Just weeks after the Food and Drug Administration (FDA) sent Johnson & Johnson a warning letter to stop making claims that its Listerine Total Care Anticavity Mouthwash is effective in removing plaque above the gum line or promoting healthy gums, a consumer filed a class action lawsuit alleging deceptive advertising.

Florida citizen Nikki Pelkey filed suit on October 5 on behalf of all Florida residents who have used Listerine Total Care.

The suit claims that Johnson & Johnson engaged in an extensive, comprehensive nationwide campaign to market the mouthwash, which included the use of television, newspapers, magazines, direct mail, the Internet, point-of-sale displays and product labeling.

“[T]he message from defendant is loud and clear – use Total Care and it will fight plaque and gingivitis, thereby avoiding gum disease. Each person who has purchased Total Care has been exposed to defendant’s misleading advertising message multiple times,” the complaint alleges.

The suit cites a commercial claiming that the mouthwash provides “Six key signs of a healthy natural mouth: tartar-free teeth, no plaque build-up, healthy gums, no tooth decay, naturally white teeth, and fresh breath.” It also references a micro Web site that advertised Total Care to “remove more plaque and then strengthen teeth for a cleaner, healthier, mouth,” and a label that lists such claims as “Strengthens Teeth, Restores Minerals to Enamel, Fights Unsightly Plaque Above the Gum Line, Helps Prevent Cavities, Kills Bad Breath Germs, and Freshens Breath.”

Those claims, in combination with the “Total Care” name, “suggests to a reasonable consumer that the product is comprehensive in function, and will provide the stated benefits, including antigingivitis and antiplaque benefits,” the suit contends.

The complaint further claims that Johnson & Johnson doesn’t posses or rely upon a scientific or reasonable basis to substantiate its claims.

The suit relies heavily upon a September 27 letter from the FDA cautioning Johnson & Johnson to stop making claims that its mouth rinse products were effective at removing plaque above the gum line (Link to letter).

“These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated,” the letters said. “We are not aware of any support for the antiplaque/antigingivitis claims or other statements suggesting that the product is comprehensive in function, providing benefits beyond those related to prevention of cavities. Thus, the product’s labeling claim that it will provide all of the benefits listed, is misleading and accordingly makes it misbranded.”

To read the complaint in Pelkey v. McNeil Consumer Healthcare, click here.

Why it matters: Advertisers should be careful about making implied claims based on words or product packaging that could be objectionable to the FDA or form the basis of a consumer class action. And companies receiving warning letters from the FDA should prepare themselves for the possibility of a lawsuit to follow.