL Consolidation: Will increased filings lead to Multi-District Litigation consolidation, significantly altering defense strategies?
- State AG Enforcement: Could the expansion of Unfair, Deceptive, or Abusive Acts and Practices (UDAAP) enforcement further amplify liabilities?
- FDA Enforcement: Will the FDA issue more formal warning letters, intensifying litigation pressure on manufacturers, retailers, and platforms?
Track Emerging Kratom Litigation and Regulatory Developments
As kratom-related litigation accelerates and regulatory pressures mount, legal professionals face a rapidly evolving landscape filled with complex risks and shifting exposures. Timely insights into emerging cases, regulatory developments, and market trends are critical to proactively manage potential impacts and anticipate changes before they occur.
Rain Intelligence provides verified, strategic intelligence on active lawsuits, investigations, regulatory actions, and critical litigation trends affecting the kratom industry. Stay informed and ahead of critical developments that could shape your litigation and compliance strategies.
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