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FDA Warns Mouthwash Makers to Stop Making Unsupported Claims

This is all the proof we need that the Food & Drug Administration is becoming more active: the agency is taking on companies that manufacture and market mouthwash, and insisting they quit making unsupported medical claims about their products. The story was reported at length in the Los Angeles Times. Here are excerpts:

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.

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 Obama took office dealing with unsubstantiated health benefits on labels and in advertising.

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, which is based in Deerfield, Ill., 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.

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.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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