FDA: Popular Mouthwashes Make False Claims
Agency Asks 3 Companies to Stop Making Claims About Effectiveness of Mouth Rinses
WebMD News Archive
Companies Respond continued...
Bonnie Jacobs, a spokeswoman for Johnson & Johnson, tells WebMD that the company has received the FDA letter and “will respond to the agency in an appropriate and timely manner.”
The agency says CVS claims that its CVS Complete Care Anticavity Mouthwash not only prevents cavities and kills germs that cause bad breath, but “promotes healthy gums,” thus mitigating disease. The agency notes that the CVS claims, like those of the other two companies, violate the Federal Food, Drug and Cosmetic Act and, without FDA approval, their mouth rinses cannot be marketed as preventive products for gum disease.
Mike DeAngelis, a spokesman for CVS, says in an email the company will “fully comply with all FDA labeling requirements.”
Similarly, a letter to Walgreen Company refers to the Walgreen Mouth Rinse Full Action. The labeling says that it “helps prevent cavities” and “helps fight visible plaque above the gum line” -- claims that would classify it as a drug, violating the Federal Food, Drug and Cosmetic Act, according the FDA.
Robert Elfinger, a Walgreen spokesman, says in an email that the company is “committed to working with the FDA on this matter and will be responding to their letter accordingly.”