‘It brings light to what you really put into your body’: a focus group study of reactions to messages about nicotine reduction in cigarettes

ObjectiveIn 2017, the US Food and Drug Administration (FDA) announced a proposed regulation to lower nicotine in cigarettes to minimally addictive levels to help smokers quit. We sought to explore effective message strategies communicating about nicotine reduction in cigarettes across the different key audiences that the regulation is most likely to influence.MethodsWe designed four types of messages: efficacy messages, risk messages, a message about alternative sources of nicotine and a compensation message. Sixteen virtual focus groups were conducted in Atlanta and San Francisco in April–May 2020. Data were analysed in NVivo 12.0 using a thematic analysis approach.FindingsExclusive smokers were receptive to both efficacy messages and risk messages. Dual users were the only group that was open to resorting to alternative sources of nicotine. Former smokers were critical of these messages as promoting the new kinds of cigarettes and potentially encouraging initiation and relapse of smoking. Non-smokers felt that efficacy messages downplayed the risks of smoking and did not scare people away from smoking. Presenting information that very low nicotine cigarettes (VLNCs) still contain harmful chemicals made smokers question continued smoking in the absence of nicotine and view VLNCs as harmful.ConclusionsMessages communicating about nicotine reduction in cigarettes might help to motivate smokers to quit and can correct the misperceptions that VLNCs are less harmful. The FDA should consider specific target audiences and use different messages that complement each other in communicating about this regulation.

Comparison between Gradual Reduced Nicotine Content and Usual Nicotine Content Groups on Subjective Cigarette Ratings in a Randomized Double-Blind Trial

In 2018, the United States Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking to reduce nicotine in tobacco products to produce a minimally addictive or nonaddictive effect, but there was a research gap in the subjective responses of reduced-nicotine-content cigarettes. We compared the responses of the modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS) between the gradually reduced nicotine content (RNC) group and the usual nicotine content (UNC) group. Linear mixed-effects models for repeated measures were used to analyze and compare the change over time for the mCEQ and CLS across the two treatment groups (RNC and UNC). We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette. At visits 8 and 9, the RNC group reported significantly lower satisfaction scores compared to UNC. Subscale analysis showed that smoking satisfaction decreased in RNC while other measures, such as cigarette enjoyment, did not change. Understanding the impact of nicotine reduction on cigarette subjective responses through evaluation and liking scales would provide valuable information to the FDA on nicotine reduction policies for cigarettes.

Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis

Background The US Food and Drug Administration (FDA) is considering reducing nicotine levels in cigarettes to “minimally or non-addictive levels.” However, important research gaps remain, and the FDA must determine when the available research is sufficient to support moving forward. Methods The authors conducted a systematic review of research articles in PubMed relating to nicotine reduction. Building on a review of risk assessment best practices, the authors also developed a risk assessment framework for tobacco regulation and used it to guide a gap analysis of nicotine reduction research. Results The final sample consisted of 78 articles. The majority examined either nicotine dependence on very low nicotine cigarettes (VLNCs) or markers of potential health effects of using VLNCs. One-third of the identified articles reported results from four large randomized controlled trials (RCTs). While these studies report promising results and suggest that a nicotine reduction rule would be a powerful tool to reduce cigarette smoking, our gap analysis suggests that there is a need for studies that better reflect the use and availability of a wide range of tobacco/nicotine products and the potential for dual- or multi-product use. Conclusion The current body of research on nicotine reduction is weighted towards RCTs, which is appropriate for a policy that has not yet been implemented anywhere in the world. The FDA must consider a wide range of factors that may impact a product standard’s public health impact, including those difficult to assess in RCTs, such as a nicotine reduction rule’s impact on smoking initiation and relapse. Implications This systematic review presents a gap analysis based on a risk assessment framework to help identify remaining research priorities to inform FDA’s potential product standard to reduce nicotine levels in cigarettes. Quickly addressing those gaps would support the FDA’s effort to develop a nicotine reduction product standard that will be effective and withstand legal challenges.