Eric Gotting Quoted in Law360 Article on 5th Circuit Scrutinizing FDA Flavored Vape Denials

Keller and Heckman Partner Eric Gotting was quoted in the Law360 article, “5th Circ. Judge ‘Hung Up’ On FDA Vape Denial Reasoning.”

The Fifth Circuit heard challenges from flavored vape makers arguing that the U.S. Food and Drug Administration (FDA) effectively applied an unannounced comparative efficacy rule when repeatedly denying applications, prompting questions from Judge Andrew Oldham about whether the agency was engaging in case-by-case review.

Eric, representing the vape companies, told the judge that the agency’s review process was too narrow and did not account for all available information, including its own youth survey data that he said showed minors were not using most of these products.

Eric argued that every part of the application should be looked at and if some part is denied, it should be explained why.

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