J.J., C.D., C.B., and D.F. v. Ashlynn Marketing Group, Inc.

Summary

The United States District Court for the Southern District of California denied Ashlynn Marketing Group, Inc.’s motion for reconsideration of an earlier order concerning claims that the company failed to warn consumers about the potentially addictive nature of kratom products. The court held that the plaintiffs’ state-law claims were not preempted by the Federal Food, Drug, and Cosmetic Act and that an addiction warning is not a disease claim under the applicable federal dietary-supplement regulations. The court also concluded that the defendant could comply with both federal and state law.

Holdings

1. Reconsideration was not warranted because defendant presented no newly discovered evidence, intervening change in controlling law, changed circumstances, or clear error, and largely repeated arguments previously considered and rejected.
2. The FDCA does not preempt plaintiffs' state-law claims because defendant can comply with both the federal labeling requirements and a state-law duty to warn consumers about kratom's potentially addictive nature.
3. A warning that kratom is or may be addictive is not a disease claim under 21 U.S.C. § 343(r)(6) or 21 C.F.R. § 101.93(g) because it does not claim to diagnose, mitigate, treat, cure, or prevent disease.
4. A supplement label may be misleading under the FDCA and applicable state law if it fails to disclose a material increased risk of disease or other harmful consequence from ordinary use, and the FDCA does not preempt claims based on that omission where the state and federal requirements are materially the same.

Questions Presented

1. Whether reconsideration was appropriate under Federal Rule of Civil Procedure 54(b), Rule 60(b), or Local Civil Rule 7.1(i).
2. Whether the court clearly erred in previously holding that the FDCA did not preempt plaintiffs' state-law claims based on the alleged failure to disclose kratom's addictive nature.
3. Whether a warning that kratom may be addictive constitutes a disease claim under 21 U.S.C. § 343(r)(6) and 21 C.F.R. § 101.93(g).
4. Whether the FDCA makes it impossible for defendant to comply simultaneously with federal law and state-law duties to disclose the potentially addictive nature of kratom.

Disposition

other