Corporate Counsel Daily, Even without 12-sample test, court could draw reasonable inference that manufacturer misbranded product, (Jun 24, 2025)

By Jeffrey H. Brochin, J.D.

The district court incorrectly dismissed the state law supplement misbranding claim due to federal preemption where the consumer failed to plead that he had used the FDA’s 12-sample testing process.

The U.S. Court of Appeals for the Ninth Circuit has reversed the district court’s dismissal of a consumer’s California consumer protection lawsuit which alleged misbranding of a dietary supplement by ProSupps USA, LLC. The complaint based its allegations of misbranding on one lab test which showed higher carbohydrate and caloric content than the “zero” represented by ProSupps on the label. The district court therefore found that, in the absence of pleading that the FDA’s sampling process was utilized, the federal Food, Drug and Cosmetic Act (FDC Act) preempted the state claims. However, the 9th Circuit disagreed, ruling that the preliminary testing of one sample was enough to avoid preemption on the pleadings because it allowed the court to draw a reasonable inference that testing a composite sample according to FDA regulations would show that the supplement was misbranded under the FDC Act (Scheibe v. ProSupps USA, LLC, No. 23-3300 (9th Cir. Jun. 23, 2025)).

Carbs, calories, and the conscientious consumer. The consumer alleged that he counts his carbohydrates and calories to meet his weight-loss and muscle-building goals. In August 2022, he reviewed the label for ProSupps’ Hydro BCAA (a dietary supplement containing an amino-acid blend used to increase the efficiency of workouts) and after determining that it contained zero carbohydrates and zero calories, he purchased the product. He also asked an independent laboratory to verify the supplement’s claim of zero carbohydrates and calories.

The laboratory tested a single 100-gram sample of the supplement using FDA-approved testing methods, and found 41.2 grams of carbohydrates in the sample, (or 5.68 grams of carbohydrates per serving) and 372 calories in the sample, (or 51 calories per serving). Based on those test results, he filed a putative class action lawsuit claiming that the supplement’s label was false and therefore violated California consumer protection laws. Notably, the laboratory test did not utilize the FDA’s 12-sample process of randomly selected Hydro BCAA.

District court’s dismissal. The manufacturer filed its motion to dismiss the state law claims citing federal preemption under the FDC Act, and the district court granted the motion. The court’s rationale was that the claims were preempted because the consumer failed to plead that he tested the supplement according to the FDA’s sampling process. Consumers can bring claims under state law alleging that foods are mislabeled, but those claims cannot impose liability beyond what the Act requires. If a product’s label complies with the Act, then the Act preempts any state-law claim that the product is mislabeled.

From “conceivable to plausible.” Because preemption is an affirmative defense ProSupps had the burden of showing that the consumer’s claims were preempted. It is only when a consumer “pleads himself out of court” by admitting all of the elements of an affirmative defense, that a complaint that may otherwise state a claim, be dismissed. According to that rule, the consumer’s complaint merely had to “nudge his claim from conceivable to plausible,” as the appeals court stated. Therefore, to state a plausible mislabeling claim—one that was not preempted—the consumer had to plead facts that allowed the district court to draw the reasonable inference that the manufacturer was liable.

Testing one sample was enough. The FDA requires manufacturers to determine a nutritional supplement’s content by testing a sample consisting of a composite of 12 subsamples (consumer packages) or 10 percent of the number of packages in the same inspection lot, whichever is smaller, randomly selected to be representative of the lot. For carbohydrates, the FDA requires testing each sample according to a method prescribed by the Association of Official Analytical Collaboration (AOAC) International.

Here, the consumer alleged that his testing methods complied with FDA regulations: he used the AOAC method for carbohydrates and bomb calorimetry for calories; however, he did not allege that he complied with the FDA’s sampling process. Instead, he simply alleged that one sample of the supplement, tested by an independent laboratory, contained more carbohydrates and calories than ProSupps listed on the supplement’s label. Nevertheless, the appeals court found that the consumer pleaded sufficient facts that would allow a court reasonably to infer that the supplement was not only mislabeled under state law, but also misbranded under the Act. In other words, his preliminary testing of that one sample was enough to avoid preemption on the pleadings because it allowed a court to draw a reasonable inference that testing a composite sample according to FDA regulations would show that the supplement was misbranded under the Act. Significantly, the consumer’s single sample contained several times more carbohydrates and calories than the FDA allows to be listed as zero on the label.

The case is No. 23-3300.

Judges: Johnstone, A.

Attorneys: Charles C. Weller (Charles C. Weller, APC) for Jacob Scheibe. Jessica N. Walker (Theodora Oringher, PC) for ProSupps USA, LLC.

Companies: ProSupps USA, LLC

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