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Executive Summary

FDA SEEKING DATA ON HIGH-ALCOHOL MOUTHWASH's POSSIBLE LINK TO CANCER in Jan. 8 letters to the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association. Based on its "concern...about the potential health risk for consumers who use oral health care drug products that contain high concentrations of alcohol," the agency is seeking data on amounts of alcohol used in such products as well as possible links between alcohol-containing mouthwashes and oral and pharyngeal cancers. FDA requested a response from the associations by March 2. In a letter to the agency dated Jan. 17, NDMA told FDA that "we are in the process of developing a response in conjunction with CTFA through our respective task groups on oral health care." In its letters to the associations, the agency noted that its concern is based on data in four recent studies indicating a link between mouthwashes with high alcohol content and cancers. The most recent study, published in the June 1, 1991 issue of Cancer Research, was authored by National Cancer Institute Biostatistics Branch Chief William Blot, PhD, et al. FDA noted the "study indicates that men and women using mouthwashes with 25% or higher alcohol content have a slightly increased risk of oral and pharyngeal cancers. Moreover, the risk rose with longer and more frequent mouthwash use." Warner-Lambert, marketer of the antiseptic mouthwash Listerine, which is 26.9% alcohol, plans to submit to FDA a "white paper" that will contain a reanalysis of the Blot study and the findings of a panel of independent experts that are reviewing the literature on studies that investigated whether there is a link between mouthwashes and oral cancers. The white paper will say that no evidence exists to support an association between alcohol- containing mouthwashes and cancer, the company said. Warner- Lambert's Consumer Health Care Products Division VP of Medical and Regulatory Affairs Joseph Clark is chairman of NDMA's oral health care products task group. Warner-Lambert says it has no plans to replace Listerine with a formulation that has a lower alcohol content. The firm is researching different flavors of the mouthwash. A cool mint flavor mouthwash with less than 20% alcohol was launched in the U.K. in 1991 ("The Pink Sheet" April 29, p. 10). FDA noted in its letter that "although these findings do not firmly establish the risk relationship between alcohol-containing mouthwash use and these cancers, they show a need to look further at this relationship." FDA said it believes the Blot study was "well designed and well controlled and that serious consideration must be given to its results to determine whether there is a need to limit the amount of alcohol permitted in oral health care drug products." The agency lists three earlier studies demonstrating an "apparent" association between mouthwash use and an increased risk of oral and pharyngeal cancers. The studies include: "Oral Cancer and Mouthwash Use," published in the Journal of the National Cancer Institute (Vol. 70, 1983) by Wynder et al.; "Oral Cancer and Mouthwash," published in the Journal of the National Cancer Institute (Vol. 70, 1983) by Blot et al.; and "Mouthwash and Oral Cancer: Carcinogen or Coincidence?" published in the Journal of Oral Surgery (Vol. 37, 1979) by Weaver et al. FDA said it is seeking from industry "any data...other than that which we have cited above, concerning a relationship between an alcohol-containing drug product and oral and pharyngeal cancers. Your comments on the published literature would also be appreciated." The agency also asked the trade associations to poll their members to "identify for the agency the alcohol-containing oral health care drug products each company manufactures and/or markets and the annual consumption for each product, if possible." FDA said it would be interested to know the names of products and specific alcohol content.

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