Abstract
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.
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