Since the 1950s, despite considerable and long-term tobacco industry and government efforts, attempts to develop a less risky cigarette that reduces harmful ingredients, generally or specifically, have failed. Moreover, even under ideal conditions with adequate scientific testing, the efficacy of purportedly reducing the severe health effects cannot be scientifically verified for up to 20 years after introduction of a product on the market. A key and central provision in the 2009 U.S. Food and Drug Administration (FDA) legislation is to reduce the risk or harm of cigarettes. Because creating a less risky cigarette is not currently possible, this renders the efficacy of the 2009 FDA legislation highly uncertain, with a large risk that the proposed program may not reduce harm.