Decisions of the FDA on premarket tobacco product applications: Changes in the number of unique devices and liquids used by US adults who frequently use electronic nicotine delivery systems, 2020–2023

Abstract

INTRODUCTION The majority of decisions on electronic nicotine delivery system (ENDS) premarket tobacco product applications (PMTAs) were made from October 2020 to February 2023; 99% (>25 million) had determinations by March 2023 and just twenty-three received marketing granted orders. We examined the unique devices and liquids used among US adults frequently using ENDS before, during, and after a majority of PMTA decisions were made. METHODS Data are from waves 1-5 (W1: May–Oct 2020, n=1179; W5: Feb–Apr 2023, n=1290) of a longitudinal survey of US adults (≥21 years) using ENDS ≥5 days/week. User-submitted photos of participants’ most used devices and liquids were coded. Descriptive analyses and Wilcoxon signed-rank tests were used to understand the number and types of unique devices and liquids used in W1-W5, and the top brands in each wave. RESULTS From W1-W5, the number of unique ENDS device models and liquid products used by participants increased from 279 to 357 (p<0.001) and 546 to 695 (p<0.001), respectively. More unique devices in W5 versus W1 were disposable (W1: 16.5%; W5: 36.1%); fewer were disposable pod (W1: 6.5%; W5: 3.1%) or tank (W1: 53.8%; W5: 30.8%) devices. Liquids were primarily sweet-flavored (W1: 81.1%; W5: 82.0%). The median liquid nicotine concentration increased from 12 to 50 mg/mL. In W5, few participants used FDA-approved devices (n=17; 1.3%) or liquids (n=6; 0.5%), and Elf Bar was the most commonly used device and liquid brand. Results for all waves are reported. CONCLUSIONS Despite PMTA decisions, an increase in the number of unique device models and liquid products used among adults who frequently use ENDS was observed from 2020 to 2023. Few participants in 2023 were using FDA-approved devices or liquids. Further research and monitoring are needed to inform how FDA prioritizes enforcement actions and what types of enforcement actions are effective.