If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine. Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. So discovered the plaintiff in Gwinn v. Laird Superfood, Inc., 2023 U.S. Dist. LEXIS159513 (S.D.N.Y. Sep. 8, 2023).
Plaintiff brought a putative class action against the manufacturer of powdered creamer products alleging its nutrition labels inaccurately described the serving size. As noted above, in a prior decision denying defendant’s motion to dismiss, the court made clear that to avoid preemption, plaintiff had to prove a very specific claim. That is because the FDCA “expressly preempts any requirement for nutrition labeling of food that is not identical to the requirements of the Act.” Id. at *10.
The FDCA has very explicit rules for how a manufacturer displays serving size. A serving size is “an amount customarily consumed” and it must be expressed “in a common household measure that is appropriate to the food.” Id. at *2. There are also FDA regulations that state that for a powder, the serving size must contain a “reference amount” of 2 grams. The “common household measure” must be one that “most closely approximates the reference amount.” What that means is that the creamer labels would need to say something like, a serving size is “1 tsp. (2 grams)” and provide the number of servings per container. The rub is that 1 teaspoon is not always exactly the same as 2 grams. Remember, the FDA says the measure and the reference amount have to be “close,” not exact.
The regulations also state that the “number of servings” per container have to be calculated “according to the reference amount, rather than the household measure.” So, if it is an 8 ounce package of creamer, that is 227 grams. According to the FDA, the manufacturer needs to report the number of servings as 114 (227 ÷ 2). But what if the consumer measures out the creamer and doesn’t come up with 114 teaspoons of powder? She brings a lawsuit.
Then she hires an expert in metrology, the science of measurement. Plaintiff provides that expert with one container of each type of creamer at issue (different flavors). The expert empties each container to get the total weight and to loosen the powder. Then he attempts to “verify the information on the label in the same manner one would expect of any consumer”—he measures it using a standard household teaspoon. Id. at *6 (emphasis added). Then he weighed each teaspoon and found that each held more than 2 grams of the product. That means that with each serving, the consumer is actually using more than 2 grams causing the total number of servings per container to be less than the amount on the label.
That brings us back to preemption. Plaintiff’s claim can only survive if she has evidence that defendant’s label used a different measure than prescribed by the FDA. In other words, if the label complies with the requirements of the FDCA, plaintiff’s claim must be dismissed. Id. at *10-11. Plaintiff’s expert, therefore, must address this question. He did not.
The court’s first reason for striking the expert report is simply that it is irrelevant: the expert’s “consumer measurements have no bearing on whether [defendant] failed to follow the prescribed regulatory scheme.” Id. at *11. While consumers don’t have to adhere to FDA regulations in measuring their servings, the manufacturer does. At best, the expert’s opinion goes to whether FDA’s regulations result in misleading labels for a consumer – but that issue is preempted. Id.
Second, the report does not comply with Rule 702’s requirement that an expert adhere to a scientifically reliable methodology. The expert measured the creamer like a consumer, not in a manner one would expect of an expert metrologist. One very basic example is the expert did not state whether he “packed or leveled” the product in each teaspoon. As any home baker knows, there is a drastic difference between a heaping teaspoon of sugar and level teaspoon or firmly packed brown sugar and sifted powder sugar. If the expert’s report doesn’t have even the type of information you would find in a standard recipe, it is difficult to conclude it applies the necessary scientific rigor for admissibility.