What Drives Tobacco Control Policy?

1802 This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons. org/licenses/by-nc-nd/3.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals. 1 As published in Nicotine and Tobacco Research (NTR), 2 and re-emphasized at the SRNT meeting, the FDA claims to be committed to a science-based regulatory agenda, rather than one based on political or special-interest concerns. Some question this FDA claim. It makes little sense to impose little or no regulatory burden on cigarettes currently on the market while attempting to remove far-lower-risk and less-addictive e-cigarettes and related vapor devices (e-cigs) from the market, and hesitating to grant Swedish Match's snus products MRTP status. It makes even less sense to deal with pharmaceutical nicotine products (patches, gums, etc.) as if they have no nicotine. A major problem with the FDA Tobacco Law relates to the requirement that the manufacturer of a new or reduced risk product document that it will not harm nonusers of the product (ie, will not recruit nonusers to nicotine addiction). Unfortunately, FDA's interpretation of this wording imposes a cost burden so substantial that, if unchanged, it will eliminate all of the smaller companies and all of the customizable products from the e-cig marketplace. 3 One might expect that advertising a product as lower-risk than cigarettes might recruit nonsmoking teens to nicotine addiction. Recent experience with e-cigs in both the United Kingdom and the United States provides convincing evidence that such advertising, while it may recruit some to product experimentation, will recruit very few to continuing use, while attracting large numbers of teen smokers away from cigarettes. 4–6 Allowing e-cig manufacturers to reference this class-of product experience to satisfy the harm-to-nonusers provision of the law would eliminate a currently proposed unbearable cost burden. If FDA determines it does not have the administrative flexibility to re-interpret this provision of the law, public health authorities could urge congressional action to amend it. The cigarette is the most addictive and hazardous tobacco product , and the dominant nicotine-delivery product in the United States. All of the commonly quoted American data on tobacco-related illness and death relate to this one product. 7 Despite public statements to the contrary, snus and the other smokeless products that …