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MERRELL DOW CEPACOL PLAQUE CLAIMS ARE SUBJECT OF FDA WARNING

Executive Summary

MERRELL DOW CEPACOL PLAQUE CLAIMS ARE SUBJECT OF FDA WARNING letter threatening regulatory action. FDA's April 20 letter cites Merrell Dow subsidiary Lakeside Pharmaceutical for making plaque treatment/prevention claims on the mouthwash/gargle product and for labeling which "fails to bear adequate directions for use for such conditions." Cepacol labeling identifies the product as an "Antibacterial Plaque Fighting Formula." Labeling also states that "Cepacol . . . kills germs that cause bad breath and plaque buildup." FDA contends that it is "not aware of any evidence that . . . the combination of ingredients found in Cepacol is . . . safe and effective for the treatment and/or prevention of plaque." Lakeside has not yet replied to the letter but said it plans to meet with the FDA in the "next week to 10 days." FDA's warning letter follows a March 29 regulatory letter to Vipont Pharmaceutical for plaque claims on its Viadent toothpaste and oral rinse. Vipont is in "on-going discussions" with the FDA over the label claims, according to the Agency. The firm just recently released television ads about its Viadent products, asserting the active ingredient, sanguinaria, is "effective against 98%" of plaque-causing bacteria. Last year, FDA notified marketers of Colgate (Colgate-Palmolive), Aqua-Fresh (Beecham Products), Plax (Oral Labs), Viadent (Vipont), Listerine (Warner-Lambert) and Check-Up (S.C. Johnson's subsidiary Rydelle-Lion) that their claims violated OTC drug product regulations for dentifrices and oral care products. Colgate, along with Crest marketer Procter & Gamble and Pepsodent marketer Chese-Pond's (which did not receive letters), have since revised their claims. A number of the firms have continued to make the plaque claims, however. Warner-Lambert, for example, reached an agreement with FDA where they would not respond to their warning letter until the firm was given access to the minutes of a closed Oral Care Panel meeting held several years ago. The company has not yet received the minutes. Current print ads for Listerine say "Pick one. Gingivitis . . . An early, reversible form of gum disease. Or Listerine . . . To help prevent and reduce plaque and gingivitis." The ad states the mouthwash was the first non-prescription rinse to receive the American Dental Association's (ADA) Council on Dental Therapeutics "Seal of Acceptance for helping to prevent and reduce plaque above the gumline and gingivitis."
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