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Food and Drug Commissioner David Kessler''s landmark 1996 decision to propose regulation of tobacco as a drug marked him as one of the most prominent appointees in the first Clinton Administration -- one both revered and reviled. Kessler''s controversial decision sparked widespread debate, even becoming a hot-button issue in the 1996 presidential campaign. It was, however, a decision which had capped a long process, dating back to Kessler''s tenure in the Bush Administration, and one which involved an exceptionally wide range of forces and factors -- from anti- smoking advocacy groups to key Congressional committees and the tobacco companies themselves.; This case describes the way Commissioner Kessler operated the complex, multivariable political and scientific environment in which he found himself. It describes how he came to the decision to make smoking a high- profile focus of FDA action and the ways in which he justified the new round of regulatory restrictions he proposed. It allows for discussion of the separable roles that leaders, both appointed and elected, tend to play: 1) policy analyst/policy entrepreneur; 2) department/agency manager; and 3) advocate or public leader.