On May 11, 2020, the Second Circuit in Critcher v. L’Oréal USA, Inc., affirmed the dismissal of a putative class action, holding that the broad preemption clause of the Food Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 379s, barred plaintiffs from seeking to impose additional or different labeling requirements through their state consumer protection law claims, where Congress and the FDA already had provided for specific labeling requirements.
In Critcher, purchasers of the defendant’s “liquid cosmetics” products claimed that while the net-quantities on the products’ labels were accurate, the product packaging was misleading because it omitted critical information that the creams could not be fully dispensed from the containers. Because they could not utilize the represented quantity of product, the plaintiffs claimed that they were deceived into buying more of the cosmetics than they could use. The District Court dismissed the complaint, concluding, among other things, that the claims were expressly preempted by the FDCA, and alternatively, preempted by the Federal Packaging Labeling Act (FPLA), 15 U.S.C. § 1451, et seq.
On appeal, the plaintiffs argued that mere compliance with that net quantity disclosure requirement was not enough because it had the effect of making the packaging misleading in that a consumer would think the amount identified on the label is the amount accessible. The Second Circuit noted that, under this theory of liability, a manufacturer would need to make an additional disclosure on its packaging to avoid liability, to the effect that some product cannot be retrieved or that the product accessible is less than the net quantity displayed on the package label.
But, the “FDCA preempts not only those state laws that are in conflict with it (i.e., any law that is ‘different from’ the FDCA), but also any state law that provides for labeling requirements that are not exactly the same as those set forth in the FDCA and its regulations (i.e., any law that is ‘in addition to’ the FDCA).” As such, the plaintiffs’ theory, the Court explained, could not survive the FDCA preemption clause:
If Plaintiffs were permitted to move forward with their claims, they would be using state law to impose labeling requirements on top of those already mandated in the FDCA and the regulations promulgated thereunder. These would be requirements “different from” or “in addition to, ”or otherwise “not identical with, ”those requirements that federal law already imposes. This is exactly what the FDCA does not permit.
In so holding, the Court noted that the Seventh Circuit had made similar conclusions with respect to the preemption provision in the related context of FDCA-food regulation, 21 U.S.C. § 343-1, that blocks state-law claims unless the requirements of the state law are “identical” to those that federal law imposes.
Importantly, the Circuit Court rejected the plaintiffs’ argument that their claims survived preemption because they were “consistent with” FDCA requirements that labels not be “false and misleading” and thus were not “different from” or “in addition to” the FDCA requirements. Plaintiffs’ theory would in fact seek to impose labeling additions. “If we were to impose such additional labeling requirements, we would be construing state law to impose many ‘requirements’ that are not contained in the federal statute, or in the regulations issued thereunder, and to disrupt what Congress intended to be a uniform – and federally-led – regulatory scheme.” Similarly, the Court rejected plaintiffs’ dubious “product-defect theory,” finding that all of the state law claims “seek to impose labeling requirements that are additional to, or different from, those that federal law has established” and thus plaintiffs “cannot avoid the sweeping preemptive force of the FDCA.”
Relatedly, in July 2020, the Ninth Circuit is set to hear oral argument in Kroessler v. CVS Health Corp., where the District Court concluded that plaintiffs’ state law false label claims were expressly preempted by the FDCA, as amended by the Nutrition Labeling and Education Act (“NLEA”). The NLEA defines “structure/function” claims for dietary supplements and distinguishes such claims from “disease claims.” See 21 U.S.C. § 343(r)(6).