Cal.S.Ct.: Food label suits not preempted
The California Supreme Court unanimously held that the Food, Drug and Cosmetic Act (ACT) does not preempt private enforcement of a state food labeling law that is identical to the FDCA. In re Farm Raised Salmon Cases, --- Cal.Rptr.3d ---, 2008 WL 351637 (Feb. 11, 2008) (No. S147171).
The court noted that the FDCA explicitly permits identical state requirements for food labels, and held that private enforcement of those laws was not inconsistent with the FDCA and was distinguishable from an attempt to privately enforce the FDCA.
The consolidated cases before the court all alleged that producers of farmed salmon failed to label their product as including artificial coloring, in violation of California’s Sherman Act, Cal. Health & Saf. Code § 109875 et seq. The defendants asserted that these claims were preempted under 21 U.S.C. § 337(a), which states that all “proceedings for the enforcement…of [the FDCA] shall be by…the United States.” They argued that, while § 337(a) by its terms applies only to actions under the federal law itself, it would pose an obstacle to Congress’s objectives if identical claims could be brought by individuals under state law.
The supreme court began by noting that consumer protection generally, and deceptive marketing and food marketing in particular, “are within the states’ historic police powers,” and therefore subject to “a strong presumption against preemption.” The court pointed out that California had, in fact, been regulating food marketing in the 1860s.
As to the FDCA, the court observed that the FDCA “clearly and unmistakably” permits parallel state laws regarding food labeling. Section 343-1 of the FDCA states that states may not establish any food labeling requirement “that is not identical to the requirement[s]” of the FDCA. However, the statutory text and legislative history “said absolutely nothing about proscribing the range of available remedies states might choose to provide for the violation of those laws.” The defendants had pointed to this statement by Rep. Harry Waxman about § 343-1:
[The preemption provision] recognizes the importance of the State role: by allowing States to adopt standards that are identical to the Federal standard, which may be enforced in State court; by allowing the States to enforce the Federal standard in Federal court.
The court, however found this statement did not support preemption of identical state claims, since Rep. Waxman specified that only states could enforce in federal court, but did not specify who could enforce in state court.
Moreover, the court noted an uncodified provision in the FDCA amendments stating that they “shall not be construed to preempt any provision of state law, unless such provision is expressly preempted under [§ 343-1].” Pub. L. No. 101-535, § 6(c)(1) (1990). The court stated that this provision signaled Congress’s intention for state and federal law to coexist, and its intent to limit any implied preemption under the FDCA. The court also pointed to the numerous and detailed preemption provisions throughout the FDCA as supporting the conclusion that Congress carefully calibrated the scope of preemption.
The court noted that two decisions of the U.S. Supreme Court had ruled out preemption of private suits under state law in light of preemption provisions similar to § 343-1 of the FDCA. See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (noting that since states were free to adopt rules for medical devices that parallel FDCA, they are also free to provide private remedies); Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (holding no private remedy exists under Federal Insecticide, Fungicide, and Rodenticide Act, but noting privately enforceable state laws paralleling that Act were not precluded).
As to § 337(a), the court criticized the “Defendants’ starting assumption” that a private suit under the Sherman Act is a “procedure to enforce” the FDCA:
That the Sherman Law imposes obligations identical to those imposed by the FDCA, as it must under section 343-1, does not substantively transform plaintiffs' action into one seeking to enforce federal law. Rather, it merely reflects Congress's considered judgment that states should uniformly regulate food labeling using identical standards.
The court distinguished all the cases cited by the defendants, noting that each concerned claims “based on violations of the FDCA itself….By contrast, plaintiffs’ claims in this case do not require referring to, or applying, the FDCA.” The court closed by noting that precluding private remedies under state law would be “a serious intrusion into state sovereignty” (quoting Medtronic), and one that Congress appeared to have made “a conscious choice” to avoid.
This case is one example of a wide range of preemption arguments being litigated under the FDCA in various areas. The U.S. Supreme Court is set to decide three FDCA preemption cases this term: Riegel v. Medtronic, No. 06-179 (preemption of tort claims based on premarket-approved medical devices); Warner-Lambert v. Kent, No. 06-1498 (preemption of prescription drug tort claims based on fraudulent FDA applications); and Wyeth v. Levine, No. 06-1249 (preemption of prescription drug tort claims based on FDA-approved labels).