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.
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).
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.
“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,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.
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 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.
To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. 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.
Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days. Failure to do so may result in seizure of the product, or other civil or criminal penalties.
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