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Deceptive Mouthwash Claims

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.

The claims suggest the products, which are used by millions of Americans every day, are effective in preventing gum disease when no such benefit has been proven, the FDA said recently.

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.

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, which is based in Deerfield, Ill., the company has claimed that its Mouth Rinse Full Action "helps fight visible plaque above the gum line."

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.

The warning to Johnson & Johnson, of New Brunswick, N.J., follows a string of regulatory problems over the last year, including recalls of hip implants and contact lenses, plus a massive recall of Children's Tylenol and other over-the-counter medications that are the subject of congressional and grand jury investigations.

If you have purchased any of these mouthwash products, based on the representation that the product removes plaque and would like to seek a refund of your purchase price, please contact our office at (561) 684-6330 or toll free at (800) 443-4529. Or, fill out the form at the left side of this page and someone from our office will contact you to discuss your situation further.