FDA warns 3 companies over unproven claims on mouth rinses

October 19, 2010

FDA has issued warning letters to three companies that manufacture mouth-rinse products and market them with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

FDA has issued warning letters to three companies that manufacture mouth-rinse products and market them with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

The agency sent warning letters to Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corp. (CVS Complete Care Anticavity Mouthwash), and Walgreen Co. (Walgreen Mouth Rinse Full Action).

The products contain the active ingredient sodium fluoride, which FDA has determined to be effective in preventing cavities but which has not been found to be effective in removing plaque or preventing gum disease.

Federal law prohibits a company from claiming its product is effective in treating a disease unless those claims have been reviewed and approved by FDA in a new drug application, or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter drug monograph.