Tobacco Product Applications

Millions of adults use tobacco products, despite efforts to persuade people never to start or to quit once they do. For these adult tobacco consumer who cannot or will not quit using tobacco products, reduced risk tobacco products offer an opportunity to reduce the harm associated with tobacco use, particularly cigarette smoking.​
U.S. Smokeless Tobacco Company filed a Modified Risk Tobacco Product Application (MRPTA) on Copenhagen Fine Cut Snuff on March 20, 2018. The application requests FDA authorization to make one claim: “IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”
The application includes an analysis of U.S. government data from the National Health Interview Survey (NHIS) mortality linkage and the National Longitudinal Mortality Study (NLMS).  These data sets are two large, nationally representative, publicly available data sources maintained by the Centers for Disease Control and the U.S. Census.  We believe these data and decades of epidemiology substantiate the modified risk claim.  Ultimately, FDA will determine whether USSTC can communicate the modified risk claim it is seeking.
Click here​ to view the application on FDA's website.