Expert Elicitation on the Behavioral Impacts of a Nicotine Standard

In support of the U.S. Food and Drug Administration’s Center for Tobacco Products, IEc conducted a formal elicitation of expert judgments on the behavioral impacts of a regulation that would limit the nicotine content of cigarettes to levels too low to establish or sustain addiction. The elicitation solicited judgments on the likely effects of the regulation on initiation and cessation of cigarette use, as well as the use of alternative products that would not be subject to standard. These judgments served as inputs to FDA’s analysis of the potential impact of a nicotine standard on public health, helping to characterize both the magnitude of potential health benefits and the breadth of uncertainty around these effects.

To conduct the elicitation, IEc assembled a panel of eight experts, identified and recruited based on their contributions to research on factors that influence different forms of tobacco use. Over the course of two online workshops, we briefed the experts on the project’s context and provided training in providing the types of probabilistic judgments the elicitation sought. We also facilitated presentation and discussion of the relevant literature and other information the experts believed should be considered in assessing the likely impacts of the potential product standard. Following these workshops, we elicited the initial judgments of each expert, employing a structured protocol specifically developed for the effort. We then convened a third workshop, during which we presented a summary of the experts’ responses and facilitated a discussion of the results. This process provided members of the panel with the opportunity to interact and discuss divergent views. Each expert then had the opportunity to reconsider his or her initial estimates and submit a revised response to the elicitation questionnaire.

In accordance with federal guidelines on potentially influential scientific assessments, IEc solicited an independent peer review of the elicitation process; this review endorsed the approach and the use of its findings in characterizing the likely impacts of the potential product standard. The judgments the experts provided subsequently served as inputs to FDA’s analysis of the impact of the potential standard on public health. This analysis was published online in the New England Journal of Medicine, along with a summary report on the elicitation and its findings.