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Executive Summary

ANTI-PLAQUE DATA DEADLINE IS MARCH 18, 1991, FDA SAYS in a notice published in the Sept. 19 issue of the Federal Register. The call-for-data on anti-plaque claims in dental and oral health care products is described by FDA as the "initial step" in the final segment of the OTC oral cavity product review. The 180-day deadline is supported implicitly by the agency's well-publicized previous statements of interest in the data. FDA OTC Drug Evaluation Division Director William Gilbertson announced the agency's intent to issue a call-for-data over two years ago, in August 1988. In late December 1989, FDA reconstituted the Dental Device Panel as the Dental Products Panel to broaden its scope and permit it to participate in the review of anti-plaque claims. At that time, FDA said it would expand the panel from seven members to nine members, adding two new members who were more experienced with drug claims. Several firms with anti-plaque claims maintain they have already collected and/or submitted supporting information to FDA as part of the agency's on-going discussions of the appropriateness of current claims. A key issue in FDA's review of the data submitted in response to the Federal Register notice will be the agency's position on the type of acceptable studies. FDA OTC Drug Evaluation Division staffer Jeanne Rippere previously stated that the panel will expect "well-controlled" safety and efficacy studies of the ingredients under review ("The Pink Sheet" July 23, T&G-8). "Because [anti-plaque] claims are drug claims," FDA says, "the safety and effectiveness of ingredients used in products making plaque reduction and removal claims must be demonstrated." Vipont says it is "fully prepared to respond in detail" to the agency request for anti-plaque data with safety and efficacy data from more than 100 studies on its Viadent oral rinse and toothpaste products. Vipont says FDA's data review is an opportunity to expand the Viadent labeling to include gingivitis claims. Vipont said it recently has completed long-term studies to support both plaque and gingivitis claims. Among data to be submitted to the agency are three long-term studies and several shorter-term studies "demonstrating up to a 57% reduction in plaque and gingivitis," the firm maintains. "The long-term study data also showed that up to 100% of patients using Viadent oral health products experienced reductions in plaque," the firm says. During the data review period, manufacturers may continue to market the products under the "good faith belief" that the products are GRAS/E and not misbranded. However, the agency notes,"such products are marketed at the risk that the agency may adopt a position requiring relabeling, recall, or other regulatory action." In providing the data, firms must show they have marketed the products "to a material extent and for a material time," FDA said. Marketers with new anti-plaque ingredients should go the NDA route before marketing. The agency considers anti-plaque claims to include: "For the reduction or prevention of plaque, tartar, calculus, film, sticky deposits, bacterial build-up, and gingivitis." FDA indicates it is more skeptical of other related claims: "For the reduction, prevention, or treatment of gum disease, inflamed gums, swollen gums, bleeding gums, pyorrhea, Vincent's infection, periodontal disease, or tooth-destroying acids,...'promotes healthy gums' [and] 'conditions gums.'" However, the agency says it will accept data on those claims as well.

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