Abstract
The enactment of the Family Smoking Prevention and Tobacco Control Act in 2009 gave the US Food and Drug Administration (FDA) authority to regulate tobacco products—specifically, cigarettes, smokeless tobacco, and roll-your-own tobacco products. That authority was extended to all products that contain tobacco-derived substances, including nicotine, in 2016, when the FDA’s “Deeming Rule” went into effect, capturing products such as e-cigarettes, cigars, and shisha within the FDA’s authority. This chapter focuses on the FDA regulation of e-cigarettes under the Deeming Rule, including the current pre-market authorization requirements that could result in an effective ban on e-cigarettes in the United States.
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Notes
- 1.
21 U.S.C § 387(20) (2017) defines “tobacco product manufacturer” as “any person, including any repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product or (B) imports a finished tobacco product for sale or distribution in the United States.” According to the FDA , establishments (i.e., vape shops) that mix and/or prepare combinations of e-liquids or create or modify aerosolizing apparatuses for direct sale to consumers for use in e-vapor devices (ENDS) are tobacco product manufacturers . Vape shops that are manufacturers are subject to all of the statutory and regulatory requirements that apply to manufacturers, including the requirements to register their establishments, list their products, and obtain pre-market authorization.
- 2.
Depending on the activities a vape shop engages in, it can be a tobacco product retailer, a tobacco product manufacturer, or both. Retailers and manufacturers are subject to inspection by the FDA. A vape shop is a retailer if it sells tobacco products, including e-vapor devices and e-liquids, to individuals for personal consumption . This includes retailers who sell tobacco products in brick-and-mortar establishments or through the Internet. For a summary of requirements that apply to vape shops, see the FDA’s webinar The “Deeming Rule”: Vape Shops (FDA 2016a, b, c).
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Chowdhury, A. (2017). Regulation of E-Cigarettes in the United States. In: Savona, E., Kleiman, M., Calderoni, F. (eds) Dual Markets. Springer, Cham. https://doi.org/10.1007/978-3-319-65361-7_18
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