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news.The US Food and Drug Administration (FDA) has issued warning letters to three firms Johnson & Johnson, CVS Corporation and Walgreen Company which manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums.
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The mouth rinse products include J&J’s Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash and Walgreen Mouth Rinse Full Action.
The claims suggest that the products are effective in preventing gum disease when no such benefit has been demonstrated, FDA said.
FDA has determined that sodium fluoride, the active ingredient of mouth rinse products, is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.
FDA Center for Drug Evaluation and Research Office of Compliance director Deborah Autor said that it is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled.
The FDA actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.