Eric Gotting Quoted in Nicotine Insider Article on FDA’s Vape Review Rule

Keller and Heckman Partner Eric Gotting was quoted in the Nicotine Insider article, “5th Circuit Deals Big Blow to FDA Vape Review Rule.” The article discusses the Fifth Circuit’s decision to vacate the U.S. Food and Drug Administration’s (FDA) marketing denial order for various vaping companies, ruling that the Agency’s comparative-efficacy standard is a substantive rule that should have been adopted through the notice-and-comment process required by the Administrative Procedure Act. 

Representing the vaping companies, Eric stated during oral arguments in April that FDA had gone beyond an individualized review process and effectively created a binding evidentiary requirement for flavored e-cigarette applications without formal rulemaking. The Fifth Circuit agreed, finding that FDA had used informal adjudication to establish a substantive rule affecting a broad class of applicants and had therefore violated the APA’s notice-and-comment requirements.

To read the full article, please click here.