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 non-tobacco-flavored
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, FDA 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.

(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.

(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.

Whether FDA's marketing denial order was arbitrary and capricious