claim of failure to warn of kratom's addiction potential not preempted; a "disease claim" involves helping, not causing, disease

J.J. v. Ashlynn Marketing Gp., 2025 WL 1811854, No. 24-cv-00311-GPC-MSB (S.D. Cal. Jul. 1, 2025)

Plaintiffs sued on behalf of putative nationwide, California, and NY classes, alleging that Ashlynn failed to warn consumers of the potentially addictive nature of its products, which contain dried leaves from a plant called kratom. As alleged, “the active alkaloids in kratom ... work on the exact same opioid receptors in the human brain as morphine and its analogs” and it “has the same risks of addiction, dependency, and painful withdrawal symptoms, among various other negative side effects.” As a result, plaintiffs allege that kratom “has sunk its hooks into tens of thousands of unsuspecting customers and caused them serious physical, psychological, and financial harm.”

The symptoms of kratom withdrawal include: “irritability, anxiety, difficulty concentrating, depression, sleep disturbance including restless legs, tearing up, runny nose, muscle and bone pain, muscle spasms, diarrhea, decreased appetite, chills, inability to control temperature, and extreme dysphoria and malaise.” However, because it “does not produce a debilitating ‘high’ like cocaine or heroin, it is very easy for users to take the drug every day without feeling as though they are developing a drug addiction or harming themselves.”

Plaintiffs alleged that defendant had superior knowledge compared to reasonable consumers, and that it had received numerous user reports about the addictive potential of kratom in the United States. They also alleged that defendant interacted with growers and distributors in Southeast Asia who have disclosed the addictive nature of kratom to it. Nonetheless, its product only had “a bog-standard disclaimer stating that the Products are not regulated or evaluated by the FDA.”

product front ("all natural")

product back with disclaimer of FDA approval

Defendant argued that the FDCA preempted the claim because a warning about addiction would be a prohibited “disease” claim. A disease claim explicitly or implicitly claims “to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” As the court easily concluded, a disclosure that a supplement has addictive qualities is not a “claim to diagnose, mitigate, treat, cure, or prevent” disease. “Instead, such a disclosure informs the consumer that, rather than improving one’s health, kratom has exactly the opposite effect.” The defendant “can easily comply with state laws and the FDCA by avoiding false, misleading, or deceptive statements or omissions regarding kratom’s alleged addictiveness.”

The court did, however, dismiss nationwide class allegations because of differences in the consumer protection laws of the various states on reliance, burdens of proof, statutes of limitations, and damages.

Plaintiffs could bring claims for “unpurchased products” (forms in which they didn’t buy kratom) because the products were all substantially similar for purposes of their claims.

NY statutory and common law fraudulent omission claims: A plaintiff bringing a fraudulent omission claim must show either that (1) “the business alone possessed the relevant information,” or (2) “a consumer could not reasonably obtain the information.” This was sufficiently alleged; although defendant didn’t have exclusive knowledge of the risks, “an omission can still be actionable where it is shown that a consumer could not reasonably obtain the omitted information.”

At the pleading stage, it was enough to allege that “selective online materials or niche federally funded studies” are not “reasonably accessible or comprehensible to consumers”; that kratom is marketed as providing benefits without disclosure of its addictive potential, and, “most importantly,” “that consumers are not aware of the risks of kratom consumption before making their purchases because the available information is either difficult to access or, as with the medical literature, incomprehensible to the average person.” Misinformation about kratom is allegedly rampant.

California: A fraudulent omission must either (1) “be contrary to a representation actually made by the defendant,” or (2) “an omission of a fact the defendant was obliged to disclose.” A defendant “has a duty to disclose when either (1) the defect at issue relates to an unreasonable safety hazard or (2) the defect is material, ‘central to the product’s function,’ and the plaintiff alleges … (1) the defendant is in a fiduciary relationship with the plaintiff; (2) the defendant had exclusive knowledge of material facts not known to the plaintiff; (3) the defendant actively conceals a material fact from the plaintiff; or (4) the defendant makes partial representations but also suppresses some material facts.” This too was done.

Although there was a lot of public information about kratom, it was conflicting, and many documents referenced “complex studies” or were “difficult-to-access reports and letters.” It was plausible that the manufacturer had superior knowledge compared to the average consumer. Defendant argued that its labels directed users to consult with a doctor before use, who in turn would have informed a user of kratom’s addictiveness. But “Defendant cannot simply place the onus of warning consumers of the potential adverse effects of its kratom products on consumers’ doctors by adding boilerplate language to its labels.”

Claims for equitable relief also survived because plaintiffs adequately alleged that public injunctive relief would be appropriate. California class members and members of the public are still at risk of harm—public safety harms can’t be redressed through money damages.