WASHINGTON (Reuters) April 23 - The U.S. Food and Drug Administration (FDA) 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 company 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.
Zila Senior Vice President and General Manager David Barshis said the company disseminated the materials in late 2006 and early 2007 before 3M acquired full rights to Peridex in May 2007. 3M's Omni Preventive Care unit had already been selling the product since 2000 under a separate arrangement.
Barshis said it would make that point to the FDA, calling the letter a "nonissue."
"It's a long time ago. I'm really kind of surprised that there's such a lag because we haven't even owned the business (Peridex) for a year," he told Reuters.
A spokeswoman for the FDA did not have immediate 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% 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.
Barshis said the mailing went to general dentists, but did not have more details.
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.
Shares of Zila were off 11% at 25 cents in afternoon trade on Nasdaq.
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