Three companies that manufacture and market mouth rinse products have received warning letters from the U.S. Food and Drug Administration (FDA) regarding claims that they remove plaque above the gum line or promote healthy gums, though no such benefit has been proven.
Below are the names of the companies and their corresponding products:
CVS Corporation – CVS Complete Care Anticavity Mouthwash
Johnson & Johnson – Listerine Total Care Anticavity Mouthwash
Walgreen Company – Walgreen Mouth Rinse Full Action
These products contain the active ingredient sodium fluoride. The agency has determined that while this ingredient is effective in preventing cavities, it has not been found to be effective in preventing gum disease or removing plaque.
According to the FDA, “Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the 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 (OTC) drug monograph.”
The FDA is unaware of injuries or adverse health effects related to the use of the mouth-rinse products.