FDA to Walgreens, CVS: Mouthwash isn't a drug, change your labels

Johnson & Johnson, CVS Caremark Corp. and Walgreen Co. were accused of violating U.S. law by promoting their mouthwashes to prevent plaque and gum disease.

J&J's Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash and Walgreen Mouth Rinse Full Action are subject to rules governing new drugs because of their claims to prevent disease, according to warning letters released today by the U.S. Food and Drug Administration. The FDA ordered the companies to fix their labeling within 15 days.

Locally, Walgreens is based in Deerfield and CVS has operations in Northbrook.

The main ingredient in these products, sodium fluoride, hasn't been shown to be effective in removing plaque or preventing gum disease, the FDA said. The warnings are part of the agency's effort to crack down on what it calls "an increasing number" of mouth rinses that claim to have benefits.

"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 Autor, head of the FDA's office of drug compliance, in a separate statement.

The agency also questioned in its warning letters dated yesterday the use of product names that suggest the mouthwashes provide "complete" or "total" benefits beyond preventing cavities. No injuries or health complications have been reported regarding the use of these products, the FDA said.

Companies RespondJJ plans to respond to the FDA's letter "in an appropriate and timely manner," Bonnie Jacobs, a spokeswoman for the New Brunswick, New Jersey-based company, said in an e- mail. Walgreen, of Deerfield, Illinois, is "committed to working with the FDA on this matter and will be responding to their letter accordingly," said Jim Cohn, a company spokesman, in an e-mail.CVS will review the matter and have its supplier make any necessary revisions to its product label, Michael DeAngelis, a spokesman for the Woonsocket, Rhode Island-based company, said in an e-mail.JJ, the world's largest maker of health-care products, rose 40 cents to $62.43 at 4 p.m. in New York Stock Exchange composite trading. CVS gained 84 cents, or 2.7 percent, to $31.45. Walgreen, the largest U.S. drug-store chain, added $3.46, or 11 percent, to $33.81 after earlier reporting an increase in fiscal fourth-quarter profit that exceeded analysts' estimates.