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FDA warns companies about mouth rinse claims

Rockville, Md.—The Food and Drug Administration warned three companies Sept. 28 to cease crediting their mouth rinses with preventing periodontal disease. None of the products is ADA Accepted Products.

The FDA cited the companies' claims that their mouth rinses remove plaque above the gum line or promote healthy gums. They sent warning letters to Johnson & Johnson for its Listerine Total Care Anticavity Mouthwash; CVS Corporation for CVS Complete Care Anticavity Mouthwash; and Walgreen Company for Walgreen Mouth Rinse Full Action. Each of the products in question lists sodium fluoride as the active ingredient, an ingredient the FDA agrees is effective in preventing cavities but unproven in removing plaque or preventing gum disease.

"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, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research in a news release.

Under 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 in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter drug monograph," the FDA said.

All ADA Accepted products undergo a rigorous screening process before being accepted into the ADA Seal Program.

"In today's competitive environment, it's easy to understand the temptation to make claims beyond those substantiated by sound science," said ADA President Ron Tankersley. "But, consumers can more accurately compare products when the products' claims are based on a standardized scientific methodology. The ADA Seal Program makes every effort to assure consumers that products that receive the Seal “say what they do, and do what they say'."

Members of the ADA Council on Scientific Affairs, ADA staff scientists and other experts review each product for specific criteria. These include ingredient lists; data from clinical and laboratory studies regarding a product's safety, effectiveness and promotional claims; and evidence that the company under review has manufacturing and laboratory facilities that are properly supervised and adequate to assure purity and uniformity of the product and that the product is manufactured in compliance with good manufacturing practices. Only after a product has demonstrated its safety and effectiveness will the ADA Council on Scientific Affairs award the Seal to that product.

Upon receiving the FDA warning letters, the companies have 15 days to correct the violations or risk seizure of the product or other civil or criminal penalties, the FDA said.

For more information, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227522.htm.

For more information regarding the ADA Seal Program or to see a list of accepted mouthrinses, visit http://www.ada.org/sealprogramproducts.aspx.