FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ. - Tobacco Reporter
The Fifth Circuit Court questioned the FDA's claim of not banning flavored vapes, suggesting its application rejections constitute a de facto ban.Summary
A Fifth Circuit panel expressed doubt regarding the FDA’s assertion that it hasn’t effectively banned flavored refillable e-cigarettes. Judges noted the FDA has approved only a tiny fraction of premarket tobacco product applications (PMTAs), leading Judge Wilson to state that a near-total denial rate equates to a “de facto ban.” The case originates from VDX Distro Inc., challenging the FDA’s rejection of its menthol-flavored vaping products. While the FDA argued some products *have* been approved, judges questioned whether any flavored e-cigarettes were authorized without demonstrating superior smoking cessation benefits compared to tobacco flavors. VDX’s counsel contends the FDA violated the Tobacco Control Act by implementing unannounced standards, effectively halting all open-system refillable devices. Industry groups, including R.J. Reynolds Vapor Co., supported this claim, arguing the FDA applies stricter standards to flavored vapes than other nicotine products. The court’s questioning signals increased scrutiny of FDA tobacco regulation, with potential consequences for future flavored vape product authorizations.
(Source：Tobacco Reporter)
