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FDA cracks down on mouthwash

The federal government is cracking down on claims being made by companies that make and market mouthwash.

The Food and Drug Administration Tuesday 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," the FDA said.

The warning letters were sent to Johnson & Johnson, which makes Listerine Total Care Anticavity Mouthwash, CVS Corp., which sells CVS Complete Care Anticavity Mouthwash, and the Walgreen Co., which markets Walgreen Mouth Rinse Full Action.

The products contain sodium fluoride, which is effective in preventing cavities but has not been shown to be effective in removing plaque or preventing gum disease, the FDA said.

The agency said there was no evidence anyone had been harmed by the products. Consumers can continue to use them to prevent cavities. But the public "should be aware that the FDA has no data to show that these products can prevent gum disease," the agency said.

Companies that received FDA warning letters are required to take appropriate action to correct the violations within 15 days. "Failure to do so may result in seizure of the product, or other civil or criminal penalties," the FDA said.

By Rob Stein  | September 28, 2010; 2:10 PM ET
Categories:  Dental Health, Dentistry, FDA, Family Health  
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Comments

So, what are mouthwashes good for, anyway???

Have been using Listerine in the belief it kills some bacteria.

Posted by: Spectator | September 28, 2010 3:49 PM | Report abuse

Listerine, for example, can make that claim because alcohol, which is a primary ingredient, does kill germs.

Posted by: StevieB82 | September 28, 2010 4:03 PM | Report abuse

Here come the "civil fines" to support "Obummercare" and other "Cash for Flunkers" programs.

what part of "antiseptic" does the FDA fail to understand?

Take your best shot, FDA.

Posted by: Computer_Forensics_Expert_Computer_Expert_Witness | September 28, 2010 5:12 PM | Report abuse

I wish the FDA would do something real instead of crack down on claims made by products that are actually effective, but not supported by double blind clinical trials. Treating everything that has a health benefit as if it were a drug, is insane and a waste of time.

Congratulations, FDA, for finding something totally useless -- pushing semantics of what comprises a drug -- and prosecuting people who grow walnuts and make pomegranate juice and disinfectant mouthwash, and claim that their products are healthful -- instead of ensuring a safe food supply.

Posted by: AsperGirl | September 28, 2010 6:28 PM | Report abuse

I think as Americans, we all should be free to believe what we wish to be true. If, for example, my faith informs me that mouthwash is "actually effective" at promoting gum health, or that global warming or evolution are mere myths, no watchdog organization or set of scientists should have the temerity to contradict me with fancy evidence, facts, or double-blind studies. That's just un-American and infringes upon my RIGHT to be ignorant!

Posted by: Nitina | September 28, 2010 9:14 PM | Report abuse

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