Eric Gotting Quoted in Law360 Article on 5th Circ. Telling FDA To ‘Rethink’ Rule

Keller and Heckman Partner Eric Gotting was quoted in the Law360 article, "5th Circ. Tells FDA To 'Rethink' Rule Behind E-Cig Rejection." The article reports that the Fifth Circuit vacated the U.S. Food and Drug Administration’s (FDA) denials of several flavored e-cigarette product applications, finding that the Agency’s use of a "comparative efficacy requirement" constituted a substantive rule that should have been adopted through the notice-and-comment process required under the Administrative Procedure Act. The court directed FDA to reconsider, properly adopt, or otherwise revisit the standard on remand.

Representing the vaping companies, Eric stated during oral arguments in April that FDA was not considering all available information, including its own youth survey data, which he said showed that minors were not using many of the products at issue. Following the ruling, Eric told Law360, "We are pleased with the Fifth Circuit's careful analysis and recognition that FDA cannot impose a binding, across-the-board [premarket tobacco product application] evidentiary standard without notice-and-comment rulemaking." He added, "This is an important decision for the [electronic nicotine delivery systems] industry, as well as adult smokers seeking lower risk alternatives to cigarettes."

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