Maternal & Infant Health Benefits of a Nicotine Product Standard in the United States

Importance Cigarette smoking during pregnancy increases the risks of miscarriage, ectopic pregnancy, placental complications, hypertensive disorders of pregnancy, and infant mortality. Reducing smoking in pregnancy remains a pressing public health priority.

To project the impact of a proposed nicotine product standard on maternal complications and infant mortality using the Smoking, E-cigarette use, and Pregnancy (SEP) microsimulation model. Design, Settings, and Participants Individual-level, annual‐cycle microsimulation of U.S. females of reproductive age that tracks smoking, vaping, pregnancy, and pregnancy outcomes was constructed. Model inputs were drawn from national surveillance and vital statistics, including National Health Interview Survey (NHIS) for general population, Behavioral Risk Factor Surveillance System (BRFSS) (2016–2023) for smoking/vaping among pregnant women and NVSS Natality/Linked Birth–Infant Death files for late-pregnancy morbidities and infant mortality. Policy effects on tobacco and e-cig usage transitions are based on FDA’s expert-elicitation and used to simulate outcomes under status quo vs. the new policy from 2027-2100. Exposure Smoking and vaping. Main Outcome(s) Maternal outcomes during pregnancy (ectopic pregnancy, miscarriage, placenta previa, placental abruption, hypertensive disorders of pregnancy/pre-eclampsia, eclampsia), infant mortality, pregnancy-related costs, and maternal Quality Adjusted Life Years (QALYs).

Under the nicotine product standard (policy start 2027), smoking in pregnancy falls sharply from 6.0% in 2027 to 1.2% by 2040. These behavioral shifts translate into large perinatal gains through 2100: approximately 167,000 ectopic pregnancies, 950,000 miscarriages, 15,000 placenta previa, 62,000 placental abruptions, 167,000 hypertensive disorders of pregnancy/pre-eclampsia, 9,000 eclampsia cases, and 64,000 infant deaths are averted cumulatively. Maternal health improves as well, with 103,000 pregnancy QALYs gained. Health system spending falls despite conservative costing, with $4.9 billion in pregnancy-related medical costs avoided. Across uncertainty bounds, direction and magnitude of benefit remain favorable for all maternal morbidities and infant deaths, indicating that new policy yields substantial and durable health gains alongside meaningful cost offsets.

A proposed nicotine product standard is projected to improve maternal and infant outcomes and yield sizable pregnancy-related health gains and cost offsets. The SEP model complements prior tobacco policy evaluation frameworks while focusing on maternal and infant health. Competing Interest Statement The authors have declared no competing interest. Funding Statement Research reported in this publication was supported by the National Institute on Drug Abuse (K01DA056424). Dr. Tam and Dr. Skolnick are also supported by the National Cancer Institute (U01CA253858, U54CA229974). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Funding: Research reported in this publication was supported by the National Institute on Drug Abuse (K01DA056424). Dr. Tam and Dr. Skolnick are also supported by the National Cancer Institute (U01CA253858, U54CA229974). Disclaimer: The opinions expressed in this article are the authors’ own and do not reflect the views of the National Institutes of Health, the Department of Health and Human Services or the US government. Data Availability All data used in this study are publicly available online from the US Centers for Disease Control and Prevention (CDC) and the National Center for Health Statistics (NCHS). Specifically: adult tobacco use data from NHIS, BRFSS questionnaires for constructing smoking/vaping indicators, NVSS Natality Public Use documentation, and NSFG survey files and documentation. Direct access links: NHIS Adult Tobacco Use overview: https://archive.cdc.gov/www_cdc_gov/nchs/nhis/tobacco/tobacco_overview.htm BRFSS Questionnaires: https://www.cdc.gov/brfss/questionnaires/index.htm NVSS Natality Public Use File (User Guide 2023): https://ftp.cdc.gov/pub/health_statistics/nchs/dataset_documentation/DVS/natality/UserGuide2023.pdf NSFG Homepage: https://www.cdc.gov/nchs/nsfg/index.htm These resources are open-access and contain only deidentified public-use data. No special permissions or data-sharing agreements are required to obtain them. https://www.cdc.gov/nchs/nsfg/index.htm https://ftp.cdc.gov/pub/health_statistics/nchs/dataset_documentation/DVS/natality/UserGuide2023.pdf https://www.cdc.gov/brfss/questionnaires/index.htm https://archive.cdc.gov/www_cdc_gov/nchs/nhis/tobacco/tobacco_overview.htm