FDA warns Walgreens about mouthwash claims

Posted Sep. 28, 2010 at 12:22 p.m.

The Food and Drug Administration on Tuesday warned Johnson & Johnson, CVS and Walgreens to stop making “unproven“ claims that their mouthwash products are effective in removing plaque or preventing gum disease.

In a warning letter sent to each company, regulators specifically targeted Johnson & Johnson’s “Listerine Total Care Anticavity Mouthwash“, CVS’s “CVS Complete Care Anticavity Mouthwash“ and Walgreen’s “Walgreen Mouth Rinse Full Action.”

“These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease,“ the agency said in a statement.

“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,“ said Deborah Author, director of the Office of Compliance with the FDA.

According to federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA.

The agency said it is unaware of any injuries or adverse health effects related to the use of the mouth rinse products.

The FDA has given all three companies 15 days to take “appropriate action“ to correct the violations or else face product seizure or other civil or criminal penalties.

The warning to a growing litany of problems for Johnson & Johnson.

On Thursday, the company faces a second Congressional hearing into a string of recalls of its non-prescription drugs such as Tylenol, Benadryl and Motrin. Those drugs are made by Johnson & Johnson’s McNeil Consumer Healthcare division.

McNeil has issued nine recalls of those drugs over the past year. In April, McNeil recalled 135 million bottles of children’s and infant’s Motrin, Tylenol, Benadryl and Zyrtec drugs for quality issues. It was the largest recall of children’s non-prescription drugs.

The Committee on Oversight and Government Reform, which has been investigating McNeil, held its first hearing about the recalls in May.

During the hearing, lawmakers disclosed that McNeil also tried to conduct a secret recall of more than 88,000 Motrin tablets in June 2009 for a possible defect in the drugs.

Johnson & Johnson CEO William Weldon did not testify at the May hearing. Weldon was again invited by the committee to testify at Thursday’s hearing.

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  1. Kent Sep. 29, 2010 at 9:33 a.m.

    This heavy-handed ruling is absurd…almost comical. Maybe the FDA has myopia? It should be obvious that anything that helps remove food particles from teeth and/or gums will help reduce oral decay and disease. Even a mouthwash with plain water is better than none at all. Do they need clinical trials to prove that? If the FDA had shown that these mouthwashes are no better than plain water in helping reduce tooth decay or gum disease then it might make some sense. As is, it makes little sense.

  2. Slywy Sep. 29, 2010 at 11:35 a.m.

    Not true, Kent. Only physical removal (e.g., flossing, hygienist visits) prevents gum disease as the stuff gets under the gumline. Tooth brushing and mouthwashes don’t impact that, and you can have gum disease despite using mouthwash if you have buildup and gum pockets.

  3. Jeeper Sep. 29, 2010 at 12:31 pm

    Sort of like running your car through a full-touch and a touch-less wash. Touch-less washes still leave a film over the paint.

  4. Lucy Sep. 29, 2010 at 5:33 pm

    It makes a great mixer, too!

  5. Kent Sep. 30, 2010 at 6:59 a.m.

    Slywy… A mouthwash…any kind… that removes food particles is physical removal of potentially damaging materials that can cause local bacterial build-up leading to oral disease. Does it prevent disease? Of course not, but it can be an important part of dental hygiene along with brushing and flossing, esp. if the wash is used after brushing. Nothing can PREVENT disease, but a mouthwash can help.