Katie Bond is a partner, and Samuel A. Butler is an associate, in the Washington, DC office of Keller and Heckman LLP.

It’s common practice in journalism to issue a notice when a mistake finds its way into print. This is not an erratum! Rather, it is a follow-up made necessary when the Ninth Circuit issued a ruling in an FDCA preemption case, Davidson v. Sprout Foods, Inc., that runs directly contrary to our post of two months ago. There, we wrote that it had “long been the law in the Eighth and Ninth Circuits that a state-law claim is preempted by the Food, Drug, and Cosmetic Act unless (1) the alleged conduct violates the FDCA but (2) that violation is not the basis of the lawsuit.” That was true then, but it is true no longer, at least as concerns the Ninth Circuit, at least when state law incorporates the requirements of the FDCA.

By way of review, in our previous article, we wrote that this way of expressing preemption got at the idea that, “if the conduct is permitted by the FDCA, a state law cannot prohibit it. However, the FDCA contains no private right of action, so a plaintiff cannot sue simply based on allegations that conduct violates the FDCA.” The wrinkle here comes from California’s “analogue” to the FDCA, the Sherman Law. The Sherman Law incorporates all federal food labeling standards by reference. California’s Unfair Competition Law, in turn, provides a private right of action to anyone who has lost money as a result of unfair competition, which it defines as including any practice that violates another law. Thus while the FDCA contains no private right of action, the Sherman Law imposes the same food labeling requirements as the FDCA and does have a private right of action. So all plaintiffs have to do is to allege a violation of the Sherman Law in labeling that violates FDCA requirements, and they can proceed on the basis of the UCL’s private right of action, right?

It depends on whom you ask. In a 2–1 decision authored by Judge Schroeder, the Ninth Circuit said that the FDCA does not preempt plaintiffs from prosecuting a case based on the Sherman Law’s incorporation of the FDCA’s food labeling requirements. Judge Collins wrote a dissent on this point, arguing that a plaintiff cannot sue based on allegations that conduct violates the FDCA, even if those allegations are recast as allegations that conduct violates the Sherman Act.

The decision has to do with nutrient content claims, which generally are not permitted on food intended for infants or children under 2 years old. Sprout Foods sold food pouches that characterized the levels of various nutrients, such as “3g of Protein.” The plaintiffs did not allege that these claims were false, only that making them violated the Sherman Act. Judge Seeborg of the Northern District of California dismissed the case in October 2022, finding that the FDCA’s prohibition on private enforcement impliedly preempted private enforcement of the Sherman Law.

There is no disagreement about many of the issues here: the FDCA allows states to pass laws establishing standards identical to the FDCA’s, and states can enforce those laws. The majority concluded that Congress did not intend to preclude private citizens from bringing lawsuits based on violations of state-law analogues of the FDCA because (1) “There is no reason we can perceive why Congress would permit states to enact particular legislation and then deny enforcement by their citizens,” (2) it would be “spectacularly odd” for Congress to intend to preempt private enforcement of state laws identical to the FDCA without even “hinting” at this intent in the statute, and (3) private enforcement of state laws does not conflict with federal enforcement of the FDCA. The Supreme Court has permitted common-law tort claims alleging injury resulting from violation of the FDCA, and the majority also asserted that the presumption against preemption the Ninth Circuit applies in the absence of express preemption would in and of itself be sufficient to permit private enforcement of the Sherman Law.

Judge Collins, in dissent, pointed out that allowing private enforcement of standards adopted from federal law would ultimately amount to private enforcement of the federal standard. Looking at the cases allowing claims referencing FDCA violations to proceed, the rule drawn by the dissent is that the FDCA does not preempt state law tort claims that do not draw their content exclusively from the FDCA, “such as, for example, a negligence claim predicated on a duty to warn that matches the FDCA’s requirements.” On the other hand, a complaint alleging only that the defendant violated the FDCA is preempted. As the dissent puts it, these are distinct claims, one of which has independent content supporting a result parallel to the federal requirement, the other of which is merely “parasitic” and makes no allegation beyond that of an FDCA violation. An advertiser selling a dietary supplement that does not provide the promised benefits is engaging in deceptive advertising, and the fact that this conduct also violates the FDCA does not deprive the plaintiff of the right to bring a false advertising case. As above, the conduct violates the FDCA, but the lawsuit is not merely a result of an FDCA violation. The law is no longer, however, quite so clear in the Ninth Circuit.

Perhaps the most intriguing argument made by the dissent, however, is that the majority simply ignores the possibility of implied preemption. As the majority put it, “[t]he dissent never comes to grip with the fact that the text of § 337(a) (FDCA § 310(a)) addresses only enforcement of the federal law.” Without explicit language in the statute, according to the majority, there is no basis for a bar on private enforcement of state laws incorporating the FDCA’s standards. This is perhaps the most dispiriting aspect of the decision. While the majority opinion undercuts what had heretofore been a reasonably clear articulation of the principle of preemption in FDCA cases, it is the apparent shot across the bow of any notion of implied preemption that is likely to have the furthest-reaching consequences. And to fire such a shot without acknowledging this consequence or even “hinting” at its basis is, indeed, “spectacularly odd.”