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FDA: Popular Mouthwashes Make False Claims

Agency Asks 3 Companies to Stop Making Claims About Effectiveness of Mouth Rinses
By
WebMD Health News
Reviewed by Laura J. Martin, MD

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.

Companies Respond

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.

How Do I Measure Up? Get the Facts Fast!

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Only 18.5% of Americans never floss. You are missing out on a simple way to make a big difference in the health of your mouth. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Floss removes food trapped between the teeth and removes the film of bacteria that forms there before it turns to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Try flossing just one tooth to get started.

You are one of 31% of Americans who don't floss daily. You are missing out on a simple way to make a big difference in the health of your mouth. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Aim for 3 more days!

You are one of 31% of Americans who don't floss daily, but you're well on your way to making a positive impact on your teeth and gums. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Aim for all 7 days!

Only 50.5% of Americans floss daily, and good for you that you are one of them! Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Congratulations on your good oral health habit!

SOURCES:

American Dental Association, Healthy People 2010

This tool is intended only for adults 18 and older.

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