Alexis R Miranda, Joanne G Patterson, Devin LaPolt, Ruva P Rumano, Alexa M Reynoso, Micah L Berman, Brittney L Keller-Hamilton, Megan E Roberts, Amy K Ferketich, Patricia J Zettler
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A Call for Regulatory Clarity: "Switch" and "Quit Smoking" Marketing among Online Disposable E-Cigarette Sellers.
FDA generally regulates products containing nicotine under its tobacco authorities, unless those products are intended for smoking cessation—in which case, they are regulated as drugs that must be FDA-approved as safe and effective. Accordingly, for e-cigarettes, questions arise about where the line is between a tobacco product intended merely for recreational use and a drug product intended for smoking cessation. Against this background, this Research Letter describes a content analysis of certain claims made by 28 online e-cigarette retailers and argues that our findings suggest a need for additional regulatory clarity about when e-cigarettes are appropriately regulated as smoking cessation drug-delivery devices rather than tobacco products.