Listerine: A Mouthwash That Leaves Your Breath Feeling Clean and Litigious

On September 27th, the Food and Drug Administration (FDA) sent Johnson & Johnson a warning letter to cease making claims that its Listerine Total Care Anti-cavity Mouthwash “Fights Unsightly Plaque Above the Gum Line,” and further stated that the very name of the product “Total Care Anti-Cavity Mouthwash” is deceptive and misleading, as it suggests that the product is comprehensive in function in the fight against plaque, gingivitis, and other precursors to tooth decay.

On October 5th, Florida citizen Nikki Pelkey filed suit a class action lawsuit in Florida Southern District Court on behalf of all Florida residents who have used Listerine Total Care.   The substantive claims in the suit are premised almost in their entirety on the FDA warning letter, posted just one week before filing.

In Pelky v. McNeil Consumer Healthcare, the Plaintiff claims that the Defendant 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.

The complaint also references a Listerine commercial which claims that the product 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 Web page 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.”

As detailed in the FDA letter, the Pelky suit further alleges that Johnson & Johnson doesn’t posses or rely upon a scientific or reasonable basis to substantiate its claims; another violation referenced in the FDA’s letter.

The lesson should be abundantly clear:  if your advertising copy, scripts, or packaging makes any unsubstantiated claim that provokes a reaction from the FDA, it will likely draw the attention of litigious consumers, whose attorneys eye the FDA website like a pack of wolves around a wounded sheep.



Author: Seth Heyman
Seth D. Heyman is a California attorney with extensive experience in advertising and marketing law, corporate law, contracts, governmental regulations, international business, and Internet law. He has counseled numerous successful companies, both public and private, and was responsible for regulatory compliance, contract management, corporate governance, and HR best practices for multiple organizations in many diverse industries, including marketing, telecommunications, energy, and technology development. He offers insight and guidance on federal and state direct mail, TV, radio, telemarketing, and Internet marketing laws, as well as online promotions, Internet privacy, data protection regulations, and similar matters.

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