The Food and Drug Administration today sent warning letters to the operators of three major mouthwash brands -- Listerine, CVS and Walgreens -- that claim their products prevent gum disease, when no scientific proof exists to back such claims.
The culprits, all major household names, promoted their mouthwashes as effective in removing plaque and supporting healthy gums, regulators say. The mouth rinse products are Johnson & Johnson's Listerine Total Care Anticavity Mouthwash, CVS Complete Care Anticavity Mouthwash, and Walgreens Mouth Rinse Full Action.
In its letter to Johnson & Johnson, the FDA says sodium fluoride, the sole active ingredient in Listerine, does not mitigate, prevent, or remove plaque, a well-known precursor to gum disease, and thus cannot be regarded as a drug. However, the claims on the label boast the mouthwash "fights unsightly plaque above the gum line" and "prevents cavities," which, if true, would classify Listerine as a drug.
The agency also says the appearance of the "Total Care" phrase in the front panel of the product suggests Listerine is comprehensive in function and offers benefits beyond prevention of cavities. Based on such marketing, the product is misbranded and its claims misleading, regulators say. Their letters to CVS and Walgreen have similar criticisms.
Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been expressly reviewed and approved by the FDA, or unless the active ingredient has been recognized as safe and effective for use in over-the-counter medications.
The FDA says its actions are part of an effort to curtail an increasing number of Food Drug and Cosmetic Act violations among marketers of mouthwash products that make unproven claims of therapeutic benefits.
Asked to explain the spike in deceitful advertising by such companies, FDA spokeswoman Elaine Bobo told Consumer Ally only: "It's interesting, but at this time we don't have enough trend data that would allow us to speculate on why that is happening."
Listerine, CVS, Walgreens told to stop making unproven claims on mouthwash