E-cigarette companies’ court actions against the US FDA: key arguments and decisions

At least 41 companies have petitioned the courts for review of their Marketing Denial Orders (MDO). Many companies filed two types of proceedings with the courts: one to review their MDO and another petitioning a stay of their MDO while pending review.

This report tracks and analyses the challenges brought to court by vape companies against their MDO of their premarket tobacco product applications (PMTA).

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Table of contents

  1.  Executive summary
  2. Introduction
  3. Companies that have petitioned for review of their MDO
  4. The arguments
  5. Standard of review of the FDA – the “fatal flaw” approach
  6. Outcome – what are the judges deciding?

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