Tobacco Regulatory Science: Research to Inform Regulatory Action at the Food and Drug Administration’s Center for Tobacco Products

Abstract

The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation.

Hiding the tobacco power wall reduces cigarette smoking risk in adolescents: using an experimental convenience store to assess tobacco regulatory options at retail point-of-sale

“…Legal challenges by the tobacco industry eventually led the town to rescind the law. The success of overcoming legal challenges and implementing any TCA-driven advertising regulations at POS is dependent, in part, on the extent to which a given regulatory approach is supported by the empirical literature 23. The results of the current study provide evidence that could help to inform regulatory decisions at POS for the FDA-CTP.…”

“…Adolescents were the focus of this study because they are particularly vulnerable to tobacco advertising22 and are a focus of tobacco regulatory efforts in the USA 23. The recruitment ads contained no information about smoking or tobacco in order to reduce potential sample biases and simply indicated that the study focused on teens’ purchasing habits at convenience stores.…”

Defining Tobacco Regulatory Science Competencies

“…5 As used in this paper, TRS refers to research intended to inform the FDA's regulation of tobacco. Notably, some important tobacco regulatory activitiessuch as enacting tobacco taxes or clean indoor air laws-are outside the authority of the FDA and are left to Congress or state and local governments.…”

Cognitive Effects of Very Low Nicotine Content Cigarettes, With and Without Nicotine Replacement, in Smokers With Schizophrenia and Controls

“…8 The U.S. Food and Drug Administration (FDA) acquired regulatory authority over tobacco products in 2009, with the enactment of the Family Smoking Prevention and Tobacco Control Act. 9 One of the top priorities of the FDA's Center for Tobacco Products is to fund research studies that examine the effects of reducing the nicotine content of cigarettes, 10 which has been proposed as a means of reducing tobacco dependence in the United States). 11,12 This regulatory strategy could be particularly beneficial to smokers, such as SS, who have difficulty accessing effective smoking cessation treatments.…”