Summary
The Ninth Circuit reversed the dismissal of a putative class action alleging that ProSupps USA mislabeled its Hydro BCAA dietary supplement under California consumer protection laws. The court held that the plaintiff’s single-sample testing, using FDA-prescribed testing methods but not the FDA’s twelve-sample process, plausibly supported an inference that the product was misbranded under federal law. Accordingly, the state-law claims were not preempted at the pleading stage.
Topics
Practice areas
Questions Presented
- Whether the Food, Drug, and Cosmetic Act preempts California consumer-protection claims alleging that a dietary supplement is misbranded when the plaintiff's testing used FDA-approved testing methods but did not follow the FDA's twelve-sample sampling process.
- Whether, at the pleading stage, a single-sample test may support a reasonable inference that testing a composite sample under the FDA's required sampling process would establish that the product is misbranded under federal law.
Holdings
- A plaintiff's failure to plead that nutrition testing followed the FDA's twelve-sample sampling process does not preclude a court from drawing a reasonable inference that a food's label violates the Food, Drug, and Cosmetic Act and therefore does not require dismissal on preemption grounds.
Key quotations
“We hold that a plaintiff’s failure to plead nutrition testing according to the FDA’s sampling process does not preclude a court from drawing a reasonable inference that a food’s label violates the Act.” (141 F.4th at 1105)
“Because Scheibe alleged facts that allow a reasonable inference that the supplement is misbranded under the Act, his complaint survives preemption on a motion to dismiss.” (141 F.4th at 1105)
Factual background
ProSupps sold Hydro BCAA, a dietary supplement whose label stated that each serving contained zero grams of carbohydrates and zero calories. Scheibe bought the supplement for weight-loss and muscle-building purposes and had an independent laboratory test a single 100-gram sample using FDA-approved testing methods. The testing found 5.68 grams of carbohydrates and 51 calories per serving, substantially exceeding the FDA's allowable margins for zero-carbohydrate and zero-calorie labeling. Scheibe sued under California consumer-protection laws, although he did not allege that he used the FDA's twelve-sample sampling process.
Procedural history
Scheibe filed a putative class action under the Class Action Fairness Act, alleging that ProSupps's Hydro BCAA dietary supplement falsely stated that it contained zero carbohydrates and zero calories. After Scheibe amended his complaint, ProSupps moved to dismiss, arguing that the claims were preempted because Scheibe did not allege compliance with the FDA's twelve-sample testing process. The district court granted the motion, and the Ninth Circuit reversed.