FDA WARNING_LETTER - Johnson & Johnson Consumer Group of Companies, Inc. - November 23, 2010

This FDA Warning Letter, dated 10-NWJ-17, addresses Johnson and Johnson Consumer Products, Inc. regarding their Listerine Total Care Anticavity Mouthwash. The product's label claims include "Strengthens Teeth, Restores Minerals to Enamel, Fights Unsightly Plaque Above the Gum Line, Helps Prevent Cavities, Kills Bad Breath Germs, and Freshens Breath."

The FDA determined that the claims "Fights Unsightly Plaque Above the Gum Line" and "Prevents Cavities" classify the product as a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act). While the "Anticavity" claim and the active ingredient, sodium fluoride 0.0221% (0.01% w/v fluoride ion), are covered by the Final Monograph for Anticaries Drug Products for Over-the-Counter Use (21 CFR Part 355), the "Fights Unsightly Plaque Above the Gum Line" claim is not.

The antiplaque/antigingivitis claims are addressed in an Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products, but sodium fluoride is not among the active ingredients under consideration for an antiplaque/antigingivitis monograph. Therefore, as formulated and labeled, Listerine Total Anticavity Mouthwash is not generally recognized as safe and effective for its antiplaque indications, rendering