U.S. FDA says Zila mouth rinse promotion misleading

The U.S. Food and Drug Administration has warned Zila Pharmaceuticals Inc about promoting its Peridex oral rinse without including information about possible risks, according to a letter released on Tuesday.

A letter and a brochure for the rinse, which is approved to treat gingivitis, also made unproven claims about how well Peridex worked and made false statements about competitors’ products, the FDA wrote in an April 18 letter to Zila Pharmaceuticals, a unit of Zila Inc.

It was not immediately clear when the promotional materials were used.

3M acquired rights to Peridex in May 2007. Its Omni Preventive Care unit has sold the product since 2000.

Representatives for Zila and the FDA could not be reached for comment.

The agency said in its letter that Zila’s promotion claimed that the effect of Peridex could last up to 12 hours and kill up to 97 percent of bacteria.

“These claims as to the effectiveness of Peridex in the oral cavity are misleading because they are not supported by substantial evidence or substantial clinical experience,” the FDA wrote.

Zila’s letter and the brochure were intended to be mailed together to health professionals along with the product’s FDA-approved label information, according to the FDA.

Including the label, which details the product’s risks, was not sufficient, the FDA wrote in the letter, posted on its Web site on Tuesday.