Why We Need User Fees for Electronic Nicotine Delivery System Products

Abstract

Although first patented in 1965, electronic cigarettes did not enter significant domestic use until circa 2010. Subsequently, adult use of electronic nicotine delivery system (ENDS) products, including electronic cigarettes and vaporizers, has grown, with an estimated 2.8% of adults engaged in daily use. 1 The launch of flavored ENDS corresponded with a rise in adolescent use, triggering increased skepticism in the public health community and congressional oversight. It is within this environment that the US Food and Drug Administration (FDA) has struggled to regulate the ENDS product marketplace within the confines of its statutory authority and strike a balance between limiting new users while offering current smokers the benefits of reduced-risk products, deploying ENDS products as a harm-reduction product. 2 In this Viewpoint, we review recent challenges in ENDS product regulation, the history of FDA user fees in other product markets, and the potential benefit of modeling ENDS product user fees after pharmaceutical product and device user fees. Recent Tobacco Regulatory ChallengesDespite being available for domestic purchase for more than a decade, the first ENDS device did not receive marketing authorization from the FDA's Center for Tobacco Products (CTP) until October 2021, when CTP authorized RJ Reynolds' Vuse product after nearly 2 years of review. Shortly thereafter-and after 3 years of review-CTP granted marketing authorization to 4 oral smokeless tobacco products, with critics noting that sales ceased 2 years prior. Moreover, CTP failed to meet a court-ordered deadline of September 9, 2021, to complete review of more than 6 million previously submitted ENDS premarket tobacco product applications, 3 inclusive of a decision on Juul's products, the leading seller in the ENDS market. These regulatory challenges have not occurred in a vacuum. Product sales for ENDS accelerated in conjunction with increased past 30-day use by high schoolers from 2.8% in 2012 4 to 13.3% in 2018, 5 coinciding with decreasing combustible cigarette use. Domestically, combustible tobacco use accounts for more annual mortality than 2020 COVID-19 deaths through its contribution to 3 of the 4 leading causes of death: heart disease, cancer, and chronic obstructive pulmonary disease. Thus, cessation and harm reduction remain a continued concern for 34 million cigarette smokers in the US.In this setting, ENDS products, while controversial, may-if regulated appropriately-represent another form of consumer-driven harm reduction 6 or even cessation for adult smokers. 7 Thus, it is no surprise that public health advocates and industry alike find themselves increasingly frustrated by the status quo, with the FDA's lack of timeliness and transparency around regulatory decisions that affect the public health and ambiguous product standards required for market entry impeding access to appropriately regulated reduced-risk products. The History of FDA User FeesUser fees were born in the early 1990s in an environment where lengthy review times,...