FDA Says No to Mouthwash Makers' Gum Health Claims

WASHINGTON -- The FDA warned three mouthwash manufacturers to stop implying their products prevent gum disease or remove plaque without support for the claims.

The agency issued warning letters to Johnson & Johnson, CVS Corporation, and Walgreen Company, which manufacture the products Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash, and Walgreen Mouth Rinse Full Action, respectively. The letters disputed claims on each products' label that the mouthwash fights plaque or promotes healthy gums.

The active ingredient of the noted products is sodium fluoride, which is approved by the FDA to prevent cavities but is not indicated as a plaque remover or gum disease preventer, the agency said in a statement.
In order to include such claims on the product label, the companies would have to submit a new drug application for use in that indication, the statement said.

"It is important for the FDA to take appropriate enforcement action when companies make false or unproved product claims to ensure that consumers are not misinformed or misled," Deborah Autor, of the FDA's Center for Drug Evaluation and Research, said in the statement.

The letters noted the companies have 15 days to respond with corrective actions taken or plans to fix labeling violations. Failure to fix the faults may result in legal repercussions as strict as seizure and injunction, the warning letters said.

The FDA received no reports of adverse events related to the use of the affected mouthwash products, the agency statement said.

By Cole Petrochko