Whether FDA's marketing denial order was arbitrary and capricious

QUESTION PRESENTED In 2016, FDA extended its jurisdiction over “tobacco products” under the Federal Food, Drug, and Cosmetic Act to electronic nicotine delivery systems (“ENDS”)— products that contain no tobacco themselves and are a less harmful alternative to combustible cigarettes. FDA’s decision required Petitioners to obtain marketing authorization from FDA to continue selling their products. Petitioners submitted premarket applications that followed closely the instructions for supporting evidence FDA provided in public meetings, a guidance document, and a proposed rule. Approximately one year later, FDA denied Petitioners’ applications for ENDS products based on a new, previously unannounced evidentiary standard requiring data from studies comparing the flavored products to tobacco-flavored ENDS products in terms of their efficacy at promoting adult smokers’ switching or cigarette reduction over time. Because Petitioners’ applications lacked this longitudinal comparative efficacy evidence, F'DA failed to consider the marketing and sales-access restrictions the agency had previously described as “critical” to its determination and rejected other evidence in Petitioners’ applications, including from certain studies FDA had previously recommended. The Fourth Circuit found FDA’s decision not arbitrary or capricious under the Administrative Procedure Act. The questions presented are: (1) Whether FDA’s marketing denial order was arbitrary and capricious because the agency failed to timely notify Petitioners of the new evidentiary standard before denying their applications. ia (2)Whether FDA ignored relevant factors and important aspects of the problem to Petitioners’ prejudice when the agency failed to consider or rejected evidence that FDA had previously instructed Petitioners to include.