FDA Warns Three Mouthwash Companies to Stop False Claims

Kathleen Blanchard's picture
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Today the FDA issued warning letters to Johnson & Johnson, CVS Corporation and Walgreen Company for marketing mouthwash with false claims about gum disease prevention. The companies are marketing Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash and Walgreen Mouth Rinse Full Action respectively that the government says are not effective for preventing gum disease.

According to Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, “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 products contain sodium fluoride that can prevent cavities, but there is no evidence the compound removes plaque or prevents gum disease, say officials.

The companies have 15 days under federal law to take action. Otherwise, the FDA can seize the mouthwash products or impose civil and criminal penalties.

Mouthwash Claims Require FDA Approval

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Before a product can be marketed with health claim it has to be reviewed by the FDA. Over-the-counter products that make claims for disease prevention require FDA approval.

The FDA issues the warnings about mouthwash preventing gum disease and removing plaque as an effort to slow down false claims about the therapeutic benefits of products that are unproven and becoming increasingly more common, violating the Federal Food Drug and Cosmetic Act (FFDCA).

Consumers can use the mouthwash products without fear of adverse health effects. However, sodium fluoride in the products is unlikely to keep consumers from free from gum disease – but they should help prevent cavities.

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