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Three Makers of Mouthwash Warned about False Claims
by admin on: June 15th, 2011

On September 28, 2010, The U.S. Food and Drug administration (FDA) announced that warning letters were sent to three companies that make mouthwash, including:

  • Listerine Total Care Anti-Cavity Mouthwash (Johnson & Johnson)
  • Walgreen Mouth Rinse Full Action (Walgreen Company)
  • CVS Complete Care Anti-cavity Mouthwash (CVS Corporation)

These three companies made claims suggesting that the active ingredient (sodium fluoride) either removes plaque above the gum line or promotes healthy gums. While sodium fluoride has been demonstrated to effectively prevent the formation of cavities, there is no evidence to indicate that sodium fluoride is effective at removing plaque or is effective at preventing the onset of gum disease.

Federal law states that a company cannot make claims that their product (or products) is effective at treating a disease unless there is data to support these claims. Additionally, the company must submit a new drug application and had this application (and the supporting data) approved by the FDA.

In the press release from the FDA, the director of the Office of Compliance in FDA???s Center for Drug Evaluation and Research (Deborah Autor) stated that it is important that the FDA appropriately safeguard customers from being misled or misinformed. In order to accomplish this task, the FDA will take appropriate action to prevent companies from making unproven claims about their product(s).

The letters sent by the FDA represent the continuing efforts by the FDA to stem the increase in the number of Federal Food Drug and Cosmetic Act (FFDCA) violations filed against these companies (or the marketing agencies/marketing departments working for the companies) that have made unsubstantiated claims that their products provide therapeutic benefits.

The FDA also noted in their announcement that no one has suffered any injury from the use of the above listed mouthwashes, and that the mouthwashes are effective as a product for cavity prevention.

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