FDA orders mouthwash makers to stop unsupported claims on gum disease

By Andrew Zajac

Tribune Washington Bureau

WASHINGTON — The Food and Drug Administration has warned three companies that market mouth rinse products to stop making unsupported claims that they remove plaque and promote healthy gums.

The claims suggest the products, which are used by countless Americans every day, are effective in preventing gum disease when no such benefit has been proven, the FDA said Tuesday.

The agency said warning letters were sent to Johnson & Johnson, maker of Listerine Total Care Anticavity Mouthwash, and to two drug store giants — CVS Corporation, which sells CVS Complete Care Anticavity Mouthwash, and Walgreen Company, which sells Walgreen Mouth Rinse Full Action.

The letters are the latest in a stream of warnings issued to food and drug producers by the FDA and the Federal Trade Commission since President Barack Obama took office dealing with unsubstantiated health benefits on labels and in advertising.

“We’ve got a much more aggressive FDA and FTC, there’s no question about it,” said John Villafranco, a Washington attorney who specializes in advertising and consumer protection issues.

Villafranco said that in contrast to Europe, where regulators list permissible claims for food and drugs, “and you’re either on the list or you’re not, in the U.S. there’s been a more flexible standard” — which now is becoming less forgiving.

Under U.S. law, a company cannot assert that a product is effective in treating a disease unless the claim has been approved by the FDA, or the active ingredient generally has been recognized as safe and effective for the claim.

All three mouthwashes cited contain as their active ingredient sodium fluoride, which prevents cavities, but which FDA has not found to be effective in removing plaque or preventing gum disease.

In the case of Walgreen, which is headquartered in Deerfield, Ill., the company has claimed that its Mouth Rinse Full Action “Helps fight visible Plaque Above the Gum Line.”

Rinsing does disrupt plaque, but the effect is similar with plain water or mouthwash, said Jonathan Shenkin, a pediatric dentist and assistant professor of health policy at Boston University’s School of Dental Medicine. “It’s the act of rinsing. Sodium fluoride doesn’t remove plaque,” Shenkin said.

By making an unproven medical claim, Walgreen effectively positioned its mouthwash as a new drug, for which tests to prove safety and effectiveness would be required, according to the FDA letter to the company.

A Walgreen spokesman said that “we are committed to working with the FDA on this matter and will be responding to their letter accordingly.”

The warning to Johnson & Johnson, of New Brunswick, N.J., follows a string of regulatory problems over the past year, including recalls of hip implants and contact lenses, plus a massive recall of Children’s Tylenol and other over-the-counter medications that are the subject of congressional and grand jury investigations.

Regarding the mouthwash complaint, Johnson & Johnson, in a statement said the company “will respond to the agency in an appropriate and timely manner.”

A spokesman for Woonsocket, R.I.- based CVS said the company is reviewing the FDA’s letter, but “our policy is to fully comply with all FDA labeling requirements.”

All three companies are required to respond to the warning letters within 15 days and face possible civil or criminal penalties for failing to correct violations.

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