An End to Ends?: Rethinking the Adjudication and Regulation of Flavored Electronic Nicotine Delivery Systems in the United States

Authors

• Elizabeth Sack

Document Type

Note

Abstract

(Excerpt)

This Note will characterize the jurisdictional nuances underlying courts’ adjudication of flavored ENDS premarket tobacco product applications (“PMTAs”). Part I will detail how Congress has legislated and delegated standard tobacco and ENDS regulation to the FDA. Additionally, Part I will discuss the biochemical pathways and harm-reduction mechanisms currently associated with ENDS. Part II will review how circuit courts have handled ENDS manufacturers’ challenges to the FDA’s denials of their PMTAs. Part III will argue that the FDA must make efforts to streamline the guidance it provides ENDS manufacturers. It will recognize that the FDA’s priorities to encourage smoking prevention amongst youth diverge from the courts’ emphasis on fostering smoking cessation amongst adults. Consequently, this Note will find that the analysis employed by the Fourth and Tenth Circuits most wholly evaluated and contextualized the FDA’s overarching goals to facilitate judicial review of flavored ENDS PMTAs in light of ongoing debates in both public health and administrative law. As such, the FDA will likely continue to deny ENDS manufacturers’ applications if they fail to devise novel marketing strategies to keep their products away from children.

Finally, this Note will advocate that, going forward, the FDA should strive to provide the clearest, non-duplicative technical guidance regarding required elements of PMTA submissions to ENDS product manufacturers, distributors, and sellers.