FDA warns companies to stop making unproven claims on mouth rinses

The FDA has issued warning letters to three companies that manufacture and market mouth rinse products 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. These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

Warning letters were sent to Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action). Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days.

Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.

For more information call (888) INFO-FDA.