After years of bruising court battles, the U.S. vaping industry has finally scored a major win against the U.S. Food & Drug Administration.
The Fifth Circuit ruled this week that FDA violated the Administrative Procedure Act when it imposed its comparative-efficacy standard without notice-and-comment rulemaking. FDA used that standard to issue more than one million marketing denial orders, producing what the court calls a “de facto ban” on nicotine-vape flavors other than tobacco.
In this breaking-news episode of RegWatch, Keller and Heckman attorney Eric P. Gotting, who represented NicQuid and argued the case, explains why the court vacated the MDOs and sent the applications back to FDA.
If the ruling sticks, could it dismantle FDA’s mass-denial system for flavored vapes and finally provide relief to the entire industry?
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