Sept. 28, 2010 -- The FDA has warned Walgreen Co., Johnson & Johnson, and CVS Corp. to stop making unproven claims that their mouth rinse products can reduce plaque above the gum line, promote gum health, and prevent gum disease. The companies claim their mouthwashes are effective in preventing gum disease, but no such benefit has been demonstrated, the FDA says in a news release. The FDA says it sent warning letters notifying the three companies of its objections to their claims and ordering them to comply with existing federal regulations. The mouth rinse products contain the active ingredient sodium fluoride, but the agency says it has determined that the substance, while effective in preventing cavities, has not been shown to remove plaque or prevent gum disease.

Claims by Mouthwash Companies The products contain misleading labeling statements, the FDA says. “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,” Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, says in a news release. The companies, under federal law, are not allowed to say products are effective in treating a disease unless those claims have been shown to be true and recognized by the FDA as being safe and effective over-the-counter products.

No Adverse Effects Reported So far, the FDA says it is unaware of any injuries or adverse health effects related to use of the mouth rinse products, but says the companies’ claims their products are beneficial to gum health lack proof. It says consumers who are using the rinses may continue to do so for cavity prevention without injury risk, but should know that the FDA has no data that show the products can prevent gum disease. The FDA says the three companies must take steps with 15 days to correct the violations, and that failure to do so may result in seizure of products or other civil or criminal penalties.