by Aster O’Leary*
In response to what has been dubbed a “youth vaping epidemic,” the Food and Drug Administration (“FDA”) has recently cracked down on non-tobacco-flavored Electronic Nicotine Delivery Systems (“ENDS”), which middle and high school students prefer over tobacco-flavored ENDS products. Recognizing that the ENDS industry is relatively new and constantly evolving, the FDA declined to mandate the inclusion of certain types of scientific studies in its guidance to the industry. However, many flavored ENDS manufacturers feel that the FDA pulled a “surprise switcheroo” when denying many of their Premarket Tobacco Product Applications (“PMTA”).1 In the denials, the FDA explained that the applications lacked long-term studies and/or controlled investigations that demonstrated that the flavored products were “appropriate for the protection of the public health.”2 Additionally, the manufacturers complained that for many of their applications, the FDA refused to consult their marketing plans, which the FDA had previously emphasized were of tantamount importance. This Contribution argues that the FDA did not violate the Administrative Procedure Act (“APA”) by modifying its approach to PMTA review. It first demonstrates denying PMTAs because they lacked long-term studies is permitted under the FDA’s flexible approach to weighing ENDS’ risks and benefits to society as a whole. It then argues that the FDA’s refusal to consult manufacturers’ marketing plans, while arbitrary and capricious, is in most cases harmless error. It concludes by questioning whether the FDA should be tasked with regulating an inherently harmful category of products in the first place.