FDA warns mouthwash makers on false claims

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration on Tuesday warned Johnson & Johnson, CVS and Walgreen 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 (CVS, Fortune 500)'s "CVS Complete Care Anticavity Mouthwash" and Walgreen's (WAG, Fortune 500) "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.

CVS spokesman Mike DeAngelis said the company is reviewing the FDA's letter and will reply within the required 15 working days of receipt.

"Our policy is to fully comply with all FDA labeling requirements," said DeAngelis.

Johnson & Johnson said its Johnson & Johnson Healthcare Products Division of McNeil PPC "is in receipt of the letter from the U.S. Food and Drug Administration and the company will respond to the agency in an appropriate and timely manner."

More heat for Johnson & Johnson

The warning adds to a growing litany of problems for Johnson & Johnson (JNJ, Fortune 500).

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. To top of page

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