FDA’s Innovative Plan to Address the Enormous Toll of Smoking

On July 28, 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced a comprehensive regulatory plan to expedite reducing the toll of more than 480 000 annual tobacco-related deaths in the United States.1 The plan is predicated on recognition that “nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”1


Although little appreciated by the public, many of whom erroneously believe that nicotine causes tobacco-related cancer, nicotine per se is not especially toxic at the doses at which people self-administer it. The real danger comes through the effects of nicotine in causing addiction to smoking, which disperses more than 7000 chemicals through the lungs into the bloodstream and then to every body organ. Seventy of those chemicals are known human carcinogens; others cause cardiovascular and pulmonary diseases, and numerous other disorders, that affect large proportions of long-term smokers. FDA’s emphasis on the centrality of smoking in tobacco-produced disease echoes the 2014 surgeon general’s report: “The burden of death and disease from tobacco use…is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.”2