 
|
Federal Register (2003)
The Federal Register, published by the Office of the Federal Register, National Archives and Records Administration, is the official daily publication for rules, proposed rules, and notices of U.S. federal agencies and organizations. The May 29, 2003 issue of the Federal Register includes FDA (Food and Drug Administration) Advisory Committee information indicating that the relationship between high-alcohol content mouthrinses and oropharyngeal cancer is unclear. It states that studies to date are contradictory and fail to show a consistent dose-response relationship between alcohol-containing mouthrinses and oral cancer. A dose-response relationship would be important for determining a causal relationship, according to this report.
In addition, the Federal Register reports that the findings of many studies may have been confounded by the presence of risk factors such as high alcoholic-beverage consumption and tobacco use among study subjects.
Conclusion
Based on the studies reviewed, the Subcommittee concludes that the available data do not support a causal relationship between the use of alcohol–containing mouthrinses and oral cancer. The vote was unanimous.
Previous | Next | Back to Clinical Library
REFERENCES
- Oral health care drug products for over-the-counter human use: antigingivitis/antiplaque drug products; establishment of a monograph; proposed rules. Part III, Department of Health and Human Services, Food and Drug Administration. Federal Register. May 29, 2003;68:32231-32287.