CHESE-POND's MENTADENT TOOTHPASTE IS UNAPPROVED "NEW DRUG," FDA SAYS

CHESE-POND's MENTADENT TOOTHPASTE IS UNAPPROVED "NEW DRUG," FDA SAYS in a March 26 warning letter, based on the product's "new combination of ingredients" -- sodium fluoride, sodium bicarbonate, and hydrogen peroxide -- and its "intended use" as a treatment for gum disease. FDA cited a promotional flyer and the patent (No. 4,687,663) for the product in concluding that "the product is intended to be used for the prevention and/or treatment of gum disease."

FDA stated in the letter that it is "not aware of any substantial scientific evidence that the combination of hydrogen peroxide, sodium bicarbonate, and sodium fluoride is generally recognized as safe and effective for the prevention of gum disease." The agency added that it also is not "aware of any dentifrice product containing the combination [of ingredients found in Mentadent] ever being marketed in this country."

Chesebrough-Pond's promotes the Mentadent formula as containing "the ingredients dentists recommend most for the the care of teeth and gums." Although the company bills the product as "The Baking Soda and Peroxide Toothpaste with Fluoride," consumer labeling for Mentadent specifies sodium fluoride as the sole active ingredient. Hydrogen peroxide (.75%) and sodium bicarbonate (5%) are among a long list of "other ingredients." Packaging says the toothpaste is to be used as "part of a complete oral hygiene regimen for healthy teeth and gums."

The FDA warning letter quotes a Chese-Pond's promotional flyer, entitled, "Introducing New Mentadent," that states that "Mentadent has accounted for an average 61% improvement in gingival bleeding" and that "80% of patients perceived an improvement in their overall health." In addition, the agency noted that a patent for the combination states that "[i]t has long been recognized that the combination of hydrogen peroxide solution with sodium bicarbonate and table salt has an excellent curative and preventive effect on gum disease caused by bacterial infections."

According to product labeling, Mentadent is packaged in a "unique" dual-chamber pump containing sodium bicarbonate and hydrogen peroxide separately, to "maximize the release of oxygen bubbles as you clean your teeth." The baking soda "provides gentle cleaning; peroxide, a clean refreshing feeling," labeling states.

However, FDA complained that Chese-Pond's fails to indicate "on the carton or dispenser . . . which individual container contains the sodium fluoride ingredient" and that carton labeling states that the combination of baking soda and peroxide in combination can "release little bubbles of oxygen [which] get to the tiny spaces at the gumline where your brush doesn't reach."

Since Chese-Pond's introduced Mentadent in the Northeast in October 1991, other baking soda/hydrogen peroxide/fluoride dentifrice products have followed. In May 1992, Zila launched PeriGel. In March, CCA Industries said it planned to launch a similar product under the name Plus White this fall.

Chese-Pond's said it still sells Mentadent primarily in the Northeast, although the product is being rolled out to other regional markets. Lintas: New York is handling the localized print and media advertising account for Mentadent.

The firm said that it will attempt "to correct the agency's misinterpretation of the facts" in a response to the FDA warning letter.

In an April 7 statement on the warning letter, Chese-Pond's declared: "We do not claim, nor do we intend to claim, that by itself Mentadent can prevent or cure gum disease." The company also asserted that "contrary to what the FDA notice would have one believe, Mentadent is not an unapproved new drug." Chese-Pond's characterized the product as "a convenient toothpaste product intended, just like any other dentifrice, to promote good oral hygiene which contributes to overall oral health."