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.
The FDA’s letter to Johnson & Johnson notes that the company claims its “Listerine Total Care Anticavity Mouthwash” strengthens teeth, restores minerals, fights plaque above the gum line and kills bad breath germs, among other things. But the letter notes that the statements are equivalent to claims that would be made for a drug, as defined by the Federal Food, Drug and Cosmetic Act, and are therefore in violation of the act.
Bonnie Jacobs, a spokeswoman for Johnson & Johnson, tells WebMD that the company has received the FDA letter and “will respond to the agency in an appropriate and timely manner.”
The agency says CVS claims that its CVS Complete Care Anticavity Mouthwash not only prevents cavities and kills germs that cause bad breath, but “promotes healthy gums,” thus mitigating disease. The agency notes that the CVS claims, like those of the other two companies, violate the Federal Food, Drug and Cosmetic Act and, without FDA approval, their mouth rinses cannot be marketed as preventive products for gum disease.
Mike DeAngelis, a spokesman for CVS, says in an email the company will “fully comply with all FDA labeling requirements.”
Similarly, a letter to Walgreen Company refers to the Walgreen Mouth Rinse Full Action. The labeling says that it “helps prevent cavities” and “helps fight visible plaque above the gum line” -- claims that would classify it as a drug, violating the Federal Food, Drug and Cosmetic Act, according the FDA.
Robert Elfinger, a Walgreen spokesman, says in an email that the company is “committed to working with the FDA on this matter and will be responding to their letter accordingly.”