Stop Making Unproven Health Claims, FDA Tells Mouthwash Makers
Three mouthwash makers – Johnson & Johnson, CVS Corporation and Walgreen Company – that say their products promote healthy gums and remove plaque above the gum have been told to stop making these claims by the FDA (Food and Drug Administration). In a warning letter, the FDA accuses them of making claims about their products without proof; the claims being that they are effective in preventing gum disease.
The mouthwashes contain sodium fluoride, which is effective in preventing cavities, the FDA writes. However, there is no proof sodium fluoride prevents gum disease or plaque.
The companies make the following mouthwashes:
CVS Corporation makes CVS Complete Care Anticavity Mouthwash.
Johnson & Johnson makes Listerine Total Care Anticavity Mouthwash.
Walgreen Company makes Walgreen Mouth Rinse Full Action.
Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said:
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.
The FDA says it is illegal to say that a product is effective in treating a medical condition or disease if those claims have not been reviewed and approved by the FDA. For this to occur a new drug application needs to be submitted, or the active ingredient must have already been recognized as effective and safe for these claims in an OTC drug monograph.
According to the FDA, the number of violations of the FFDCA (Federal Food Drug and Cosmetic Act) by mouthwash makers and sellers has been increasing. The majority of violations are related to making health claims without any proof. The Agency stresses that it aims to curb this increase.
No reports have come in of any injuries or adverse health effects linked to these mouthwashes, the FDA adds.
If you have purchased any of these mouthwashes be aware that they may help protect against cavities, but that there is no evidence demonstrating protection from gum disease, the FDA informs.
The 3 companies have been told to take “appropriate action” within 15 days. If they don’t, they may face civil or criminal penalties, as well as having their product seized. Source: FDA (Food and Drug Administration)
Written by Christian Nordqvist
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