This analysis revealed a heavy focus on Host measures (73%) and a lack of focus on Environment measures. The predominant focus on Host measures may have the unintended effect of limiting the evidence base for tobacco control and regulatory science. Further, a lack of specificity about the e-cigarette product under study will make comparing results across studies and using the outcomes to inform tobacco policy difficult.

Introduction Conduct bibliometric analyses documenting the output of NIH tobacco-related and FDA tobacco regulatory science (FDA-TRS) research portfolios. Methods PubMed Identifiers for publications between 2015 and 2020 citing tobacco funding by NIH and/or FDA were imported into NIH iCite generating measures of productivity and influence, including number of citations, journal, Relative Citation Ratios (RCR), and comparison of research influence across Web of Science (WoS) disciplines. Co-authorship and measures of centrality among and between NIH and FDA-supported investigators gauged collaboration. Results Between FY 2015 and 2020, 8160 publications cited funding from NIH tobacco-related grants, 1776 cited FDA-TRS grants and 496 cited Common funding (i.e., both NIH and FDA-TRS funding). The proportion of publications citing NIH grants declined while those citing FDA-TRS or Common funding rose significantly. Publications citing Common funding showed the highest influence (mean RCR=2.52). Publications citing FDA-TRS funding displayed higher median RCRs than publications citing NIH funding in most WoS categories. Higher translational progress was estimated over time for FDA-TRS and Common publications compared to NIH publications. Authors citing Common funding scored highest across all collaboration measures. Conclusions This study demonstrates the high bibliometric output of tobacco research overall. The rise in publications citing FDA-TRS and Common likely reflects increased funding for TRS research. Higher RCRs across WoS subject categories and trends towards human translation among FDA-TRS and Common publications indicate focus on research to inform regulation. This analysis suggests that FDA support for TRS has expanded the field of tobacco control resulting in sustained productivity, influence and collaboration. Implications This paper is the first effort to better describe the impact of tobacco research resulting from the addition of FDA funding for TRS in the past decade. The analysis provides impetus for further investigation into the publication topics and their focus which would offer insight on the specific evidence generated on tobacco control and regulation.

The US Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) funds a wide range of research studies. Methods development and modeling research (MDMR) are 2 areas of interest, as they can help advance tobacco regulatory science (TRS) by fostering data synthesis and exploration of complex relationships. Our analyses of the CTP portfolio found that 13% of publications focused on MDMR, and the most commonly addressed CTP priority research domains were knowledge, attitudes, and behaviors, and toxicity and carcinogenicity. MDMR publications were cited by 1,186 publications, 5 FDA proposed rules and guidance documents, and 3 dockets. MDMR publications are characterized as foundational research and help build the evidence base that informs policy. While MDMR represents a small portion of the CTP research portfolio, they have made important contributions to advancing TRS and informing regulatory actions.