We know this is the Drug and Device Law Blog, but the similarities between food labeling preemption and medical device preemption are just too strong for us to pass up. In both contexts, the FDCA has express preemption provisions. The Medical Device Amendments to the FDCA, prohibit any state law or regulation “which is different from, or in addition to, any” federal requirement relating to safety or effectiveness of the device. 21 U.S.C. § 360k(a). The Nutrition and Labeling Education Act, which amended the FDCA in 1990, prohibits any state law or regulation “that is not identical to” federal regulations regarding claims made on food labels. 21 U.S.C. § 343-1(a). And, in both contexts, the courts have impliedly preempted attempts by plaintiffs to privately enforce the FDA. So, non-preempted food labeling claims, like non-preempted medical device claims, have to fit through a “narrow gap” between express and implied preemption to survive. The plaintiffs’ claims in Dunn v. Ancient Brands, LLC, 2023 U.S. Dist. LEXIS 163946 (N.D.N.Y. Sep. 15, 2023) did not.
Defendant manufactures powdered bone broth that can be added to hot or cold drinks. Both the front label of the package and the Nutrition Facts Panel (“NFP”) state that there are 20 grams of protein per serving. The label does not provide the percentage daily value (“%DV”) for protein. That is how much a serving of the product contributes to the consumer’s recommended daily protein intake. The %DV is calculated using the Protein Digestibility Corrected Amino Acid Score (“PDCAAS”). Defendant’s product has a PDCAAS of 0, meaning the protein in the product in indigestible. Id. at *2-3.
That background was necessary to understand the preemption analysis in the context of the applicable regulations. FDCA regulations allow manufacturers to display protein content on their labeling either using the “nitrogen method” which indicates total protein or the PDCAAS method which indicates the amount of digestible protein. Id. at *15. If a statement about protein is made outside the NFP, like defendant’s “20g protein” on the front label, it is considered a nutrient content claim. The FDCA regulations are silent on whether nutrient content claims must be stated using the nitrogen method or the PDCAAS method. An FDA guidance, however, states that either method is appropriate. Id. at *15-16.
Plaintiffs brought two separate mislabeling claims. The “front-of-label” claim is that defendant failed to use the PDCAAS calculation for the “20g protein” claim. To make that claim, plaintiffs rely exclusively on case law that pre-dates the FDA guidance. Because a requirement that defendant use the PDCAAS calculation “is beyond what is required by the FDCA” it is expressly preempted. Id. at *17-18.
Plaintiffs’ second claim alleges misrepresentations based on defendant’s failure to include the %DV for protein on the NFP on the back of the product. That is essentially an attempt to recast the same argument as a “back-of-label” claim. Because FDCA regulations allow manufacturers to include a %DV, a state law requirement that defendant should have included it is “identical” to federal regulations and therefore not expressly preempted. Id. at *19. But, that was only the first part of the analysis. While plaintiffs’ consumer law violation claims are traditional state court claims, here they were entirely premised on allegations that defendant failed to comply with FDA’s protein testing standards. Plaintiffs tried to argue that defendant was liable because its labeling was “false and misleading.” But that misses the point that plaintiffs’ allegations are “inextricably intertwined with the FDCA regulations, in the sense that they heavily rely on FDCA violations to establish that the statements at issue are misleading.” Id. at *21. Therefore, their ”back-of-label” claim was impliedly preempted as an attempt at private FDCA enforcement.
Is Dunn done? Not quite. The court is giving plaintiffs a chance to replead their claims to see if they can make an “independent argument under state consumer laws” that does not rely on FDCA regulations. Id. at *21-22. We think extricating the FDCA as a critical element of the claim is going to be a difficult task, but we’ll keep our eyes out for Dunn Part II – when we hopefully can say what’s Dunn is done.