This week, the Ninth Circuit held that state law mislabeling claims were not preempted at the pleading stage simply because the plaintiff failed to allege use of an FDA-approved sampling process when testing the product’s nutritional content.  Scheibe v. ProSupps USA, LLC, __ F.4th __, 2025 WL 1430272 (9th Cir. Jun. 23, 2025). 

The plaintiff in the case purchased the defendant’s dietary supplement and asked an independent laboratory to verify the nutritional label’s claim that it contained no carbohydrates and no calories.  The laboratory allegedly found that the sample contained over five grams of carbs and 51 calories per serving—well above the FDA’s thresholds for foods branded as carbohydrate- and calorie-free.  Based on these test results, the plaintiff brought a putative class action in the Southern District of California asserting that the label violated California’s Consumer Legal Remedies Act, Unfair Competition Law, and False Advertising Law. 

While the laboratory allegedly used FDA-prescribed methods for measuring carbohydrates and calories, it did not use the FDA’s sampling process.  The FDA requires that manufacturers determine a dietary supplement’s nutritional content by testing (usually) 12 different samples “randomly selected to be representative of the lot.”  21 C.F.R. § 101.36(f)(1).

The Ninth Circuit confirmed that at some point, the plaintiff would need to show that the supplement was mislabeled using the FDA-approved sampling method in order to avoid preemption under the Food, Drug, and Cosmetics Act (“FDCA”).  The FDCA preempts state laws imposing labeling requirements that differ from those established under the FDCA.  And because compliance with the FDCA can be determined only via FDA-approved testing criteria, that statute necessarily preempts state law mislabeling claims proven through a sampling process not validated or accepted by the FDA.

The question presented in this appeal was when the plaintiff had to make such a showing.  The district court had held that, to avoid preemption, the plaintiff must do so at the pleadings stage, reasoning that “permitting a complaint to stand based on the testing of a single product would directly contravene the regulatory scheme the FDA has set forth.”  The district court therefore dismissed the complaint.  Scheibe v. ProSupps USA, LLC, 2023 WL 3573898, at *3 (S.D. Cal. May 18, 2023). 

The Ninth Circuit reversed.  It concluded that the plaintiff’s single test result showing higher-than-advertised carbohydrate and calorie levels in a single sample created a plausible inference that testing of twelve representative samples, as the FDA’s approved protocol requires, would show the same.  The court acknowledged that the plaintiff’s “first and only test result” could be an “outlier,” but this possibility was too speculative to warrant dismissal at the 12(b)(6) stage.  Further, the Ninth Circuit reasoned that “requir[ing] plaintiffs to perform the FDA’s sampling process” before discovery could be too burdensome, as information necessary to prove that a sample satisfies the FDA’s sampling criteria may be within a defendant’s exclusive control.   

Although Scheibe held that failure to follow the FDA’s sampling process does not automatically lead to preemption at the pleadings stage, it explicitly left open the related question of whether a plaintiff must test a food according to other aspects of the FDA’s required testing methods to avoid preemption.