The FDA has warned Walgreen Co., Johnson & Johnson, and CVS Corp. to stop making unproven claims that their mouth rinse products can reduce plaque above the gum line, promote gum health, and prevent gum disease.
The companies claim their mouthwashes are effective in preventing gum disease, but no such benefit has been demonstrated, the FDA says in a news release.
The FDA says it sent warning letters notifying the three companies of its objections to their claims and ordering them to comply with existing federal regulations.
The mouth rinse products contain the active ingredient sodium fluoride, but the agency says it has determined that the substance, while effective in preventing cavities, has not been shown to remove plaque or prevent gum disease.
Claims by Mouthwash Companies
The products contain misleading labeling statements, the FDA says.