Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so.  Our post about the Ninth Circuit’s decision is here. 

The short version is that the Davidson plaintiffs filed a putative class action claiming Sprouts mislabeled the nutritional content of certain baby foods, such as the number of grams of protein or fiber.  The plaintiffs contended this was a violation of the Sherman Act, a “mini-FDCA” law that parallels the federal FDCA, and thus established the “unlawful” prong for their California Unfair Competition Law (UCL) claim. 

Now, however, we write about the cert petition pending in the United States Supreme Court in Sprout Foods, Inc. v. Davidson.  Respondent has until March 14, 2025 to respond to the cert petition, so the case is not yet up for conference.

The issue in Sprout Foods is one of our bread-and-butter preemption issues:  The FDCA, and in particular 21 U.S.C. § 337(a) as construed in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), states that, with minor exceptions, actions to enforce the FDCA have to be brought by the federal government, because they “shall be by and in the name of the United States.”  21 U.S.C. § 337(a) (emphasis added).

As the Supreme Court recognized in Buckman, this statutory language “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the [FDCA’s] provisions.” Buckman, 531 U.S. at 349 n.4.

Because of this “no private right of action” provision, if a product liability tort claim seeks to enforce duties that “exist solely by virtue of the FDCA,” it is impliedly preempted.

On the other hand, claims that are founded “on traditional state tort law which … predate[s]” the FDCA are not impliedly preempted. Buckman, 531 U.S. at 352–53.  (But of course if the claim involves a PMA medical device and imposes state law requirements that are different from, or in addition to, those imposed by federal law, then the express preemption clause of the Medical Device Amendments to the FDCA (21 U.S.C. §360(k)(a)) kicks in, and the claim is expressly preempted.  But we digress.). 

So where does an alleged violation of food labeling provisions adopted through a mini-FDCA like the Sherman Act fit into this picture regarding “exclusive federal enforcement” versus “claims founded on traditional state tort law” that predates the FDCA?

Well, a mini-FDCA like the Sherman Act does not predate the FDCA, because by definition a mini-FDCA was enacted to incorporate FDCA requirements, so that can’t apply.

Aha, you think:  Then the FDCA’s exclusive federal remedy provision supplies the answer, and requires preemption of private litigants’ claims.

According to the Ninth Circuit, however, there was no preemption and no problem.  As our prior post explained:

Despite acknowledging that the food-labeling requirements imposed by California’s Sherman Law are, by definition, the requirements established by the FDCA, the Davidson majority held that § 337(a) does not preempt private suits to enforce those requirements because, it said, “plaintiffs are claiming violations of California law, the Sherman Law, not the federal FDCA.” [Davidson,] 2024 WL 3213277, at *6 [(9th Cir. 2024)]. According to the majority, § 337(a) has no bearing on private actions to enforce California’s Sherman Law because it “addresses only enforcement of the federal law.” Id. at *7.

In the eyes of the Davidson majority, it would make no sense to hold private Sherman Law claims impliedly preempted when a provision of the FDCA—namely, the express-preemption clause of the Nutrition Labeling and Education Act (NLEA)—allows states to adopt food-labeling requirements “identical” to those adopted under the NLEA. 21 U.S.C. § 343-1(a). There is, the majority said, “no reason … why Congress would permit states to enact particular legislation and then deny enforcement by their citizens.” Davidson, 2024 WL 3213277, at *6.

But as the prior post also explained, the Ninth Circuit’s analysis ignores important issues raised by the Ninth Circuit dissenter.  And, as we noted at the outset, Sprout Foods has now filed its cert petition, which drew very helpful amicus support from the Atlantic Legal Foundation. 

While the Davidson majority concluded that private enforcement of the FDCA’s food labeling provisions must have been intended by Congress, they never explain why Congress did not enact a private right of action to expressly authorize this.  And in the absence of an express private right of action, allowing states to adopt federal food, drug, and cosmetic provisions wholesale must be read within the context of the general FDCA provision about rights of enforcement: 21 U.S.C. § 337. 

Not only does § 337(a) prohibit private rights of action and generally make federal enforcement the exclusive remedy, § 337(b) allows state enforcement—but only under strict parameters, including pre-suit notice to the FDA and an opportunity for the FDA to intervene. 

Thus, the answer to the conundrum that the Ninth Circuit majority saw—why “permit states to enact particular legislation and then deny enforcement by their citizens”?—is answered by the statute itself: Congress permitted states to enact particular legislation, and then granted the states themselves (not their citizens) the power to enforce them, with certain procedural limitations and requirements.

Thus, the Sprout Food cert petition raises interesting issues of statutory interpretation that hopefully will garner enough attention at the Supreme Court to result in a grant.  The Ninth Circuit’s view is not widely accepted, and a split on the issues in the Circuits certainly justifies the high court’s attention and (hopefully) its ultimate reversal.