Appeals Court Presses FDA on Flavored Vape Study Requirements

A federal appeals court weighed Tuesday whether the FDA lawfully denied marketing authorization for various flavored e-cigarettes, focusing on if the agency needed to undergo rulemaking when it demanded certain studies from manufacturers.

The US Court of Appeals for the Fifth Circuit drilled down on whether the Food and Drug Administration appropriately required e-cigarette manufacturers to submit “comparative efficacy” studies in their application demonstrating that their flavored products are more effective than other tobacco-flavored products in helping adult smokers switch away from cigarettes.

“Why is the comparative efficacy requirement not a tobacco product standard?” Judge Andrew Oldham asked the US ...