plaintiffs don't have to use full FDA methods for testing nutrients to avoid FDA preemption

Scheibe v. ProSupps USA, LLC, --- F.4th ----, 2025 WL 1730272, No. 23-3300 (9th Cir. Jun. 24, 2025)

The FDA specifies testing methods for determining the amount of carbohydrates and calories in a food, as well as a sampling process for those tests requiring “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.” A dietary supplement, is “misbranded” in violation of the FDCA if its label differs by a specified margin from the results of these tests. Foods containing up to 0.5 grams of carbohydrates can be labeled as zero-carbohydrate, and foods containing up to 5 calories can be labeled as zero-calorie. State law claims that aren’t identical to FDCA violations are preempted.

This is the background for the claims here, over a dietary supplement: Hydro BCAA. The supplement’s FDA-mandated label states that each 13.8-gram serving contains 10 grams of amino acids but zero grams of carbohydrates and zero calories. Scheibe bought the supplement to help him lose weight and gain muscle mass; his preliminary testing of one sample, using a FDA-specified method, found that the supplement contained 5.68 grams of carbohydrates and 51 calories per serving, “far exceeding the FDA’s allowable margins for zero-carbohydrate and zero-calorie labeling.” He sued under California consumer protection law.

The district court dismissed the claims because he didn’t use the 12 random sample process. But a plaintiff need not prove a claim in the pleadings, and his allegations made misbranding plausible.

Anyway, because compliance with the FDCA can be determined only by the FDA’s testing methods and sampling processes, “the Act necessarily preempts mislabeling claims proven only through testing methods and sampling processes ‘not validated or accepted by the FDA for use in th[at] context.’” But ProSupps bears the burden of showing preemption, and Scheibe didn’t plead himself out of court. Instead, he pled facts allowing a reasonable inference that the supplement was misbranded. His preliminary testing “allows a court to draw a reasonable inference that testing a composite sample according to FDA regulations would show that the supplement is misbranded under the Act.” It was plausible that additional samples would contain similar amounts, and even if those samples they had far fewer carbohydrates and calories than Scheibe’s original sample, “they still could lead to a result that exceeds the margins for zero-carbohydrate or zero-calorie labels and thereby establish misbranding under the Act.” (It's not clear whether the result would be the same with lower divergences from the label. If every other sample in a 12-sample group was zero and zero, the average would be 0.47 grams of carbs and 4.25 calories per serving, just slightly below the relevant thresholds. Whether such a result is likely is of course well beyond the record and my expertise.) Maybe his test result was weird. “But the Federal Rules of Civil Procedure do not cast judges as skeptics of pleadings.”

Scheibe wasn’t arguing that every serving must have the same amount of nutrients; he was arguing for a reasonable inference about the results of the FDA-mandated twelve-sample process. Indeed, it may be “impracticable” for a plaintiff to test 12 different samples “randomly selected to be representative of the lot” before discovery opens. “[T]he fact that defendants may have exclusive control and possession of critical facts—like their own product inventory—cannot categorically prevent plaintiffs from stating a plausible claim.”