Procter & Gamble Co.'s Crest Pro-Health Rinse hit the market three years ago as an alcohol-free mouthwash that not only freshens breath but fights oral maladies such as gingivitis and plaque. The strong-selling product has caused some users to report discoloration of their teeth and numbing taste.
Cincinnati-based P&G says "99.99 percent" of users have had no complaints and that any discoloration or aftertaste is temporary.
A federal lawsuit alleging fraud in a proposed class action is pending in Georgia and the U.S. Food and Drug Administration, which approved the product, is gathering more information on complaints. The developments were first reported Wednesday by NBC's "Today" show.
Laura Brinker, a Crest spokeswoman, declined to comment on the pending litigation. She said the product is in full compliance with current standards.
A statement from Robert Gerlach, a dentist and P&G researcher, posted on the Crest Web site says the product has been tested extensively and proven to be safe and effective.
"The millions of consumers who use it every day, and the growing number of dentists who recommend it, can attest to that," Gerlach said.
Brinker said temporary discoloration can be a sign that the product is killing harmful germs, which can be brushed away, or reflect the user's eating, drinking and brushing habits.
P&G said nearly 100 million bottles - a one-liter bottle retails from $4.69 - of Pro-Health Rinse have been sold. It is the second-leading mouthwash behind Johnson & Johnson's venerable, alcohol-containing Listerine.
A J&J spokeswoman, Meghan Marschall, said in a statement that Listerine is the most-studied and most-recommended mouthwash, and that testing hasn't shown tooth staining from its use.
Pro-Health Rinse complaints have shown up repeatedly on Internet sites.
"I thought it was unusual in terms of how many people it's affecting," said Ben Popken, editor of Consumerist.com. "Sometimes you might hear from a handful, but there seems to be a pretty decent body of people saying this."
Brinker said P&G doesn't see a need for a warning label because the number of those affected is very small.
"You don't want to discourage people from using a product when they will receive very important health benefits," she said.
An FDA spokeswoman, Rita Chappelle, said the agency has received few complaints but is interested in hearing from consumers who have experienced problems as it considers whether any changes are called for.
Brinker said P&G expects more consumer calls, and considers refunds on a case-by-case basis.
Meanwhile, P&G has filed a motion to dismiss the lawsuit in Georgia, saying it doesn't make factual allegations or sustainable claims. The suit seeks unspecified damages.
An attorney who helped file the lawsuit last year, Angela McElroy Magruder of Augusta, Ga., said she began looking into it after she and 8-year-old daughter Charlotte experienced problems with food tasting bland and spotting on their teeth after using Pro-Health Rinse.
"Everybody talks about the staining, but to me, it's the taste," she said.
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