A federal judge earlier this month granted defendant’s motion to dismiss a putative class action lawsuit accusing it of using misleading labeling on its market mouthwash. See Suzanna Bowling v. Johnson & Johnson et al., No. 1:14-cv-03727 (S.D.N.Y., 11/4/14).
The issue here was preemption. Plaintiff Bowling filed this action on behalf of herself and others similarly situated, alleging that the defendant violated (1) numerous state statutes, as well as (2) the Magnuson-Moss Warranty Act (“MMWA”), when it sold Listerine Total Care (“LTC”), a line of
mouthwashes. Defendant moved to dismiss on the grounds that the state law claims were preempted by the Food Drug and Cosmetics Act (“FDCA”). (Put the MMWA issue aside for today.)
Plaintiffs alleged that purported claims that the mouthwash can help with tooth enamel issues were false. But FDA had trod on this ground in “monographs” that set out labeling regulations for over-the-counter (“OTC”) dental hygiene products. First, in 1980, the FDA published a proposed
monograph (“1980 Monograph”), which found, inter alia, that “[t]he deposition of fluoride in dental enamel has been shown to increase resistance to enamel solubility and therefore dental decay” – or in plain English, flouride is good for preserving enamel. Second, in 1995, the FDA published a final monograph (“1995 Monograph”), which permits manufacturers of OTC drugs containing sodium
fluoride (such as LTC) to market the product as “aid[ing] the prevention of dental .. . decay,”‘ along with “other truthful and nonmisleading statements [further] describing [this] use.” In other words, pursuant to the 1995 Monograph, manufacturers of OTC drugs containing sodium fluoride are allowed (1) to represent that such drugs prevent tooth decay and (2) to provide further labeling to explain how decay is prevented. Furthermore, on multiple occasions, the FDA has sent letters to manufacturers of OTC drugs containing sodium fluoride to clarify the parameters of the Monographs. In each of these letters, the FDA has objected to certain labeling practices – for example, certain representation that sodium fluoride “fights plaque”- but it has expressed no concern about the label “Restores Enamel.”
Defendant moved to dismiss. In the context of OTC drugs, the FDCA expressly preempts state law labeling requirements that are “different from,” “addition[ al] to,” or “otherwise not identical with” federal labeling requirements. Under this standard, said the court, preemption is certainly appropriate when a state law prohibits labeling that is permitted under federal law. But it is also appropriate when a state law prohibits labeling that is not prohibited under federal law. The standard, in other words, is not only whether a state law actively undermines federal law. It is whether state law diverges from federal law at all.
That means, found the court, that plaintiffs would need to plead facts suggesting that the FDA has
affirmatively prohibited the challenged label language. Otherwise, plaintiffs’ state law causes of action would be, in effect, imposing a labeling requirement that is “not identical with” labeling requirements under federal law. “Plaintiffs cannot meet this burden.” If the FDA had prohibited the
“Restores Enamel” kind of label, there would obviously have been a regulation saying so. But there was no such regulation. As it stands, observed the court, the FDA has issued a monograph directly on point but declined to indicate either in the monograph itself or in advisory interpretations of the monograph that a phrase like “Restores Enamel” is misleading. If successful, this litigation would thus do exactly what Congress sought to forbid: using state law causes of action to bootstrap labeling requirements that are “not identical with” federal regulation.