Tobacco use is the largest preventable cause of disease and death in the United States. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) signed on June 22, 2009 grants authority to FDA to regulate tobacco products. This law also gave FDA regulatory authority to regulate Modified Risk Tobacco Products (MRTP). An MRTP is any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease. FDA can issue a risk modification order authorizing the marketing of an MRTP only if the evidence submitted in an application demonstrate that the MRTP benefits the health of the population as a whole; taking into consideration users and non-users of tobacco products. This presentation describes a hypothetical case study of regulatory action by the FDA intended to predict the potential public health impact from the introduction on an MRTP into the U.S. Market. A deterministic system dynamic model coupled with a Monte Carlo Simulation is used to quantify the possible effects on tobacco use prevalence, tobacco-attributable deaths, and all-cause mortality, following the introduction of an MRTP.