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Antigingivitis/Antiplaque Combination With Other Actives Excluded In ANPR

This article was originally published in The Rose Sheet

Executive Summary

FDA's advance notice of proposed rulemaking on OTC antigingivitis/antiplaque products excludes the combination of antigingivitis/antiplaque ingredients with other oral health care ingredients. The 1notice was published in the May 29 Federal Register

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Mouthwashes and oral cancer

Health-care professionals should not recommend long-term use of mouthwashes containing alcohol in light of findings that the products contribute to oral cancer, according to a peer-reviewed study by MJ McCullough, Melbourne Dental School. In the study, recently published in the Australian Dental Journal, McCullough also holds that mouthrinses containing alcohol should be prescribed by dentists, and their use should be limited to a controlled period of time. "Patients should be provided with written instructions for mouthwash use, and mouthwash use should be restricted to adults for short durations and specific, clearly defined reasons," the researcher says. The study comprised a literature review of epidemiological evidence, supportive in vitro studies and evaluated the mechanism by which alcohol is involved in the development of oral cancer. He noted that some mouthrinses contain significant levels of alcohol and that the ethanol in such formulas degrades mucous membranes in the mouth, increasing cancer risk. In 2003, a study by the American Dental Association concluded mouthwashes are not linked to oral cancer; however, that study was criticized because it was funded by Warner-Lambert, the original marketer of Listerine. In 2003, FDA's Dental Plaque Subcommittee advised that further studies be conducted to determine the relationship between mouthrinses with high alcohol content and oral cancer and that products reveal alcohol content on the principal display panel; those recommendations were included in an FDA advance notice of proposed rulemaking on antigingivitis/antiplaque products (1"The Rose Sheet" June 2, 2003, p. 3)

Mouthwashes and oral cancer

Health-care professionals should not recommend long-term use of mouthwashes containing alcohol in light of findings that the products contribute to oral cancer, according to a peer-reviewed study by MJ McCullough, Melbourne Dental School. In the study, recently published in the Australian Dental Journal, McCullough also holds that mouthrinses containing alcohol should be prescribed by dentists, and their use should be limited to a controlled period of time. "Patients should be provided with written instructions for mouthwash use, and mouthwash use should be restricted to adults for short durations and specific, clearly defined reasons," the researcher says. The study comprised a literature review of epidemiological evidence, supportive in vitro studies and evaluated the mechanism by which alcohol is involved in the development of oral cancer. He noted that some mouthrinses contain significant levels of alcohol and that the ethanol in such formulas degrades mucous membranes in the mouth, increasing cancer risk. In 2003, a study by the American Dental Association concluded mouthwashes are not linked to oral cancer; however, that study was criticized because it was funded by Warner-Lambert, the original marketer of Listerine. In 2003, FDA's Dental Plaque Subcommittee advised that further studies be conducted to determine the relationship between mouthrinses with high alcohol content and oral cancer and that products reveal alcohol content on the principal display panel; those recommendations were included in an FDA advance notice of proposed rulemaking on antigingivitis/antiplaque products (1"The Rose Sheet" June 2, 2003, p. 3)

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