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FDA Warning to Mouthwash Makers: Stop Making Unproven Claims

By Admin on September 29, 2010 | Last updated on March 21, 2019

The FDA is taking a noticeably harder line under the Obama Administration and letters are going out to companies the agency says are making false or unsubstantiated claims about their products. Now, one more letter has hit a three companies, right in the mouth. Johnson & Johnson, along with Walgreen Co. and CVS have all received FDA warning letters telling them to stop claiming their mouthwash products remove plaque and fight gum disease.

These claims have been a centerpiece of advertising for the companies selling mouthwashes like Listerine Total Care Anticavity Mouthwash (J&J), CVS Complete Care Anticavity Mouthwash and Walgreens Mouth Rinse Full Action. The Los Angeles Times reports that no such proof exists that use of these products will prevent gum disease. Any action by a product that claims to fight a disease makes it a drug for purposes of regulation by the FDA. Unless the claims have been approved by the FDA, or the ingredient has been generally recognized as safe and effective for the claim, the company will be prohibited from making these kinds of statements in their advertising.

Many similar letters have been utilized by the agency recently, including one FDA warning just sent to POM Wonderful regarding that company's claims about the health benefits of pomegranate juice. According to The Times, the FDA is changing the way it approaches this type of advertising. “We’ve got a much more aggressive FDA and FTC, there’s no question about it,” said John Villafranco, a Washington attorney who specializes in advertising and consumer protection issues.

In the case of mouthwash, the active ingredient is sodium fluoride, which has been found to prevent cavities. However, the FDA has not found it to be effective in removing plaque or preventing gum disease. Walgreens has claimed its mouthwash helps remove plaque above the gumline. This is true, but not because of the mouthwash. It is the simple act of rinsing that helps remove plaque, according to Jonathan Shenkin, a pediatric dentist and assistant professor of health policy at Boston University’s School of Dental Medicine. Water will do just as well.

As The Times notes, this is just one more hit for the beleaguered J&J which is dealing with fallout from recalls on everything from Tylenol to hip replacements.

All companies released statements saying they will cooperate with FDA requirements.

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