A Personal Take on the Harm Reduction Debate

Mitch Zeller, J.D., was the director of the FDA’s Center for Tobacco Products from March 2013 through April 2022. The mission of CTP—established by enactment of the 2009 Family Smoking Prevention and Tobacco Control Act—is “to make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every American family.”  As Center Director, Zeller led FDA’s efforts to use the tools of product regulation to reduce disease and death from tobacco use and bring previously unavailable information about its dangers to light. In this session, Mitch will outline a brief descriptive overview of the competing positions in the harm reduction debate.  He will offer some observations on the reality of how the debate is playing out in the U.S. given the statutory and regulatory regime created by the U.S. Congress.  Mitch will then contrast the state of play in the U.S. with the UK approach and offer a suggested approach to reframe the debate.