The US Food and Drug Administration (FDA) applies the Population Health Standard in tobacco product review processes by weighing anticipated health benefits against risks associated with a given commercial tobacco product at the population level. However, systemic racism (ie, discriminatory policies and practices) contributes to an inequitable distribution of tobacco-related health benefits and risks between white and Black/African Americans at the population level. Therefore, Black-centered, antiracist data standards for tobacco product review processes are needed to achieve racial equity and social justice in US tobacco control policy. Regardless of whether FDA implements such data standards, non-industry tobacco scientists should prioritise producing and disseminating Black-centred data relevant to FDA’s regulatory authority. We describe how systemic racism contributes to disparities in tobacco-related outcomes and why these disparities are relevant for population-level risk assessments, then discuss four possible options for Black-centred data standards relevant to tobacco product review processes.
- priority/special populations
- public policy
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Contributors SC developed the concept, synthesised available data and wrote and edited the manuscript. UI and JB synthesised available data and wrote and edited the manuscript. SS synthesised available data and contributed to writing and editing the manuscript. MAP acquired funding support, provided supervision and contributed to concept development, writing and editing. HW developed the concept, synthesised available data, provided supervision and contributed to writing and editing the manuscript. SC, UI, JB, SS, MAP and HW approved the manuscript as submitted.
Funding Research reported in this publication was supported by grant number U54CA180905 from the National Cancer Institute at the National Institutes of Health and grant numbers T31RP2083 and T29DT0375 from the California Tobacco-Related Disease Research Program.
Disclaimer The funders had no role in the design and conduct of the study; collection, management, analysis or interpretation of the data; or preparation, review or approval of the manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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