Background The US Food and Drug Administration (FDA) requires a warning label on nicotine e-cigarettes and pouches: ‘This product contains nicotine. Nicotine is an addictive chemical’. Some brands marketing synthetic nicotine products have modified the warning (‘This product contains tobacco-free nicotine (TFN)…’). The public health impact of altering the warning is unknown, so we examined its impact on risk perceptions and use intentions.
Methods 1000 participants completed an anonymous online survey. Participants viewed the black-and-white FDA and TFN-modified warning labels in isolation, in a randomised order and reported on perceived addictiveness and, secondarily, use intentions. Participants then selected which label conveyed the most harm overall. Generalised estimating equations (GEEs) were used to evaluate the impact of label type and participant characteristics on perceived addictiveness and, secondarily, use intentions. Multivariable logistic regression was used to evaluate relationships between participant characteristics and choosing which label conveyed the most harm.
Results Overall, the TFN-modified label was associated with lower addictiveness ratings but not increased use intentions. Where significant interactions between label type and participant characteristics emerged, TFN-modified labelling was associated with disproportionately reduced risk perceptions or increased use intentions among vulnerable populations (eg, underage individuals, racially minoritised groups). 25.5% of participants selected the TFN-modified label as conveying the most harm, with younger individuals (<21 years) significantly less likely to choose the TFN-modified label.
Conclusions Modifying the FDA-mandated nicotine warning label to include ‘tobacco-free nicotine’ may negatively impact public health, so the FDA should enforce inclusion of its original required warning label.
- Packaging and Labelling
- Electronic nicotine delivery devices
- Non-cigarette tobacco products
Data availability statement
Data are available upon reasonable request. Data will be made available upon reasonable request to Meghan.Morean@yale.edu.
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Contributors MEM acquired funding for this rapid response project (funded by the Yale Tobacco Center of Regulatory Science (TCORS)); led project conceptualisation, investigation, data curation and project administration; as is the project guarantor. MEM also drafted the original manuscript and contributed to formal data analysis. RG led formal data analysis; she conducted the power analysis, designed the analytic plan involving generalised estimating equations and supervised MEM on formal data analysis and interpretation. SS and SK-S acquired funding for the Yale Tobacco Center of Regulatory Science (TCORS) and contributed to project conceptualisation and manuscript review and editing.
Funding Research reported in this publication was supported by grant number U54DA036151 from the National Institute on Drug Abuse (NIDA) and FDA Center for Tobacco Products (CTP).
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.
Competing interests No, there are no competing interests.
Provenance and peer review Not commissioned; externally peer reviewed.
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