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VIPONT's VIADENT ANTI-PLAQUE CLAIMS SUBJECT OF MEETING WITH FDA

Executive Summary

VIPONT's VIADENT ANTI-PLAQUE CLAIMS SUBJECT OF MEETING WITH FDA on April 15, following receipt of a March 29 regulatory letter maintaining that Viadent Anti-plaque Oral Rinse and Toothpaste are drugs and not cosmetics. FDA expects to hold additional meetings with Vipont during the next two weeks, a spokesperson said. The reg letter was issued in response to an earlier meeting and Jan. 18 letter from Vipont, in which the firm suggested Viadent could retain its cosmetic status if claims were restricted to plaque removal. Vipont had also asserted that if Viadent were considered a drug, it could not be considered a new drug and therefore would not violate FDA's OTC enforcement policy. The reg letter rejected both arguments. "We are not aware of any substantial scientific evidence that Viadent . . . or any other product containing sanguinaria as the active ingredient, is generally recognized as safe and effective for the prevention and/or treatment of plaque, gingivitis, and/or periodontal disease," FDA's reg letter states. The agency added that it does "not agree that a product similar to Viadent . . . has been marketed prior to December 4, 1975." Although FDA originally focused on Viadent's anti-plaque labeling claims, the agency later discovered additional claims made in promotional materials. The reg letter cites Vipont packaging inserts and promotional materials which claim that the active ingredient sanguinaria "works against the bacteria shown to be related to periodontal disease and caries." The materials also maintain that the rinse and toothpaste products have been proven safe and effective "for use as an antimicrobial for the prevention and treatment of plaque causing bacteria, gingivitis, and peridontal disease." The sanguinaria extract is "represented to be the active ingredient with respect to anti-plaque claims" in ads and promotional materials, the reg letter notes, adding that "the label for Viadent rinse does not disclose these facts." Claims for sanguinaria as the active plaque-removing ingredient, which did not appear on the label, include: "Viadent contains a unique plaque-controlling ingredient, sanguinaria;" and "When you swish with Viadent Oral Rinse, sanguinaria helps destroy the bacteria in plaque," the reg letter notes. Vipont, along with five other oral care product distributors, received a warning last July for making claims which the FDA said did not comply with the OTC drug product regulations for dentifrices. The companies were required to supply justification for claims; failure to do so was to risk regulatory action, seizure or an injunction. Following the letters, Colgate-Palmolive (Colgate), Procter & Gamble (Crest) and Chese-Pond's (Pepsodent) revised their claims. In 1988, Vipont forged joint marketing ventures with both Colgate-Palmolive and Japan's Sunstar to use Vipont's anti-plaque technology in products sold overseas; Viadent is currently sold in the U.S. and 19 other countries. Vipont also established a subsidiary, Vipont Research Labs, to develop a sanguinaria-containing drug product for treatment of periodontal disease. The firm filed an Investigational New Drug application for the polymer delivery system and began Phase I human clinical testing last fall. The possibility that the products may be reclassified as OTC drugs and temporarily removed from the market caused the firm's stock to drop 7 1/8, or 75%, t 9 1/2 over a two-day period. Vipont's announcement of lower-than-expected earnings was also a factor in the stock plunge. The company's stock closed at 10 April 7. Sales for the two Viadent products and the Via-jet Periodontal Irrigator reached $ 33.5 mil. in FY 1988 (ended Sept. 30), a 45.9% jump from the year before. Net income was up 67.3% to $ 3.3 mil.
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