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FDA legislation
  1. Michael Givel
  1. Correspondence to:
 Dr Michael S Givel
 Department of Political Science, University of Oklahoma, 455 West Lindsey, Room 205, Norman, OK 73019, USA; mgivel{at}

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Time to shift US federal anti-tobacco advocacy tactics

Since 2004, a highly unusual annual spectacle has occurred with the introduction in Congress of similar US Food and Drug Administration (FDA) tobacco regulation bills. Often accompanied by considerable controversy and animosities, these FDA tobacco bills have always been supported by the tobacco giant Philip Morris along with numerous health groups including the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society. At the centre of this controversy have been two important policy issues and questions. Firstly, why would a giant tobacco company actually campaign to be more stringently regulated? Secondly, given the history of tobacco industry disease, deception, and duplicity why would anti-tobacco advocates actually believe that this is in the best interest of public health and even public health advocacy?

The origins of this modern controversy began in 1996 when the FDA issued a final rule regulating tobacco as a drug and drug delivery device.1 This final rule would have greatly restricted sales and distribution of tobacco products and also created a national counter-marketing and youth access campaign.1 The industry mobilised against this rule on two fronts. Firstly, it filed a federal lawsuit in Greensboro, North Carolina to overturn the regulation.1,2 In 2000, the industry won this legal battle when the US Supreme Court ruled in a 5-4 decision that the FDA had no authority to regulate tobacco products as a drug and drug delivery device or engage in a national youth access enforcement effort.3

The second front, aggressively advanced by Philip Morris (and opposed by the rest of the tobacco industry) was a concerted effort to enact much weaker and alternative FDA regulation of tobacco.1 The goals of this effort, besides stopping a future FDA regulation regulating tobacco …

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