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Listerine mouthwash and Check-Up toothpaste are "at risk" of regulatory action for anti-plaque and gingivitis claims, FDA has told Warner-Lambert and S. C. Johnson subsidiary Rydelle-Lion. In separate June 22 letters, FDA requested justification that Listerine and Check-Up Gingival Toothpaste are "not subject to action" under the agency's OTC drug product regulations. "Otherwise," the agency said, "it is our opinion that the . . . product is marketed in violation of the Federal Food, Drug and Cosmetic Act and at risk of regulatory action." FDA questioned promotional claims that Listerine Antiseptic mouthwash is "adequate and effective for the treatment and/or prevention of plaque and gingivitis (red, swollen gums)," and labeling statements that Check-up Gingival Toothpaste is "adequate and effective for the treatment and/or prevention of gingivitis, periodontitis and gum diseases." FDA noted that its advisory review panels have not evaluated the effectiveness of oral rinses or fluoride dentifrices in the reduction or prevention of plaque, gingivitis, periodontitis or gum disease. The tentative final monograph (TFM) on Oral Health Care Products was published in the Jan. 27 Federal Register. The Dentifrice TFM notice came out Sept. 30, 1985. The agency also pointed out that no OTC products making such claims were on the market prior to the 1972 inception of the OTC Drug Review, and that none of the ingredients in Listerine or Check-Up Gingival Toothpaste are generally recognized as safe and effective (GRAS/E) for the control, treatment or prevention of plaque and gingivitis or gum disease. Last October, Listerine became the first OTC oral rinse to receive the American Dental Association's (ADA) Council on Dental Therapeutics "seal of acceptance" for the control of plaque and gingivitis. However, FDA said, "Please note that such a statement does not represent the findings and/or conclusions of the Food and Drug Administration, nor does it affect the marketing status of Listerine Antiseptic as it relates to agency enforcement policies." A spokesperson for W-L said "there are more than 20 scientific studies [which] exist to back up the claims." In addition to the data on file with ADA, the company has submitted clinical results to FDA on plaque and gingivitis. W-L expects to meet FDA about the June 22 letter, but no date has been set. An S. C. Johnson spokesperson said the company is also preparing to meet with FDA and is "confident that we can satisfactorily answer" the agency's questions and "confirm that Check-Up complies with regulatory policy." Agency scrutiny of W-L and Rydelle-Lion is expected to be followed by letters to other marketers of anti-plaque/gingivitis products. The agency also continues to plan for a formal review of plaque and gingivitis claims by an advisory review panel. Listerine's active ingredients are thymol, eucalyptus, methyl salicylate and menthol. Check-Up Gingival Toothpaste, launched earlier this summer, contains SN4X, the company's patented stabilized stannous fluoride. In addition to finding both products in violation of the GRAS/E reg for anti-plaque and gingivitis claims, the agency cited both products for failure to bear "adequate directions for use for such conditions." Furthermore, FDA said, "we do not believe that conditions such as gingivitis, gum disease or periodontitis conditions are amenable to diagnosis and self-treatment by the lay public." The plaque/gingivitis issue is being handled by the Center for Drug Evaluation's OTC Compliance Branch Chief Robert Heller. Last year, FDA announced plans to publish a notice calling for information on products used to treat plaque and tartar and is considering having it Dental Devices Panel take responsibility for a review of OTC anti-plaque products.

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