Opinion ID: 3194421
Heading Depth: 2
Heading Rank: 1

Heading: FDCA preclusion and preemption

Text: We review de novo the district court’s grant of summary judgment based on its interpretation of the FDCA, see PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 923 (9th Cir. 2010), and hold the FDCA neither precludes ThermoLife’s Lanham Act claims nor preempts its unfair competition claim. A. In deciding whether the FDCA precludes ThermoLife’s claims, the district court did not have the benefit of Pom Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014), which squarely controls the issue. Pom Wonderful 2 established that the FDCA generally does not preclude Lanham Act claims for false labeling of food. Id. at 2241. Both of the Court’s rationales applies to ThermoLife’s claims: neither the FDCA nor the Lanham Act expressly bars ThermoLife’s claims, id. at 2237; and whereas the FDCA protects public health by relying on the FDA’s expertise, Lanham Act claims like ThermoLife’s protect commercial interests by relying on the market expertise of competitors, id. at 223839. Indeed, Pom Wonderful expressly rejected most of GNI’s arguments on preclusion.1 GNI contends Pom Wonderful is distinguishable because ThermoLife’s claims “require litigation of the alleged underlying FDCA violation . . . where the FDA has not itself concluded that there was such a violation.” PhotoMedex, 601 F.3d at 924. But ThermoLife’s claims that GNI falsely advertised its products as “safe” and “natural” require no interpretation of the FDCA; and, as we explain below, ThermoLife need not demonstrate a FDCA violation to prevail on its claims that GNI falsely advertised its products as “legal” or “DSHEA-compliant.” Whatever the precedential value of the PhotoMedex rule after Pom Wonderful – an 1 See Pom Wonderful, 134 S. Ct. at 2239 (explaining that a Lanham Act plaintiff seeks to enforce unfair competition rules, not the FDCA); id. (explaining that the FDCA’s exclusive federal enforcement authority “does not indicate that Congress intended to foreclose private enforcement of other federal statutes”). 3 issue we do not decide – that rule would not bar ThermoLife’s claims. Accordingly, the FDCA does not preclude ThermoLife’s Lanham Act claims. B. The unfair competition claim also is not preempted. Although the FDCA expressly preempts state-law requirements that conflict with certain FDCA provisions, see 21 U.S.C. § 343-1, those provisions do not include § 343(a), which governs the misbranding of food through false or misleading labeling. Nor does the FDCA’s bar against private enforcement impliedly preempt the unfair competition claim. There is a general “presumption against pre-emption,” Wyeth v. Levine, 555 U.S. 555, 565 n.3 (2009), and the FDCA does not impliedly preempt claims where, as here, “the state-law duty ‘parallels’ the federal-law duty,” Stengel v. Medtronic Inc., 704 F.3d 1224, 1231 (9th Cir. 2013) (en banc). The district court’s ruling that ThermoLife abandoned its unfair competition claim was clearly erroneous. At summary judgment, ThermoLife responded to each of GNI’s arguments by contending the unfair competition claim was not preempted, the elements of that claim (and the false advertising claims) were established and the claim was timely.