A panel of the Fifth Circuit Court of Appeals expressed skepticism Tuesday over the U.S. Food and Drug Administration’s assertion that it has not effectively banned flavored refillable e-cigarette products, suggesting that the agency’s near-total rejection rate may amount to a ban in practice.
During oral arguments, U.S. Circuit Judge Cory T. Wilson noted that the FDA has approved only six applications out of hundreds of thousands submitted by manufacturers seeking authorization to sell electronic nicotine delivery systems.
“If you’re effectively at 100% denial on a certain class of products, then it is a de facto ban,” Judge Wilson said.
The case was brought by VDX Distro Inc., which challenged the FDA’s refusal to authorize its menthol-flavored refillable e-cigarette products. The company argues that the agency has adopted an unwritten policy of rejecting refillable systems unless manufacturers prove the products are more effective than tobacco-flavored versions at helping adults quit smoking traditional cigarettes.
