FDA warns companies about mouthwash products

The Food and Drug Administration has warned three companies that market mouth-rinse products to stop making unsupported claims that they remove plaque and promote healthy gums, according to a story in the Chicago Tribune.

The claims suggest the products are effective in preventing gum disease when no such benefit has been proven, the FDA said Tuesday.

The agency said warning letters were sent to Johnson & Johnson, maker of Listerine Total Care Anticavity Mouthwash, and to two drugstore giants — CVS Corp., which sells CVS Complete Care Anticavity Mouthwash, and Walgreen Co., which sells Walgreen Mouth Rinse Full Action.

The letters are the latest in a stream of warnings issued to food and drug producers by the FDA and the Federal Trade Commission since President Barack Obama took office dealing with unsubstantiated health benefits on labels and in 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.

Under U.S. law, a company cannot assert that a product is effective in treating a disease unless the claim has been approved by the FDA, or the active ingredient has been generally recognized as safe and effective for the claim.

All three mouthwashes cited contain as their active ingredient sodium fluoride, which prevents cavities, but which the FDA has not found to be effective in removing plaque or preventing gum disease.

In the case of Walgreen, the company has claimed that its Mouth Rinse Full Action “helps fight visible plaque above the gum line.”

Rinsing does disrupt plaque, but the effect is similar with plain water or mouthwash, said Jonathan Shenkin, a pediatric dentist and assistant professor of health policy at Boston University’s School of Dental Medicine.

“It’s the act of rinsing. Sodium fluoride doesn’t remove plaque,” Shenkin said.

By making an unproven medical claim, Walgreen essentially positioned its mouthwash as a new drug, for which  tests to prove safety and effectiveness would be required, according to the FDA letter to the company.

A Walgreen spokesman said that “we are committed to working with the FDA on this matter and will be responding to their letter accordingly.”


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