We have always been flummoxed by California’s Sherman Law. That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of that federal also offensive to state law. Why does this matter? Because there is no private right of under the FDCA, and 21 U.S.C. § 337 expressly reserves the right to enforce the FDCA to the United States, not private parties. Despite this, some courts have allowed private parties to evade section 337 by permitting private actions under California’s Sherman Law, even though the allegations amount to violations of the FDCA. It’s a federal wolf in California sheep’s clothing.
The Ninth Circuit recently took on this conundrum in an unpublished opinion and held that the FDCA means what it says—there is no private right of action, even if the plaintiff has shrouded its claims in the Sherman Act’s rubric. In Bubak v. Golo, LLC, No. 24-492, 2025 WL 2860044 (9th Cir. Oct. 9, 2025), the plaintiff brought a claim under California’s Unfair Competition Law (or “UCL”), which permits lawsuits by private parties who have suffered injuries because of any “unlawful, unfair, or fraudulent business act or practice.” Id. at *1. The claim was premised on an alleged violation of the FDCA “as incorporated into California law in the Sherman Food, Drug, and Cosmetic Law,” which is a typical use of the Sherman Law as an end run.
The district court dismissed the complaint, and the Ninth Circuit affirmed in an unpublished opinion, with a concurring opinion that confronts the issues head on. Citing its precedential opinion in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022) (discussed here), the Ninth Circuit held that the plaintiff’s claims were prohibited by federal law:
The FDCA expressly prohibits private enforcement. In Nexus, the plaintiff sought to avoid this prohibition by bringing claims under the UCL and other state laws that “incorporate” the FDCA. We explained, however, that these claims are preempted because they “rest upon a violation of the FDCA,” and proceedings to enforce or restrain violations of the FDCA “must be by and in the name of the United States, not a private party.”
Bubak’s claims face the same problem.
Bubak, at *1 (citing section 337, quoting Nexus Pharma). Because the plaintiff’s claims required litigating violations of the FDCA, the plain language of the statute prohibited them. Moreover, the plaintiff’s attempts to distinguish Nexus fell flat—both cases involved the Sherman Law; Nexus was not limited to pharmaceuticals; and both brought claims that existed “only by virtue of the FDCA.” Id. at *1-*2. The plaintiff’s reliance on a more recent Ninth Circuit opinion going the other way, Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), was misplaced. In Davidson, the Ninth Circuit allow state-law claims based on violations of the FDCA because the alleged violation was “plain,” whereas the alleged violations in Nexus and Bubak “required litigating.” Id. at *2. (You can read our take on Davidson case here.)
The court therefore affirmed the dismissal, but the concurring opinion offers the greater insight, particularly in urging that the court overrule Davidson. The Davidson opinion cannot be reconciled with the earlier Nexus opinion, and the idea that the plaintiffs in either case alleged claims under California’s Sherman Law, and not the FDCA, is pure fiction. The FDCA’s bar on private enforcement does not carve out an exception for “plain violations,” and there is no principled basis for concluding that the FDCA reserved enforcement of some violations to the federal government, but not others. Bubak, at *3.
The concurring opinion saw only one way to reconcile Davidson with earlier precedent. In Davidson, the plaintiffs’ claims predated enacted of the relevant provisions of Sherman Law and “thus exist[ed] independently of” federal law. Id. In the view of the concurring judge, the FDCA’s bar on private enforcement would not reach such claims, since they would not be predicated on violations of the FDCA.
We see the concurring opinion’s point, but this judge might be slicing the onion a bit too thin. If a plaintiff brought a UCL claim invoking some violation of the Sherman Law that was truly outside the FDCA, that claim theoretically could proceed. But would have to see a concrete example to believe it.
The more useful takeaway from Bubak is that California’s Sherman Law is not a highway around the FDCA’s ban on private enforcement. The opinion correctly treats Nexus as prohibiting state law claims alleging violations of the FDCA, and its attempt to cabin Davidson is equally useful, since most every claim under the FDCA will “require litigating” and thus will be preempted. Not that we would object to an opinion expressly overruling the wrongly decided Davidson opinion. That would be good, too.