A few weeks ago, we reported on Chong v. Kind LLC, 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As we noted at the time, although the case arose in the food context, its analysis is directly applicable to drug and device cases.
Today we report on another food case relevant to device, if not drug, cases, Nacarino v. Kashi Co., — F. Supp. 3d —-, 2022 WL 390815 (N.D. Cal. 2022). As in Chong, the Nacarino court was presented with state-law claims based on allegations that the defendant food manufacturer violated California law because it used one method rather than another to calculate the protein content reported on the front of product packaging. And as in Chong, the court concluded that the claims were preempted by federal law. But unlike Chong, Nacarino was decided on express- rather than implied-preemption grounds.
Like the Chong plaintiffs, the Nacarino plaintiffs alleged that the statement regarding protein content on the front of the manufacturer’s packaging was false and misleading because was it was based on an indirect measurement that allegedly overstates the amount of digestible protein in the product. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. 2022 WL 390815, at *3.
The problem for plaintiffs is that the FDCA’s implementing regulations explicitly permit use of the indirect measurement method. Thus, although the packaging statement “may well be ‘misleading’ in the colloquial sense,” “what matters is not the colloquial meaning of ‘misleading’ but the regulatory meaning.” 2022 WL 390815, at *3. The court explained that “[b]ecause the technique” used by the manufacturer to calculate protein content “is FDA-approved, the statement cannot be considered misleading within the meaning of the [FDCA].” Id. at *1.
Given that the challenged statement was not misleading under federal law, deeming the statement misleading under state law would effectively impose a state-law requirement that is “‘not identical’ to the” relevant “federal requirements.” 2022 WL 390815, at *3 (quoting 21 U.S.C. § 343-1(a)(5)). That doomed the plaintiffs’ claims because the FDCA expressly preempts any state-law nutrition-labeling requirement that is “not identical” to the federal requirements. Id.
The FDCA contains no express-preemption provision for drugs and the express-preemption provision for devices is worded differently than that applicable to food labeling. Nonetheless, Nacarino supports the proposition that the FDCA bars state-law claims based on truthful statements authorized by FDA regulations. So, while one should be mindful of the differing regulatory schemes, drug and device practitioners shouldn’t ignore relevant food cases.
Beyond its substantive holding, Nacarino also offers two practice tips. First, make use of judicial notice when useful. The Nacarino defendant was helped by bringing to the court’s attention a recent FDA pronouncement confirming the defendant’s construction of the relevant federal regulations. Second, if you have a good-faith basis for doing so, do not hesitate to advocate a position that has been rejected by other courts. The Nacarino court acknowledged that other courts considering similar claims “have come out the other way,” but nonetheless reached the conclusion it did because it “s[aw] the issue differently and decline[d] to follow their lead.” 2022 WL 390815, at *4.
Some food for thought.