It’s the holiday season, and we’re getting in the festive spirit. We like old-school jingle in our jangle (even though that’s not necessarily holiday themed), more recent, unquestionably holiday-focused jingle jangle, and even first-gift of Christmas jingle, But there may be nothing more festive than a rock-solid preemption win—particularly one from California. We think this one will put a spring in your step and a sparkle in your smile.
Silva v. Haleon US, Inc., 2024 WL 5059174 (N.D. Cal. Dec. 2, 2024) involved a motion to dismiss class action claims that a toothpaste manufacturer misled consumers by including statements that the toothpaste would “rebuild,” “restore,” and “repair” tooth enamel. Plaintiffs claimed the representations were false and misleading because, once tooth enamel is lost or damaged, it cannot be replaced with fluoride toothpaste.
As we’ve discussed in detail before, some OTC drugs are subject to FDA monographs. Those monographs are detailed regulations establishing “the conditions under which OTC (over-the-counter) drugs are generally recognized as safe and effective and not misbranded.” 21 C.F.R. § 330.10. The toothpaste in Haleon (Sensodyne) is subject to the Final Monograph for Anticaries Drug Products for Over-the-Counter Use, which covers the product’s disease claim of preventing cavities. Haleon at *2. Under 21 U.S.C. § 379r(a), state law claims are preempted when they would create a labeling requirement “that is different from or in addition to,” or “otherwise not identical with,” an applicable OTC monograph.
The defendants in Haleon relied on the monograph and existing California case law for their defense that plaintiffs’ claims were preempted. The monograph established the regulation for the products’ labeling, and plaintiffs’ claims that the terms “rebuild,” “restore” or “repair” were misleading were inconsistent with the existing regulatory framework established by the FDA.
The defendants relied on Eckler v. Neutrogena Corp., 238 Cal. App. 4th 433, 454 (Cal. Ct. App. 2015), which we previously reported on here, for its instruction that the “whole point of section 379r is that it is not up to private litigants—or judges—to decide what is ‘false or misleading.’ It is up to the FDA.” Under Eckler,
State suits seeking to require product labels inconsistent with the federal objective of national uniformity are preempted. . . . The touchstone of preemption under §379r is the effect that a finding of liability on a particular claim would have on Defendants. . . . As long as that claim imposes a “requirement” that is at variance with FDA regulations, it is preempted.
Id. at *4 (internal citations and quotations omitted). The defendants also relied on Wiltz v. Chattem, Inc., 2015 WL 3862368 (C.D. Cal. May 8, 2015), which involved an oral care product where the label stated that the product “rebuilds tooth enamel.” Id. at *5. The court in Wiltz held that the plaintiffs’ claims were preempted because there was an “express federal regulation of dental hygiene products that does not encompass a finding that ‘rebuilds tooth enamel’ is misleading.” Wiltz, 2015 WL 3862368, at *2.
In evaluating the applicable monograph, the court in Haleon found that (1) there was no FDA requirement that prohibited the claims of “repair,” “rebuild,” or “restore,” (2) the FDA determined that fluoride in toothpaste enhances remineralization, and (3) the FDA is aware of and had substantively considered similar enamel claims to those made by the plaintiffs. Id. at. *4.
Plaintiffs argued that their claims should not be preempted because a requirement that the defendants “truthfully state” the product’s efficacy would not impose a state requirement different from, in addition to, or not identical with that of the FDCA or monograph. The court disagreed, as a finding in favor of the plaintiffs would result in the prohibition of the words “restore,” “rebuild” or “repair” in connection with the toothpaste—something the FDA had not done in its regulations. Id. at *6. The court held that a ruling in plaintiffs’ favor would (1) create a labeling requirement that is different from, in addition to, or not identical with the applicable monograph, and (2) be inconsistent with the federal objective of national uniformity governing the toothpaste. Id. Given these conclusions, the plaintiffs’ claims were preempted under the express language of 21 U.S.C. § 379r.
The court also held that amendment of the plaintiffs’ complaint would be futile, since the plaintiffs admitted there were no additional facts they could allege that would avoid the court’s preemption finding. The court dismissed the complaint with prejudice. We hope that puts some jingle in your holiday jangle.