Federal Circuit Court Rules FDA Overstepped Authority by Denying E-Cigarette Marketing Applications
On Aug. 19, 2026, a three-judge panel at the Fifth ruled that the U.S. Food and Drug Administration (FDA) overstepped its authority when the agency repeatedly blocked approval of flavored e-cigarette products without a notice-and-comment period for its review standard, holding that the repeated denials constituted a rule that the agency must “rethink” or readopt the regulation properly.
The ruling vacates the FDA’s denials of various e-cigarette product applications, citing FDA’s “comparative-efficacy standard” as a new substantive standard that required notice-and-comment rulemaking under the Administrative Procedure Act (APA). According to the judges, this new standard then required FDA to deny any Premarket Tobacco Product Application (PMTA) that lacked a study showing that the product’s benefits to adult smokers outweighed risks for youth. Read more
here.