FDA defends heightened review requirement for flavored vapes at Fifth Circuit

The FDA faces legal scrutiny at the Fifth Circuit over its requirement for flavored vape manufacturers to prove their products are more effective than tobacco-flavored vapes in helping smokers quit. Vape companies argue the FDA violated the Administrative Procedure Act by implementing the 'comparative efficacy standard' without proper notice and comment. Judge Edith Jones questioned the FDA's process, suggesting the standard was developed outside adjudication and should have undergone regulatory review.