J&J Escapes Class Action over “Restores Enamel” Claims– & FDCA Prevails

On November 4, 2014, a New York federal judge granted J&J’s motion to dismiss a putative class action lawsuit which accused J&J of using false and misleading labeling to market its Listerine mouthwash.  In J&J’s motion, it argued that the claims were preempted by the federal Food, Drug, and Cosmetics Act (FD&C Act).

In the complaint, the named plaintiff, Suzanna Bowling alleged that J&J labeled its Listerine Total Care line in a manner that allowed it to charge a price premium for the Total Care products. She further alleged that they did so without making a change to the Listerine products except to include an inactive food coloring and the labeling claim that the mouthwash will “restore enamel.”

Important to the court’s ruling, the FDA has issued two monographs that dictate the labeling requirements for over-the-counter dental hygiene products.  The first, a 1980 proposed monograph and a 1995 final monograph.  The 1995 final monograph permits manufacturers of OTC dental hygiene mouthwashes containing sodium fluoride, like Listerine’s Total Care, to market the product as “aid[ing] the prevention of dental…decay,” along with “other truthful and non-misleading statements describing [this] use.”

Niether the final monograph nor any subsequently FDA issued warning letters, which further clarify the parameters of the rule, express concern regarding “Restores Enamel.”  Accordingly, the court determined that for the plaintiff to establish that her state law claims were not preempted, she would have had to “plead facts suggesting that the FDA has affirmatively prohibited the label.”  Because no regulation specifically prohibits the “Restores Enamel” label, allowing plaintiff’s claims to proceed would result in the bootstrapping of labeling requirements that are “‘not identical with'” federal regulation.  Notably, the court explained that the ruling would likely have been different if FDA had issued no guidance as to dental hygiene products.

Take away....this case is one of many recent rulings discussing the preemptive effect of the FDCA.  While the cases have been falling on both sides of the line, the specific facts of the case, including what type of attention the FDA, not just the language of the FDCA, has given to specific claims (e.g., “natural,” “evaporated cane juice,” etc.) is important in evaluating whether a plaintiff’s claims are actually actionable.  The case is also another example of why it is so important to have your claims evaluated by a competent attorney that can interpret the OTC rulemaking history, warning letters, and case law to help your company determine the level of risk associated with specific claims.

One thought on “J&J Escapes Class Action over “Restores Enamel” Claims– & FDCA Prevails

  1. Thank you Angela for that clarification, it was very helpful to my understanding of the ins and outs of allowable labeling.


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