The Science of Smokeless Tobacco
Smokeless tobacco is a non-combustible tobacco product that originated in the U.S. in the late 1600s. Over time, it has developed into various formats, including dry snuff, snus, dissolvable tobacco products and moist smokeless tobacco.
Smokeless tobacco products are made of cut or ground tobacco and usually include other added flavors and ingredients. Users chew or place the product in the oral cavity between the gum and the cheek or lip.
A variety of smokeless tobacco product types are available in the U.S. market, with further diversity of product types available internationally. The current U.S. smokeless tobacco product market is dominated by moist smokeless tobacco, but also includes snus, various types of chewing tobacco and dry snuff.
From a scientific perspective, based on decades of epidemiology, it is now accepted by most public health researchers that smokeless tobacco, while not safe, is a far less risky way to use nicotine than cigarette smoking.
Epidemiological data demonstrates that smokeless tobacco users in the U.S. have lower risks of smoking related diseases compared to cigarette smokers. According to our analysis of government data, when looking at all causes of mortality, smokeless tobacco use is at least 96 percent lower risk than cigarette smoking.1
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 the Food and Drug Administration (FDA) authorization to make one claim: “IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”
Our application includes an analysis of U.S. government data from the National Health Interview Survey mortality linkage and the National Longitudinal Mortality Study. 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.
In February 2019, an FDA scientific advisory committee reviewed our research and overwhelmingly supported the scientific accuracy of our proposed claim.
We believe that providing this accurate information to adult smokers could play a role in encouraging them to fully replace cigarette smoking with Copenhagen Snuff, with minimal unintended consequences among non-users and youth. Ultimately, the FDA will determine whether U.S. Smokeless Tobacco Company can communicate the modified risk claim it is seeking.
Click here to view the application on FDA’s website.