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Mouthwash Products Make False Claims

Mouthwash Products Make False Claims

Are you expecting too much from your mouthwash?

The FDA has warned three manufacturers of popular mouthwashes to stop making false claims on their products.

The companies, Walgreen Co., Johnson & Johnson, and CVS Corp., all claim that their mouthwashes help to ‘reduce plaque above the gum line, promote gum health, and prevent gum disease,’ but the FDA says it has found no such evidence to substantiate these statements.

In light of the findings, the agency has now sent warning letters to the companies, asking that they correct the false statements labeled on their products within 15 days, or face further legal action.

fda warns against mouthwashes that make false claims Mouthwash Products Make False Claims

FDA Says Mouthwashes Make False Claims

The active ingredient in mouth rinse products is sodium fluoride. Although this mineral has been shown to reduce and even prevent cavities, the agency said had never been shown to remove plaque or prevent gum disease.

Under federal law companies are not allowed to claim their products are effective treatments for any symptoms unless those claims are proven to be true, and have also been recognized and approved by the FDA.

Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said in recent press release:

“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” [WebMD]

The FDA explained that all three companies’ claims regarding the effectiveness of their mouthwashes were equivalent to the claims that are made for drugs, for this reason these products must be evaluated and approved by the agency in order to comply with current regulations.

In response to the letters sent by the FDA, Mike DeAngelis, a spokesman for CVS, said that the company will “fully comply with all FDA labeling requirements.” And Robert Elfinger, a Walgreen spokesman, said in an email that the company is “committed to working with the FDA on this matter and will be responding to their letter accordingly.” [WebMD]

Johnson & Johnson avoided responding directly to the letter by saying that ‘the company has received the FDA letter and “will respond to the agency in an appropriate and timely manner.”’ [WebMD]

The FDA noted that no injury or adverse effects had been found by using mouth rinses, only that the claims to reduce plaque and prevent gum disease lacked evidence. The agency explained that consumers could continue using these products without fear of injury, but should know that no data has been found to suggest they can prevent gum disease.

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  1. Bill Henrick: FDA: Popular Mouthwashes Make False Claims. WebMD, 09/28/2010.

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